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BS 5724-1(1989) : 1989 AMD 6715

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - GENERAL REQUIREMENTS FOR SAFETY

Superseded date

15-12-1990

Superseded by

BS EN 60601-1 : 2006

Published date

23-11-2012

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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

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

Committee
HCC/64
DevelopmentNote
Renumbered and superseded by BS EN 60601-1. Supersedes BS 5724-1(1979). Supersedes 85/51682 DC. (11/2005)
DocumentType
Standard
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
IEC 60601-1:2005+AMD1:2012 CSV Similar to

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

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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