ISO 13488:1996
Withdrawn
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Quality systems — Medical devices — Particular requirements for the application of ISO 9002
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Withdrawn date
04-05-2019
Language(s)
English, French
Published date
12-26-1996
Important note : All end users must be registered with an Account prior to user licenses being assigned.
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Withdrawn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 |
| SN EN ISO 13488 : 2001 | Identical |
| AS ISO 13488-2002 | Identical |
| UNI CEI EN 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 |
| CSA ISO 13488 : 1998 | Identical |
| UNE-EN ISO 13488:2001 | 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 |
| CSA ISO 7199 : 0 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) |
| 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 |
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