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  • 14/30292011 DC : 0

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    BS EN ISO 23747 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-08-2015

    Language(s):  English

    Published date: 

    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
            effects of dismantling, ageing and dropping
    Annex E (informative) - Environmental aspects
    Annex F (informative) - Reference to the Essential
            Principles
    Bibliography
    Alphabetized index of defined terms used in this standard
    Annex ZA (informative) - Relationship between this
             Document and the Essential Requirements
             Of EU Directive 93/42/EEC

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

    Comment Closes On
    Committee CH/121/5
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

    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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