ISO 13488:1996
Withdrawn
Withdrawn
Quality systems — Medical devices — Particular requirements for the application of ISO 9002
Available format(s)
Hardcopy , PDF
Language(s)
English, French
Published date
12-26-1996
Withdrawn date
04-05-2019
US$96.00
Excluding Tax where applicable
Specifies, in conjunction with the application of ISO 9002, the quality system requirements for the production and, when relevant, installation and servicing of medical devices.
| DevelopmentNote |
Will not be implemented until adopted by CEN.
|
| DocumentType |
Standard
|
| Pages |
9
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| Standards | Relationship |
| DIN EN ISO 13488:2001-02 | Identical |
| NF EN ISO 13488 : 2001 | Identical |
| NBN EN ISO 13488 : 2001 | Identical |
| NEN EN ISO 13488 : 2000 | Identical |
| NS EN ISO 13488 : 1ED 2001 | Identical |
| I.S. EN ISO 13488:2000 | Identical |
| AS ISO 13488-2002 | Identical |
| BS EN ISO 13488:2001 | Identical |
| AAMI ISO 13488 : 1996 | Identical |
| CEI UNI EN ISO 13488 : 3ED 2002 | Identical |
| EN ISO 13488 : 2000 | Identical |
| UNE-EN ISO 13488:2001 | Identical |
| JIS Q 13488:1998 | Identical |
| I.S. EN ISO 22523:2006 | EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS |
| 01/563350 DC : DRAFT AUG 2001 | BS ISO 25539-1 - CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES |
| 03/304741 DC : DRAFT APR 2003 | IEC 60601-1-6 ED.1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD - USABILITY |
| CR 14060:2000 | Medical device traceability |
| BS EN 556-1:2001 | Sterilization of medical devices. Requirements for medical devices to be designated \'STERILE\' Part 1. Requirements for terminally sterilized medical devices |
| BS EN 13795-1 : 2002 | SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS |
| BS EN ISO 22523:2006 | External limb prostheses and external orthoses. Requirements and test methods |
| CR 12401 : 1996 | DENTISTRY - GUIDANCE ON THE CLASSIFICATION OF DENTAL DEVICES AND ACCESSORIES |
| EN ISO 22523:2006 | External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006) |
| 08/30179586 DC : DRAFT MAR 2008 | BS ISO 7199 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) |
| 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 |
| BS ISO 8009-1:1997 | Reusable rubber contraceptive diaphragms Classification, sampling and requirements |
| 08/30179592 DC : DRAFT MAR 2008 | BS ISO 15675 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS |
| AAMI ST72 : 2011 : R2016 | BACTERIAL ENDOTOXIN - TEST METHODS, ROUTINE MONITORING AND ALTERNATIVES TO BATCH TESTING |
| ISO/TS 15539:2000 | Cardiovascular implants — Endovascular prostheses |
| I.S. EN 556-1:2002 | STERILISATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED STERILE - PART 1: REQUIREMENTS FOR TERMINALLY STERILISED MEDICAL DEVICES |
| 03/317861 DC : DRAFT OCT 2003 | EN ISO 22523 - EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS |
| BS ISO 25539-1 : 2003 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES |
| AAMI ST72 : 2011 | BACTERIAL ENDOTOXIN - TEST METHODS, ROUTINE MONITORING AND ALTERNATIVES TO BATCH TESTING |
| DIN EN ISO 22523:2007-04 | External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006) |
| EN 13795-1:2002+A1:2009 | Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products |
| 01/561789 DC : DRAFT APR 2001 | BS ISO 13960 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - PLASMAFILTERS |
| BS ISO 8009:2014 | Mechanical contraceptives. Reusable natural and silicone rubber contraceptive diaphragms. Requirements and tests |
| 05/30106194 DC : 0 | EN ISO 22442-2 - MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING |
| ISO 13683:1997 | Sterilization of health care products — Requirements for validation and routine control of moist heat sterilization in health care facilities |
| PD CEN/TR 15253:2005 | Health informatics. Quality of service requirements for health information interchange |
| ISO 8009:2014 | Mechanical contraceptives — Reusable natural and silicone rubber contraceptive diaphragms — Requirements and tests |
| ISO/TS 13409:2002 | Sterilization of health care products — Radiation sterilization — Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches |
| ISO 22523:2006 | External limb prostheses and external orthoses — Requirements and test methods |
| I.S. EN 13795-1:2002 | SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS |
| 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 |
| CEN/TR 15253:2005 | Health informatics - Quality of service requirements for health information interchange |
| 14/30281557 DC : 0 | BS EN ISO 7198 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES |
| ISO/TS 15843:2000 | Sterilization of health care products — Radiation sterilization — Product families and sampling plans for verification dose experiments and sterilization dose audits, and frequency of sterilization dose audits |
| 11/30227618 DC : 0 | BS ISO 11658 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - BLOOD/TISSUE CONTACT SURFACE MODIFICATIONS FOR EXTRACORPOREAL PERFUSION SYSTEMS |
| S.R. CR 14060:2000 | MEDICAL DEVICE TRACEABILITY |
| PD CR 12401:2003 | Dentistry. Guidance on the classification of dental devices and accessories |
| DIN EN 13795-1:2009-10 | SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS |
| ISO 8402:1994 | Quality management and quality assurance — Vocabulary |
| ISO 9002:1994 | Quality systems — Model for quality assurance in production, installation and servicing |
| ISO 11137:1995 | Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization |
Summarise
US$96.00
Excluding Tax where applicable
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