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    I.S. EN ISO 18562-4:2020

    Current The latest, up-to-date edition.

    Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate (ISO 18562-4:2017)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  08-03-2020

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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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 Leachable substances in condensate
    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)

    This document specifies tests for substances leached by liquid water condensing into 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 TC 121
    Document Type Standard
    Product Note The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document. THIS STANDARD IS ALSO REFERS TO - USP 35 — NF 30, Chapter 233,USP 35 — NF 30, Chapter 232
    Publisher National Standards Authority of Ireland
    Status Current
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