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  • BS ISO 18562-3:2017

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    Biocompatibility evaluation of breathing gas pathways in healthcare applications Tests for emissions of volatile organic compounds (VOCs)

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  19-02-2020

    Language(s):  English

    Published date:  31-03-2017

    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 General principles
    5 Voc emissions
    Annex A (informative) - Rationale and guidance
    Annex B (informative) - Reference to the essential
            principles
    Annex C (informative) - Terminology - Alphabetized
            index of defined terms
    Bibliography

    Abstract - (Show below) - (Hide below)

    Covers tests for the emissions of VOLATILE ORGANIC COMPOUNDS (VOCS) from the GAS PATHWAYS of a MEDICAL DEVICE, its parts or ACCESSORIES, which are intended to provide respiratory care or supply substances via the respiratory tract to a PATIENT in all environments.

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

    Committee CH/121/9
    Development Note Supersedes 15/30278537 DC. (03/2017)
    Document Type Standard
    Publisher British Standards Institution
    Status Withdrawn
    Supersedes

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

    ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 16142-1:2016 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    ASTM D 5466 : 2015 : REDLINE Standard Test Method for Determination of Volatile Organic Compounds in Atmospheres (Canister Sampling Methodology)
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 16000-6:2011 Indoor air Part 6: Determination of volatile organic compounds in indoor and test chamber air by active sampling on Tenax TA sorbent, thermal desorption and gas chromatography using MS or MS-FID
    ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum
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