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    I.S. EN 60601-2-39:2008

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    MEDICAL ELECTRICAL EQUIPMENT - PART 2-39: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PERITONEAL DIALYSIS EQUIPMENT (IEC 60601-2-39:2007 (EQV))

    Available format(s):  Hardcopy, PDF

    Superseded date:  23-05-2022

    Language(s):  English

    Published date:  31-12-2007

    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
    201.1 Scope, object and related standards
    201.2 Normative references
    201.3 Terms and definitions
    201.4 General requirements
    201.5 General requirements for testing of PD EQUIPMENT
    201.6 Classification of ME EQUIPMENT and ME SYSTEMS
    201.7 PD EQUIPMENT identification, marking and documents
    201.8 Protection against electrical HAZARDS from PD EQUIPMENT
    201.9 Protection against mechanical hazards of ME EQUIPMENT and
           ME SYSTEMS
    201.10 Protection against unwanted and excessive radiation HAZARDS
    201.11 Protection against excessive temperatures and other HAZARDS
    201.12 Accuracy of controls and instruments and protection against
           hazardous outputs
    201.13 HAZARDOUS SITUATIONS and fault conditions
    201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
    201.15 Construction of ME EQUIPMENT
    201.16 ME SYSTEMS
    201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
    202 Electromagnetic compatibility - Requirements and tests
    203 General requirements for radiation protection in diagnostic
        X-ray equipment
    206 Usability
    208 General requirements, tests and guidance for alarm systems
        in medical electrical equipment and medical electrical systems
    209 Requirements for the reduction of environmental impacts
    210 Process requirements for the development of physiologic
        closed-loop controllers
    Annexes
    Annex G (normative) - Protection against HAZARDS of ignition of
            flammable anaesthetic mixtures
    Annex AA (informative) - Particular guidance and rationale Index
             of defined terms used in this particular standard
    Index of defined terms used in this particular standard
    Annex ZA (normative) - Normative references to international
             publications with their corresponding European
             publications
    Annex ZZ (informative) - Coverage of Essential Requirements of
             EC Directives

    Abstract - (Show below) - (Hide below)

    Pertains to PD EQUIPMENT intended for use either by medical staff or under the supervision of medical experts, including PD EQUIPMENT operated by the PATIENT, regardless of whether the PD EQUIPMENT is used in a hospital or domestic environment.

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    Development Note Supersedes I.S. EN 50072. (06/2005) For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By
    Supersedes

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

    IEC 60601-1-10:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers
    EN 60601-1-10:2008/A1:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS (IEC 60601-1-10:2007)
    EN 60601-1-9:2008/A1:2013 MEDICAL ELECTRICAL EQUIPMENT - PART 1-9: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR ENVIRONMENTALLY CONSCIOUS DESIGN (IEC 60601-1-9:2007/A1:2013)
    IEC 60601-1-9:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
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