BS ISO 25539-1 : 2003
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES
Hardcopy , PDF
English
01-01-2003
31-10-2009
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes
5.1 General
5.2 Delivery system
5.3 Implant
6 Materials
7 Design evaluation
7.1 General
7.2 Delivery (and/or endovascular) system
7.3 Implant
7.4 Preclinical in vivo evaluation
7.5 Clinical evaluation
8 Manufacturing
9 Sterilization
9.1 Products supplied sterile
9.2 Products supplied non-sterile
9.3 Sterilization residuals
10 Packaging
10.1 Protection from damage in storage and transport
10.2 Marking
10.3 Information supplied by the manufacturer
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
Bibliography
Defines requirements for endovascular prostheses, based upon current medical knowledge.
| Committee |
CH/150/2
|
| DevelopmentNote |
Supersedes 01/563350 DC. (04/2003) Renumbered and superseded by BS EN ISO 25539-1. (12/2009)
|
| DocumentType |
Standard
|
| Pages |
52
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 25539-1:2017 | Identical |
| 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 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 14971:2007 | Medical devices — Application of risk management to medical devices |
| 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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