• 04/30106146 DC : DRAFT MARCH 2004

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    BS EN 60601-1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE

    Available format(s): 

    Superseded date:  30-11-2006

    Language(s): 

    Published date:  24-11-2012

    Publisher:  British Standards Institution

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

    FOREWORD
    INTRODUCTION
    1. Scope, object and related standards
        1.1 Scope
        1.2 Object
        1.3 Particular standards
        1.4 Collateral standards
    2. Normative references
    3. Terminology and definitions
    4. General requirements
        4.1 Conditions for application to ME EQUIPMENT or ME SYSTEMS
        4.2 RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS
        4.3 ESSENTIAL PERFORMANCE
        4.4 EXPECTED SERVICE LIFE
        4.5 Equivalent safety for ME EQUIPMENT or ME SYSTEMS
        4.6 ME EQUIPMENT or ME SYSTEMS parts that contact the PATIENT
        4.7 NORMAL CONDITION and SINGLE FAULT CONDITION for
             ME EQUIPMENT
        4.8 Components of ME EQUIPMENT
        4.9 Use of COMPONENTS WITH HIGH-INTEGRITY CHARACTERISTICS in
             ME EQUIPMENT
        4.10 Power supply
        4.11 Power input
    5. General requirements for testing ME EQUIPMENT
        5.1 TYPE TESTS
        5.2 Number of samples
        5.3 Ambient temperature, humidity, atmospheric pressure
        5.4 Other conditions
        5.5 Supply voltages, type of current, nature of supply,
             frequency
        5.6 Repairs and modifications
        5.7 Humidity preconditioning treatment
        5.8 Sequence of tests
        5.9 Determination of APPLIED PARTS and ACCESSIBLE PARTS
    6. Classification of ME EQUIPMENT and ME SYSTEMS
        6.1 General
        6.2 Protection against electric shock
        6.3 Protection against harmful ingress of water or
             particulate matter
        6.4 Method(s) of sterilization
        6.5 Suitability for use in an OXYGEN RICH ENVIRONMENT
        6.6 Mode of operation
    7, ME EQUIPMENT identification, marking and documents
        7.1 General
        7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
        7.3 Marking on the inside of ME EQUIPMENT or ME EQUIPMENT parts
        7.4 Marking of controls and instruments
        7.5 Safety signs
        7.6 Symbols
        7.7 Colours of the insulation of conductors
        7.8 Indicator lights and controls
        7.9 ACCOMPANYING DOCUMENTS
    8. Protection against electrical HAZARDS from ME EQUIPMENT
        8.1 Fundamental rule of protection against electric shock
        8.2 Requirements related to power sources
        8.3 Classification of APPLIED PARTS
        8.4 Limitation of voltage, current or energy
        8.5 Separation of parts
        8.6 Protective earthing, functional earthing and
             potential equalization of ME EQUIPMENT
        8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
        8.8 Insulation
        8.9 CREEPAGE DISTANCES and AIR CLEARANCES
        8.10 Components and wiring
        8.11 MAINS PARTS, components and layout
    9. Protection against MECHANICAL HAZARDS of ME EQUIPMENT and
        ME SYSTEMS
        9.1 MECHANICAL HAZARDS of ME EQUIPMENT
        9.2 HAZARDS associated with moving parts
        9.3 HAZARD associated with surfaces, corners and edges
        9.4 Instability HAZARDS
        9.5 Expelled parts HAZARD
        9.6 Noise, vibration and acoustic energy (including
             infra- and ultrasound)
        9.7 Pressure vessels and parts subject to pneumatic
             and hydraulic pressure
        9.8 HAZARDS associated with support systems
    10. Protection against unwanted and excessive radiation HAZARDS
        10.1 X-Radiation
        10.2 Alpha, beta, gamma, neutron radiation and other
             particle radiation
        10.3 Microwave radiation
        10.4 Lasers and laser light emitting diodes
        10.5 Other visual electromagnetic radiation
        10.6 Infrared radiation
        10.7 Ultraviolet radiation
    11. Protection against excessive temperatures and other HAZARDS
        11.1 Excessive temperatures in ME EQUIPMENT
        11.2 Fire prevention
        11.3 Constructional requirements for fire ENCLOSURES OF
             ME EQUIPMENT
        11.4 ME EQUIPMENT and ME SYSTEMS intended for use with
             flammable anaesthetics
        11.5 ME EQUIPMENT and ME SYSTEMS intended for use in
             conjunction with flammable agents
        11.6 Overflow, spillage, leakage, ingress of water,
             cleaning, disinfection, sterilization and
             compatibility with substances used with the ME
             EQUIPMENT
        11.7 Biocompatibility of ME EQUIPMENT and ME SYSTEMS
        11.8 Interruption of the power supply/SUPPLY
             MAINS to ME EQUIPMENT
    12. Accuracy of controls and instruments and protection
        against hazardous outputs
        12.1 Accuracy of controls and instruments
        12.2 USABILITY
        12.3 Alarm systems
        12.4 Protection against hazardous output
    13. Hazardous situations and fault conditions
        13.1 Specific hazardous situations
        13.2 SINGLE FAULT CONDITIONS
    14. PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
        14.1 General
        14.2 Documentation
        14.3 RISK MANAGEMENT plan
        14.4 PEMS DEVELOPMENT LIFE-CYCLE
        14.5 Problem resolution
        14.6 RISK MANAGEMENT PROCESS
        14.7 Requirement Specification
        14.8 Architecture
        14.9 Design and implementation
        14.10 VERIFICATION
        14.11 PEMS VALIDATION
        14.12 Modification
        14.13 Connection of PEMS by NETWORK/DATA COUPLING to
              other equipment
    15. Construction of ME EQUIPMENT
        15.1 Arrangements of controls and indicators of ME EQUIPMENT
        15.2 Serviceability
        15.3 Mechanical strength
        15.4 ME EQUIPMENT components and general assembly
        15.5 MAINS SUPPLY TRANSFORMERS of ME EQUIPMENT and
              transformers providing separation in accordance
              with 8.5
    16. ME SYSTEMS
        16.1 General requirements for the ME SYSTEMS
        16.2 ACCOMPANYING DOCUMENTS of an ME SYSTEM
        16.3 Power supply
        16.4 ENCLOSURES
        16.5 SEPARATION DEVICES
        16.6 LEAKAGE CURRENTS
        16.7 Protection against MECHANICAL HAZARDS
        16.8 Interruption of the power supply to parts of an ME SYSTEM
        16.9 ME SYSTEM connections and wiring
    17. Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
    ANNEXES
    Annex A (Informative) General guidance and rationale
    Annex B (Informative) Sequence of testing
    Annex C (Informative) Guide to marking and labelling 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 structures, 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
    Bibliography
    Index of defined terms
    Index of abbreviations and acronyms
    Editing notes for the second CDV

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

    Comment Closes On
    Committee CH/62/1
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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