DIN EN ISO 11137-1:2015-11
Withdrawn
Withdrawn
View Superseded by
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)
Available format(s)
Hardcopy , PDF
Language(s)
German, English
Published date
11-01-2015
Withdrawn date
01-29-2021
Superseded by
US$216.72
Excluding Tax where applicable
This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.
| Committee |
TC 198
|
| DevelopmentNote |
Supersedes DIN EN 552. (07/2006) DRAFT AMD 2 issued in October 2017. (10/2017)
|
| DocumentType |
Standard
|
| Pages |
50
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 11137-1:2006 | Identical |
| NF EN ISO 11137-1 : 2016 | Identical |
| NBN EN ISO 11137-1 : 2015 | Identical |
| NEN EN ISO 11137-1 : 2015 | Identical |
| NS EN ISO 11137-1 : 2015 | Identical |
| I.S. EN ISO 11137-1:2015 | Identical |
| BS EN ISO 11137-1:2015 | Identical |
| EN ISO 11137-1:2015 | Identical |
| UNE-EN ISO 11137-1:2015 | Identical |
| DIN HDBK 267/2 : 2ED 2014 | |
| 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) |
| DIN EN ISO 8836:2015-02 | Suction catheters for use in the respiratory tract (ISO 8836:2014); German version EN ISO 8836:2014 |
| DIN EN ISO 7199:2015-06 (Draft) | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016) |
| DIN EN ISO 11137-3:2015-08 (Draft) | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL (ISO 11137-3:2017) |
| DIN EN ISO 13408-1:2015-12 | Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013) |
| DIN EN ISO 25539-3:2012-03 | Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011) |
| DIN EN ISO 16061:2015-09 | Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
| 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 16672:2015-12 | Ophthalmic implants - Ocular endotamponades (ISO 16672:2015) |
| VDI 2083 Blatt 9.2:2017-01 | Cleanroom technology - Consumables in the cleanroom |
| 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 ISO 8536-10:2015-11 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 10: ACCESSORIES FOR FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-10:2015) |
| DIN EN ISO 8536-9:2015-11 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 9: FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-9:2015) |
| 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 20072:2013-10 | AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009) |
| DIN EN ISO 25539-2:2013-05 | Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012) |
| DIN EN ISO 11737-1:2009-09 | STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS |
| DIN EN ISO 8536-11:2015-11 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 11: INFUSION FILTERS FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-11:2015) |
| DIN EN ISO 14630:2013-03 | Non-active surgical implants - General requirements (ISO 14630:2012) |
| 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 14534:2015-08 | Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
| DIN HDBK 263 : 4ED 2014 | |
| DIN HDBK 268 : 3ED 2015 | NICHT AKTIVE MEDIZINPRODUKTE - HORIZONTALE, HARMONISIERTE EUROPAEISCHE NORMEN GEMAESS EU-RICHTLINIEN AUF DEM GEBIET DER MEDIZIN |
| DIN EN ISO 10451:2010-11 | Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010) |
| DIN EN ISO 11737-2:2010-04 | STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS |
| DIN EN ISO 8536-8:2015-11 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 8: INFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 8536-8:2015) |
| DIN EN ISO 5840:2009-08 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
| 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) |
| ISO 11607-2:2006 | Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes |
| ANSI N43.10 : 2001(R2010) | SAFE DESIGN AND USE OF PANORAMIC, WET SOURCE STORAGE GAMMA IRRADIATORS (CATEGORY 4) AND DRY SOURCE STORAGE GAMMA IRRADIATORS (CATEGORY 2) |
| DIN EN ISO 13485:2016-08 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) |
| ISO 11737-2:2009 | Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
| ISO 11737-1:2006 | Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| DIN EN ISO 14001:2015-11 | Environmental management systems - Requirements with guidance for use (ISO 14001:2015); German and English version EN ISO 14001:2015 |
| DIN EN ISO 11137-3:2015-08 (Draft) | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL (ISO 11137-3:2017) |
| ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management |
| DIN EN ISO 14040:2009-11 | Environmental management - Life cycle assessment - Principles and framework (ISO 14040:2006); German and English version EN ISO 14040:2006 |
| AAMI TIR17 : 2008 | COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION |
| ISO/TS 11139:2006 | Sterilization of health care products — Vocabulary |
| ISO 11137-3:2017 | Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control |
| DIN EN ISO 11607-2:2014-11 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES (ISO 11607-2:2006 + AMD 1.:2014) |
| DIN EN ISO 11737-2:2010-04 | STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS |
| ISO 11137-2:2013 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
| DIN EN ISO 9000:2015-11 | QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY (ISO 9000:2015) |
| ISO 14001:2015 | Environmental management systems — Requirements with guidance for use |
| DIN EN ISO 22442-2:2016-05 | Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2015) |
| ISO 10993-1:2009 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 22442-2:2015 | Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling |
| DIN EN ISO 22442-3:2008-03 | MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE) AGENTS |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| DIN EN ISO 9001:2015-11 | QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (ISO 9001:2015) |
| ISO 22442-3:2007 | Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents |
| DIN EN ISO 11737-1:2009-09 | STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 11137:1995 | Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization |
| ISO 14040:2006 | Environmental management — Life cycle assessment — Principles and framework |
| ISO 10012-1:1992 | Quality assurance requirements for measuring equipment — Part 1: Metrological confirmation system for measuring equipment |
| 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) |
Summarise
US$216.72
Excluding Tax where applicable
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