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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY
15-12-1990
23-11-2012
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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