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BS ISO 25539-1 : 2003

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES
Available format(s)

Hardcopy , PDF

Superseded date

10-31-2009

Language(s)

English

Published date

01-01-2003

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 (04/2003) Renumbered and superseded by BS EN ISO 25539-1.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Superseded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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