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    I.S. EN ISO 26782:2009

    Current The latest, up-to-date edition.

    ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE MEASUREMENT OF TIME FORCED EXPIRED VOLUMES IN HUMANS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2009

    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 requirements
    5 Identification, marking and documents
    6 Measurement range
    7 Performance requirements
    8 Constructional requirements
    9 Cleaning, sterilization and disinfection
    10 Biocompatibility
    Annex A (informative) Rationale
    Annex B (normative) Testing accuracy, linearity and impedance
            of spirometers
    Annex C (normative) Defined test profiles
    Annex D (informative) Environmental aspects
    Annex E (informative) Reference to the essential principals
    Bibliography
    Alphabetized index of defined terms used in this International
    Standard
    Annex ZA (informative) Relationship between this standard and
             the Essential Requirements of EU Directive 93/42/EEC

    Abstract - (Show below) - (Hide below)

    Defines requirements for SPIROMETERS intended for the assessment of pulmonary function in humans weighing more than 10 kg.

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

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current

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

    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 23747:2015 Anaesthetic and respiratory equipment Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO/TR 16142:2006 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
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