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  • EN ISO 26782:2009/AC:2009

    Current The latest, up-to-date edition.

    Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans - Technical Corrigendum 1 (ISO 26782:2009/Cor 1:2009)

    Available format(s): 

    Language(s): 

    Published date:  15-11-2009

    Publisher:  Comite Europeen de Normalisation

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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)

    Committee CEN/TC 215
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    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 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
    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
    PD 6461-1:1995 General metrology Basic and general terms (VIM)
    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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