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  • 11/30227618 DC : 0

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    BS ISO 11658 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - BLOOD/TISSUE CONTACT SURFACE MODIFICATIONS FOR EXTRACORPOREAL PERFUSION SYSTEMS

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-05-2012

    Language(s):  English

    Published date: 

    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 Requirements
    5 Tests
    Bibliography

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

    Comment Closes On
    Committee CH/150/2
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    ISO 15676:2016 Cardiovascular implants and artificial organs — Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
    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 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 15675:2016 Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters
    ISO 7199:2016 Cardiovascular implants and artificial organs Blood-gas exchangers (oxygenators)
    ISO 10993-11:2017 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
    ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
    ISO 15674:2016 Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    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
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