• BS 5724-1(1989) : 1989 AMD 6715

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY

    Available format(s): 

    Superseded date:  15-12-1990

    Language(s): 

    Published date:  23-11-2012

    Publisher:  British Standards Institution

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

    National foreword
    Committees responsible
    Section one - General
    1 Scope and object
    2 Terminology and definitions
    3 General requirements
    4 General requirements for tests
    5 Classification
    6 Identification, marking and documents
    7 Power input
    Section two - Environmental conditions
    8 Not used
    9 Not used
    10 Environmental conditions
    11 Not used
    12 Not used
    Section three - Protection against electric shock
                    hazards
    13 General
    14 Requirements related to classification
    15 Limitation of voltage and/or energy
    16 ENCLOSURES and PROTECTIVE COVERS
    17 Separation
    18 Protective earthing, functional earthing and
        potential equalization
    19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY
        CURRENTS
    20 Dielectric strength
    Section four - Protection against mechanical hazards
    21 Mechanical strength
    22 Moving parts
    23 Surfaces, corners and edges
    24 Stability in NORMAL USE
    25 Expelled parts
    26 Vibration and noise
    27 Pneumatic and hydraulic power
    28 Suspended masses
    Section five - Protection against hazards from
                    unwanted or excessive radiation
    29 X-radiation
    30 Alpha, beta, gamma, neutron radiation and other
        particle radiation
    31 Microwave radiation
    32 Light radiation (including lasers)
    33 Infra-red radiation
    34 Ultraviolet radiation
    35 Acoustical energy (including ultrasonics)
    36 Electromagnetic compatibility
    Section six - Protection against hazards of ignition
                    of flammable anaesthetic mixtures
    37 Locations and basic requirements
    38 Marking and ACCOMPANYING DOCUMENTS
    39 Common requirements for CATEGORY AP and CATEGORY APG
        EQUIPMENT
    40 Requirements and tests for CATEGORY AP EQUIPMENT,
        parts and components thereof
    41 Requirements and tests for CATEGORY APG EQUIPMENT,
        parts and components thereof
    Section seven - Protection against excessive
                    temperatures and other safety hazards
    42 Excessive temperatures
    43 Fire prevention
    44 Overflow, spillage, leakage, humidity, ingress of
        liquids, cleaning, sterilization and disinfection
    45 Pressure vessels and parts subject to PRESSURE
    46 Human errors
    47 Electrostatic charges
    48 Material in APPLIED PARTS in contact with the body
        of the PATIENT
    49 Interruption of the power supply
    Section eight - Accuracy of operating data and
                    and protection against hazardous output
    50 Accuracy of operating data
    51 Protection against hazardous output
    Section nine - Abnormal operation and fault conditions;
                    environmental tests
    52 Abnormal operation and fault conditions
    53 Environmental tests
    Section ten - Constructional requirements
    54 General
    55 ENCLOSURES and covers
    56 Components and general assembly
    57 MAINS PARTS, components and layouts
    58 Protective earthing - Terminals and connections
    59 Construction and layout
    Tables
    I Specified atmospheric conditions
    II Marking on the outside of EQUIPMENT
    III Recommended colours of indicator lights and their
           meaning for EQUIPMENT
    IV Allowable values of continuous LEAKAGE and
           PATIENT AUXILIARY CURRENTS, in milliamperes
    V Test voltages
    VI Not used
    VII Not used
    VIII Drop height
    IX Gas-tightness of cord inlets
    Xa Allowable maximum temperatures
    Xb Allowable maximum temperatures
    XI Maximum temperatures under fault conditions
    XII Temperature limits of motor windings in deg C
    XIII Test torques for rotating controls
    XIV Not used
    XV NOMINAL cross-sectional area of POWER SUPPLY
           CORDS
    XVI CREEPAGE DISTANCES and AIR CLEARANCES in
           millimetres
    XVII Not used. See note in Table XVI
    XVIII Testing of cord anchorages
    XIX Maximum allowable temperatures at 25 deg C
           ambient temperature of mains supply transformer
           windings under overload and short-circuit
           conditions
    XX Test current for mains supply tranformers
    NUMEROUS FIGURES
    Appendices
    A General guidance and rationale
    B Testing during manufacture and/or installation
    C Sequence of testing
    D Symbols on marking
    E Survey of insulation paths and test circuits
    F Test apparatus for flammable mixtures
    G Impact-test apparatus
    H Screwed terminal connections
    J Mains supply transformers
    K Examples of the connection of the APPLIED PART for
        measurement of the PATIENT LEAKAGE CURRENT
    L References - Publications mentioned in the standard
    INDEX of defined terms
    National appendix
    A Index

    Abstract - (Show below) - (Hide below)

    Applies to the safety of MEDICAL ELECTRICAL EQUIPMENT. Although primarily concerned with safety, this standard contains some requirements regarding operation where it is connected with safety. Excludes SAFETY HAZARDS resulting from the intended physiological function of EQUIPMENT. Appendices are only mandatory when made so by an explicit statement in the main test. Includes sections on environmental conditions, protection against electric shock, mechanical hazards, radiation, ignition of flammable anaesthetic mixtures, excess temperatures and other safety hazards, accuracy of operating data and protection against hazardous output, abnormal operation and fault conditions, environmental tests and constructional requirements. AMD 3 RENUMBERS THIS STANDARD

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

    Committee HCC/64
    Development Note Renumbered and superseded by BS EN 60601-1. Supersedes BS 5724-1(1979). Supersedes 85/51682 DC. (11/2005)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    BS 6015:1980 Glossary of terms used in anaesthesiology
    BS EN 60601-2-9:1997 Medical electrical equipment. Particular requirements for safety Specification for patient contact dosemeters used in radiotherapy with electrically connected radiation detectors
    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 EN 60601-2-35:1997 Medical electrical equipment. Particular requirements for safety Specification for blankets, pads and mattresses intended for heating in medical use
    BS EN 61223-3-3:1997 Evaluation and routine testing in medical imaging departments Acceptance tests - Imaging performance of X-ray equipment for digital subtraction angiograp hy
    BS 7725-2.1:1994 Evaluation and routine testing in medical imaging departments. Constancy tests Method for film processors
    BS EN 60601-2-32:1995 Medical electrical equipment. Particular requirements for safety Specification for associated equipment of X-ray equipment
    BS 5724-3.12:1991 Medical electrical equipment. Particular requirements for performance Method of declaring parameters for lung ventilators
    BS 3456-3.21:1981 Specification for safety of household and similar electrical appliances. Complete particular specifications Portable immersion heaters
    BS 7725-1:1994 Evaluation and routine testing in medical imaging departments. General
    BS EN 61266:1995 Ultrasonics. Hand-held probe Doppler foetal heartbeat detectors. Performance requirements and methods of measurement and reporting
    BS 5724-3.1:Supplement No. 1:1990 Medical electrical equipment. Particular requirements for performance Methods of declaring functional performance characteristics of medical electron accelerators in the range 1 MeV to 50 MeV. Guide to functional performance values
    BS 7088:1989 Specification for pneumatic tourniquet equipment
    BS 5724-3.129:Supplement No. 1:1994 Medical electrical equipment. Particular requirements for performance Methods of declaring functional performance characteristics of radiotherapy simulators. Guide to functional performance values
    BS 6058:1989 Method of specifying and verifying the characteristics of rotating anode X-ray tubes and X-ray tube assemblies used in medical diagnosis
    BS EN 1280-1:1997 Agent specific filling systems for anaesthetic vaporizers Rectangular keyed filling systems
    BS 5724-2.15:1989 Medical electrical equipment. Particular requirements for safety Specification for capacitor discharge X-ray generators
    BS EN 61168:1994 Medical electrical equipment. Particular requirements for performance. Methods of declaring functional performance characteristics of radiotherapy simulators
    BS 6301:1982 Specification for safety requirements for apparatus for connection to British Telecommunications networks
    BS 5724-2.14:1989 Medical electrical equipment. Particular requirements for safety Specification for electroconvulsive therapy equipment
    BS 3456-101:1987 Specification for safety of household and similar electrical appliances General requirements
    BS 7068:1989 Specification for alternating pressure air mattresses
    BS 7522-1:1992 Low vision aids Specification for hand and stand magnifiers, including magnifiers with an integral source of illumination

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

    BS 2011-2.1B:1977 Environmental testing. Tests Tests B. Dry Heat
    BS 6458-2.3:1985 Fire hazard testing for electrotechnical products. Test methods Bad-connection test with heaters
    BS 6458-2.2(1984) : 1984 FIRE HAZARD TESTING FOR ELECTROTECHNICAL PRODUCTS - METHODS OF TEST - NEEDLE FLAME TEST
    ISO 2882:1979 Rubber, vulcanized — Antistatic and conductive products for hospital use — Electrical resistance limits
    IEC 60079-5:2015 RLV Explosive atmospheres - Part 5: Equipment protection by powder filling "q"
    BS 6458-2.1:1984 Fire hazard testing for electrotechnical products. Test methods Glow-wire test
    IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
    IEC 60245-4:2011 Rubber insulated cables - Rated voltages up to and including 450/750 V - Part 4: Cords and flexible cables
    IEC 60079-6:2015 Explosive atmospheres - Part 6: Equipment protection by liquid immersion "o"
    ISO 2878:2017 Rubber, vulcanized or thermoplastic Antistatic and conductive products Determination of electrical resistance
    BS 6201-3:1982 Fixed capacitors for use in electronic equipment Specification for fixed capacitors for radio interference suppression. Selection of methods of test and general requirements
    CISPR 11:2015 RLV Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement
    BS 5750-1:1987 Quality systems Specification for design/development, production, installation and servicing
    ISO 1853:2011 Conducting and dissipative rubbers, vulcanized or thermoplastic Measurement of resistivity
    BS 5724-2.24(1989) : 1989 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR HUMIDIFIERS
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