BS-5724-2.6-1985 IEC-60601-2-6-1984.pdf
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1、BRITISH STANDARD BS 5724-2.6: 1985 IEC 601-2-6: 1984 Incorporating Amendment No. 1 Medical electrical equipment Part 2: Particular requirements for safety Section 2.6 Specification for microwave therapy equipment (Implementation of CENELEC HD 395.2.6) UDC 615.47:621.313:614.8:621.3.029.63 Licensed C
2、opy: sheffieldun sheffieldun, na, Fri Dec 01 13:49:46 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 5724-2.6:1985 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
3、May 1985 BSI 01-2000 The following BSI references relate to the work on this standard: Committee reference LEL/103 Draft for comment 81/20262 DC ISBN 0 580 14394 5 Committees responsible for this British Standard The preparation of this British Standard was entrusted by the Health Care Standards Com
4、mittee (HCC/-) to Technical Committee LEL/103, upon which the following bodies were represented: Bath Institute of Medical Engineering Biological Engineering Society British Institute of Radiology British Medical Association British Surgical Trades Association Incorporated College of Radiographers D
5、epartment 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 Association Ministr
6、y of Defence National Radiological Protection Board Royal College of Physicians of London Royal College of Surgeons of England Scottish Health Services The following bodies were also represented in the drafting of the standard, through sub-committees and panels: Association of X-ray Equipment Manufa
7、cturers (BEAMA Ltd.) British Association for Rheumatology and Rehabilitation British Cardiac Society British Dental Trade Association Chartered Society of Physiotherapy Institute of Medical Laboratory Sciences Institution of Electronic and Radio Engineers Royal Society of Medicine Amendments issued
8、since publication Amd. No.Date of issueComments 7017July 1992Indicated by a sideline in the margin Licensed Copy: sheffieldun sheffieldun, na, Fri Dec 01 13:49:46 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 5724-2.6:1985 BSI 01-2000i Contents Page Committees responsibleInside front cover National
9、forewordii Section 1. General 1Scope and object1 2Terminology and definitions1 3General requirements1 4General requirements for tests1 5Classification1 6Identification, marking and documents1 7Power input2 Section 2. Safety requirements2 Section 3. Protection against electric shock hazards 13General
10、2 14Requirements related to classification2 15Limitation of voltage and/or current3 16Enclosures and PROTECTIVE COVERS3 19Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS3 20Dielectric strength3 Section 4. Protection against mechanical hazards3 Section 5. Protection against hazards from un
11、wanted or excessive radiation 29X-radiation3 30Alpha, beta, gamma, neutron radiation and other particle radiation3 31Microwave radiation3 36Electromagnetic compatibility3 Section 6. Protection against hazards of explosions in medically used rooms4 Section 7. Protection against excessive temperatures
12、, fire and other hazards, such as human errors 42Excessive temperatures4 Section 8. Accuracy of operating data and protection against incorrect output 50Accuracy of operating data4 51Protection against incorrect output4 Section 9. Fault conditions causing overheating and/or mechanical damage; enviro
13、nmental tests5 Section 10. Constructional requirements 54General5 55Enclosures and covers5 Appendix B Testing during manufacture and/or installation6 Appendix AA Rationale6 Annex Z (informative) National deviations from HD 395.2.68 Figure 101 Measurement of UNWANTED RADIATION5 Publications referred
14、toInside back cover Licensed Copy: sheffieldun sheffieldun, na, Fri Dec 01 13:49:46 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 5724-2.6:1985 ii BSI 01-2000 National foreword This British Standard has been prepared under the direction of the Health Care Standards Committee. It is identical with IE
15、C Publication 601-2-6 “Medical electrical equipment” Part 2 “Particular requirements for the safety of microwave therapy equipment”, published in 1984 by the International Electrotechnical Commission (IEC). This Particular Standard amends and supplements BS 5724-1 hereinafter called the General Stan
16、dard. As stated in 1.3 of the General Standard, the requirements of this Particular Standard take precedence over those of the General Standard. This Section of BS 5724 is also in agreement with Harmonization Document HD 395.2.6, published by the European Committee for Electrotechnical Standardizati
17、on (CENELEC). As in the General Standard, the 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
18、 are numbered starting from 101; additional appendices are lettered AA, BB, etc., 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, sub-clause or specified paragraph of the Gener
19、al Standard is replaced by the text of this standard. “Amendment” means that the clause, sub-clause 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 St
20、andard. A rationale for the most important requirements 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 s
21、tandard. Terminology and conventions. The text of the International 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
22、 are used. Requirements, compliance with which can be tested, and definitions: in roman type. Explanations, advice, general statements, exceptions and references: in small roman type. Test specifications: in italic type. Terms defined in clause 2 of the General Standard and this Particular Standard:
23、 small capitals. There is no corresponding British Standard to CISPR Publication 11. The Technical Committee has reviewed the provisions of CISPR Publication 11, to which reference is made in the text, and has decided that they are acceptable for use in conjunction with this standard. Cross-referenc
24、e International StandardCorresponding British Standard IEC 601-1:1977BS 5724 Medical electrical equipment Part 1:1979 Specification for general safety requirements (Technically equivalent) Licensed Copy: sheffieldun sheffieldun, na, Fri Dec 01 13:49:46 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 5
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