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  • BS ISO 25539-1 : 2003

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-10-2009

    Language(s):  English

    Published date:  01-01-2003

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    Defines requirements for endovascular prostheses, based upon current medical knowledge.

    General Product Information - (Show below) - (Hide below)

    Committee CH/150/2
    Development Note Supersedes 01/563350 DC. (04/2003) Renumbered and superseded by BS EN ISO 25539-1. (12/2009)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    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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