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  • BS EN ISO 23747:2015

    Current The latest, up-to-date edition.

    Anaesthetic and respiratory equipment. Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  31-08-2015

    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 requirements
    5 Identification, marking and documents
    6 PEFM measurement range
    7 Performance requirements
    8 Dismantling and reassembly
    9 Effects of mechanical ageing
    10 Effects of dropping a hand-held PEFM
    11 Cleaning, sterilization, and disinfection
    12 Compatibility with substances
    13 Biocompatibility
    Annex A (informative) - Rationale for tests and examples
            of test apparatus
    Annex B (normative) - Determination of error, repeatability,
            and resistance to PEFM output
    Annex C (normative) - Determination of frequency response
    Annex D (normative) - Test methods for determination of the
            effectsof dismantling, ageing and dropping
    Annex E (informative) - Environmental aspects
    Annex F (informative) - Reference to the Essential
            Principles
    Annex G (informative) - Terminology - Alphabetized index of
            defined terms
    Bibliography
    Annex ZA (informative) - Relationship between this Document and
             the Essential Requirements of EU Directive 93/42/EEC

    Abstract - (Show below) - (Hide below)

    Describes requirements for peak expiratory flow meters (PEFMs) intended for the assessment of pulmonary function in spontaneously breathing humans.

    Scope - (Show below) - (Hide below)

    This International Standard specifies requirements for a peak expiratory flow meter (pefm) intended for the assessment of pulmonary function in spontaneously breathing humans. This International Standard covers all medical devices that measure peak expiratory flowrate in spontaneously breathing humans either as part of an integrated lung function medical device or as a stand-alone medical device. Planning and design of products applying to this International Standard are to consider the environmental impact from the product during its life cycle. Environmental aspects are addressed in AnnexE. NOTE Additional aspects of environmental impact are addressed in ISO14971.

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

    Committee CH/121/9
    Development Note Supersedes BS EN 13826 and 06/30136646 DC. (08/2007) Supersedes 08/30192545 DC. (04/2009) Supersedes 14/30292011 DC. (08/2015)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

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

    ISO 128-40:2001 Technical drawings General principles of presentation Part 40: Basic conventions for cuts and sections
    ISO/IEC TR 10000-1:1998 Information technology Framework and taxonomy of International Standardized Profiles Part 1: General principles and documentation framework
    ISO 10241:1992 International terminology standards Preparation and layout
    ISO 690:2010 Information and documentation Guidelines for bibliographic references and citations to information resources
    ISO 128-34:2001 Technical drawings General principles of presentation Part 34: Views on mechanical engineering drawings
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    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 690-2:1997 Information and documentation Bibliographic references Part 2: Electronic documents or parts thereof
    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 128-44:2001 Technical drawings General principles of presentation Part 44: Sections on mechanical engineering drawings
    ISO 128-30:2001 Technical drawings General principles of presentation Part 30: Basic conventions for views
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    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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