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ISO 10993-1:2009

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

View Superseded by
withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Withdrawn date

05-03-2019

Published date

13-10-2009

ISO 10993-1:2009 describes:

  • the general principles governing the biological evaluation of medical devices within a risk management process;
  • the general categorization of devices based on the nature and duration of their contact with the body;
  • the evaluation of existing relevant data from all sources;
  • the identification of gaps in the available data set on the basis of a risk analysis;
  • the identification of additional data sets necessary to analyse the biological safety of the medical device;
  • the assessment of the biological safety of the medical device.

DocumentType
Standard
Pages
22
PublisherName
International Organization for Standardization
Status
Withdrawn
SupersededBy
Supersedes

I.S. EN ISO 4049:2009 DENTISTRY - POLYMER-BASED RESTORATIVE MATERIALS
ONORM EN ISO 10993-11 : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY
DIN EN ISO 12417-1 E : 2016 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
DIN EN ISO 25424:2011-09 STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
13/30271558 DC : 0 BS EN ISO 15841 - DENTISTRY - WIRES FOR USE IN ORTHODONTICS
ASTM F 2224 : 2009 : R2014 Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
99/562423 DC : DRAFT APR 99 BS:ENISO 14937 - STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL CRITERIA FOR CHARACTERIZATION OF A STERILIZING AGENT AND DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS
03/108761 DC : DRAFT MAY 2003 EN ISO 10477 - DENTISTRY - POLYMER-BASED CROWN AND BRIDGE MATERIALS
UNE-EN ISO 25539-2:2013 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)
DIN EN ISO 11135-1:2007-08 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
CSA ISO 10993-10 : 0 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SENSITIZATION
CSA Z23747 : 2008 : R2013 ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS
13/30263420 DC : 0 BS EN ISO 17730 - DENTISTRY - FLUORIDE VARNISHES
BS ISO 16840-2:2018 Wheelchair seating Determination of physical and mechanical characteristics of seat cushions intended to manage tissue integrity
ISO 14708-7:2013 Implants for surgery Active implantable medical devices Part 7: Particular requirements for cochlear implant systems
AAMI RD17 : 2007 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS AND HEMOFILTERS
I.S. EN ISO 5840:2009 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES
I.S. EN ISO 5364:2016 ANAESTHETIC AND RESPIRATORY EQUIPMENT - OROPHARYNGEAL AIRWAYS (ISO 5364:2016)
01/562154 DC : DRAFT JUNE 2001 BS EN ISO 10993-12 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS
12/30228200 DC : 0 BS ISO 8600-1 - ENDOSCOPES - MEDICAL ENDOSCOPES AND ENDOTHERAPY DEVICES - PART 1: GENERAL REQUIREMENTS
I.S. EN 12180:2000 NON-ACTIVE SURGICAL IMPLANTS - BODY CONTOURING IMPLANTS - SPECIFIC REQUIREMENTS FOR MAMMARY IMPLANTS
10/30212297 DC : 0 BS ISO 11040-6 - PREFILLED SYRINGES - PART 6: PLASTIC BARRELS FOR INJECTABLES
CSA ISO 5361 : 2014 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS
DD ISO/TS 10993-20:2006 Biological evaluation of medical devices Principles and methods for immunotoxicology testing of medical devices
ANSI/AAMI/ISO 10993-3:2014 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY, AND REPRODUCTIVE TOXICITY
BS ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications Evaluation and testing within a risk management process
DIN EN ISO 20795-2:2013-06 DENTISTRY - BASE POLYMERS - PART 2: ORTHODONTIC BASE POLYMERS (ISO 20795-2:2013)
I.S. EN 15424:2007 STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
07/30160957 DC : 0 EN ISO 10993-5 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY
16/30333382 DC : 0 BS EN ISO 22112 - DENTISTRY - ARTIFICIAL TEETH FOR DENTAL PROSTHESES
BS EN ISO 1135-5:2015 Transfusion equipment for medical use Transfusion sets for single use with pressure infusion apparatus
I.S. EN ISO 22523:2006 EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS
DIN EN 868-10:2009-09 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 10: ADHESIVE COATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
13/30276989 DC : 0 BS EN ISO 11070 - STERILE, SINGLE-USE INTRAVASCULAR CATHETER INTRODUCERS
BS EN ISO 5840-2:2015 Cardiovascular implants. Cardiac valve prostheses Surgically implanted heart valve substitutes
PD ISO/TS 17665-3:2013 Sterilization of health care products. Moist heat Guidance on the designation of a medical device to a product family and processing category for steam sterilization
ISO/TS 20993:2006 Biological evaluation of medical devices Guidance on a risk-management process
I.S. EN 13824:2005 STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS
I.S. EN ISO 11137-1:2015 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11137-1:2006, INCLUDING AMD 1:2013)
I.S. EN 12022:1999 BLOOD GAS EXCHANGERS
I.S. EN ISO 16744:2004 DENTISTRY - BASE METAL MATERIALS FOR FIXED DENTAL RESTORATIONS
04/30103836 DC : DRAFT JUL 2004 ISO 11979-5 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY
16/30331650 DC : 0 BS EN ISO 8637-1 - EXTRACORPOREAL SYSTEMS FOR BLOOD PURIFICATION - PART 1: HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
I.S. EN 13503-8:2000 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS
I.S. EN ISO 1135-5:2015 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 1135-5:2015)
17/30302767 DC : 0 BS ISO 13779-2 - IMPLANTS FOR SURGERY - HYDROXYAPATITE - PART 2: THERMALLY SPRAYED COATINGS OF HYDROXYAPATITE
I.S. EN ISO 10555-1:2013 INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS (ISO 10555-1:2013/AMD 1:2017)
DIN EN ISO 13017:2016-05 DENTISTRY - MAGNETIC ATTACHMENTS (ISO 13017:2012 + AMD.1:2015)
AAMI ISO 10993-11 : 2006 : R2014 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY
UNI EN ISO 10271 : 2011 DENTISTRY - CORROSION TEST METHODS FOR METALLIC MATERIALS
BS ISO 18562-4:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications Tests for leachables in condensate
CSA Z10535.1 : 2015 HOISTS FOR THE TRANSFER OF DISABLED PERSONS - REQUIREMENTS AND TEST METHODS
04/300654 DC : DRAFT JAN 2004 BS EN ISO 14630 - NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
14/30295067 DC : 0 BS EN ISO 16671 - OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY
02/564514 DC : DRAFT OCT 2002 BS EN ISO 8536-4 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED
DIN EN ISO 7197:2009-08 NEUROSURGICAL IMPLANTS - STERILE, SINGLE-USE HYDROCEPHALUS SHUNTS AND COMPONENTS
16/30339666 DC : 0 BS EN ISO 11609 - DENTISTRY - DENTIFRICES - REQUIREMENTS, TEST METHODS AND MARKING
05/30138123 DC : DRAFT AUG 2005 BS ISO 8836 - SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
03/100426 DC : DRAFT JAN 2003 BS EN ISO 10993-18 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
00/561676 DC : DRAFT APRIL 2000 DRAFT BS EN ISO 10993-3 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY
08/30187781 DC : DRAFT AUG 2008 BS EN ISO 10993-16 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES
BS ISO 13175-3:2012 Implants for surgery. Calcium phosphates Hydroxyapatite and beta-tricalcium phosphate bone substitutes
ISO 10993-11:2017 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
17/30332162 DC : 0 BS EN ISO 7494-1 - DENTISTRY - STATIONARY DENTAL UNITS AND DENTAL PATIENT CHAIRS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS
ISO 13179-1:2014 Implants for surgery Plasma-sprayed unalloyed titanium coatings on metallic surgical implants Part 1: General requirements
04/30081258 DC : DRAFT MARCH 2004 BS EN ISO 11737-1 - STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1 - DETERMINATION OF A POPULATION OF MICRO ORGANISMS ON PRODUCTS
I.S. EN ISO 10555-6:2017 INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 6: SUBCUTANEOUS IMPLANTED PORTS (ISO 10555-6:2015)
11/30212473 DC : 0 BS EN ISO 10993-3 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY
DIN EN ISO 8638:2014-03 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS (ISO 8638:2010)
14/30297754 DC : 0 BS EN ISO 16408 - DENTISTRY - ORAL HYGIENE PRODUCTS - ORAL RINSES
BS ISO 18666:2015 Traditional Chinese medicine. General requirements of moxibustion devices
17/30357486 DC : 0 BS EN ISO 15747 - PLASTIC CONTAINERS FOR INTRAVENOUS INJECTIONS
BS ISO 11040-3:2012 Prefilled syringes Seals for dental local anaesthetic cartridges
BS EN ISO 16671 : 2015 OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY
15/30278540 DC : 0 BS ISO 18562-4 - BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 4: TESTS FOR LEACHABLES IN CONDENSATE
15/30314608 DC : 0 BS EN ISO 7153-1 - SURGICAL INSTRUMENTS - MATERIALS - PART 1: METALS
10/30205392 DC : 0 BS ISO 7494-1 - DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS
16/30282706 DC : 0 BS ISO 11608-6 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 6: ON-BODY DELIVERY SYSTEMS
BS EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
BS EN ISO 13688:2013 Protective clothing. General requirements
PREN ISO 24234 : DRAFT 2013 DENTISTRY - DENTAL AMALGAM (ISO/DIS 24234:2013)
17/30351717 DC : 0 BS EN ISO 11607-1 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
12/30266398 DC : 0 BS EN ISO 20795-2 - DENTISTRY - BASE POLYMERS - PART 2: ORTHODONTIC BASE POLYMERS
DIN EN ISO 8638 E : 2014 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS (ISO 8638:2010)
ANSI/AAMI/ISO 25539-2:2012 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS
12/30266392 DC : 0 BS EN ISO 20795-1 - DENTISTRY - BASE POLYMERS - PART 1: DENTURE BASE POLYMERS
03/103025 DC : DRAFT JAN 2003 BS EN ISO 11199-2 - WALKING AIDS MANIPULATED BY BOTH ARMS - REQUIREMENTS AND TEST METHODS - PART 2: ROLLATORS
AAMI ISO 17665-1 : 2006 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
CSA Z11135-1 :2009 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
02/565247 DC : DRAFT DEC 2002 ISO 8637 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
BS ISO 14972:1998 Sterile obturators for single use with over-needle peripheral intravascular catheters
CSA ISO 10993-4 : 1997 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD
CSA ISO 8637 : 2012 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
08/30133979 DC : DRAFT MAY 2008 BS ISO 23409 - MALE CONDOMS - REQUIREMENTS AND TEST METHODS FOR CONDOMS MADE FROM SYNTHETIC MATERIALS
ASTM F 2560 : 2006 Standard Specification for Supralaryngeal Airways and Connectors
CSA ISO 14937 : 2011 STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
CSA ISO 8637 : 2012 : R2017 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
I.S. EN ISO 14607:2009 NON-ACTIVE SURGICAL IMPLANTS - MAMMARY IMPLANTS - PARTICULAR REQUIREMENTS (ISO 14607:2018)
DIN EN ISO 21563:2013-12 Dentistry - Hydrocolloid impression materials (ISO 21563:2013)
ISO 23409:2011 Male condoms Requirements and test methods for condoms made from synthetic materials
CSA ISO 14971 : 2007 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
DIN EN ISO 3630-5:2012-01 DENTISTRY - ENDODONTIC INSTRUMENTS - PART 5: SHAPING AND CLEANING INSTRUMENTS (ISO 3630-5:2011)
CSA Z17665-1:09 (R2019) Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (Adopted ISO 17665-1:2006, first edition, 2006-08-15, with Canadian deviations)
AAMI ISO 11607-1 : 2006 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS
ONORM EN ISO 5840-3 : 2013 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES (ISO 5840-3:2013)
ISO 5910:2018 Cardiovascular implants and extracorporeal systems Cardiac valve repair devices
DIN EN ISO 7199:2015-06 (Draft) CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016)
ISO 19227:2018 Implants for surgery — Cleanliness of orthopedic implants — General requirements
BS EN ISO 10993-16:2017 Biological evaluation of medical devices Toxicokinetic study design for degradation products and leachables
CSA Z314.14 : 2015 SELECTION AND USE OF PACKAGING (STERILE BARRIER SYSTEMS) IN HEALTHCARE SETTINGS
ANSI/AAMI/ISO 5840-3:2013 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES
ISO 4049:2009 Dentistry Polymer-based restorative materials
CSA ISO 7199 : 0 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS)
ISO 18397:2016 Dentistry Powered scaler
S.R. CEN ISO/TS 16775:2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 (ISO/TS 16775:2014)
CAN/CSA-ISO/TS 16775:17 Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 (Adopted ISO technical specification 16775:2014, first edition, 2014-05-15)
ANSI/AAMI/ISO 10993-14:2001(R2011) BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 14: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM CERAMICS
DIN EN ISO 14607:2009-08 NON-ACTIVE SURGICAL IMPLANTS - MAMMARY IMPLANTS - PARTICULAR REQUIREMENTS
ANSI/AAMI/ISO 15674:2016 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HARD-SHELL CARDIOTOMY/VENOUS RESERVOIR SYSTEMS (WITH/WITHOUT FILTER) AND SOFT VENOUS RESERVOIR BAGS
AAMI ISO 10993-2 : 2006 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 2: ANIMAL WELFARE REQUIREMENTS
AAMI ISO 10993-5 : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY
AAMI AT6 : 2013 AUTOLOGOUS TRANSFUSION DEVICES
AAMI ISO 10993-17 : 2002 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 17: ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES
ISO/TR 15499:2016 Biological evaluation of medical devices Guidance on the conduct of biological evaluation within a risk management process
CSA Z17665-1 : 2009 : FR STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
UNE-EN ISO 22442-1:2016 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
ASTM F 2848 : 2017 : REDLINE Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns
ONORM EN ISO 14607 : 2009 NON-ACTIVE SURGICAL IMPLANTS - MAMMARY IMPLANTS - PARTICULAR REQUIREMENTS
I.S. EN ISO 10993-11:2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY (ISO 10993-11:2006)
UNE-EN ISO 1135-3:2017 Transfusion equipment for medical use - Part 3: Blood-taking sets for single use (ISO 1135-3:2016)
UNI EN ISO 28319 : 2010 DENTISTRY - LASER WELDING
I.S. EN ISO 10993-16:2017 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES (ISO 10993-16:2010)
DIN EN 868-10 E : 2009 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 10: ADHESIVE COATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
ASTM F 623 : 1999 : R2006 Standard Performance Specification for Foley Catheter
AAMI ISO 11137-1:2006 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
17/30358661 DC : 0 BS EN 13795-2 - SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 2: CLEAN AIR SUITS
17/30360912 DC : 0 BS EN 868-10 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 10: ADHESIVE COATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
UNE-EN ISO 11607-1:2017 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006, including Amd 1:2014)
CSA ISO 10993-7 : 1998 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
UNI EN 14683 : 2014 MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
ISO 14607:2007 Non-active surgical implants Mammary implants Particular requirements
CSA Z364.1.1-Z364.1.2 : 0 HAEMODIALYZERS, HAEMOFILTERS, AND HAEMOCONCENTRATORS/EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYZERS, HAEMOFILTERS, AND HAEMOCONCENTRATORS
DIN EN ISO 11070:2015-03 STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES (ISO 11070:2014)
ISO 7405:2008 Dentistry Evaluation of biocompatibility of medical devices used in dentistry
ISO 11070:2014 Sterile single-use intravascular introducers, dilators and guidewires
ASTM F 3089 : 2014 Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions
ISO 5832-14:2007 Implants for surgery Metallic materials Part 14: Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy
ISO 15676:2016 Cardiovascular implants and artificial organs — Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
PD ISO/TS 17137:2014 Cardiovascular implants and extracorporeal systems. Cardiovascular absorbable implants
ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
ASTM F 2027 : 2016 : REDLINE Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
I.S. EN ISO 3826-1:2013 PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS (ISO 3826-1:2013)
EN ISO 8536-4:2013/A1:2013 INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 8536-4:2010/AMD 1:2013)
DIN EN ISO 11979-5:2010-11 Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006)
DIN EN ISO 11499:2014-09 DENTISTRY - SINGLE-USE CARTRIDGES FOR LOCAL ANAESTHETICS (ISO 11499:2014)
DIN EN ISO 22442-1:2016-05 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
DIN EN ISO 10993-17 E : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 17: ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES
DIN EN ISO 10993-10 E : 2003 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010)
DIN EN ISO 10993-11 E : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY
DIN EN ISO 10993-15 E : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS
UNE-EN ISO 24234:2015 Dentistry - Dental amalgam (ISO 24234:2015)
DIN EN ISO 10993-13 E : 2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES
DIN EN ISO 7376:2010-01 ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION
DIN EN 1642:2012-06 Dentistry - Medical devices for dentistry - Dental implants
DIN EN ISO 10993-12 E : 2012 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS (ISO 10993-12:2012)
EN ISO 10993-9:2009 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
DIN EN ISO 11609:2016-07 (Draft) DENTISTRY - DENTIFRICES - REQUIREMENTS, TEST METHODS AND MARKING (ISO 11609:2017)
BS EN ISO 6871-1:1997 Dental base metal casting alloys Cobalt-based alloys
UNE-EN ISO 16408:2016 Dentistry - Oral care products - Oral rinses (ISO 16408:2015)
BS EN 1782 : 1998 TRACHEAL TUBES AND CONNECTORS
BS EN ISO 10139-2:2009 Dentistry. Soft lining materials for removable dentures Materials for long-term use
BS EN 867-5:2001 Non-biological systems for use in sterilizers Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S
BS EN ISO 1561:1998 Dental casting wax
BS EN ISO 10993-12:2012 Biological evaluation of medical devices Sample preparation and reference materials
ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
BS EN ISO 11499:2014 Dentistry. Single-use cartridges for local anaesthetics
ISO 81060-1:2007 Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type
ISO 8637:2010 Cardiovascular implants and extracorporeal systems Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
UNE-EN ISO 11608-1:2015 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014)
BS EN ISO 22803:2005 Dentistry. Membrane materials for guided tissue regeneration in oral and maxillofacial surgery. Contents of a technical file
BS EN ISO 7885:2010 Dentistry. Sterile injection needles for single use
BS EN ISO 10271:2011 Dentistry. Corrosion test methods for metallic materials
BS EN ISO 7153-1:2016 Surgical instruments. Materials Metals
ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
BS EN 455-3:2015 Medical gloves for single use Requirements and testing for biological evaluation
ISO 8638:2010 Cardiovascular implants and extracorporeal systems Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
UNE-EN ISO 10993-6:2017 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
BS EN ISO 22523:2006 External limb prostheses and external orthoses. Requirements and test methods
BS EN ISO 14534:2015 Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements
BS EN 15424:2007 Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
BS EN ISO 9394:2012 Ophthalmic optics. Contact lenses and contact lens care products. Determination of biocompatibility by ocular study with rabbit eyes
BS EN ISO 14160:2011 Sterilization of health care products. Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives. Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
ISO 9394:2012 Ophthalmic optics — Contact lenses and contact lens care products — Determination of biocompatibility by ocular study with rabbit eyes
BS EN 12342 : 1998 BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
BS EN ISO 7376 : 2009-08 ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION
UNE-EN ISO 16672:2016 Ophthalmic implants - Ocular endotamponades (ISO 16672:2015)
BS EN ISO 14630:2012 Non-active surgical implants. General requirements
BS EN ISO 10993-3:2014 Biological evaluation of medical devices Tests for genotoxicity, carcinogenicity and reproductive toxicity
BS EN 13824:2004 Sterilization of medical devices. Aseptic processing of liquid medical devices. Requirements
BS EN ISO 6876:2012 Dentistry. Root canal sealing materials
DIN EN 12342:1998-09 BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
I.S. EN ISO 11608-1:2015 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS (ISO 11608-1:2014)
DIN EN 12342:2010-01 BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
I.S. EN ISO 10535:2006 HOISTS FOR THE TRANSFER OF DISABLED PERSONS - REQUIREMENTS AND TEST METHODS
DIN EN 12470-3:2000-04 CLINICAL THERMOMETERS - PART 3: PERFORMANCE OF COMPACT ELECTRICAL THERMOMETERS (NON-PREDICTIVE AND PREDICTIVE) WITH MAXIMUM DEVICE
EN 12011 : 1998 INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
EN 1282-2:2005+A1:2009 Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)
EN 13503-8 : 2000 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS
EN ISO 5364:2016 Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2016)
EN 12182:2012 Assistive products for persons with disability - General requirements and test methods
EN 12181 : 1998 OROPHARYNGEAL AIRWAYS
EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
EN 12022 : 1999 BLOOD GAS EXCHANGERS
DIN EN ISO 21649:2010-01 Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006)
EN ISO 22523 : 2006 EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS (ISO 22523:2006)
DIN EN 15424:2007-08 STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
EN ISO 9693 : 2000 METAL-CERAMIC DENTAL RESTORATIVE SYSTEMS
EN 12470-3:2000+A1:2009 Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device
UNI EN ISO 14160 : 2011 STERILIZATION OF HEALTH CARE PRODUCTS - LIQUID CHEMICAL STERILIZING AGENTS FOR SINGLE-USE MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - REQUIREMENTS FOR CHARACTERIZATION, DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
EN 12180 : 2000 NON-ACTIVE SURGICAL IMPLANTS - BODY CONTOURING IMPLANTS - SPECIFIC REQUIREMENTS FOR MAMMARY IMPLANTS
CEN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2014)
EN ISO 5366-1:2009 Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000)
EN 12470-2:2000+A1:2009 Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers
NF EN ISO 10993-18 : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
UNI EN ISO 10993-12 : 2012 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS
ONORM EN ISO 10993-2 : 2006 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 2: ANIMAL WELFARE REQUIREMENTS
NF EN ISO 10993-10 : 2013 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION
VDI 5700 Blatt 1:2015-04 Reprocessing hazards - Risk management in reprocessing of medical devices - Measures for risk control
ONORM EN ISO 7439 : 2015 COPPER-BEARING CONTRACEPTIVE INTRAUTERINE DEVICES - REQUIREMENTS AND TESTS (ISO 7439:2015)
ONORM EN ISO 9333 : 2006 DENTISTRY - BRAZING MATERIALS
ONORM EN ISO 11608-1 : 2015 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS (ISO 11608-1:2014)
ONORM EN ISO 11608-3 : 2012 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 3: FINISHED CONTAINERS (ISO 11608-3:2012)
ANSI Z80.27 : 2014 OPHTHALMICS - IMPLANTABLE GLAUCOMA DEVICES
EN ISO 6872:2015/A1:2018 DENTISTRY - CERAMIC MATERIALS (ISO 6872:2015/AMD 1:2018)
DIN EN ISO 28399:2011-05 DENTISTRY - PRODUCTS FOR EXTERNAL TOOTH BLEACHING
ONORM EN ISO 11979-5 : 2010 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY
DIN EN ISO 3826-4:2015-12 PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHAERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015)
UNI EN ISO 26782 : 2009 ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE MEASUREMENT OF TIME FORCED EXPIRED VOLUMES IN HUMANS
ISO 13960:2010 Cardiovascular implants and extracorporeal systems Plasmafilters
06/30160058 DC : 0 BS EN ISO 8536-4 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED
15/30275224 DC : 0 BS ISO 18242 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CENTRIFUGAL BLOOD PUMPS
BS ISO 17966:2016 Assistive products for personal hygiene that support users. Requirements and test methods
EN ISO 7494-1:2011 Dentistry - Dental units - Part 1: General requirements and test methods (ISO 7494-1:2011)
BS EN ISO 20072:2013 Aerosol drug delivery device design verification. Requirements and test methods
13/30283691 DC : 0 BS EN ISO 1135-4 - TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED
UNE-EN ISO 17730:2015 Dentistry - Fluoride varnishes (ISO 17730:2014)
AAMI ISO 81060-1 : 2007 NON INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE
ISO 11199-2:2005 Walking aids manipulated by both arms Requirements and test methods Part 2: Rollators
17/30345938 DC : 0 BS ISO 20698 - CATHETER SYSTEMS FOR NEURAXIAL APPLICATION - STERILE AND SINGLE-USE CATHETERS AND ACCESSORIES
I.S. EN ISO 21563:2013 DENTISTRY - HYDROCOLLOID IMPRESSION MATERIALS (ISO 21563:2013)
UNE-EN ISO 16061:2015 Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
07/30169357 DC : 0 BS ISO 25841 - FEMALE CONDOMS - REQUIREMENTS AND TEST METHODS
10/30214551 DC : 0 BS ISO 20126 - DENTISTRY - MANUAL TOOTHBRUSHES - GENERAL REQUIREMENTS AND TEST METHODS
ASTM F 2224 : 2009 Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
UNI EN 868-10 : 2009 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 10: ADHESIVE COATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
BS EN ISO 8836:2014 Suction catheters for use in the respiratory tract
I.S. EN ISO 17665-1:2006 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
BS ISO 8600-1:2015 Endoscopes. Medical endoscopes and endotherapy devices General requirements
I.S. EN ISO 1567:2000 DENTISTRY - DENTURE BASE POLYMERS
BS ISO 5832-14:2007 Implants for surgery. Metallic materials Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy
09/30168902 DC : DRAFT JAN 2009 BS ISO 27020 - DENTISTRY - BRACKETS AND TUBES FOR USE IN ORTHODONTICS
AAMI/ISO TIR15499:2017 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE ON THE CONDUCT OF BIOLOGICAL EVALUATION WITHIN A RISK MANAGEMENT PROCESS
15/30310645 DC : 0 BS EN ISO 8536-14 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 14: CLAMPS AND FLOW REGULATORS FOR TRANSFUSION AND INFUSION EQUIPMENT WITHOUT FLUID CONTACT
UNE-EN ISO 13504:2013 Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment (ISO 13504:2012)
04/30085448 DC : DRAFT MARCH 2004 ISO 15854 - DENTISTRY - CASTING AND BASEPLATE WAXES
16/30346829 DC : 0 BS ISO 16038 - MALE CONDOMS - GUIDANCE ON THE USE OF ISO 4074 AND ISO 23409 IN THE QUALITY MANAGEMENT CONDOMS
DIN EN ISO 9693-1:2012-06 DENTISTRY - COMPATIBILITY TESTING - PART 1: METAL-CERAMIC SYSTEMS (ISO 9693-1:2012)
CSA Z8638 : 2008 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
I.S. EN ISO 8536-14:2018 INFUSION EQUIPMENT FOR MEDICAL USE - PART 14: CLAMPS AND FLOW REGULATORS FOR TRANSFUSION AND INFUSION EQUIPMENT WITHOUT FLUID CONTACT (ISO 8536-14:2016)
PREN 14683 : DRAFT 2017 MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
PD CEN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2
PREN 13795-1 : DRAFT 2017 SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 1: SURGICAL DRAPES AND GOWNS
BS ISO 19614:2017 Traditional Chinese medicine. Pulse graph force transducer
13/30267665 DC : 0 BS EN ISO 24234 - DENTISTRY - DENTAL AMALGAM
UNI EN ISO 10873 : 2010 DENTISTRY - DENTURE ADHESIVES
08/30168815 DC : DRAFT MAR 2008 BS EN ISO 4049 - DENTISTRY - POLYMER-BASED RESTORATIVE MATERIALS
16/30332214 DC : 0 BS EN ISO 9917-2 - DENTISTRY - WATER-BASED CEMENTS - PART 2: RESIN-MODIFIED CEMENTS
ANSI/AAMI/ISO 15675:2016 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS
03/105714 DC : DRAFT MAR 2003 ISO 24234 - DENTISTRY - MERCURY AND ALLOYS FOR DENTAL AMALGAM
08/30179586 DC : DRAFT MAR 2008 BS ISO 7199 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS)
UNI EN ISO 7376 : 2009-10 ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION
AAMI ISO 5361 : 2012 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS
07/30167336 DC : DRAFT AUG 2007 BS EN 868-10 - PACKAGING MATERIALS FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 10: ADHESIVE COATED NONWOVEN MATERIALS OF POLYOLEFINES FOR USE IN THE MANUFACTURE OF SEALABLE POUCHES, REELS AND LIDS - REQUIREMENTS AND TEST METHODS
DIN EN ISO 1135-5:2016-06 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 1135-5:2015)
DIN EN ISO 1135-3 E : 2017 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016)
ISO 20696:2018 Sterile urethral catheters for single use
BS EN ISO 21563:2013 Dentistry. Hydrocolloid impression materials
UNI EN ISO 5367 : 2015 ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS
AAMI ISO 10993-7:2008(R2012) BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
BS EN ISO 8536-13:2016 Infusion equipment for medical use Graduated flow regulators for single use with fluid contact
15/30321715 DC : 0 BS ISO 15675 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS
17/30357741 DC : 0 BS ISO 11040-6 - PREFILLED SYRINGES - PART 6: PLASTIC BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING
DIN EN ISO 8836 E : 2015 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014)
ISO 11040-6:2012 Prefilled syringes Part 6: Plastic barrels for injectables
14/30303657 DC : 0 BS EN ISO 1135-3 - TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SET FOR SINGLE USE
I.S. EN ISO 5840-3:2013 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES (ISO 5840-3:2013)
14/30281560 DC : 0 BS EN ISO 5840-2 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES
16/30301330 DC : 0 BS ISO 19614 - TRADITIONAL CHINESE MEDICINE - PULSE GRAPH FORCE TRANSDUCER
BS ISO 11658:2012 Cardiovascular implants and extracorporeal systems. Blood/tissue contact surface modifications for extracorporeal perfusion systems
14/30292011 DC : 0 BS EN ISO 23747 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS
ISO 20308:2017 Traditional Chinese medicine — Gua Sha instruments
BS EN ISO 7199:2017 Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators)
BS ISO 13179-1:2014 Implants for surgery. Plasma-sprayed unalloyed titanium coatings on metallic surgical implants General requirements
06/30145887 DC : DRAFT FEB 2006 EN ISO 10993-12 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS
11/30212235 DC : 0 BS EN ISO 13504 - DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT
04/19976241 DC : DRAFT AUG 2004
13/30281504 DC : 0 BS EN 455-3 - MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION
15/30321712 DC : 0 BS ISO 15674 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HARD-SHELL CARDIOTOMY/VENOUS RESERVOIR SYSTEMS (WITH/WITHOUT FILTER) AND SOFT VENOUS RESERVOIR BAGS
15/30321957 DC : 0 BS EN ISO 7199 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS BLOOD-GAS EXCHANGERS (OXYGENATORS)
ISO 18189:2016 Ophthalmic optics Contact lenses and contact lens care products Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions
15/30280904 DC : 0 BS ISO 18190 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - GENERAL REQUIREMENTS FOR AIRWAYS AND RELATED EQUIPMENT
02/563622 DC : DRAFT AUG 2002 BS EN ISO 1562 - DENTISTRY - CASTING GOLD ALLOYS
17/30323851 DC : 0 BS ISO 19894 - WALKING TROLLEYS - REQUIREMENTS AND TEST METHODS
BS EN ISO 9693-2:2016 Dentistry. Compatibility testing Ceramic-ceramic systems
BS EN 868-9:2009 Packaging for terminally sterilized medical devices Uncoated nonwoven materials of polyolefines. Requirements and test methods
BS ISO 18241:2016 Cardiovascular implants and extracorporeal systems. Cardiopulmonary bypass systems. Venous bubble traps
06/30097290 DC : DRAFT FEB 2006 ISO 10993-7 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
17/30286363 DC : 0 BS EN ISO 19023 - DENTISTRY - ORTHODONTIC ANCHOR SCREWS
14/30294895 DC : 0 BS EN ISO 8537 - STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN
14/30281863 DC : 0 BS EN ISO 5364 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - OROPHARYNGEAL AIRWAYS
BS EN 45502-2-3:2010 Active implantable medical devices Particular requirements for cochlear and auditory brainstem implant systems
04/30048205 DC : DRAFT JUL 2004 BS EN ISO 17665 - STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
06/30160368 DC : 0 BS EN 80100 - BASIC SAFETY AND ESSENTIAL PERFORMANCE REQUIREMENTS OF CLINICAL THERMOMETER FOR BODY TEMPERATURE MEASUREMENT
09/30168835 DC : 0 BS EN ISO 7885 - STERILE DENTAL INJECTION NEEDLES FOR SINGLE USE
03/103026 DC : DRAFT JAN 2003 BS EN ISO 5840 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES
UNI EN ISO 3630-5 : 2012 DENTISTRY - ENDODONTIC INSTRUMENTS - PART 5: SHAPING AND CLEANING INSTRUMENTS
AAMI ISO 5840 : 2005 : R2010 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES
BS ISO 15674:2009 Cardiovascular implants and artificial organs. Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
15/30303073 DC : 0 BS ISO 25841 - FEMALE CONDOMS - REQUIREMENTS AND TEST METHODS
09/30168908 DC : DRAFT FEB 2009 BS ISO 28319 - DENTISTRY - SUITABILITY OF METALLIC MATERIALS FOR LASER WELDING
15/30290736 DC : 0 BS EN ISO 10993-4 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD
08/30179592 DC : DRAFT MAR 2008 BS ISO 15675 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS
BS ISO 81060-1 : 2007 COR 2012 NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE
16/30302520 DC : 0 BS ISO 19611 - TRADITIONAL CHINESE MEDICINE - AIR EXHAUST CUPPING APPARATUS FOR MEDICAL USE
AAMI ISO 5840 :2005 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES
BS EN ISO 20795-1:2013 Dentistry. Base polymers Denture base polymers
DIN EN ISO 10555-6:2017-11 INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 6: SUBCUTANEOUS IMPLANTED PORTS (ISO 10555-6:2015)
ASTM F 3087 : 2015 Standard Specification for Acrylic Molding Resins for Medical Implant Applications
09/30173553 DC : 0 BS ISO 10873 - DENTISTRY - DENTURE ADHESIVES
CSA Z8836 :2011 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
AAMI ISO 20857 : 2010 STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
AAMI/ISO TIR17665-3:2014(R2016) STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION
CSA Z8836 : 2011 : R2015 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
ISO/TR 11991:1995 Guidance on airway management during laser surgery of upper airway
UNI CEN ISO/TS 17665-2 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
BS EN ISO 10555-1 : 2013 INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS
I.S. EN ISO 5361:2016 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS (ISO/DIS 5361:2014)
UNI EN ISO 5840-3 : 2013 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES
CSA Z17665-1 : 2009 : R2014 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
ASTM F 2064 : 2017 : REDLINE Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
ISO 11712:2009 Anaesthetic and respiratory equipment — Supralaryngeal airways and connectors
EN ISO 8536-14:2018 Infusion equipment for medical use - Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact (ISO 8536-14:2016)
ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
CSA Z314.10.1 : 2015 SELECTION AND USE OF GOWNS AND DRAPES INTENDED FOR USE IN HEALTH CARE SETTINGS
BS ISO 7199 : 2009 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS)
UNE-EN ISO 20072:2013 Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009)
BS EN ISO 11070 : 2014 STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES
ISO/TR 37137:2014 Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants
ASTM F 2475 : 2011 : REDLINE Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
I.S. EN ISO 27020:2010 DENTISTRY - BRACKETS AND TUBES FOR USE IN ORTHODONTICS
UNE-EN ISO 20795-2:2013 Dentistry - Base polymers - Part 2: Orthodontic base polymers (ISO 20795-2:2013)
BS EN ISO 10993-11:2009 Biological evaluation of medical devices Tests for systemic toxicity
AAMI ISO 5367 : 2015 ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS
17/30360918 DC : 0 BS EN 868-9 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 9: UNCOATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
I.S. EN ISO 14457:2017 DENTISTRY - HANDPIECES AND MOTORS (ISO 14457:2017)
I.S. EN ISO 25424:2011 STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
ANSI/AAMI/ISO 15676:2016 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - REQUIREMENTS FOR SINGLE-USE TUBING PACKS FOR CARDIOPULMONARY BYPASS AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO)
AAMI BE83 : 2006 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
BS EN ISO 13017 : 2012 DENTISTRY - MAGNETIC ATTACHMENTS
AAMI ISO 8638 : 2010 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS AND HEMOFILTERS
I.S. EN ISO 12417-1:2015 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
AAMI ISO TIR 17137 : 2014 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIOVASCULAR ABSORBABLE IMPLANTS
AAMI ISO 8836 : 2015 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
AAMI ISO 8638 : 2010 : R2015 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS AND HEMOFILTERS
AAMI TIR30 : 2011 A COMPENDIUM OF PROCESSES, MATERIALS, TEST METHODS, AND ACCEPTANCE CRITERIA FOR CLEANING REUSABLE MEDICAL DEVICES
UNE-EN ISO 1135-5:2016 Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2015)
ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 1: Evaluation and testing within a risk management process
ISO/TR 10993-9:1994 Biological evaluation of medical devices — Part 9: Degradation of materials related to biological testing
DIN EN ISO 10477:2005-01 DENTISTRY - POLYMER BASED CROWN AND BRIDGE MATERIALS
I.S. EN ISO 8536-13:2016 INFUSION EQUIPMENT FOR MEDICAL USE - PART 13: GRADUATED FLOW REGULATORS FOR SINGLE USE WITH FLUID CONTACT (ISO 8536-13:2016)
UNI EN ISO 14607 : 2009 NON-ACTIVE SURGICAL IMPLANTS - MAMMARY IMPLANTS - PARTICULAR REQUIREMENTS
CSA ISO 11712:14 (R2019) Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors (Adopted ISO 11712:2009, first edition, 2009-05-15)
BS EN ISO 14607:2009 Non-active surgical implants. Mammary implants. Particular requirements
BS EN ISO 5367:2014 Anaesthetic and respiratory equipment. Breathing sets and connectors
UNE-EN ISO 14457:2013 Dentistry - Handpieces and motors (ISO 14457:2012)
UNE-EN ISO 5367:2015 Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014)
CSA ISO 10993-13 : 0 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES
CSA ISO 10993-16 : 0 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES
AAMI ISO 14971 : 2007 : INC : ERR 1 : 2007 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
ONORM EN ISO 7405 : 2013 DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008 + AMD 1:2013)
ISO 18666:2015 Traditional Chinese medicine General requirements of moxibustion devices
UNI EN ISO 28399 : 2011 DENTISTRY - PRODUCTS FOR EXTERNAL TOOTH BLEACHING
BS EN ISO 6872 : 2015 DENTISTRY - CERAMIC MATERIALS
UNE-EN ISO 9693-1:2012 Dentistry - Compatibility testing - Part 1: Metal-ceramic systems (ISO 9693-1:2012)
UNI EN 868-9 : 2009 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 9: UNCOATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
ASTM F 623 : 1999 : R2013 Standard Performance Specification for Foley Catheter
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 14457:2017 Dentistry — Handpieces and motors
DIN EN 14683 E : 2014 MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
BS EN 868-10:2009 Packaging for terminally sterilized medical devices Adhesive coated nonwoven materials of polyolefines. Requirements and test methods
EN ISO 21563:2013 Dentistry - Hydrocolloid impression materials (ISO 21563:2013)
ASTM F 2051 : 2000 : R2014 Standard Specification for Implantable Saline Filled Breast Prosthesis
UNI EN ISO 10993-11 : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY
ASTM F 3036 : 2013 Standard Guide for Testing Absorbable Stents
NF EN ISO 7376 : NOV 2009 ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION
DIN EN ISO 3826-1:2013-09 PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS (ISO 3826-1:2013)
DIN EN ISO 10271:2011-10 DENTISTRY - CORROSION TEST METHODS FOR METALLIC MATERIALS
ISO 8836:2014 Suction catheters for use in the respiratory tract
ISO 5367:2014 Anaesthetic and respiratory equipment — Breathing sets and connectors
EN ISO 14937:2009 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
I.S. EN ISO 14971:2012 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007, CORRECTED VERSION 2007-10-01)
UNI EN ISO 3826-1 : 2013 PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS
DIN EN 1641:2010-02 Dentistry - Medical devices for dentistry - Materials
DIN EN ISO 6875:2011-10 DENTISTRY - PATIENT CHAIR
DIN EN ISO 23747:2015-12 ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS (ISO 23747:2015)
DIN EN ISO 1135-4:2016-06 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 1135-4:2015)
DIN EN ISO 6876:2012-10 Dentistry - Root canal sealing materials (ISO 6876:2012)
DIN EN 12182:2012-07 Assistive products for persons with disability - General requirements and test methods
DIN EN ISO 22112:2016-04 (Draft) DENTISTRY - ARTIFICIAL TEETH FOR DENTAL PROSTHESES (ISO 22112:2017)
DIN EN 12470-2:2009-11 Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers (includes Amendment A1:2009)
DIN EN ISO 17665-1:2006-11 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
DIN EN 1782:2009-12 TRACHEAL TUBES AND CONNECTORS
DIN EN ISO 22803:2006-01 Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004)
DIN EN ISO 22674:2016-09 Dentistry - Metallic materials for fixed and removable restorations and appliances (ISO 22674:2016)
DIN EN ISO 11199-2:2005-07 Walking aids manipulated by both arms - Requirements and test methods - Part 2: Rollators (ISO 11199-2:2005)
DIN EN ISO 4074:2016-05 NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS (ISO 4074:2015)
DIN EN ISO 10993-18:2009-08 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005); German version EN ISO 10993-18:2009
DIN EN ISO 14971:2013-04 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
DIN EN ISO 16672:2015-12 Ophthalmic implants - Ocular endotamponades (ISO 16672:2015)
DIN EN ISO 10993-12:2012-10 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
DIN EN ISO 9394:2013-01 Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes (ISO 9394:2012)
DIN EN ISO 5840-2 E : 2016 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES (ISO 5840-2:2015)
BS EN ISO 7864:2016 Sterile hypodermic needles for single use. Requirements and test methods
BS EN ISO 10535:2006 Hoists for the transfer of disabled persons. Requirements and test methods
UNE-EN ISO 3107:2011 Dentistry - Zinc oxide/eugenol cements and zinc oxide/non-eugenol cements (ISO/FDIS 3107:2010)
UNE-EN ISO 11608-3:2013 Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers (ISO 11608-3:2012)
BS EN ISO 10993-15:2009 Biological evaluation of medical devices Identification and quantification of degradation products from metals and alloys
BS EN ISO 10993-5:2009 Biological evaluation of medical devices Tests for in vitro cytotoxicity
BS EN ISO 7439:2015 Copper-bearing contraceptive intrauterine devices. Requirements and tests
BS EN 45502-1:2015 Implants for surgery. Active implantable medical devices General requirements for safety, marking and for information to be provided by the manufacturer
BS EN ISO 10993-6:2016 Biological evaluation of medical devices Tests for local effects after implantation
BS EN ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives Application of risk management
UNE-EN ISO 10993-10:2013 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
BS EN ISO 10993-9 : 2009-12 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS
UNE-EN ISO 23747:2016 Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2015)
ISO 7199:2016 Cardiovascular implants and artificial organs Blood-gas exchangers (oxygenators)
ISO 25424:2009 Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices
BS EN 12470-3 : 2000 CLINICAL THERMOMETERS - PART 3: PERFORMANCE OF COMPACT ELECTRICAL THERMOMETERS (NON-PREDICTIVE AND PREDICTIVE) WITH MAXIMUM DEVICE
I.S. EN ISO 10993-6:2016 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016)
I.S. EN ISO 14534:2015 OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS (ISO 14534:2011)
EN ISO 15841:2014 Dentistry - Wires for use in orthodontics (ISO 15841:2014)
I.S. EN ISO 6875:2011 DENTISTRY - PATIENT CHAIR
EN ISO 15854:2005 Dentistry - Casting and baseplate waxes (ISO 15854:2005)
I.S. EN ISO 5366-1:2009 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - PART 1: TUBES AND CONNECTORS FOR USE IN ADULTS
EN ISO 5840-2:2015 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015)
I.S. EN ISO 22794:2009 DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE
I.S. EN ISO 7153-1:2016 SURGICAL INSTRUMENTS - MATERIALS - PART 1: METALS (ISO 7153-1:2016)
I.S. EN ISO 23747:2015 ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS (ISO 23747:2015)
I.S. EN ISO 1135-4:2015 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 1135-4:2015)
ONORM EN ISO 7376 : 2010 ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION
I.S. EN ISO 22112:2017 DENTISTRY - ARTIFICIAL TEETH FOR DENTAL PROSTHESES (ISO 22112:2017)
I.S. EN ISO 14937:2009 STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
ONORM EN ISO 25539-2 : 2013 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS (ISO 25539-2:2012)
DIN EN 12470-4:2001-02 CLINICAL THERMOMETERS - PART 4: PERFORMANCE OF ELECTRICAL THERMOMETERS FOR CONTINUOUS MEASUREMENT
ONORM EN ISO 8836 : 2015 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014)
I.S. EN ISO 11334-1:2007 ASSISTIVE PRODUCTS FOR WALKING MANIPULATED BY ONE ARM - REQUIREMENTS AND TEST METHODS - PART 1: ELBOW CRUTCHES
I.S. EN ISO 9626:2016 STAINLESS STEEL NEEDLE TUBING FOR THE MANUFACTURE OF MEDICAL DEVICES - REQUIREMENTS AND TEST METHODS
I.S. EN ISO 10993-5:2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY (ISO 10993-5:2009)
UNI EN ISO 10993-18 : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
I.S. EN 12182:2012 ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS
DIN EN ISO 7885:2010-06 Dentistry - Sterile injection needles for single use (ISO 7885:2010)
DIN EN ISO 16744:2004-05 DENTISTRY - BASE METAL MATERIALS FOR FIXED DENTAL RESTORATIONS
I.S. EN ISO 7439:2015 COPPER-BEARING CONTRACEPTIVE INTRAUTERINE DEVICES - REQUIREMENTS AND TESTS (ISO 7439:2015)
I.S. EN ISO 9394:2012 OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - DETERMINATION OF BIOCOMPATIBILITY BY OCULAR STUDY WITH RABBIT EYES (ISO 9394:2012)
I.S. EN ISO 6876:2012 DENTISTRY - ROOT CANAL SEALING MATERIALS (ISO 6876:2012)
I.S. EN ISO 8537:2016 STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN (ISO 8537:2016)
I.S. EN ISO 14160:2011 STERILIZATION OF HEALTH CARE PRODUCTS - LIQUID CHEMICAL STERILIZING AGENTS FOR SINGLE-USE MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - REQUIREMENTS FOR CHARACTERIZATION, DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
I.S. EN ISO 11608-3:2012 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 3: FINISHED CONTAINERS (ISO 11608-3:2012)
I.S. EN ISO 22442-1:2015 MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT (ISO 22442-1:2015)
I.S. EN ISO 11499:2014 DENTISTRY - SINGLE-USE CARTRIDGES FOR LOCAL ANAESTHETICS (ISO 11499:2014)
I.S. EN 1642:2011 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS
I.S. EN ISO 15854:2005 DENTISTRY - CASTING AND BASEPLATE WAXES
I.S. EN ISO 10993-17:2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 17: ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES (ISO 10993-17:2002)
I.S. EN ISO 11609:2017 DENTISTRY - DENTIFRICES - REQUIREMENTS, TEST METHODS AND MARKING (ISO 11609:2017)
I.S. EN ISO 4074:2015 NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS (ISO 4074:2015)
I.S. EN ISO 9917-1:2007 DENTISTRY - WATER-BASED CEMENTS - PART 1: POWDER/LIQUID ACID-BASE CEMENTS
I.S. EN ISO 10139-2:2016 DENTISTRY - SOFT LINING MATERIALS FOR REMOVABLE DENTURES - PART 2: MATERIALS FOR LONG-TERM USE (ISO 10139-2:2016)
I.S. EN ISO 16408:2015 DENTISTRY - ORAL CARE PRODUCTS - ORAL RINSES (ISO 16408:2015)
I.S. EN ISO 11608-2:2012 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 2: NEEDLES (ISO 11608-2:2012)
I.S. EN ISO 14727:1999 DENTAL IMPLANTS - PREFABRICATED PARTS CONNECTING SUPRASTRUCTURES TO DENTAL IMPLANTS - CONTENTS OF TECHNICAL FILE
I.S. EN ISO 7885:2010 DENTISTRY - STERILE INJECTION NEEDLES FOR SINGLE USE
I.S. EN ISO 10993-3:2014 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY (ISO 10993-3:2014)
I.S. EN ISO 15841:2014 DENTISTRY - WIRES FOR USE IN ORTHODONTICS (ISO 15841:2014)
DIN EN ISO 11499:1999-08 DENTISTRY - SINGLE-USE CARTRIDGES FOR LOCAL ANAESTHETICS (ISO 11499:2014)
I.S. EN ISO 4823:2015 DENTISTRY - ELASTOMERIC IMPRESSION MATERIALS (ISO/DIS 4823:2013)
I.S. EN ISO 24234:2015 DENTISTRY - DENTAL AMALGAM (ISO 24234:2015)
I.S. EN 1641:2009 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS
DIN EN ISO 28158:2010-12 DENTISTRY - INTEGRATED DENTAL FLOSS AND HANDLES
I.S. EN 12470-2:2000 CLINICAL THERMOMETERS - PART 2: PHASE CHANGE TYPE (DOT MATRIX) THERMOMETERS
EN ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
I.S. EN ISO 10993-2:2006 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 2: ANIMAL WELFARE REQUIREMENTS (ISO 10993-2:2006)
I.S. EN ISO 10451:2010 DENTISTRY - CONTENTS OF TECHNICAL FILE FOR DENTAL IMPLANT SYSTEMS
I.S. EN ISO 10993-12:2012 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS (ISO 10993-12:2012)
DIN EN ISO 24234:2015-08 DENTISTRY - DENTAL AMALGAM (ISO 24234:2015)
EN ISO 5840-3:2013 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013)
I.S. EN ISO 6877:2006 DENTISTRY - ROOT-CANAL OBTURATING POINTS
I.S. EN ISO 14630:2012 NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 14630:2012)
I.S. EN 45502-1:2015 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER
I.S. EN 1282-2:2005 TRACHEOSTOMY TUBES - PART 2: PAEDIATRIC TUBES
I.S. EN ISO 10993-10:2013 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010)
I.S. EN ISO 6874:2015 DENTISTRY - POLYMER-BASED PIT AND FISSURE SEALANTS (ISO 6874:2015)
I.S. EN ISO 7864:2016 STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS (ISO/DIS 7864:2014)
I.S. EN ISO 22674:2016 DENTISTRY - METALLIC MATERIALS FOR FIXED AND REMOVABLE RESTORATIONS AND APPLIANCES (ISO 22674:2016)
I.S. EN ISO 10993-13:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES (ISO 10993-13:2010)
I.S. EN ISO 10993-14:2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 14: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM CERAMICS (ISO 10993-14:2001)
I.S. EN ISO 11199-2:2005 WALKING AIDS MANIPULATED BY BOTH ARMS - REQUIREMENTS AND TEST METHODS - PART 2: ROLLATORS
I.S. EN ISO 16672:2015 OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES (ISO 16672:2015)
DIN EN ISO 5366-1:2009-07 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - PART 1: TUBES AND CONNECTORS FOR USE IN ADULTS
DIN EN 1733:2003-02 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
UNI EN 1642 : 2012 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS
UNI EN ISO 6876 : 2012 DENTISTRY - ROOT CANAL SEALING MATERIALS
BIS IS/ISO 14708-3 : 2008 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 3: IMPLANTABLE NEUROSTIMULATORS
VDI 5700 Blatt 2:2017-06 Reprocessing hazards - Risk management in reprocessing of medical devices - Trainings
VDI 3823 Blatt 4:2006-11 Vacuum coating quality assurance - Testing of vacuum coated plastics
OVE/ONORM EN 60601-1 : 2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005 + COR.:2006 + COR.:2007 + A1:2012)
DIN EN ISO 1135-3:2017-05 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016)
UNI EN ISO 11070 : 2015 STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES
BS ISO 11040-6:2012 Prefilled syringes Plastic barrels for injectables
UNE-EN ISO 5840-2:2016 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015)
ISO 20697:2018 Sterile drainage catheters and accessory devices for single use
DIN EN ISO 9693-2 E : 2016 DENTISTRY - COMPATIBILITY TESTING - PART 2: CERAMIC-CERAMIC SYSTEMS (ISO 9693-2:2016)
15/30282343 DC : 0 BS ISO 18746 - TRADITIONAL CHINESE MEDICINE - INTRADERMAL ACUPUNCTURE NEEDLES
DIN EN ISO 8637:2014-03 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS (ISO 8637:2010, INCLUDING AMENDMENT 1:2013-04-01)
04/30048118 DC : DRAFT MAY 2004 BS EN ISO 11135 - STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
UNI EN ISO 81060-1 : 2012 NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE
16/30339096 DC : 0 BS EN ISO 7886-3 - STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 3: AUTO-DISABLE SYRINGES FOR FIXED-DOSE IMMUNIZATION
ANSI/AAMI/ISO 20857:2010(R2015) STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
BS ISO 17218:2014 Sterile acupuncture needles for single use
I.S. EN ISO 1562:2004 DENTISTRY - CASTING GOLD ALLOYS
I.S. EN ISO 81060-1:2012 NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE (ISO 81060-1:2007)
I.S. EN ISO 12163:2000 DENTAL BASEPLATE/MODELLING WAX (ISO 12163:1999)
DIN EN ISO 10555-6 E : 2017 INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 6: SUBCUTANEOUS IMPLANTED PORTS (ISO 10555-6:2015)
15/30281262 DC : 0 BS ISO 18666 - TRADITIONAL CHINESE MEDICINE - GENERAL REQUIREMENTS OF MOXIBUSTION DEVICES
ISO 10993-16:2017 Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
I.S. EN 12442-1:2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK
ISO 20126:2012 Dentistry Manual toothbrushes General requirements and test methods
ISO 13019:2018 Tissue-engineered medical products — Quantification of sulfated glycosaminoglycans (sGAG) for evaluation of chondrogenesis
09/30168905 DC : 0 BS ISO 28158 - DENTISTRY - INTEGRATED DENTAL FLOSS HOLDERS
DIN EN ISO 5367 E : 2015 ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS (ISO 5367:2014)
AAMI ISO 11137-1 : 2006 : INC : AMD 1 : 2013 : R201000 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
16/30337378 DC : 0 BS EN ISO 28319 - DENTISTRY - LASER WELDING
13/30285624 DC : 0 BS EN ISO 16061 - INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
07/30164125 DC : 0 BS ISO 20795-1 - DENTISTRY - BASE POLYMERS - PART 1: DENTURE BASE POLYMERS
DIN EN ISO 7199 E : 2017 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016)
11/30215841 DC : 0 BS EN ISO 14457 - DENTISTRY - HAND PIECES AND MOTORS
I.S. EN ISO 20795-2:2013 DENTISTRY - BASE POLYMERS - PART 2: ORTHODONTIC BASE POLYMERS (ISO 20795-2:2013)
ISO 6877:2006 Dentistry Root-canal obturating points
17/30361518 DC : 0 BS ISO 6474-2 - IMPLANTS FOR SURGERY - CERAMIC MATERIALS - PART 2: COMPOSITE MATERIALS BASED ON A HIGH-PURITY ALUMINA MATRIX WITH ZIRCONIA REINFORCEMENT
05/30093244 DC : DRAFT FEB 2005 EN ISO 11334-1 - WALKING AIDS MANIPULATED BY ONE ARM - REQUIREMENTS AND TEST METHODS - PART 1: ELBOW CRUTCHES
ISO 29942:2011 Prophylactic dams — Requirements and test methods
BS EN ISO 10993-4:2017 Biological evaluation of medical devices Selection of tests for interactions with blood
EN ISO 16671:2015/A1:2017 OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2015/AMD 1:2017)
14/30255135 DC : 0 BS EN ISO 11607-1:2009/A1 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
I.S. EN ISO 10139-1:2005 DENTISTRY - SOFT LINING MATERIALS FOR REMOVABLE DENTURES - PART 1: MATERIALS FOR SHORT-TERM USE (ISO 10139-1:2018)
I.S. EN ISO 9693-2:2016 DENTISTRY - COMPATIBILITY TESTING - PART 2: CERAMIC-CERAMIC SYSTEMS (ISO 9693-2:2016)
PREN 868-10 : DRAFT 2017 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 10: ADHESIVE COATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
BS ISO 15675:2009 Cardiovascular implants and artificial organs. Cardiopulmonary bypass systems. Arterial blood line filters
BS ISO 7198:1998 Cardiovascular implants. Tubular vascular prostheses
BS ISO 10555-6 : 2015 INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 6: SUBCUTANEOUS IMPLANTED PORTS
11/30243462 DC : 0 BS EN ISO 9394 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - DETERMINATION OF BIOCOMPATIBILITY BY OCULAR STUDY WITH RABBIT EYES
ISO 8637-1:2017 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
BS ISO 25841:2017 Female condoms. Requirements and test methods
11/30219230 DC : 0 BS ISO 13175-3 - IMPLANTS FOR SURGERY - CALCIUM PHOSPHATES - PART 3: HYDROXYAPATITE AND BETA-TRICALCIUM PHOSPHATE BONE SUBSTITUTES
04/30109833 DC : 0 ISO 8836 - SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
BS EN ISO 7197:2009 Neurosurgical implants. Sterile, single-use hydrocephalus shunts and components
DIN EN ISO 18397 E : 2016 DENTISTRY - POWERED SCALER (ISO 18397:2016)
DIN EN ISO 25539-1:2015-07 (Draft) CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
DIN EN ISO 8637 E : 2014 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS (ISO 8637:2010, INCLUDING AMENDMENT 1 2013-04-01)
I.S. EN 12181:1998 OROPHARYNGEAL AIRWAYS
09/30168911 DC : 0 BS ISO 28399 - DENTISTRY - PRODUCTS FOR EXTERNAL TOOTH BLEACHING
DIN EN ISO 11607-1:2014-11 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006 + AMD 1.:2014)
BS EN ISO 9693-1:2012 Dentistry. Compatibility testing Metal-ceramic systems
11/30227250 DC : 0 BS EN ISO 21563 - DENTISTRY - HYDROCOLLOID IMPRESSION MATERIALS
BS ISO 18190:2016 Anaesthetic and respiratory equipment. General requirements for airways and related equipment
BS EN ISO 81060-1:2012 Non-invasive sphygmomanometers Requirements and test methods for non-automated measurement type
17/30343686 DC : 0 BS EN ISO 7405 - DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY
DIN EN ISO 26782:2010-02 Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009 + Cor. 1:2009) (includes Corrigendum AC:2009)
BS EN ISO 5364:2016 Anaesthetic and respiratory equipment. Oropharyngeal airways
17/30319534 DC : 0 BS ISO 13019 - TISSUE-ENGINEERED MEDICAL PRODUCTS - QUANTIFICATION OF SULPHATED GLYCOSAMINOGLYCANS (SGAG) FOR EVALUATION OF CHONDROGENESIS
PREN ISO 11608-2 : DRAFT 2010 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 2: NEEDLES
BS EN ISO 12417-1:2015 Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products General requirements
BS EN ISO 20795-2:2013 Dentistry. Base polymers Orthodontic base polymers
13/30257549 DC : 0 BS EN ISO 11499 - DENTISTRY - SINGLE-USE CARTRIDGES FOR LOCAL ANAESTHETICS
I.S. EN ISO 3630-5:2011 DENTISTRY - ENDODONTIC INSTRUMENTS - PART 5: SHAPING AND CLEANING INSTRUMENTS (ISO 3630-5:2011)
UNI EN ISO 7494-1 : 2011 DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS
02/561161 DC : DRAFT FEB 2002 BS EN ISO 16408 - DENTISTRY - ORAL HYGIENE PRODUCTS - ORAL RINSES
ISO 8536-14:2016 Infusion equipment for medical use Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact
CAN/CSA-ISO 5364:16 ANAESTHETIC AND RESPIRATORY EQUIPMENT - OROPHARYNGEAL AIRWAYS
UNE-EN ISO 5364:2017 Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2016)
DIN EN ISO 17730 E : 2015 DENTISTRY - FLUORIDE VARNISHES (ISO 17730:2014)
02/562119 DC : DRAFT MAY 2002 BS EN ISO 7376 - LARYNGOSCOPES FOR TRACHEAL INTUBATION
UNE-EN ISO 16671:2016 Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015)
UNI EN ISO 25424 : 2011 STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
EN ISO 10555-6:2017 Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports (ISO 10555-6:2015)
ANSI/AAMI/ISO 25539-1:2017 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES
14/30263397 DC : 0 BS EN ISO 22674 - DENTISTRY - METALLIC MATERIALS FOR FIXED AND REMOVABLE RESTORATIONS AND APPLIANCES
17/30336573 DC : 0 BS EN ISO 20696 - STERILE URETHAL CATHETERS FOR SINGLE USE
BS ISO 8536-12 : 2007 INFUSION EQUIPMENT FOR MEDICAL USE - PART 12: CHECK VALVES
ASTM F 2347 : 2015 : REDLINE Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
14/30290166 DC : 0 BS ISO 16142-1 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON-IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
BS ISO 23409:2011 Male condoms. Requirements and test methods for condoms made from synthetic materials
CSA ISO 11712 : 2014 ANAESTHETIC AND RESPIRATORY EQUIPMENT - SUPRALARYNGEAL AIRWAYS AND CONNECTORS
BS EN ISO 17254:2016 Dentistry. Coiled springs for use in orthodontics
DIN EN ISO 1135-5 E : 2016 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 1135-5:2015)
09/30207531 DC : 0 BS EN ISO 14534 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS
ISO 18242:2016 Cardiovascular implants and extracorporeal systems — Centrifugal blood pumps
17/30338806 DC : 0 BS EN ISO 25424 - STERILIZATION OF HEALTH CARE PRODUCTS - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
10/30169478 DC : 0 BS EN ISO 9693-1 - DENTISTRY - COMPATIBILITY TESTING - PART 1: METAL-CERAMIC SYSTEMS
BS EN ISO 7494-1:2011 Dentistry. Dental units General requirements and test methods
10/30208977 DC : 0 BS EN ISO 11608-1 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS
AAMI ISO 81060-1:2007(R2013) NON INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE
ANSI/AAMI/ISO TIR10993-19:2006 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 19: PHYSICOCHEMICAL, MORPHOLOGICAL, AND TOPOGRAPHICAL CHARACTERIZATION OF MATERIALS
AAMI TIR 11 : 2005 SELECTION AND USE OF PROTECTIVE APPAREL AND SURGICAL DRAPES IN HEALTH CARE FACILITIES
15/30275221 DC : 0 BS ISO 18241 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIOPULMONARY BYPASS SYSTEMS - VENOUS BUBBLE TRAPS
16/30346835 DC : 0 BS ISO 20789 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - PASSIVE HUMIDIFIERS
11/30228364 DC : 0 BS EN ISO 10555-1 - INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS
BS EN ISO 17730:2014 Dentistry. Fluoride varnishes
03/317861 DC : DRAFT OCT 2003 EN ISO 22523 - EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS
17/30332217 DC : 0 BS EN ISO 28158 - DENTISTRY - INTEGRATED DENTAL FLOSS AND HANDLES
ASTM F 623 : 1999 : EDT 1 Standard Performance Specification for Foley Catheter
CSA Z8836 : 2011 : FR SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
UNI EN ISO 20072 : 2013 AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS
I.S. EN ISO 28158:2010 DENTISTRY - INTEGRATED DENTAL FLOSS AND HANDLES
UNI EN ISO 21563 : 2013 DENTISTRY - HYDROCOLLOID IMPRESSION MATERIALS
UNI EN ISO 8836 : 2015 A SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
CSA ISO 10993-5 : 0 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY
UNE-EN ISO 8836:2015 Suction catheters for use in the respiratory tract (ISO 8836:2014)
08/30178723 DC : DRAFT AUG 2008 BS ISO 15798 - OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES
CSA ISO 8638 : 2012 : R2017 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
BS EN ISO 5840-3:2013 Cardiovascular implants. Cardiac valve prostheses Heart valve substitutes implanted by transcatheter techniques
BS EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
03/101659 DC : DRAFT JAN 2003 ISO 22803 - DENTISTRY - MEMBRANE MATERIALS FOR GUIDED TISSUE REGENERATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE
CSA Z11135-1 : 2009 : R2014 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
CSA ISO 14937 : 2011 : R2016 STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
I.S. EN ISO 11199-1:1999 WALKING AIDS MANIPULATED BY BOTH ARMS - REQUIREMENTS AND TEST METHODS - PART 1: WALKING FRAMES
CSA ISO 8637 : 2012 : INC : AMD 1 : 2015 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
ANSI/AAMI/ISO 22442-1:2016 MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT
CAN/CSA-Z7376:12 (R2017) Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (Adopted ISO 7376:2009, second edition, 2009-08-15, with Canadian deviations)
UNI EN ISO 20795-1 : 2013 DENTISTRY - BASE POLYMERS - PART 1: DENTURE BASE POLYMERS
DIN EN ISO 5840-2:2016-05 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015)
I.S. EN ISO 28319:2010 DENTISTRY - LASER WELDING AND FILLER MATERIALS (ISO 28319:2018)
CAN/CSA-Z314-18 Canadian medical device reprocessing
ISO 18241:2016 Cardiovascular implants and extracorporeal systems — Cardiopulmonary bypass systems — Venous bubble traps
EN ISO 10873:2010 Dentistry - Denture adhesives (ISO 10873:2010)
ASTM F 2103 : 2011-03 GUIDE FOR CHARACTERIZATION AND TESTING OF CHITOSAN SALTS AS STARTING MATERIALS INTENDED FOR USE IN BIOMEDICAL AND TISSUE-ENGINEERED MEDICAL PRODUCT APPLICATIONS
CSA ISO 10993-9 : 0 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS
CSA Z17665-2:09 (R2019) Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009, IDT)
AAMI ISO 10993-10 : 2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION
ANSI/AAMI/ISO 10993-6:2016 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION
AAMI ISO 10993-7 : 2008 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
I.S. EN ISO 5840-2:2015 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES (ISO 5840-2:2015)
ANSI/AAMI/ISO 11658:2012 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - BLOOD/TISSUE CONTACT SURFACE MODIFICATIONS FOR EXTRACORPOREAL PERFUSION SYSTEMS
AAMI ISO 14937:2009 STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
ANSI/AAMI ISO 17665-1:2006(R2013) STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
AAMI ISO 10993-14 : 2001 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 14: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM CERAMICS
ANSI/AAMI/ISO TIR10993-20:2006 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 20: PRINCIPLES AND METHODS FOR IMMUNOTOXICOLOGY TESTING OF MEDICAL DEVICES
ANSI/AAMI/ISO 18241:2016 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIOPULMONARY BYPASS SYSTEMS - VENOUS BUBBLE TRAPS
ANSI/AAMI/ISO 10993-2:2006(R2014) BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 2: ANIMAL WELFARE REQUIREMENTS
AAMI ISO 10993-15 : 2000 : R2011 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS
AAMI ISO 14708-5 : 2010 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 5: CIRCULATORY SUPPORT DEVICES
I.S. EN ISO 8637:2014 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS (ISO 8637:2010, INCLUDING AMENDMENT 1 2013-04-01)
NF EN ISO 7197 : 2009 NEUROSURGICAL IMPLANTS - STERILE, SINGLE-USE HYDROCEPHALUS SHUNTS AND COMPONENTS
UNE-EN ISO 7494-1:2012 Dentistry - Dental units - Part 1: General requirements and test methods (ISO 7494-1:2011)
UNI EN ISO 5361 : 2013 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS
BS EN ISO 20126 : 2012 DENTISTRY - MANUAL TOOTHBRUSHES - GENERAL REQUIREMENTS AND TEST METHODS (ISO 20126:2012)
AAMI TIR30:2011(R2016) A COMPENDIUM OF PROCESSES, MATERIALS, TEST METHODS, AND ACCEPTANCE CRITERIA FOR CLEANING REUSABLE MEDICAL DEVICES
ISO 11658:2012 Cardiovascular implants and extracorporeal systems — Blood/tissue contact surface modifications for extracorporeal perfusion systems
ISO 15675:2016 Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters
ISO 7494-1:2011 Dentistry Dental units Part 1: General requirements and test methods
AAMI ISO 11135-1 : 2007 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
DIN EN ISO 6872:2015-11 DENTISTRY - CERAMIC MATERIALS (ISO 6872:2015)
EN ISO 10993-11:2009 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)
I.S. EN ISO 7405:2009 DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008)
AAMI RD16 : 2007 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HEMODIALYZERS, HEMODIAFILTERS, HEMOFILTERS AND HEMOCONCENTRATORS
NF EN ISO 14607 : 2009 NON-ACTIVE SURGICAL IMPLANTS - MAMMARY IMPLANTS - PARTICULAR REQUIREMENTS
I.S. EN ISO 8638:2014 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS (ISO 8638:2010)
EN ISO 15798:2013/A1:2017 OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013/AMD 1:2017)
I.S. EN ISO 11070:2014 STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES (ISO 11070:2014)
ISO 18562-4:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 4: Tests for leachables in condensate
ASTM F 2808 : 2017 : REDLINE Standard Test Method for Performing Behind-the-Knee (BTK) Test for Evaluating Skin Irritation Response to Products and Materials That Come Into Repeated or Extended Contact with Skin
ISO 15798:2013 Ophthalmic implants Ophthalmic viscosurgical devices
BS EN ISO 10555-6:2017 Intravascular catheters. Sterile and single-use catheters Subcutaneous implanted ports
DIN EN ISO 4049:2010-03 DENTISTRY - POLYMER-BASED RESTORATIVE MATERIALS
UNI EN ISO 5364 : 2011 ANAESTHETIC AND RESPIRATORY EQUIPMENT - OROPHARYNGEAL AIRWAYS
EN ISO 19023:2018 Dentistry - Orthodontic anchor screws (ISO 19023:2018)
ASTM F 623 : 1999 Standard Performance Specification for Foley Catheter
CSA Z314.10.2 : 2015 LAUNDERING, MAINTENANCE, AND PREPARATION OF REUSABLE GOWNS, DRAPES, AND WRAPPERS FOR HEALTH CARE SETTINGS AND LAUNDRIES
UNI EN ISO 8637 : 2014 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
ASTM F 2883 : 2011 Standard Guide for Characterization of Ceramic and Mineral Based Scaffolds used for Tissue-Engineered Medical Products (TEMPs) and as Device for Surgical Implant Applications (Withdrawn 2020)
ISO 16840-10:2014 Wheelchairs Resistance to ignition of non-integrated seat and back support cushions Part 10: Requirements and test methods
ISO/TS 17665-3:2013 Sterilization of health care products Moist heat Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization
I.S. EN ISO 7197:2009 NEUROSURGICAL IMPLANTS - STERILE, SINGLE-USE HYDROCEPHALUS SHUNTS AND COMPONENTS
ISO 6872:2015 Dentistry Ceramic materials
ISO 27020:2010 Dentistry Brackets and tubes for use in orthodontics
EN ISO 10139-1:2018 Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use (ISO 10139-1:2018)
BS EN ISO 28319:2010 Dentistry. Laser welding
BS EN ISO 11607-1:2017 Packaging for terminally sterilized medical devices Requirements for materials, sterile barrier systems and packaging systems
EN ISO 10477:2004 Dentistry - Polymer-based crown and bridge materials (ISO 10477:2004)
ISO 9917-2:2017 Dentistry — Water-based cements — Part 2: Resin-modified cements
EN ISO 20126:2012/A1:2018 DENTISTRY - MANUAL TOOTHBRUSHES - GENERAL REQUIREMENTS AND TEST METHODS (ISO 20126:2012/AMD 1:2018)
BS EN ISO 11137-1:2015 Sterilization of health care products. Radiation Requirements for development, validation and routine control of a sterilization process for medical devices
BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
I.S. EN ISO 16671:2015 OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2015)
I.S. EN ISO 20126:2012 DENTISTRY - MANUAL TOOTHBRUSHES - GENERAL REQUIREMENTS AND TEST METHODS (ISO 20126:2012)
ISO 10555-6:2015 Intravascular catheters Sterile and single-use catheters Part 6: Subcutaneous implanted ports
I.S. EN ISO 8836:2014 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014)
ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
DIN EN ISO 22523:2007-04 External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)
DIN EN 12470-3:2009-11 CLINICAL THERMOMETERS - PART 3: PERFORMANCE OF COMPACT ELECTRICAL THERMOMETERS (NON-PREDICTIVE AND PREDICTIVE) WITH MAXIMUM DEVICE
DIN EN ISO 22794:2009-11 Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007, corrected version 2009-01-15)
DIN EN 12470-4:2009-11 CLINICAL THERMOMETERS - PART 4: PERFORMANCE OF ELECTRICAL THERMOMETERS FOR CONTINUOUS MEASUREMENT
DIN EN ISO 9917-1:2008-01 DENTISTRY - WATER-BASED CEMENTS - PART 1: POWDER/LIQUID ACID-BASE CEMENTS
DIN EN ISO 11199-3:2005-07 WALKING AIDS MANIPULATED BY BOTH ARMS - REQUIREMENTS AND TEST METHODS - PART 3: WALKING TABLES
DIN EN ISO 7439:2015-08 Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2015)
DIN EN ISO 11608-2 E : 2012 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 2: NEEDLES (ISO 11608-2:2012)
DIN EN ISO 11608-3 E : 2013 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 3: FINISHED CONTAINERS (ISO 11608-3:2012)
DIN EN ISO 10993-7:2009-02 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
ONORM EN ISO 14160 : 2011 STERILIZATION OF HEALTH CARE PRODUCTS - LIQUID CHEMICAL STERILIZING AGENTS FOR SINGLE-USE MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - REQUIREMENTS FOR CHARACTERIZATION, DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 14160:2011)
DIN EN 455-3:2015-07 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
DIN EN ISO 21606 E : 2007 DENTISTRY - ELASTOMERIC AUXILIARIES FOR USE IN ORTHODONTICS
DIN EN ISO 10993-3:2015-02 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY (ISO 10993-3:2014)
DIN EN ISO 15841:2014-12 Dentistry - Wires for use in orthodontics (ISO 15841:2014)
DIN EN ISO 11979-5 E : 2010 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY
DIN EN ISO 11334-1:2007-04 Assistive products for walking manipulated by one arm - Requirements and test methods - Part 1: Elbow crutches (ISO 11334-1:2007)
DIN EN ISO 11608-1:2015-04 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014)
BS EN 12022:1999 Blood-gas exchangers
ISO 1135-5:2015 Transfusion equipment for medical use — Part 5: Transfusion sets for single use with pressure infusion apparatus
ISO 10271:2011 Dentistry Corrosion test methods for metallic materials
ISO 21606:2007 Dentistry — Elastomeric auxiliaries for use in orthodontics
BS EN ISO 11334-1:2007 Assistive products for walking manipulated by one arm. Requirements and test methods Elbow crutches
BS EN ISO 21649:2009 Needle-free injectors for medical use. Requirements and test methods
ISO 7197:2006 Neurosurgical implants Sterile, single-use hydrocephalus shunts and components
UNE-EN ISO 10993-3:2015 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
UNI EN ISO 8536-4 : 2013 INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED
ISO 3630-5:2011 Dentistry Endodontic instruments Part 5: Shaping and cleaning instruments
ISO 10993-3:2014 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
UNE-EN ISO 9626:2017 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016)
BS EN ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices. Requirements and test methods
BS EN ISO 10993-18:2009 Biological evaluation of medical devices Chemical characterization of materials
ISO 20795-1:2013 Dentistry Base polymers Part 1: Denture base polymers
UNE-EN ISO 11609:2017 Dentistry - Dentifrices - Requirements, test methods and marking (ISO 11609:2017)
BS EN ISO 23747:2015 Anaesthetic and respiratory equipment. Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
ISO 15854:2005 Dentistry Casting and baseplate waxes
ISO 5840:2005 Cardiovascular implants Cardiac valve prostheses
BS EN ISO 1135-4:2015 Transfusion equipment for medical use Transfusion sets for single use, gravity feed
BS EN ISO 10993-10:2013 Biological evaluation of medical devices Tests for irritation and skin sensitization
ISO 5364:2016 Anaesthetic and respiratory equipment — Oropharyngeal airways
BS EN 12470-5:2003 Clinical thermometers Performance of infra-red ear thermometers (with maximum device)
ISO 11199-1:1999 Walking aids manipulated by both arms Requirements and test methods Part 1: Walking frames
DIN EN ISO 10993-10:2014-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
UNE-EN ISO 6874:2015 Dentistry - Polymer-based pit and fissure sealants (ISO 6874:2015)
ISO 22794:2007 Dentistry Implantable materials for bone filling and augmentation in oral and maxillofacial surgery Contents of a technical file
UNE-EN ISO 7439:2015 Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2015)
DIN EN ISO 10993-15:2009-10 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)
ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
UNE-EN ISO 15841:2015 Dentistry - Wires for use in orthodontics (ISO 15841:2014)
DIN EN ISO 10993-17:2009-08 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
ISO 21649:2006 Needle-free injectors for medical use — Requirements and test methods
UNE-EN ISO 14160:2012 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011)
ISO 6871-2:1994 Dental base metal casting alloys Part 2: Nickel-based alloys
BS EN 12523:1999 External limb prostheses and external orthoses. Requirements and test methods
BS EN 30-1-2:2012 Domestic cooking appliances burning gas. Safety Appliances having forced-convection ovens and/or grills
UNE-EN ISO 11499:2014 Dentistry - Single-use cartridges for local anaesthetics (ISO 11499:2014)
I.S. EN ISO 10993-18:2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS (ISO 10993-18:2005)
EN 868-10:2009 Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
EN ISO 7376:2009 Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2009)
I.S. EN ISO 10993-7:2008 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS (ISO 10993-7:2008)
I.S. EN ISO 7376:2009 ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION
I.S. EN 868-10:2009 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 10: ADHESIVE COATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
I.S. EN ISO 10271:2011 DENTISTRY - CORROSION TEST METHODS FOR METALLIC MATERIALS
EN ISO 10993-18:2009 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
UNE-EN 1282-2:2006 Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)
I.S. EN ISO 11979-5:2006 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY
EN ISO 8836:2014 Suction catheters for use in the respiratory tract (ISO 8836:2014)
EN ISO 13017:2012/A1:2015 DENTISTRY - MAGNETIC ATTACHMENTS (ISO 13017:2012/AMD 1:2015)
EN ISO 11979-5:2006 Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006)
EN ISO 17730:2014 Dentistry - Fluoride varnishes (ISO 17730:2014)
EN ISO 10271:2011 Dentistry - Corrosion test methods for metallic materials (ISO 10271:2011)
EN 868-9:2009 Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
UNE-EN ISO 7885:2010 Dentistry - Sterile injection needles for single use (ISO 7885:2010)
UNE-EN 1782:1998 TRACHEAL TUBES AND CONNECTORS.
EN ISO 3630-5:2011 Dentistry - Endodontic instruments - Part 5: Shaping and cleaning instruments (ISO 3630-5:2011)
EN ISO 25539-2:2012 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)
I.S. EN ISO 10993-9:2009-12 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS (ISO 10993-9:2009)
EN ISO 28158:2010 Dentistry - Integrated dental floss and handles (ISO 28158:2010)
EN ISO 3826-4:2015 Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015)
EN ISO 16744:2003 Dentistry - Base metal materials for fixed dental restorations (ISO 16744:2003)
EN ISO 22112:2017 Dentistry - Artificial teeth for dental prostheses (ISO 22112:2017)
EN 1782:1998+A1:2009 Tracheal tubes and connectors
UNI EN 12470-4 : 2009 CLINICAL THERMOMETERS - PART 4: PERFORMANCE OF ELECTRICAL THERMOMETERS FOR CONTINUOUS MEASUREMENT
UNI EN ISO 5840 : 2009 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES
UNI EN ISO 10993-10 : 2013 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION
UNI EN ISO 3107 : 2011 DENTISTRY - ZINC OXIDE/EUGENOL AND ZINC OXIDE/NON-EUGENOL CEMENTS
UNI EN ISO 6875 : 2011 DENTISTRY - PATIENT CHAIR
UNI EN 1641 : 2010 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS
ONORM EN ISO 15798 : 2013 AMD 1 2018 OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013)
UNI EN 12470-3 : 2009 CLINICAL THERMOMETERS - PART 3: PERFORMANCE OF COMPACT ELECTRICAL THERMOMETERS (NON-PREDICTIVE AND PREDICTIVE) WITH MAXIMUM DEVICE
UNI EN ISO 10993-3 : 2015 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY
UNI EN ISO 10993-15 : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS
UNI EN ISO 10451 : 2010 DENTISTRY - CONTENTS OF TECHNICAL FILE FOR DENTAL IMPLANT SYSTEMS
EN 45502-1:2015 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER
UNI EN ISO 11609 : 2010 DENTISTRY - DENTIFRICES - REQUIREMENTS, TEST METHODS AND MARKING
UNI EN ISO 9917-1 : 2008 DENTISTRY - WATER-BASED CEMENTS - PART 1: POWDER/LIQUID ACID-BASE CEMENTS
UNI EN ISO 10993-14 : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 14: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM CERAMICS
CSA ISO 10993-11 : 0 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TEST FOR SYSTEMIC TOXICITY
UNI EN ISO 10993-13 : 2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES
UNI EN 12470-2 : 2009 CLINICAL THERMOMETERS - PART 2: PHASE CHANGE TYPE (DOT MATRIX) THERMOMETERS
UNI EN ISO 5366-1 : 2009 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - PART 1: TUBES AND CONNECTORS FOR USE IN ADULTS
UNI EN 1282-2 : 2009 TRACHEOSTOMY TUBES - PART 2: PAEDIATRIC TUBES
BS EN ISO 7405 : 2008 DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008)
UNI EN ISO 11499 : 2014 DENTISTRY - SINGLE-USE CARTRIDGES FOR LOCAL ANAESTHETICS
UNI EN ISO 11608-2 : 2012 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 2: NEEDLES
ONORM EN ISO 10993-7 : 2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
UNI EN ISO 14937 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
UNI EN ISO 11608-3 : 2013 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 3: FINISHED CONTAINERS
UNI EN 12342 : 2009 BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
UNI CEI EN 45502-2-3 : 2010 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS
UNI EN ISO 7885 : 2010 DENTISTRY - STERILE INJECTION NEEDLES FOR SINGLE USE
UNI EN 12182 : 2012 ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS
UNI EN ISO 10993-7 : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
UNI EN ISO 9394 : 2013 OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - DETERMINATION OF BIOCOMPATIBILITY BY OCULAR STUDY WITH RABBIT EYES
I.S. EN ISO 21606:2007 DENTISTRY - ELASTOMERIC AUXILIARIES FOR USE IN ORTHODONTICS
UNI EN ISO 14630 : 2013 NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
UNI EN ISO 10993-5 : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY
UNI EN 1782 : 2009 TRACHEAL TUBES AND CONNECTORS
UNI EN ISO 10993-17 : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 17: ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES
DIN EN ISO 20795-1:2013-06 DENTISTRY - BASE POLYMERS - PART 1: DENTURE BASE POLYMERS (ISO 20795-1:2013)
UNE-EN ISO 5361:2017 Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016)
AAMI ISO 11607-1 : 2006 : R2010 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS
DIN EN ISO 9693-2:2016-07 DENTISTRY - COMPATIBILITY TESTING - PART 2: CERAMIC-CERAMIC SYSTEMS (ISO 9693-2:2016)
DIN EN ISO 13504:2012-10 DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT (ISO 13504:2012)
DIN EN ISO 16061:2015-09 Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
DIN EN ISO 20857 E : 2013 STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 20857:2010)
CSA ISO 11607-1 : 2016 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
ISO 16971:2015 Ophthalmic instruments Optical coherence tomograph for the posterior segment of the human eye
BS EN ISO 25539-2:2012 Cardiovascular implants. Endovascular devices Vascular stents
BS EN ISO 28399:2011 Dentistry. Products for external tooth bleaching
ISO 18746:2016 Traditional Chinese medicine — Sterile intradermal acupuncture needles for single use
BS EN ISO 3630-5:2011 Dentistry. Endodontic instruments Shaping and cleaning instruments
15/30270433 DC : 0 BS EN ISO 17254 - DENTISTRY - COILED SPRINGS FOR USE IN ORTHODONTICS
CSA Z23747:2008 ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS
EN ISO 17254:2016 Dentistry - Coiled springs for use in orthodontics (ISO 17254:2016)
PREN ISO 14160 : DRAFT 2009 STERILIZATION OF HEALTH CARE PRODUCTS - LIQUID CHEMICAL STERILIZING AGENTS FOR SINGLE-USE MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - REQUIREMENTS FOR CHARACTERIZATION, DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
CSA Z17665-2:09 (R2019) Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (Adopted ISO/TS 17665-2:2009, first edition, 2009-01-15)
ISO 18190:2016 Anaesthetic and respiratory equipment — General requirements for airways and related equipment
BS ISO 14949:2001 Implants for surgery. Two-part addition-cure silicone elastomers
DIN EN ISO 3826-4 E : 2015 PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015)
UNI EN ISO 20795-2 : 2013 DENTISTRY - BASE POLYMERS - PART 2: ORTHODONTIC BASE POLYMERS
08/30184486 DC : DRAFT JUNE 2008 BS EN ISO 1135-4 - TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE
BS EN ISO 25424:2011 Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
BS EN ISO 25539-1:2017 Cardiovascular implants. Endovascular devices Endovascular prostheses
I.S. EN ISO 9693-1:2012 DENTISTRY - COMPATIBILITY TESTING - PART 1: METAL-CERAMIC SYSTEMS (ISO 9693-1:2012)
08/30192448 DC : DRAFT DEC 2008 BS ISO 14708-5 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 5: CIRCULATORY SUPPORT DEVICES
DIN EN ISO 1135-3:2014-12 (Draft) TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016)
BS ISO TR 11991:1995 Guidance on airway management during laser surgery of upper airway
13/30260084 DC : 0 BS ISO 17256 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - RESPIRATORY THERAPY TUBING AND CONNECTORS
DIN EN ISO 28319:2016-06 (Draft) DENTISTRY - LASER WELDING
10/30168824 DC : 0 BS EN ISO 6876 - DENTISTRY - ROOT CANAL SEALING MATERIALS
BS EN ISO 27020:2010 Dentistry. Brackets and tubes for use in orthodontics
ISO 16038:2017 Male condoms — Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
BS ISO 11712:2009 Anaesthetic and respiratory equipment. Supralaryngeal airways and connectors
15/30304642 DC : 0 BS ISO 11040-8 - PREFILLED SYRINGES - PART 8: REQUIREMENTS AND TEST METHODS FOR FINISHED PRIFILLED SYRINGES
UNI EN ISO 13688 : 2013 PROTECTIVE CLOTHING - GENERAL REQUIREMENTS
I.S. EN ISO 5367:2014 ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS (ISO 5367:2014)
BS ISO 8009:2014 Mechanical contraceptives. Reusable natural and silicone rubber contraceptive diaphragms. Requirements and tests
11/30243761 DC : 0 BS ISO 14708-7 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 7: PARTICULAR REQUIREMENTS FOR COCHLEAR IMPLANT SYSTEMS
I.S. EN ISO 9333:2006 DENTISTRY - BRAZING MATERIALS
I.S. EN 12011:1998 INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
BS EN ISO 13504:2012 Dentistry. General requirements for instruments and related accessories used in dental implant placement and treatment
I.S. EN 1819:1998 LARYNGOSCOPES FOR TRACHEAL INTUBATION - PARTICULAR REQUIREMENTS
AAMI ISO TIR 17665-2 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1
BS EN ISO 18397:2016 Dentistry. Powered scaler
BS ISO 6474-2:2012 Implants for surgery. Ceramic materials Composite materials based on a high-purity alumina matrix with zirconia reinforcement
ISO 14949:2001 Implants for surgery — Two-part addition-cure silicone elastomers
PREN 455-3 : DRAFT 2013 MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION
15/30289037 DC : 0 BS EN ISO 7886-1 - STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 1: SYRINGES FOR MANUAL USE
UNE-EN ISO 8536-13:2017 Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2016)
11/30219211 DC : 0 BS EN ISO 5840-3 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY MINIMALLY INVASIVE TECHNIQUES
CEI UNI EN ISO 14971 : 2013 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
I.S. EN ISO 11135-1:2007 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
13/30283636 DC : 0 BS ISO 13179-1 - IMPLANTS FOR SURGERY - PLASMA-SPRAYED UNALLOYED TITANIUM COATINGS ON SURGICAL IMPLANTS - PART 1: GENERAL REQUIREMENTS
BS ISO 11040-4:2015 Prefilled syringes Glass barrels for injectables and sterilized subassembled syringes ready for filling
04/30075452 DC : DRAFT FEB 2004 BS EN ISO 6874 - DENTISTRY - POLYMER-BASED PIT AND FISSURE SEALANTS
14/30295064 DC : 0 BS EN ISO 16672 - OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES
UNE-EN ISO 20857:2013 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
I.S. EN ISO 20857:2013 STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 20857:2010)
14/30296389 DC : 0 BS EN ISO 7864 - STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS
ISO 19023:2018 Dentistry — Orthodontic anchor screws
04/30057302 DC : DRAFT DEC 2004 BS EN ISO 9333 - DENTAL BRAZING MATERIALS
09/30180393 DC : 0 BS EN ISO 10451 - DENTISTRY - CONTENTS OF TECHNICAL FILE FOR DENTAL IMPLANT SYSTEMS
13/30259011 DC : 0 BS ISO 17218 - STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE
14/30281859 DC : 0 BS ISO 5361 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS
AAMI ISO 8637 : 2010 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HEMODIALYZERS, HEMODIAFILTERS, HEMOFILTERS AND HEMOCONCENTRATORS
16/30310674 DC : 0 BS EN ISO 14457 - DENTISTRY - HANDPIECES AND MOTORS
13/30273499 DC : 0 BS ISO 11040-4 - PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING
PD ISO/TR 15499:2016 Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
14/30302761 DC : 0 BS ISO 11249 - MECHANICAL CONTRACEPTIVES - GUIDANCE FOR CLINICAL EVALUATION OF INTRA-UTERINE CONTRACEPTIVE DEVICES (IUDS)
BS EN ISO 10477:2004 Dentistry. Polymer-based crown and bridge materials
13/30233325 DC : 0 BS EN 45502-1 - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER
02/564513 DC : DRAFT OCT 2002 BS EN ISO 1135-4 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE
I.S. EN ISO 10477:2004 DENTISTRY - POLYMER-BASED CROWN AND BRIDGE MATERIALS
ANSI/AAMI/ISO 11607-1:2006/(R)2015 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS
UNI EN ISO 13504 : 2012 DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT
14/30257546 DC : 0 BS ISO 17966 - ASSISTIVE PRODUCTS FOR PERSONAL HYGIENE THAT SUPPORT USERS - REQUIREMENTS AND TEST METHODS
BS ISO 16038:2017 Male condoms. Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
09/30157765 DC : 0 BS EN ISO 14160 REV - STERILIZATION OF HEALTH CARE PRODUCTS - LIQUID CHEMICAL STERILIZING AGENTS FOR SINGLE-USE MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - REQUIREMENTS FOR CHARACTERIZATION, DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
BS 7208-17(1998) : 1998 OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS
AAMI TIR41 : 2011 ACTIVE IMPLANTABLE MEDICAL DEVICES - GUIDANCE FOR DESIGNATION OF LEFT VENTRICLE AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEAD CONNECTORS AND PULSE GENERATOR CONNECTOR CAVITIES FOR IMPLANTABLE PACEMAKERS AND IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
15/30266276 DC : 0 BS ISO 18189 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - CYTOTOXICITY TESTING OF CONTACT LENSES AND CONTACT LENS CARE SOLUTIONS
14/30261590 DC : 0 BS EN ISO 10993-6 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION
DIN ISO 5832-14:2009-12 IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 14: WROUGHT TITANIUM 15-MOLYBDENUM 5-ZIRCONIUM 3-ALUMINIUM ALLOY
DIN EN ISO 13688:2013-12 Protective clothing - General requirements (ISO 13688:2013)
BS EN ISO 5361:2016 Anaesthetic and respiratory equipment. Tracheal tubes and connectors
BS EN 30993-5:1994 Biological evaluation of medical devices Tests for cytotoxicity, in vitro methods
15/30278530 DC : 0 BS ISO 18562-1 - BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
07/30164697 DC : 0 ISO 20857 - STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF AN INDUSTRIAL STERILIZATION PROCESS FOR MEDICAL DEVICES
UNI EN ISO 15854 : 2005 DENTISTRY - CASTING AND BASEPLATE WAXES
EN ISO 11199-1:1999 WALKING AIDS MANIPULATED BY BOTH ARMS - REQUIREMENTS AND TEST METHODS - PART 1: WALKING FRAMES
13/30279967 DC : 0 BS EN ISO 6872 - DENTISTRY - CERAMIC MATERIALS
BS ISO 18189:2016 Ophthalmic optics. Contact lenses and contact lens care products. Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions
08/30170164 DC : DRAFT AUG 2008 BS EN ISO 10993-10 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION
BS ISO 20308:2017 Traditional Chinese medicine. Gua Sha instruments
12/30244415 DC : DRAFT APR 2012 BS ISO 27427 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS
13/30263389 DC : 0 BS EN ISO 4823 - DENTISTRY - ELASTOMERIC IMPRESSION MATERIALS
16/30331653 DC : 0 BS EN ISO 8637-2 - EXTRACORPOREAL SYSTEMS FOR BLOOD PURIFICATION - PART 2: EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
UNI EN ISO 7197 : 2009 NEUROSURGICAL IMPLANTS - STERILE, SINGLE-USE HYDROCEPHALUS SHUNTS AND COMPONENTS
16/30319982 DC : 0 BS ISO 20308 - TRADITIONAL CHINESE MEDICINE - GUA SHA INSTRUMENTS
10/30209603 DC : 0 BS EN ISO 11608-2 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 2: NEEDLES
UNI CEI EN ISO 14971 : 2012 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
02/565260 DC : DRAFT DEC 2002 ISO 8638 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
NF ISO 18562-1 : 2017 BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
AAMI ISO 10993-13:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES
CSA Z7376 : 2012 ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION
BS EN ISO 16061:2015 Instrumentation for use in association with non-active surgical implants. General requirements
16/30328610 DC : 0 BS ISO 20749 - DENTISTRY - PRE-CAPSULATED DENTAL AMALGAM
AAMI ISO 14708-4 : 2008 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 4: IMPLANTABLE INFUSION PUMPS
17/30357890 DC : 0 BS ISO 20495 - TRADITIONAL CHINESE MEDICINE - SKIN ELECTRICAL RESISTANCE MEASUREMENT DEVICE
ANSI/AAMI/ISO 10993-5:2009(R2014) BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY
ANSI/AAMI/ISO 14160:2011(R2016) STERILIZATION OF HEALTH CARE PRODUCTS - LIQUID CHEMICAL STERILIZING AGENTS FOR SINGLE-USE MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - REQUIREMENTS FOR CHARACTERIZATION, DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
EN ISO 14160:2011 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011)
UNE-EN ISO 12417-1:2016 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015)
ASTM F 1635 : 2016 : REDLINE Standard Test Method for <emph type="bdit">in vitro</emph> Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
UNI EN ISO 25539-2 : 2013 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS
ISO 13175-3:2012 Implants for surgery — Calcium phosphates — Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes
UNI EN ISO 20857 : 2013 STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
DIN EN ISO 25539-2:2013-05 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)
AAMI ISO 12417-1 : 2015 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS
AAMI ISO 10993-16:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES
CSA Z11135-1 : 2009 : FR STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
ASTM F 2726 : 2008 Standard specification for fixation devices for tracheal tubes and other airway devices
DIN EN ISO 20857:2013-08 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
15/30278537 DC : 0 BS ISO 18562-3 - BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 3: TESTS FOR EMISSIONS OF VOLATILE ORGANIC COMPOUNDS (VOCS)
UNE-EN ISO 21563:2014 Dentistry - Hydrocolloid impression materials (ISO 21563:2013)
PREN ISO 20795-1 : DRAFT 2012 DENTISTRY - BASE POLYMERS - PART 1: DENTURE BASE POLYMERS (ISO/FDIS 20795-1:2012)
PREN ISO 20795-2 : DRAFT 2012 DENTISTRY - BASE POLYMERS - PART 2: ORTHODONTIC BASE POLYMERS (ISO/FDIS 20795-2:2012)
UNI EN ISO 27020 : 2011 DENTISTRY - BRACKETS AND TUBES FOR USE IN ORTHODONTICS
AAMI ISO 14971 : 2007 : R2010 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
UNI EN ISO 8638 : 2014 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
I.S. EN ISO 15798:2013 OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013)
I.S. EN ISO 13017:2012 DENTISTRY - MAGNETIC ATTACHMENTS (ISO 13017:2012)
ISO 25841:2017 Female condoms — Requirements and test methods
AAMI BE78 : 2002 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND DELAYED TYPE HYPERSENSITIVITY
I.S. EN ISO 7494-1:2011 DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS
I.S. EN ISO 7886-1:1998 STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 1: SYRINGES FOR MANUAL USE (ISO 7886-1:2017)
UNE-EN ISO 20795-1:2013 Dentistry - Base polymers - Part 1: Denture base polymers (ISO 20795-1:2013)
CSA ISO 10993-6 : 1997(R2009) BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION
UNE-EN ISO 17254:2017 Dentistry - Coiled springs for use in orthodontics (ISO 17254:2016)
UNI EN ISO 9693-1 : 2012 DENTISTRY - COMPATIBILITY TESTING - PART 1: METAL-CERAMIC SYSTEMS
ANSI/AAMI/ISO 10993-9:2009(R2014) BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS
I.S. EN ISO 25539-1:2017 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
ANSI/AAMI/ISO TIR16775:2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
AAMI/ISO TIR17665-2:2009(R2016) STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1
I.S. EN ISO 9917-2:2017 DENTISTRY - WATER-BASED CEMENTS - PART 2: RESIN-MODIFIED CEMENTS (ISO 9917-2:2017)
ANSI/AAMI/ISO 14708-1:2014 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER
PREN 868-9 : DRAFT 2017 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 9: UNCOATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
I.S. EN ISO 11607-1:2017 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006, INCLUDING AMD 1:2014)
ISO 11040-3:2012 Prefilled syringes — Part 3: Seals for dental local anaesthetic cartridges
ISO 6474-2:2012 Implants for surgery Ceramic materials Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement
ISO 17218:2014 Sterile acupuncture needles for single use
ISO/TS 16506:2017 Dentistry Polymer-based luting materials containing adhesive components
ISO 11040-8:2016 Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes
PREN ISO 3826-1 : DRAFT 2010 PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS
ISO 17510:2015 Medical devices — Sleep apnoea breathing therapy — Masks and application accessories
ISO 14708-4:2008 Implants for surgery Active implantable medical devices Part 4: Implantable infusion pumps
BS EN ISO 28158:2010 Dentistry. Integrated dental floss and handles
17/30359567 DC : 0 BS EN 14683 - MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
UNI EN ISO 11607-1 : 2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
DIN EN ISO 7405:2013-12 DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008 + AMD. 1:2013)
ASTM F 3223 : 2017 Standard Guide for Characterization and Assessment of Tissue Engineered Medical Products (TEMPs) for Knee Meniscus Surgical Repair and/or Reconstruction
EN ISO 28319:2018 Dentistry - Laser welding and filler materials (ISO 28319:2018)
ASTM F 2695 : 2012 : REDLINE Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
ASTM F 2051 : 2000 Standard Specification for Implantable Saline Filled Breast Prosthesis
EN 14683:2014 Medical face masks - Requirements and test methods
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
ISO 1562:2004 Dentistry Casting gold alloys
UNI EN ISO 7405 : 2013 DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY
I.S. EN ISO 9693:2000 METAL-CERAMIC DENTAL RESTORATIVE SYSTEMS
ISO 15674:2016 Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
EN ISO 20608:2018 Dentistry - Powder jet handpieces and powders (ISO 20608:2018)
EN ISO 4049:2009 Dentistry - Polymer-based restorative materials (ISO 4049:2009)
ISO/TS 10993-19:2006 Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials
EN ISO 14607:2018 Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018, Corrected version 2018-08)
UNI EN ISO 28158 : 2010 DENTISTRY - INTEGRATED DENTAL FLOSS AND HANDLES
EN ISO 10993-4:2017 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
ISO/TS 10993-20:2006 Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
ISO 5366-3:2001 Anaesthetic and respiratory equipment Tracheostomy tubes Part 3: Paediatric tracheostomy tubes
ISO 16840-2:2018 Wheelchair seating — Part 2: Determination of physical and mechanical characteristics of seat cushions intended to manage tissue integrity
ISO 8009:2014 Mechanical contraceptives — Reusable natural and silicone rubber contraceptive diaphragms — Requirements and tests
I.S. EN 14683:2014 MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01)
BS EN ISO 11607-1:2020 Packaging for terminally sterilized medical devices Requirements for materials, sterile barrier systems and packaging systems
I.S. EN ISO 8536-4:2013 INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 8536-4:2010)
DIN EN ISO 6877:2006-07 Dentistry - Root-canal obturating points (ISO 6877:2006)
DIN EN ISO 6874:2015-12 DENTISTRY - POLYMER-BASED PIT AND FISSURE SEALANTS (ISO 6874:2015)
BS EN ISO 8536-4 : 2013 INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED
DIN EN ISO 3107:2011-06 Dentistry - Zinc oxide/eugenol cements and zinc oxide/non-eugenol cements (ISO 3107:2011)
DIN EN ISO 21649 E : 2010 NEEDLE-FREE INJECTORS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS
UNE-EN ISO 6875:2012 Dentistry - Patient chair (ISO 6875:2011)
DIN EN ISO 11608-1 E : 2015 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS (ISO 11608-1:2014)
DIN EN ISO 10993-9:2010-04 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
DIN EN ISO 14160:2011-10 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011)
DIN EN ISO 14630:2013-03 Non-active surgical implants - General requirements (ISO 14630:2012)
DIN EN ISO 8536-4:2013-07 INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 8536-4:2010 + AMD 1:2013)
DIN EN ISO 16408:2015-12 DENTISTRY - ORAL CARE PRODUCTS - ORAL RINSES (ISO 16408:2015)
DIN EN ISO 14534:2015-08 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
DIN EN ISO 10993-5:2009-10 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY
BS EN ISO 1567:2001 Dentistry. Denture base polymers
ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
BS EN ISO 10993-14:2009 Biological evaluation of medical devices Identification and quantification of degradation products from ceramics
ISO 13504:2012 Dentistry — General requirements for instruments and related accessories used in dental implant placement and treatment
BS EN ISO 11608-2:2012 Needle-based injection systems for medical use. Requirements and test methods Needles
UNE-EN ISO 1135-4:2016 Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2015)
BS EN ISO 11979-5:2006 Ophthalmic implants. Intraocular lenses Biocompatibility
BS EN 12181:1998 Oropharyngeal airways
BS EN ISO 9333:2006 Dentistry. Brazing materials
ISO 21563:2013 Dentistry Hydrocolloid impression materials
UNE-EN ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)
ISO 10993-13:2010 Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices
BS EN ISO 3107:2011 Dentistry. Zinc oxide/eugenol cements and zinc oxide/ non-eugenol cements
ISO 14727:1998 Dental implants Prefabricated parts connecting suprastructures to dental implants Contents of technical file
BS EN ISO 13716:2000 Dentistry. Reversible-irreversible hydrocolloid impression material systems
BS EN ISO 11199-3:2005 Walking aids manipulated by both arms. Requirements and test methods Walking tables
ISO 11609:2017 Dentistry — Dentifrices — Requirements, test methods and marking
DIN EN ISO 9394 E : 2013 OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - DETERMINATION OF BIOCOMPATIBILITY BY OCULAR STUDY WITH RABBIT EYES (ISO 9394:2012)
ISO 20857:2010 Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO/TS 16775:2014 Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2
ISO 16744:2003 Dentistry Base metal materials for fixed dental restorations
ISO 1135-3:2016 Transfusion equipment for medical use Part 3: Blood-taking sets for single use
ISO 16061:2015 Instrumentation for use in association with non-active surgical implants General requirements
ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 9693-1:2012 Dentistry Compatibility testing Part 1: Metal-ceramic systems
ISO 3826-1:2013 Plastics collapsible containers for human blood and blood components Part 1: Conventional containers
ISO 7153-1:2016 Surgical instruments Materials Part 1: Metals
ISO 7376:2009 Anaesthetic and respiratory equipment Laryngoscopes for tracheal intubation
EN ISO 28399:2011 Dentistry - Products for external tooth bleaching (ISO 28399:2011)
ISO 16408:2015 Dentistry — Oral care products — Oral rinses
ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
BS EN ISO 10993-7:2008 Biological evaluation of medical devices Ethylene oxide sterilization residuals
ISO 7885:2010 Dentistry Sterile injection needles for single use
UNE-EN ISO 7153-1:2017 Surgical instruments - Materials - Part 1: Metals (ISO 7153-1:2016)
BS EN ISO 10993-2:2006 Biological evaluation of medical devices Animal welfare requirements
BS EN ISO 1562:2004 Dentistry. Casting gold alloys
BS EN 12011:1998 Instrumentation to be used in association with non-active surgical implants. General requirements
BS EN ISO 16408:2015 Dentistry. Oral care products. Oral rinses
BS EN ISO 3826-1:2013 Plastics collapsible containers for human blood and blood components Conventional containers
UNE-EN ISO 10139-2:2016 Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use (ISO 10139-2:2016)
BS EN ISO 17665-1:2006 Sterilization of health care products. Moist heat Requirements for the development, validation and routine control of a sterilization process for medical devices
BS EN ISO 15854:2005 Dentistry. Casting and baseplate waxes
UNE-EN ISO 10271:2012 Dental metallic materials - Corrosion test methods (ISO 10271:2011)
BS EN ISO 14937:2009 Sterilization of health care products. General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
AAMI TIR11:2005(R2015) SELECTION AND USE OF PROTECTIVE APPAREL AND SURGICAL DRAPES IN HEALTH CARE FACILITIES
ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
BS EN ISO 6871-2:1997 Dental base metal casting alloys Nickel-based alloys
BS EN ISO 12163:2000 Dental baseplate/modelling wax
BS EN ISO 21606:2007 Dentistry. Elastomeric auxiliaries for use in orthodontics
BS EN ISO 11608-3:2012 Needle-based injection systems for medical use. Requirements and test methods Finished containers
ISO 20072:2009 Aerosol drug delivery device design verification Requirements and test methods
BS EN ISO 11199-1:1999 Walking aids manipulated by both arms. Requirements and test methods Walking frames
UNE-EN ISO 4074:2016 Natural rubber latex male condoms - Requirements and test methods (ISO 4074:2015)
ISO 8536-13:2016 Infusion equipment for medical use Part 13: Graduated flow regulators for single use with fluid contact
ISO 1135-4:2015 Transfusion equipment for medical use — Part 4: Transfusion sets for single use, gravity feed
BS EN ISO 14727:1999 Dental implants. Prefabricated parts connecting suprastructures to dental implants. Contents of technical file
DIN EN ISO 21606:2007-10 Dentistry - Elastomeric auxiliaries for use in orthodontics (ISO 21606:2007)
UNE-EN 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
ISO 15841:2014 Dentistry Wires for use in orthodontics
BS EN ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
UNE-EN ISO 10993-12:2013 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
ISO 5840-3:2013 Cardiovascular implants Cardiac valve prostheses Part 3: Heart valve substitutes implanted by transcatheter techniques
ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
ISO 10993-14:2001 Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics
00/565497 DC : DRAFT DEC 2000 BS IEC 60601-1 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR SAFETY AND ESSENTIAL PERFORMANCE
ISO 17665-1:2006 Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
UNE-EN ISO 3826-1:2013 Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013)
BS EN ISO 11334-4:1999 Walking aids manipulated by one arm. Requirements and test methods Walking sticks with three or more legs
ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
ISO 17254:2016 Dentistry — Coiled springs for use in orthodontics
BS EN 12470-4 : 2001 CLINICAL THERMOMETERS - PART 4: PERFORMANCE OF ELECTRICAL THERMOMETERS FOR CONTINUOUS MEASUREMENT
ISO 10139-2:2016 Dentistry Soft lining materials for removable dentures Part 2: Materials for long-term use
ISO 16672:2015 Ophthalmic implants Ocular endotamponades
ISO 10535:2006 Hoists for the transfer of disabled persons Requirements and test methods
ISO 25539-2:2012 Cardiovascular implants Endovascular devices Part 2: Vascular stents
UNE-EN 1642:2012 Dentistry - Medical devices for dentistry - Dental implants
UNE-EN ISO 4049:2010 Dentistry - Polymer-based restorative materials (ISO 4049:2009)
ISO 6874:2015 Dentistry Polymer-based pit and fissure sealants
ISO 22674:2016 Dentistry — Metallic materials for fixed and removable restorations and appliances
BS EN 13503-8:2000 Ophthalmic implants. Intraocular lenses Fundamental requirements
ISO 6875:2011 Dentistry Patient chair
ISO 14534:2011 Ophthalmic optics Contact lenses and contact lens care products Fundamental requirements
BS EN ISO 6877:2006 Dentistry. Root-canal obturating points
UNE-EN ISO 9394:2013 Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes (ISO 9394:2012)
ISO 11979-5:2006 Ophthalmic implants Intraocular lenses Part 5: Biocompatibility
ISO 22112:2017 Dentistry — Artificial teeth for dental prostheses
DIN EN ISO 10993-13:2010-11 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
I.S. EN 455-3:2015 MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION
ISO 5361:2016 Anaesthetic and respiratory equipment — Tracheal tubes and connectors
ISO 6876:2012 Dentistry — Root canal sealing materials
ISO 1567:1999 Dentistry Denture base polymers
ISO 7439:2015 Copper-bearing contraceptive intrauterine devices — Requirements and tests
DIN EN ISO 11608-2:2012-12 Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles (ISO 11608-2:2012)
ISO 4823:2015 Dentistry Elastomeric impression materials
ISO 9917-1:2007 Dentistry Water-based cements Part 1: Powder/liquid acid-base cements
ISO 24234:2015 Dentistry Dental amalgam
BS EN ISO 11199-2:2005 Walking aids manipulated by both arms. Requirements and test methods Rollators
ISO 23747:2015 Anaesthetic and respiratory equipment Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
BS EN ISO 6875:2011 Dentistry. Patient chair
UNE-EN ISO 14534:2015 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
BS EN ISO 22112:2017 Dentistry. Artificial teeth for dental prostheses
ISO 8536-4:2010 Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed
ISO 11334-4:1999 Walking aids manipulated by one arm Requirements and test methods Part 4: Walking sticks with three or more legs
BS EN ISO 24234 : 2004 DENTISTRY - DENTAL AMALGAM
ISO 13017:2012 Dentistry Magnetic attachments
ISO 22523:2006 External limb prostheses and external orthoses — Requirements and test methods
UNE-EN ISO 11070:2015 Sterile single-use intravascular introducers, dilators and guidewires (ISO 11070:2014)
ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO 20795-2:2013 Dentistry Base polymers Part 2: Orthodontic base polymers
ISO 5840-2:2015 Cardiovascular implants Cardiac valve prostheses Part 2: Surgically implanted heart valve substitutes
ISO 11608-1:2014 Needle-based injection systems for medical use Requirements and test methods Part 1: Needle-based injection systems
UNE-EN ISO 14937:2010 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
ISO 11334-1:2007 Assistive products for walking manipulated by one arm Requirements and test methods Part 1: Elbow crutches
UNE-EN ISO 14630:2013 Non-active surgical implants - General requirements (ISO 14630:2012)
AAMI ISO 10993-4 : 2002 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD
UNE-EN 45502-2-3:2010 Active implantable medical devices -- Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
BS EN 1282-2 : 2005 TRACHEOSTOMY TUBES - PART 2: PAEDIATRIC TUBES
ISO 14160:2011 Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
BS EN ISO 5840:2009 Cardiovascular implants. Cardiac valve prostheses
BS EN 30993-4:1994 Biological evaluation of medical devices Selection of tests for interactions with blood
BS EN ISO 10451:2010 Dentistry. Contents of technical file for dental implant systems
ISO 12417-1:2015 Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements
BS EN ISO 11609:2017 Dentistry. Dentifrices. Requirements, test methods and marking
ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
ISO 3107:2011 Dentistry — Zinc oxide/eugenol cements and zinc oxide/non-eugenol cements
BS EN ISO 6874:2015 Dentistry. Polymer-based pit and fissure sealants
UNE-EN ISO 10993-9:2010 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
BS EN ISO 5366-1:2004 Anaesthetic and respiratory equipment. Tracheostomy tubes Tubes and connectors for use in adults
BS EN ISO 10993-13:2010 Biological evaluation of medical devices Identification and quantification of degradation products from polymeric medical devices
ISO 11499:2014 Dentistry — Single-use cartridges for local anaesthetics
BS EN 30993-3:1994 Biological evaluation of medical devices Tests for genotoxicity, carcinogenicity and reproductive toxicity
UNE-EN ISO 7864:2017 Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
ISO 4074:2015 Natural rubber latex male condoms Requirements and test methods
BS EN 12180:2000 Non-active surgical implants. Body contouring implants. Specific requirements for mammary implants
ISO 10451:2010 Dentistry — Contents of technical file for dental implant systems
ISO 11608-2:2012 Needle-based injection systems for medical use Requirements and test methods Part 2: Needles
ISO 9693-2:2016 Dentistry Compatibility testing Part 2: Ceramic-ceramic systems
ISO 11608-3:2012 Needle-based injection systems for medical use Requirements and test methods Part 3: Finished containers
BS EN ISO 22794:2009 Dentistry. Implantable materials for bone filling and augmentation in oral and maxillofacial surgery. Contents of a technical file
ISO 11199-3:2005 Walking aids manipulated by both arms Requirements and test methods Part 3: Walking tables
ISO 9333:2006 Dentistry — Brazing materials
BS EN 12182:2012 Assistive products for persons with disability. General requirements and test methods
BS EN 1641:2004 Dentistry. Medical devices for dentistry. Materials
ISO 5366-1:2000 Anaesthetic and respiratory equipment Tracheostomy tubes Part 1: Tubes and connectors for use in adults
I.S. EN ISO 10993-15:2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS (ISO 10993-15:2000)
EN 30-1-2:2012 Domestic cooking appliances burning gas - Safety - Part 1-2: Appliances having forced-convection ovens and/or grills
EN ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006)
EN ISO 1567 : 2000 DENTISTRY - DENTURE BASE POLYMERS
EN ISO 8536-13:2016 Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2016)
EN ISO 11199-3 : 2005 WALKING AIDS MANIPULATED BY BOTH ARMS - REQUIREMENTS AND TEST METHODS - PART 3: WALKING TABLES
EN ISO 20795-1:2013 Dentistry - Base polymers - Part 1: Denture base polymers (ISO 20795-1:2013)
EN ISO 24234:2015 Dentistry - Dental amalgam (ISO 24234:2015)
EN ISO 10993-6:2016 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
EN ISO 11334-4 : 1999 WALKING AIDS MANIPULATED BY ONE ARM - REQUIREMENTS AND TEST METHODS - WALKING STICKS WITH THREE OR MORE LEGS
EN ISO 1135-3:2017 Transfusion equipment for medical use - Part 3: Blood-taking sets for single use (ISO 1135-3:2016)
EN 15424:2007 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
EN ISO 3107:2011 Dentistry - Zinc oxide/eugenol cements and zinc oxide/non-eugenol cements (ISO 3107:2011)
EN ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
EN ISO 22674:2016 Dentistry - Metallic materials for fixed and removable restorations and appliances (ISO 22674:2016)
EN ISO 21649:2009 Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006)
EN ISO 6876:2012 Dentistry - Root canal sealing materials (ISO 6876:2012)
EN ISO 5361:2016 Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016)
EN 1733 : 2002 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
EN ISO 21606:2007 Dentistry - Elastomeric auxiliaries for use in orthodontics (ISO 21606:2007)
EN ISO 10993-10:2013 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
EN ISO 7153-1:2016 Surgical instruments - Materials - Part 1: Metals (ISO 7153-1:2016)
EN ISO 6874:2015 Dentistry - Polymer-based pit and fissure sealants (ISO 6874:2015)
EN ISO 11608-2:2012 Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles (ISO 11608-2:2012)
EN ISO 10993-15:2009 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)
EN ISO 11137-1:2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
EN ISO 7197:2009 Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007)
EN ISO 22803:2005 Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004)
EN ISO 14727:1998/AC:1998 DENTAL IMPLANTS - PREFABRICATED PARTS CONNECTING SUPRASTRUCTURES TO DENTAL IMPLANTS - CONTENTS OF TECHNICAL FILE
EN 12342:1998+A1:2009 Breathing tubes intended for use with anaesthetic apparatus and ventilators
EN ISO 10139-2:2016 Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use (ISO 10139-2:2016)
EN 1641:2009 Dentistry - Medical devices for dentistry - Materials
UNI CEN ISO/TS 16775 : 2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
EN ISO 11499:2014 Dentistry - Single-use cartridges for local anaesthetics (ISO 11499:2014)
EN 45502-2-3:2010 Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)
EN 1642:2011 Dentistry - Medical devices for dentistry - Dental implants
EN ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
EN ISO 10451:2010 Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010)
EN ISO 10993-14:2009 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)
EN 30993-6 : 1994 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION
EN ISO 9333:2006 Dentistry - Brazing materials (ISO 9333:2006)
EN ISO 16408:2015 Dentistry - Oral care products - Oral rinses (ISO 16408:2015)
EN ISO 22794:2009 Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007, corrected version 2009-01-15)
EN 30993-4 : 1993 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD
EN ISO 9693-2:2016 Dentistry - Compatibility testing - Part 2: Ceramic-ceramic systems (ISO 9693-2:2016)
EN 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
EN ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
EN ISO 20072:2013 Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009)
EN ISO 20857:2013 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
EN ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)
EN ISO 9917-2:2017 DENTISTRY - WATER-BASED CEMENTS - PART 2: RESIN-MODIFIED CEMENTS (ISO 9917-2:2017)
EN 12470-4:2000+A1:2009 Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement
EN 30993-3 : 1993 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY
EN ISO 14534:2015 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
EN ISO 11609:2017 Dentistry - Dentifrices - Requirements, test methods and marking (ISO 11609:2017)
EN ISO 9394:2012 Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes (ISO 9394:2012)
EN ISO 11608-1:2015 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014)
EN 30993-5 : 1994 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - TESTS FOR CYTOTOXICITY - IN VITRO METHODS
EN ISO 9693-1:2012 Dentistry - Compatibility testing - Part 1: Metal-ceramic systems (ISO 9693-1:2012)
EN ISO 14630:2012 Non-active surgical implants - General requirements (ISO 14630:2012)
EN ISO 9917-1:2007 Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements (ISO 9917-1:2007)
EN ISO 1562 : 2004 DENTISTRY - CASTING GOLD ALLOYS
EN ISO 27020:2010 Dentistry - Brackets and tubes for use in orthodontics (ISO 27020:2010)
EN ISO 17665-1 : 2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
EN ISO 1135-5:2015 Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2015)
EN ISO 11608-3:2012 Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers (ISO 11608-3:2012)
EN ISO 11334-1:2007 Assistive products for walking manipulated by one arm - Requirements and test methods - Part 1: Elbow crutches (ISO 11334-1:2007)
EN ISO 20795-2:2013 Dentistry - Base polymers - Part 2: Orthodontic base polymers (ISO 20795-2:2013)
EN ISO 12417-1:2015 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015)
EN ISO 4074:2015 Natural rubber latex male condoms - Requirements and test methods (ISO 4074:2015)
EN ISO 23747:2015 Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2015)
EN ISO 18397:2016 Dentistry - Powered scaler (ISO 18397:2016)
EN 13824 : 2004 STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS
EN ISO 5367:2014 Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014)
EN ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016)
EN ISO 7439:2015 Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2015)
EN ISO 13504:2012 Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment (ISO 13504:2012)
EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
EN ISO 7885:2010 Dentistry - Sterile injection needles for single use (ISO 7885:2010)
EN ISO 6875:2011 Dentistry - Patient chair (ISO 6875:2011)
EN ISO 10993-17:2009 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
EN ISO 3826-1:2013 Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013)
DIN EN ISO 20126 E : 2012 DENTISTRY - MANUAL TOOTHBRUSHES - GENERAL REQUIREMENTS AND TEST METHODS (ISO 20126:2012)
08/30156451 DC : DRAFT AUG 2008 BS EN ISO 10993-13 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES
DIN EN ISO 17730:2015-03 Dentistry - Fluoride varnishes (ISO 17730:2014); German version EN ISO 17730:2014
EN ISO 10555-1:2013/A1:2017 INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS (ISO 10555-1:2013/AMD 1:2017)
12/30210881 DC : DRAFT APR 2012 BS EN ISO 5367 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS
ISO 14708-1:2014 Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
DIN EN ISO 20072:2013-10 AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009)
ONORM EN ISO 11070 : 2015 STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES (ISO 11070:2014)
DIN EN ISO 18397:2016-09 DENTISTRY - POWERED SCALER (ISO 18397:2016)
DIN EN ISO 5840-3:2013-06 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013)
CSA ISO 27427 : 2014 ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS
BS EN ISO 20857:2013 Sterilization of health care products. Dry heat. Requirements for the development, validation and routine control of a sterilization process for medical devices
ANSI/AAMI/ISO 14937:2009(R2013) STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
ISO 8536-12:2007 Infusion equipment for medical use Part 12: Check valves
01/561789 DC : DRAFT APR 2001 BS ISO 13960 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - PLASMAFILTERS
04/30105055 DC : DRAFT MAY 2004 ISO 8600-1 - OPTICS AND OPTICAL INSTRUMENTS - MEDICAL ENDOSCOPES AND ENDOTHERAPY DEVICES - PART 1: GENERAL REQUIREMENTS
02/563797 DC : DRAFT SEP 2002 BS EN ISO 11199-3 - WALKING AIDS MANIPULATED BY BOTH ARMS - REQUIREMENTS AND TEST METHODS - PART 3: WALKING TABLES
PREN 45502-1 : DRAFT 2013 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER
13/30290370 DC : 0 BS ISO 17510 - MEDICAL DEVICES - SLEEP APNOEA BREATHING THERAPY - MASKS AND APPLICATION ACCESSORIES
I.S. EN ISO 25539-2:2012 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS (ISO 25539-2:2012)
02/121895 DC : DRAFT APR 2002 BS EN 13060 - SMALL STEAM STERILIZERS
08/30168851 DC : DRAFT JULY 2008 BS EN ISO 11609 - DENTISTRY - DENTIFRICES - REQUIREMENTS, TEST METHODS AND MARKING
16/30331656 DC : 0 BS ISO 8637-3 - EXTRACORPOREAL SYSTEMS FOR BLOOD PURIFICATION - PART 3: PLASMAFILTERS
ASTM F 1441 : 2003 Standard Specification for Soft-Tissue Expander Devices
BS EN ISO 1135-3:2017 Transfusion equipment for medical use Blood-taking sets for single use
DIN EN ISO 10873:2010-12 Dentistry - Denture adhesives (ISO 10873:2010)
I.S. EN ISO 13504:2012 DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT (ISO 13504:2012)
10/30203224 DC : 0 BS ISO 13022 - MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES
15/30316155 DC : 0 BS ISO 16840-2 - WHEELCHAIR SEATING - PART 2: DETERMINATION OF PHYSICAL AND MECHANICAL CHARACTERISTICS OF DEVICES INTENDED TO MANAGE TISSUE INTEGRITY - SEAT CUSHIONS
10/30233840 DC : 0 BS ISO 3826-1 - PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS
I.S. EN ISO 13688:2013 PROTECTIVE CLOTHING - GENERAL REQUIREMENTS (ISO 13688:2013)
BS ISO 27427:2013 Anaesthetic and respiratory equipment. Nebulizing systems and components
17/30358658 DC : 0 BS EN 13795-1 - SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 1: SURGICAL DRAPES AND GOWNS
DIN EN ISO 12417-1:2016-02 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
AAMI ISO 10993-9 : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS
ANSI/AAMI/ISO 10993-10:2010(R2014) BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION
UNE-EN ISO 5840-3:2013 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013)
14/30273278 DC : 0 BS EN ISO 18397 - DENTISTRY - POWERED SCALER
BS EN ISO 10873:2010 Dentistry. Denture adhesives
AAMI ISO 10993-15 : 2000 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS
I.S. EN ISO 18397:2016 DENTISTRY - POWERED SCALER (ISO 18397:2016)
BS ISO 20749 : 2017 DENTISTRY - PRE-CAPSULATED DENTAL AMALGAM
16/30335531 DC : 0 BS EN ISO 10993-16 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES
DD ISO/TS 10993-19:2006 Biological evaluation of medical devices Physico-chemical, morphological and topographical characterization of materials
I.S. EN ISO 10873:2010 DENTISTRY - DENTURE ADHESIVES
PD ISO/TS 16506:2017 Dentistry. Polymer-based luting materials containing adhesive components
BS ISO 29942:2011 Prophylactic dams. Requirements and test methods
12/30251858 DC : 0 BS ISO 4074 - NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS
16/30312836 DC : 0 BS ISO 19227 - CLEANING OF ORTHOPEDIC IMPLANTS - GENERAL REQUIREMENTS
PD ISO/TR 37137:2014 Cardiovascular biological evaluation of medical devices. Guidance for absorbable implants
CSA ISO 10993-2 : 1997 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 2: ANIMAL WELFARE REQUIREMENTS
DIN EN 14683:2014-07 MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
BS EN ISO 3826-4:2015 Plastics collapsible containers for human blood and blood components Aphaeresis blood bag systems with integrated features
ANSI/AAMI BE83:2006(R2011) BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
DD CEN ISO/TS 17665-2:2009 Sterilization of health care products. Moist heat Guidance on the application of ISO 17665-1
UNE-EN ISO 27020:2011 Dentistry - Brackets and tubes for use in orthodontics (ISO 27020:2010)
BS EN ISO 9917-2:2017 Dentistry. Water-based cements Resin-modified cements
DIN EN ISO 27020:2011-04 DENTISTRY - BRACKETS AND TUBES FOR USE IN ORTHODONTICS
AAMI ISO 7199 : 2009 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS)
07/30163763 DC : 0 BS ISO 7405 - DENTISTRY - PRECLINICAL EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY - TEST METHODS FOR DENTAL MATERIALS
PREN ISO 11499 : DRAFT 2013 DENTISTRY - SINGLE-USE CARTRIDGES FOR LOCAL ANAESTHETICS (ISO/DIS 11499:2013)
BS ISO 16840-10:2014 Wheelchairs. Resistance to ignition of non-integrated seat and back support cushions Requirements and test methods
08/30179589 DC : DRAFT MAR 2008 BS ISO 15674 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HARD-SHELL CARDIOTOMY/VENOUS RESERVOIR SYSTEMS (WITH/WITHOUT FILTER) AND SOFT VENOUS RESERVOIR BAGS
CSA Z8637 : 2008 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
16/30310949 DC : 0 BS ISO 5910 - CARDIOVASCULAR IMPLANTS AND EXTRACOPOREAL SYSTEMS - CARDIAC VALVE REPAIR DEVICES
CSA ISO 5840 : 0 CARDIOVASCULAR IMPLANTS - CARIDAC VALVE PROSTHESES
04/30048301 DC : DRAFT MAY 2004 BS EN ISO 11137-1 - STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
14/30263393 DC : 0 BS EN ISO 9693-2 - DENTISTRY - COMPATIBILITY TESTING - PART 2: CERAMIC-CERAMIC SYSTEMS
DIN ISO 8536-12:2013-04 Infusion equipment for medical use - Part 12: Check valves (ISO 8536-12:2007 + Amd. 1:2012)
15/30314236 DC : 0 BS ISO 15676 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - REQUIREMENTS FOR SINGLE-USE TUBING PACKS FOR CARDIOPULMONARY BYPASS AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO)
CSA Z17665-2 : 2009 : R2014 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
S.R. CEN ISO/TS 17665-2:2009 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
CSA ISO 8638 : 2012 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
04/19975667 DC : 0 BS ISO 15676 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - SINGLE - USE TUBING PACKS FOR CARDIOPULMONARY BYPASS AND EXTRACORPOREAL MEMBRANCE OXYGENATION
07/30162839 DC : 0 BS EN ISO 10993-9 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS
UNI EN ISO 15841 : 2014 DENTISTRY - WIRES FOR USE IN ORTHODONTICS
DIN ISO 5832-14:2009-12 IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 14: WROUGHT TITANIUM 15-MOLYBDENUM 5-ZIRCONIUM 3-ALUMINIUM ALLOY
DIN EN ISO 8836:2015-02 Suction catheters for use in the respiratory tract (ISO 8836:2014); German version EN ISO 8836:2014
09/30168805 DC : 0 BS EN ISO 3107 - DENTISTRY - ZINC OXIDE/EUGENOL CEMENTS AND ZINC OXIDE/NON-EUGENOL CEMENTS
13/30283694 DC : 0 BS EN ISO 1135-5 - TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS
BS ISO 7197:1997 Neurosurgical implants. Sterile, single-use hydrocephalus shunts and components
11/30227618 DC : 0 BS ISO 11658 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - BLOOD/TISSUE CONTACT SURFACE MODIFICATIONS FOR EXTRACORPOREAL PERFUSION SYSTEMS
DIN EN ISO 5367:2015-02 Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014)
08/30168864 DC : DRAFT MAY 2008 BS ISO 20795-2 - DENTISTRY - BASE POLYMERS - PART 2: ORTHODONTIC BASE POLYMERS
15/30283697 DC : 0 BS EN ISO 8536-13 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 13: GRADUATED FLOW REGULATORS FOR SINGLE USE WITH FLUID CONTACT
07/30167333 DC : DRAFT AUG 2007 BS EN 868-9 - PACKAGING MATERIALS FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 9: UNCOATED NONWOVEN MATERIALS OF POLYOLEFINES FOR USE IN THE MANUFACTURE OF SEALABLE POUCHES, REELS AND LIDS - REQUIREMENTS AND TEST METHODS
02/560790 DC : DRAFT FEB 2002 BS EN ISO 16671 - OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY
ASTM F 2887 : 2017 : REDLINE Standard Specification for Total Elbow Prostheses
ISO/TS 17137:2014 Cardiovascular implants and extracorporeal systems Cardiovascular absorbable implants
DIN EN 868-9:2009-09 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 9: UNCOATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
I.S. EN ISO 3826-4:2015 PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHAERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015)
ISO 11040-4:2015 Prefilled syringes Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
05/30060678 DC : DRAFT SEP 2005 BS EN ISO 22794 - DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE
EN ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
BS EN 14683:2014 Medical face masks. Requirements and test methods
AAMI ISO 10993-16 : 2010 : R2014 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES
CSA ISO 5367 : 2014 BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
I.S. EN ISO 1135-3:2017 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016)
AAMI ISO TIR 17665-3:2014 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION
AAMI ISO 14708-4:2008(R2011) IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 4: IMPLANTABLE INFUSION PUMPS
CSA ISO 14971 : 2007 : R2017 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
CSA ISO 14971 : 2007 : R2012 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
CSA ISO 8637 : 2012 : INC : AMD 1 : 2015 : R2017 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
UNI EN ISO 4049 : 2009 DENTISTRY - POLYMER-BASED RESTORATIVE MATERIALS
ONORM EN ISO 5840-2 : 2015 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES (ISO 5840-2:2015)
I.S. EN ISO 28399:2011 DENTISTRY - PRODUCTS FOR EXTERNAL TOOTH BLEACHING
PREN ISO 11608-1 : DRAFT 2010 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS
PREN 13795-2 : DRAFT 2017 SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 2: CLEAN AIR SUITS
BS EN ISO 11607-1 : 2009 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
AAMI ISO 11137-1 : 2006 : R2010 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
EN ISO 11199-2:2005 Walking aids manipulated by both arms - Requirements and test methods - Part 2: Rollators (ISO 11199-2:2005)
I.S. EN ISO 20608:2018 DENTISTRY - POWDER JET HANDPIECES AND POWDERS (ISO 20608:2018)
AAMI ISO 14160 : 2011 STERILIZATION OF HEALTH CARE PRODUCTS - LIQUID CHEMICAL STERILIZING AGENTS FOR SINGLE-USE MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - REQUIREMENTS FOR CHARACTERIZATION, DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
AAMI ISO 10993-2 : 2006 : R2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 2: ANIMAL WELFARE REQUIREMENTS
ANSI/AAMI/ISO 10993-12:2012 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS
ANSI/AAMI/ISO 18242:2016 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CENTRIFUGAL BLOOD PUMPS
I.S. EN ISO 16061:2015 INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015)
I.S. EN ISO 20795-1:2013 DENTISTRY - BASE POLYMERS - PART 1: DENTURE BASE POLYMERS (ISO 20795-1:2013)
DIN EN ISO 10993-11:2015-12 (Draft) BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY
I.S. EN ISO 19023:2018 DENTISTRY - ORTHODONTIC ANCHOR SCREWS (ISO 19023:2018)
ISO 10555-1:2013 Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
I.S. EN 45502-2-3:2010 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS
ISO/TR 14283:2018 Implants for surgery Essential principles of safety and performance
I.S. EN ISO 17730:2014 DENTISTRY - FLUORIDE VARNISHES (ISO 17730:2014)
EN ISO 10993-16:2017 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
ISO 10139-1:2018 Dentistry — Soft lining materials for removable dentures — Part 1: Materials for short-term use
I.S. EN ISO 6872:2015 DENTISTRY - CERAMIC MATERIALS (ISO 6872:2015)
CSA Z5361 : 2003 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS
ISO 16671:2015 Ophthalmic implants — Irrigating solutions for ophthalmic surgery
ISO 20749:2017 Dentistry — Pre-capsulated dental amalgam
ISO 16037:2002 Rubber condoms for clinical trials Measurement of physical properties
UNE-EN ISO 9693-2:2016 Dentistry - Compatibility testing - Part 2: Ceramic-ceramic systems (ISO 9693-2:2016)
ISO 20608:2018 Dentistry — Powder jet handpieces and powders
DIN EN ISO 20126:2012-06 DENTISTRY - MANUAL TOOTHBRUSHES - GENERAL REQUIREMENTS AND TEST METHODS (ISO 20126:2012)
UNE-EN ISO 10993-4:2018 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
ISO 17966:2016 Assistive products for personal hygiene that support users Requirements and test methods
ISO 14708-5:2010 Implants for surgery Active implantable medical devices Part 5: Circulatory support devices
I.S. EN ISO 7199:2017 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016)
BIS IS/ISO 5364 : 2008 ANAESTHETIC AND RESPIRATORY EQUIPMENT - OROPHARYNGEAL AIRWAYS
ASTM F 1441 : 2003 : R2009 Standard Specification for Soft-Tissue Expander Devices
UNE-EN ISO 3630-5:2012 Dentistry - Endodontic instruments - Part 5: Shaping and cleaning instruments (ISO 3630-5:2011)
DIN EN ISO 7494-1:2011-11 DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS (ISO 7494-1:2011)
ASTM F 748 : 2016 : REDLINE Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
UNI EN ISO 22794 : 2009 DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE
UNI EN ISO 17730 : 2015 DENTISTRY - FLUORIDE VARNISHES
ASTM F 2212 : 2011 : REDLINE Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
ASTM F 2051 : 2000 : R2006 Standard Specification for Implantable Saline Filled Breast Prosthesis
ASTM F 1441 : 2003 : R2014 Standard Specification for Soft-Tissue Expander Devices
CSA ISO 10993-3 : 1997 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY
UNE-EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)
ISO 28158:2010 Dentistry Integrated dental floss and handles
ISO 16391:2002 Aids for ostomy and incontinence Irrigation sets Requirements and test methods
EN ISO 14457:2017 Dentistry - Handpieces and motors (ISO 14457:2017)
EN ISO 7405:2008/A1:2013 DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008)
ISO 8600-1:2015 Endoscopes — Medical endoscopes and endotherapy devices — Part 1: General requirements
ASTM F 2847 : 2017 : REDLINE Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments
NF EN ISO 14160 : 2011 STERILIZATION OF HEALTH CARE PRODUCTS - LIQUID CHEMICAL STERILIZING AGENTS FOR SINGLE-USE MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - REQUIREMENTS FOR CHARACTERIZATION, DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
I.S. EN 868-9:2009 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 9: UNCOATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
EN ISO 6877:2006 Dentistry - Root-canal obturating points (ISO 6877:2006)
I.S. EN ISO 20072:2013 AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009)
I.S. EN ISO 10993-4:2017 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD (ISO 10993-4:2017)
ISO 27427:2013 Anaesthetic and respiratory equipment — Nebulizing systems and components
ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
ONORM EN ISO 3826-1 : 2013 PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS (ISO 3826-1:2013)
DIN EN ISO 10993-14 E : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 14: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM CERAMICS
DIN EN ISO 10993-18 E : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
DIN EN ISO 11137-1:2015-11 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11137-1:2006, INCLUDING AMD 1:2013)
DIN EN ISO 10535:2007-04 Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006)
DIN EN ISO 10451:2010-11 Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010)
DIN EN ISO 10993-6:2009-08 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016)
ISO 28399:2011 Dentistry Products for external tooth bleaching
ISO 13688:2013 Protective clothing — General requirements
ISO 25539-1:2017 Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses
BS EN ISO 11135-1:2007 Sterilization of health care products. Ethylene oxide Requirements for development, validation and routine control of a sterilization process for medical devices
DIN EN ISO 10993-14:2009-08 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)
UNE-EN ISO 22674:2016 Dentistry - Metallic materials for fixed and removable restorations and appliances (ISO 22674:2016)
BS EN ISO 22674:2016 Dentistry. Metallic materials for fixed and removable restorations and appliances
BS EN ISO 10993-17:2009 Biological evaluation of medical devices Establishment of allowable limits for leachable substances
BS EN ISO 11608-1:2015 Needle-based injection systems for medical use. Requirements and test methods Needle-based injection systems
ISO 10873:2010 Dentistry Denture adhesives
BS EN ISO 4823:2015 Dentistry. Elastomeric impression materials
ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
ISO 22803:2004 Dentistry — Membrane materials for guided tissue regeneration in oral and maxillofacial surgery — Contents of a technical file
BS EN ISO 15841:2014 Dentistry. Wires for use in orthodontics
EN ISO 7199:2017 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016)
BS EN ISO 4049:2009 Dentistry. Polymer-based restorative materials
BS EN ISO 16744:2003 Dentistry. Base metal materials for fixed dental restorations
BS EN 1733:2002 Suction catheters for use in the respiratory tract
BS EN 1642:2011 Dentistry. Medical devices for dentistry. Dental implants
ISO 3826-4:2015 Plastics collapsible containers for human blood and blood components — Part 4: Aphaeresis blood bag systems with integrated features
ISO 17730:2014 Dentistry Fluoride varnishes
BS EN ISO 16672:2015 Ophthalmic implants. Ocular endotamponades
ISO 14630:2012 Non-active surgical implants General requirements
ISO/TS 17665-2:2009 Sterilization of health care products Moist heat Part 2: Guidance on the application of ISO 17665-1
DIN EN ISO 11608-3:2013-01 Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers (ISO 11608-3:2012)
BS EN ISO 4074:2015 Natural rubber latex male condoms. Requirements and test methods
BS EN ISO 9917-1:2007 Dentistry. Water-based cements Powder/liquid acid-base cements
DIN EN ISO 5840:2009-08 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES
EN 45502-1 : 2015 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER
EN ISO 16061:2015 Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)
DIN EN ISO 4823:2015-12 Dentistry - Elastomeric impression materials (ISO 4823:2015)
UNI EN ISO 10993-9 : 2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS
EN ISO 4823:2015 Dentistry - Elastomeric impression materials (ISO 4823:2015)
EN 12470-5 : 2003 CLINICAL THERMOMETERS - PART 5: PERFORMANCE OF INFRA-RED EAR THERMOMETERS (WITH MAXIMUM DEVICE)
ONORM EN ISO 10993-9 : 2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS
EN ISO 1135-4 : 2015 COR 2016 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 1135-4:2015)
DIN EN ISO 10993-11:2009-08 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY
DIN EN ISO 1562:2004-08 DENTISTRY - CASTING GOLD ALLOYS
EN 12442-1 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK
EN ISO 5840:2009 Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)
DIN EN 13824:2005-02 STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS
EN 12523 : 1999 EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS
DIN EN ISO 14937:2010-03 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
EN ISO 10535:2006 Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006)
EN ISO 13688:2013 Protective clothing - General requirements (ISO 13688:2013)
DIN EN ISO 15854:2005-10 Dentistry - Casting and baseplate waxes (ISO 15854:2005)
DIN EN ISO 25539-1:2017-09 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
DIN EN ISO 10993-6:2017-09 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016)
EN ISO 10993-7 : 2008 COR 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS (ISO 10993-7:2008/COR 1:2009)
DIN EN 1282-2:2009-12 TRACHEOSTOMY TUBES - PART 2: PAEDIATRIC TUBES
I.S. EN ISO 3107:2011 DENTISTRY - ZINC OXIDE/EUGENOL CEMENTS AND ZINC OXIDE/NONEUGENOL CEMENTS
CEN ISO/TS 17665-2:2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009)
DIN EN ISO 10993-10:2003-02 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010)
BS 5081-2(1993) : 1993 AMD 9104 STERILE HYPODERMIC SYRINGES AND NEEDLES - SPECIFICATION FOR STERILE HYPODERMIC NEEDLES FOR SINGLE USE
ONORM EN 455-3 : 2015 MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION
ONORM EN ISO 5367 : 2015 ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS (ISO 5367:2014)

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