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    I.S. EN ISO 17510:2020

    Current The latest, up-to-date edition.

    Medical devices - Sleep apnoea breathing therapy - Masks and application accessories

    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 Information to be supplied by the manufacturer
    5 Construction requirements
    6 Vibration and noise
    Annex A (informative) Particular guidance and rationale
    Annex B (normative) Exhaust flow test procedure
    Annex C (normative) Resistance to flow (pressure drop)
    Annex C (normative) Resistance to flow (pressure drop)
    Annex D (normative) Anti-asphyxia valve pressure testing
    Annex E (normative) Determination of the inspiratory and expiratory resistance under single fault condition
    Annex F (normative) Carbon Dioxide rebreathing
    Annex G (normative) Vibration and noise
    Annex H (informative) Guide to information to be supplied by the manufacturer
    Annex I (informative) Reference to the essential principles
    Annex J (informative) Terminology — alphabetized index of defined terms
    Bibliography

    Abstract - (Show below) - (Hide below)

    This International Standard applies to masks and their accessories used to connect sleep apnoea breathing therapy equipment to the patient.

    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.
    Publisher National Standards Authority of Ireland
    Status Current
    Supersedes
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