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  • BS 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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

    Available format(s):  Hardcopy, PDF

    Superseded date:  14-08-2019

    Language(s):  English

    Published date:  31-03-2009

    Publisher:  British Standards Institution

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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
    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 the BASIC SAFETY and ESSENTIAL PERFORMANCE of PERITONEAL DIALYSIS ME EQUIPMENT.

    Scope - (Show below) - (Hide below)

    Applies to the basic safety and essential performance of peritoneal dialysis medical electrical equipment. It applies to peritoneal dialysis equipment intended for use either by medical staff or under the supervision of medical experts, including peritoneal dialysis equipment operated by the patient, regardless of whether the peritoneal dialysis equipment is used in a hospital or domestic environment. This second edition cancels and replaces the first edition of IEC 60601-2-39. It constitutes a technical revision. Major changes since the last edition include a summary of additional essential performance requirements.

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

    Committee CH/150/2
    Development Note Supersedes BS EN 50072 & 97/560940 DC. (11/2005) Supersedes BS 5724-2.39(1999). (03/2009) 2008 version remains current. 2008 Edition Re-issued in March 2012 & incorporates AMD 11 2011. (04/2012) Supersedes BS 5724-2.29(1992) (08/2015)
    Document Type Standard
    Publisher British Standards Institution
    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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