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  • BS EN 60601-1 : 2006

    Current The latest, up-to-date edition.

    MEDICAL ELECTRICAL EQUIPMENT PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2006

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    INTRODUCTION
    1 Scope, object and related standards
    2 Normative references
    3 Terminology and definitions
    4 General requirements
    5 General requirements for testing ME EQUIPMENT
    6 Classification of ME EQUIPMENT and ME SYSTEMS
    7 ME EQUIPMENT identification, marking and documents
    8 Protection against electrical HAZARDS from ME EQUIPMENT
    9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT
       and ME SYSTEMS
    10 Protection against unwanted and excessive radiation
       HAZARDS
    11 Protection against excessive temperatures and other
       HAZARDS
    12 Accuracy of controls and instruments and protection
       against hazardous outputs
    13 HAZARDOUS SITUATIONS and fault conditions for
       ME EQUIPMENT
    14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
       (PEMS)
    15 Construction of ME EQUIPMENT
    16 ME SYSTEMS
    17 Electromagnetic compatibility of ME EQUIPMENT and ME
       SYSTEMS
    Annex A (informative) - General guidance and rationale
    Annex B (informative) - Sequence of testing
    Annex C (informative) - Guide to marking and labeling
            requirements for ME EQUIPMENT and ME SYSTEMS
    Annex D (informative) - Symbols on marking
    Annex E (informative) - Examples of the connection of the
            measuring device (MD) for measurement of the PATIENT
            LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT
    Annex F (informative) - Suitable measuring supply circuits
    Annex G (normative) - Protection against HAZARDS of ignition
            of flammable anaesthetic mixtures
    Annex H (informative) - PEMS structure, PEMS DEVELOPMENT
            LIFE-CYCLE and documentation
    Annex I (informative) - ME SYSTEMS aspects
    Annex J (informative) - Survey of insulation paths
    Annex K (informative) - Simplified PATIENT LEAKAGE
            CURRENT diagrams
    Annex L (normative) - Insulated winding wires for use without
            interleaved insulation
    Annex M (normative) - Reduction of pollution degrees
    Bibliography
    Annex ZA (normative) - Normative references to international
             publications with their corresponding European
             publications
    Annex ZZA (informative) - Coverage of Essential Requirements
              of EC Directives
    Annex ZZB (informative) - Relationship between this European
              Standard and the Essential Requirements of EU
              Directive 90/385/EEC on Active Implantable
              Medical Devices

    Abstract - (Show below) - (Hide below)

    Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.

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

    Committee CH/62/1
    Development Note Renumbers and supersedes BS 5724-1(1989). 1990 version incorporates amendment 6715 to BS 5724-1(1989). Supersedes BS 5724-1(1979), 94/507215 DC, 04/30106146 DC, BS EN 60601-1-1 & Supersedes BS EN 60601-1-4 & BS 5724-1-4 (1997). Supersedes 11/30193150 DC (02/2012) 2006 + A11 2011 Edition is still active & will be withdrawn on 24-12-2018. (12/2013) 2006 Edition Re-Issued in November 2014 & incorporates AMD 12 2014. 2006 + A1 2013 Edition is still active & will be withdrawn on 26/03/2015. (11/2014)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    BS 4274-1:2003 Visual acuity test types Test charts for clinical determination of distance visual acuity. Specification
    BS 5724-2.127(1995) : 1995 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT
    BS 4272-2:1996 Anaesthetic and analgesic machines Specification for intermittent (demand) flow analgesic machines for use with 50/50% (V/V) nitrous oxide and oxygen
    BS 5724-2.124(1998) : 1998 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFUSION PUMPS AND CONTROLLERS

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    IEC 60050-195:1998 International Electrotechnical Vocabulary (IEV) - Part 195: Earthing and protection against electric shock
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    ISO 23529:2016 Rubber General procedures for preparing and conditioning test pieces for physical test methods
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    IEC 60050-151:2001 International Electrotechnical Vocabulary (IEV) - Part 151: Electrical and magnetic devices
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    NFPA 53 : 2016 MATERIALS, EQUIPMENT, AND SYSTEMS USED IN OXYGEN-ENRICHED ATMOSPHERES
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    EN 60252-1 : 2011 AMD 1 2013 AC MOTOR CAPACITORS - PART 1: GENERAL - PERFORMANCE, TESTING AND RATING - SAFETY REQUIREMENTS - GUIDANCE FOR INSTALLATION AND OPERATION (IEC 60252-1:2010/A1:2013)
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    EN 61672-1:2013 Electroacoustics - Sound level meters - Part 1: Specifications
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    EN 60320-1:2015/AC:2016 APPLIANCE COUPLERS FOR HOUSEHOLD AND SIMILAR GENERAL PURPOSES - PART 1: GENERAL REQUIREMENTS (IEC 60320-1:2015/COR1:2016)
    EN 60851-5:2008/A1:2011 WINDING WIRES - TEST METHODS - PART 5: ELECTRICAL PROPERTIES (IEC 60851-5:2008)
    IEC 60990:2016 Methods of measurement of touch current and protective conductor current
    ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
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    ISO 5805:1997 Mechanical vibration and shock — Human exposure — Vocabulary
    IEC 60730-1:2013+AMD1:2015 CSV Automatic electrical controls - Part 1: General requirements
    EN 60079-2:2014/AC:2015 EXPLOSIVE ATMOSPHERES - PART 2: EQUIPMENT PROTECTION BY PRESSURIZED ENCLOSURE 'P' (IEC 60079-2:2014)
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