BS-5724-2.4-1985 IEC-60601-2-4-1983.pdf
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1、BRITISH STANDARD BS 5724-2.4: 1985 IEC 601-2-4: 1983 Medical electrical equipment Part 2: Particular requirements for safety Section 2.4 Specification for cardiac defibrillators and cardiac defibrillator-monitors UDC 615.47:621.313:614.8:616.12 008.3 76 Licensed Copy: sheffieldun sheffieldun, na, Fr
2、i Dec 01 13:52:15 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 5724-2.4:1985 This British Standard, having been prepared under the direction of the Health Care Standards Committee, was published under the authority of the Board of BSI and comes into effect on 31 July 1985 BSI 02-2000 The following
3、BSI references relate to the work on this standard: Committee reference HCC/93 Draft for comment 80/25763 DC ISBN 0 580 14509 3 Committees responsible for this British Standard The preparation of this British Standard was entrusted by the Health Care Standards Committee (HCC/-) to Technical Committe
4、e HCC/93 upon which the following bodies were represented: Association of Anaesthetists of Great Britain and Ireland Bath Institute of Medical Engineering Biological Engineering Society British Institute of Radiology British Medical Association British Surgical Trades Association Incorporated Colleg
5、e of Radiographers Department of Health and Social Security Department of Trade and Industry (National Physical Laboratory) Electro Medical Trade Association Limited GAMBICA (BEAMA Ltd.) Hospital Physicists Association Institute of Hospital Engineering Intensive Care Society Medical Sterile Products
6、 Association Ministry of Defence National Radiological Protection Board Royal College of Physicians of London Royal College of Surgeons of England Scottish Health Services The following body was also represented in the drafting of the standard, through sub-committees and panels: Cardiothoracic Insti
7、tute Amendments issued since publication Amd. No.Date of issueComments Licensed Copy: sheffieldun sheffieldun, na, Fri Dec 01 13:52:15 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 5724-2.4:1985 BSI 02-2000i Contents1) Page Committees responsibleInside front cover National forewordiii Section 1. Gen
8、eral 1Scope and object1 2Terminology and definitions1 4General requirements for tests2 5Classification2 6Identification, marking and documents2 7Power input3 Section 2. Safety requirements Section 3. Protection against electric shock hazards 14Requirements related to classification3 17Insulation and
9、 PROTECTIVE IMPEDANCES4 19Continuous LEAKAGE CURRENTS AND PATIENT AUXILIARY CURRENTS5 20Dielectric strength5 Section 4. Protection against mechanical hazards Section 5. Protection against hazards from unwanted or excessive radiation Section 6. Protection against hazards of explosions in medically us
10、ed rooms Section 7. Protection against excessive temperatures, fire and other hazards such as human errors 42Excessive temperatures7 44Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection7 46Human errors7 Section 8. Accuracy of operating data and protec
11、tion against incorrect output 50Accuracy of operating data8 51Protection against incorrect output9 Section 9. Fault conditions causing overheating and/or mechanical damage; environmental tests Section 10. Constructional requirements 56Components and general assembly9 57MAINS PARTS, components and la
12、yout10 Section 101. Additional requirements relating to safety 101Charging time11 102INTERNAL ELECTRICAL POWER SOURCE11 103Endurance11 104SYNCHRONIZER11 105Recovery of the CARDIAC MONITOR after defibrillation12 106Disturbance of the CARDIAC MONITOR from charging or internal discharging12 Appendix B
13、Testing during manufacture and/or installation19 Appendix AA Rationale19 Figure 101 Symbols for marking of defibrillation-protected EQUIPMENT of type BF and CF (see Sub-clause 6.1)13 1) Only clauses with text differing from that given in BS 5724-1 are included in this list. Licensed Copy: sheffieldu
14、n sheffieldun, na, Fri Dec 01 13:52:15 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 5724-2.4:1985 ii BSI 02-2000 Page Figure 102 Dynamic test for limitation of energy from different parts of the EQUIPMENT (see Item bb) of Clause 17)13 Figure 103 Dynamic test for limitation of energy from different
15、parts of the EQUIPMENT (see Item cc) of Clause 17)14 Figure 104 Test apparatus for flexible cords and their anchorages (see test 2 of Item c) of Sub-clause 56.101)15 Figure 105 Arrangement for test of recovery after defibrillation (see Sub-clause 105.1) not to scale15 Figure 106 Arrangement of monit
16、oring electrodes on sponge (see Sub-clause 105.2)16 Figure 107 Arrangement for recovery test after defibrillation (see Sub-clause 105.2)16 Figure 108 Arrangement for test of disturbance from charging and internal discharging (see Clause 106)17 Figure 109 Isolation of defibrillator circuit from separ
17、ate monitoring electrodes (see Appendix AA, Rationale on Clause 20)18 Publications referred toInside back cover Licensed Copy: sheffieldun sheffieldun, na, Fri Dec 01 13:52:15 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 5724-2.4:1985 BSI 02-2000iii National foreword This British Standard has been
18、prepared under the direction of the Health Care Standards Committee. The text is identical with IEC Publication 601-2-4 “Medical electrical equipment” Part 2 “Particular requirements for the safety of cardiac defibrillators and cardiac defibrillator-monitors”, published in 1983 by the International
19、Electrotechnical Commission (IEC). This particular Standard amends and supplements BS 5724-1 hereafter called the General Standard. As stated in 1.3 of the General Standard, the requirements of this Particular Standard take precedence over those of the General Standard. As in the General Standard, t
20、he requirements are followed by compliance tests. The numbers of the sections and clauses in this standard refer to the related sections and clauses in the General Standard. Clauses, subclauses or figures that are additional to those of the General Standard are numbered starting from 101; the additi
21、onal appendix is lettered AA and additional items aa), bb), etc. The changes from the text of the General Standard are specified by the use of the following words. “Replacement” means that the clause, subclause or specified paragraph of the General Standard is replaced by the text of this standard.
22、“Amendment” means that the clause, subclause or specified paragraph of the General Standard is amended as indicated by the text of this standard. “Addition” means that the text of this standard is additional to the requirements of the General Standard. A rationale for the most important requirements
23、 is given in Appendix AA. It is considered that a knowledge of the reasons for the requirements will not only facilitate the proper application of the standard, but will expedite any subsequent revision. This appendix does not form part of the standard. Terminology and conventions. The text of the I
24、nternational Standard has been approved as suitable for publication as a British Standard without deviation. Some terminology and certain conventions are not identical with those used in British Standards. In particular the following print types are used. Requirements, compliance with which can be t
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