01/563350 DC : DRAFT AUG 2001
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS ISO 25539-1 - CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES
03-27-2003
11-23-2012
Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Intended performance
5 Design attributes
6 Materials
7 Design evaluation
8 Manufacturing
9 Sterilization
10 Packaging
Annex A (informative) Attributes of endovascular devices -
Technical and clinical considerations
Annex B (informative) Bench and analytical tests
Annex C (informative) Definitions of reportable clinical
events
Annex D (informative) Bibliography
| Committee |
CH/23/-/1
|
| DocumentType |
Draft
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| ISO 11070:2014 | Sterile single-use intravascular introducers, dilators and guidewires |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| EN 556:1994 + A1:1998 | STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE" |
| EN 550 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION |
| 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 11135:2014 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 13488:1996 | Quality systems — Medical devices — Particular requirements for the application of ISO 9002 |
| ISO 10555-2:1996 | Sterile, single-use intravascular catheters Part 2: Angiographic catheters |
| ISO 7198:2016 | Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| EN 868-1 : 1997 | PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS |
| 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 14630:2012 | Non-active surgical implants — General requirements |
| ISO/TS 15539:2000 | Cardiovascular implants Endovascular prostheses |
| EN 552:1994/A2:2000 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION |
| EN 12006-3:1998+A1:2009 | Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices |
| ISO 10555-3:2013 | Intravascular catheters — Sterile and single-use catheters — Part 3: Central venous catheters |
| ISO 10555-1:2013 | Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements |
| ISO 11607:2003 | Packaging for terminally sterilized medical devices |
| ISO 14971-1:1998 | Medical devices Risk management Part 1: Application of risk analysis |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects Good clinical practice |
| ISO 11134:1994 | Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization |
| ISO 11137:1995 | Sterilization of health care products Requirements for validation and routine control Radiation sterilization |
| EN 554 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT |
| ISO 10555-4:2013 | Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation catheters |
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