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 615.47:621.313:614.8:621.3.029.63BS5724-2.6:
2、1985 This British Standard, having been prepared under the directionof the Health Care Standards Committee, was published under the authority ofthe Board of BSI and comes intoeffect on 31May1985 BSI 01-2000 The following BSI references relate to the work on this standard: Committee reference LEL/103
3、 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 Committee (HCC/-) to Technical Committee LEL/103, upon which the following bodies were represented: Bath Institute of
4、 Medical Engineering Biological Engineering Society British Institute of Radiology British Medical Association British Surgical Trades Association Incorporated College of Radiographers Department of Health and Social Security Department of Trade and Industry (National Physical Laboratory) Electro Me
5、dical Trade Association Limited GAMBICA (BEAMA Ltd.) Hospital Physicists Association Institute of Hospital Engineering Intensive Care Society Medical Sterile Products Association Ministry of Defence National Radiological Protection Board Royal College of Physicians of London Royal College of Surgeon
6、s 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 Manufacturers (BEAMA Ltd.) British Association for Rheumatology and Rehabilitation British Cardiac Society British Denta
7、l Trade Association Chartered Society of Physiotherapy Institute of Medical Laboratory Sciences Institution of Electronic and Radio Engineers Royal Society of Medicine Amendments issued since publication Amd. No. Date of issue Comments 7017 July 1992 Indicated by a sideline in the marginBS5724-2.6:1
8、985 BSI 01-2000 i Contents Page Committees responsible Inside front cover National foreword ii Section 1. General 1 Scope and object 1 2 Terminology and definitions 1 3 General requirements 1 4 General requirements for tests 1 5 Classification 1 6 Identification, marking and documents 1 7 Power inpu
9、t 2 Section 2. Safety requirements 2 Section 3. Protection against electric shock hazards 13 General 2 14 Requirements related to classification 2 15 Limitation of voltage and/or current 3 16 Enclosures and PROTECTIVE COVERS 3 19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS 3 20 Dielec
10、tric strength 3 Section 4. Protection against mechanical hazards 3 Section 5. Protection against hazards from unwanted or excessive radiation 29 X-radiation 3 30 Alpha, beta, gamma, neutron radiation and other particle radiation 3 31 Microwave radiation 3 36 Electromagnetic compatibility 3 Section 6
11、. Protection against hazards of explosions in medically used rooms 4 Section 7. Protection against excessive temperatures, fire and other hazards, such as human errors 42 Excessive temperatures 4 Section 8. Accuracy of operating data and protection against incorrect output 50 Accuracy of operating d
12、ata 4 51 Protection against incorrect output 4 Section 9. Fault conditions causing overheating and/or mechanical damage; environmental tests 5 Section 10. Constructional requirements 54 General 5 55 Enclosures and covers 5 Appendix B Testing during manufacture and/or installation 6 Appendix AA Ratio
13、nale 6 Annex Z (informative) National deviations from HD 395.2.6 8 Figure 101 Measurement of UNWANTED RADIATION 5 Publications referred to Inside back coverBS5724-2.6:1985 ii BSI 01-2000 National foreword This British Standard has been prepared under the direction of the Health Care Standards Commit
14、tee. It is identical with IEC Publication601-2-6 “Medical electrical equipment” Part2 “Particular requirements for the safety of microwave therapy equipment”, published in1984 by the International Electrotechnical Commission (IEC). This Particular Standard amends and supplements BS5724-1 hereinafter
15、 called the General Standard. As stated in1.3 of the General Standard, the requirements of this Particular Standard take precedence over those of the General Standard. This Section of BS5724 is also in agreement with Harmonization Document HD395.2.6, published by the European Committee for Electrote
16、chnical Standardization (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
17、 the General Standard are numbered starting from101; additional appendices are letteredAA, BB, etc., and additional itemsaa), 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 para
18、graph of the General 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
19、 of the General Standard. A rationale for the most important requirements is given inAppendix 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 f
20、orm part of the standard. 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 foll
21、owing print types 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 inclause2 of the General Standard and this Parti
22、cular Standard: small capitals. There is no corresponding British Standard to CISPR Publication11. The Technical Committee has reviewed the provisions of CISPR Publication11, to which reference is made in the text, and has decided that they are acceptable for use in conjunction with this standard. C
23、ross-reference International Standard Corresponding British Standard IEC 601-1:1977 BS 5724 Medical electrical equipment Part 1:1979 Specification for general safety requirements (Technically equivalent)BS5724-2.6:1985 BSI 01-2000 iii A British Standard does not purport to include all the necessary
24、provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pagesi toiv, pages1to8, an
25、inside back cover and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover.iv blankBS5724-2.6:1985 BSI 01-2000 1 Section 1. General 1 Scope and object This clause of the Gen
26、eral Standard applies except as follows: 1.1 Scope Addition: This Particular Standard specifies requirements forthe safety of MICROWAVE THERAPY EQUIPMENT used in medical practice, as defined in Sub-clause2.1.101, hereinafter referred to as EQUIPMENT. This standard does not apply to EQUIPMENT specifi
27、ed for hyperthermia. 2 Terminology and definitions This clause of the General Standard applies except as follows: 2.1.5 APPLIED PART Addition: Accessible parts of APPLICATORS and their associated connecting cables or waveguides and their connectors. Additional definitions: 2.1.101 MICROWAVE THERAPY
28、EQUIPMENT EQUIPMENT for the treatment of the PATIENT by means of a propagated electromagnetic field in the frequency range of more than300MHz but not exceeding30GHz 2.1.102 APPLICATOR radiator, i.e.an aerial with a directional effect, such as a dipole with reflector, a dipole array, open waveguide o
29、r dielectric radiator for local application of microwave energy to the PATIENT 2.1.103 PHANTOM device, intended to simulate parts of the PATIENT for test purposes 2.12.101 RATED OUTPUT POWER value of the maximum high-frequency power averaged over at least1s which can be fed into a MATCHED LOAD 2.12.
30、102 UNWANTED RADIATION microwave radiation which is not incident on the PATIENT for treatment purposes 2.12.103 MATCHED LOAD resistive load normally in the range507 to757, which, when replacing the APPLICATOR, results in a voltage standing wave ratio (VSWR) not exceeding1.5in the APPLICATOR connecti
31、ng cable or waveguide 3 General requirements This clause of the General Standard applies. 4 General requirements for tests This clause of the General Standard applies except as follows: 4.1 Item b) Addition: Additional routine tests: SeeAppendix B. 5 Classification This clause of the General Standar
32、d applies except as follows: 5.1 Amendment: Delete CLASS III EQUIPMENT. 5.6 Amendment: Delete all except CONTINUOUS OPERATION. 6 Identification, marking and documents This clause of the General Standard applies except as follows: 6.1 Marking on the outside of the EQUIPMENT p) Output Replacement: RAT
33、ED OUTPUT POWER in watts. MATCHED LOAD in ohms. Operating frequency in megahertz or gigahertz. q) Physiological effects (symbols and warning statements) Replacement: Symbol No.8 of TableD.II in AppendixD of the General Standard (non-ionizing radiation) shall be applied to any ACCESS COVER the remova
34、l of which results in the emission of a microwave power density in excess of10mW/cm 2when measured under the conditions of Sub-clause31.2. Compliance shall be checked by inspection of any ACCESS COVER for the presence of this symbol. Where an ACCESS COVER is not so marked, the test of Sub-clause31.2
35、 shall be performed with the ACCESS COVER removed.BS5724-2.6:1985 2 BSI 01-2000 6.2 Marking on the inside of EQUIPMENT or EQUIPMENT parts Additional items: aa) The symbol specified in Itemq) of Sub-clause6.1 shall be applied to any internal ACCESS COVER the removal of which may result in the EQUIPME
36、NT failing to comply with the requirement ofSub-clause31.2. Compliance shall be checked by the test of Sub-clause31.2 with the internal ACCESS COVER removed if it is not marked with the above symbol and also with any external ACCESS COVER not bearing this symbol removed. bb) Symbol No.14 of TableD.I
37、 in AppendixD of the General Standard (consult ACCOMPANYING DOCUMENTS) shall be displayed on or near components or on panels giving access to components the adjustment or replacement of which may result in the EQUIPMENT failing to comply with the requirements for interference suppression. Compliance
38、 shall be checked by inspection. 6.8.2 Instructions for use Additional item: aa) The instructions for use shall contain the following statements and information: a) The correct procedures for positioning the APPLICATOR for a particular treatment while minimizing the irradiation of other parts of the
39、 body. b) Advice that the output power should be switched off when the APPLICATOR is being positioned for treatment. c) Advice that the APPLICATOR should not be directed towards the eyes or testes. d) A recommendation that the PATIENT should be provided with microwave protection goggles, where appro
40、priate. e) Advice on the potential hazards of conductive objects or materials near to the PATIENT: Microwave energy should not be applied to persons wearing metallic jewellery or clothing containing metallic material (for example metallic buttons, clips or thread). Parts of the body of the PATIENT c
41、ontaining metallic implants (for example a medullary nail) should not be treated unless specialized medical advice is obtained. Hearing aids should be removed from the body. PATIENTS with implanted cardiac pacemakers or electrodes should be excluded from treatment with microwaves and from areas wher
42、e the EQUIPMENT is operated. f) Confirmation that when small areas of the body, for example a wrist are treated, the APPLICATOR should be positioned so that sensitive areas (e.g.eyes, testes) are not in the line of the radiation which is not intercepted by the area (wrist) being treated. g) Informat
43、ion on the type and size of APPLICATOR recommended for treating various parts of the body and the maximum power allowable for a particular APPLICATOR. h) A warning statement that persons not receiving treatment should not be allowed to remain within a distance of1.5m from a microwave APPLICATOR whil
44、e it is being used for treatment. i) The USERS attention should be directed to the need for care when handling APPLICATORS, since rough handling may change the directional characteristics of the APPLICATOR. j) Advice that PATIENTS with reduced thermal sensitivity in the proposed area of treatment sh
45、ould normally not be treated with microwave therapy. 6.8.3 Technical description Addition: The technical description supplied with the EQUIPMENT shall provide information on the precautions to be observed when the warning symbols mentioned in Itemq) of Sub-clause6.1 andSub-clause6.2 are displayed. 7
46、 Power input This clause of the General Standard applies withthe EQUIPMENT operated as specified in Sub-clause50.2. Section 2. Safety requirements Clauses8 to12 of the General Standard apply. Section 3. Protection against electric shock hazards 13 General This clause of the General Standard applies.
47、 14 Requirements related to classification This clause of the General Standard applies except as follows: 14.3 CLASS III EQUIPMENT: Does not apply. 14.4 MICROWAVE EQUIPMENT shall not be CLASS III EQUIPMENT.BS5724-2.6:1985 BSI 01-2000 3 15 Limitation of voltage and/or current This clause of the Gener
48、al Standard applies. 16 Enclosures and PROTECTIVE COVERS This clause of the General Standard applies except as follows: Item a) Addition: For the purposes of this sub-clause LIVE PARTS include parts which are energized at the operating frequency. Clauses17 and18 of the General Standard apply. 19 Con
49、tinuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS This clause of the General Standard applies except as follows: The PATIENT LEAKAGE CURRENT from accessible parts of a floating APPLIED PART shall not exceed the limits given in TableIV of the General Standard when tested as specified: Compliance shall be checked by measurement of the PATIENT LEAKAGE CURRENT in such a way that no r.f. oscillations occur, only d.c. and low-frequency voltages being present. 20 Dielectric strength This clause of the General Standard applies. Section 4. Protection against mechan
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