EN 60601-2-3-1993 en Medical electrical equipment Part 2 Particular requirements for the safety of short-wave therapy equipment (Incorporates Amendment A1 1998 Remains Current)《医用电.pdf

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1、BRITISH STANDARD BS EN 60601-2-3:1993 BS5724-2.3: 1992 IEC601-2-3: 1991 Incorporating Amendment No.1 to BS5724-2.3:1992 (renumbers theBS asBSEN60601-2-3: 1993) and implementing Amendment No.1 to BSEN60601-2-3: 1993 not published separately Medical electrical equipment Part2: Particular requirements

2、for thesafety of short-wave therapy equipment The European Standard EN60601-2-3:1993 with the incorporation of its amendment A1:1998 has the status of a BritishStandard ICS 11.040.60BSEN60601-2-3:1993 This BritishStandard, having been prepared under the directionof the Health Care Standards Policy C

3、ommittee, waspublished under the authorityof the Standards Boardand comes into effect on 31January1992 BSI03-2000 First published November1983 Second edition January1992 The following BSI references relate to the work on this standard: Committee reference HCC/94 Draft for comment88/51885 DC ISBN 0 5

4、80 20508 8 Committees responsible for this BritishStandard The preparation of this BritishStandard was entrusted by the Health Care Standards Policy Committee (HCC/-) to Technical Committee HCC/94, upon which the following bodies were represented: British Society for Rheumatology Chartered Society o

5、f Physiotherapy Department of Health Electromedical Trade Association Limited Institute of Physical Sciences in Medicine (IPSM) Ministry of Defence Royal Society of Medicine Amendments issued since publication Amd. No. Date Comments 7879 August 1993 10420 April 1999 Indicated by a sideline in the ma

6、rginBSEN60601-2-3:1993 BSI 03-2000 i Contents Page Committees responsible Inside front cover National foreword ii Foreword 2 Section 1. General Introduction 3 1 Scope and object 3 2 Terminology and definitions 4 3 General requirements 4 4 General requirements for tests 4 5 Classification 4 6 Identif

7、ication, marking and documents 4 7 Power input 5 Section 2. Environmental conditions Section 3. Protection against electric shock hazards 13 Text deleted 14 Requirements related to classification 6 17 Separation 6 18 Text deleted 19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS 6 20 Die

8、lectric strength 6 Section 4. Protection against mechanical hazards Section 5. Protection against hazards from unwanted or excessive radiation 36 Electromagnetic compatibility 7 Section 6. Protection against hazards of ignition of flammable anaesthetic mixtures Section 7. Protection against excessiv

9、e temperatures and other safety hazards 42 Excessive temperatures 7 Section 8. Accuracy of operating data and protection against hazardous output 50 Accuracy of operating data 7 51 Protection against hazardous output 8 Section 9. Abnormal operation and fault conditions; environmental tests Section 1

10、0. Constructional requirements 56 Components and general assembly 9 Appendix AA Rationale 11 Annex ZA (normative) Other international publications quoted in this Standardwith the references of relevant European publications 13 Figure 101 R.F. dielectric strength test 9 Figure 102 Test probe 9 Figure

11、 103 Power measuring device for capacitive APPLICATORS 10 Figure 104 Example of a power measuring device for inductive applicators 10 Publication(s) referred to Inside back coverBSEN60601-2-3:1993 ii BSI 03-2000 National foreword This Section of BS5724 has been prepared under the direction of the He

12、alth Care Standards Policy Committee and is identical with IEC Publication601-2-3 “Medical electrical equipment Part2: Particular requirements for the safety of short-wave therapy equipment”, published by the International Electrotechnical Commission (IEC). In1993 the European Committee for Electrot

13、echnical Standardization (CENELEC) accepted IEC601-2-3:1991 as European Standard EN60601-2-3:1993. As a consequence of implementing the European Standard, this BritishStandard is renumbered as BS EN60601-2-3 and any reference to BS5724-2.3 should be read as a reference to BS EN60601-2-3. This Part s

14、upersedes the1983 edition of BS5724-2.3 which is withdrawn. The main difference between this edition and the previous edition is that it is based on the1989 edition of the General Standard BS5724-1. Further differences are given in the introduction. This Particular Standard amends and supplements BS

15、5724-1, hereinafter referred to as the General Standard. As stated in clause 1.3 of the General Standard, the requirements of a Particular Standard take precedence over those of the General Standard. As in the General Standard the requirements are followed by compliance tests. The numbers of the sec

16、tions 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 from101, the additional appendix is lettered AA, and additional items aa), bb), etc. The cha

17、nges 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. “Amendment” means that the clause, subclause or specified paragraph of t

18、he General Standard is amended as indicated by the text of this standard. “Addition” means that the text of the standard is additional to the requirements of the General Standard The Technical Committee has reviewed the provisions of CISPR Publication11, to which reference is made in clause36 of the

19、 text, and has decided that they are acceptable for use in conjunction with this standard. NOTEIn BS5724-2.3:1983, the note to clause36 of IEC601-2-3 was replaced by a reference to Statutory Instrument S.I.1895/1963 which is applicable to short-wave therapy equipment. This S.I. is expected to be wit

20、hdrawn in1992 when it will be replaced by legislation arising from the Electromagnetic Compatibility Directive89/336/EEC. Cross-references International Standard Corresponding BritishStandard IEC601-1:1977 BS5724 Medical electrical equipment Part1:1979 Specification for general safety requirements (

21、Technically equivalent) IEC601-1:1988 BS5724 Medical electrical equipment Part1:1989 General requirements for safety (Identical)BSEN60601-2-3:1993 BSI 03-2000 iii Textual errors. When adopting the text of the International Standard, the textual errors listed below were discovered. They have been mar

22、ked in the text and have been reported to the IEC in a proposal to amend the text of the International Standard. In the last line of6.8.3 delete “Sub-clause50.2” and substitute “Clause50”. In line7 of clause42, delete “Sub-clause50.2” and substitute “Clause50 of this Particular Standard”. In line3 o

23、f51.2 delete “Sub-clause50.2” and substitute “Clause50 of this Particular Standard”. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of its

24、elf confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pagesi toiv, theENtitle page, pages2 to14, an inside back cover and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. T

25、his will be indicated in the amendment table on the inside front cover.iv blankEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN60601-2-3 April1993 +A1 November1998 UDC 615.841:615.849.11:621.3.029.55/.62:001.4.620.1:614.8 Supersedes HD395.2.3 S1:1985 Descriptors: Medical electrical equipment, sh

26、ort wave therapy, instructions for use, electrical safety, testing, construction, definitions, requirements Medical electrical equipment Part2.Particularrequirements for the safety of short-wave therapy equipment (includes amendment A1:1998) (IEC601-2-3:1991+A1:1998) Appareils lectromdicaux Deuxime

27、partie: Rgles particulires de scurit pour appareils de thrapie ondes courtes (inclut lamendement A1:1998) (CEI601-2-3:1991+A1:1998) Medizinische elektrische Gerte Teil2. Besondere Festlegungen fr die Sicherheit von Kurzwellen-Therapiegerten (enthlt nderung A1:1998) (IEC601-2-3:1991+A1:1998) This Eur

28、opean Standard was approved by CENELEC on 1992-12-09; its amendment A1 was approved by CENELEC on 1998-10-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any a

29、lteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CENELEC member. This European Standard exists in three official versions (English, French, German). A version in any other language made b

30、y translation under the responsibility of a CENELEC member into its own language and notified to the Central Secretariat has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland,

31、 Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland andUnitedKingdom. CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassa

32、rt 35, B-1050 Brussels 1993 Copyright reserved to CENELEC members Ref.No.EN60601-2-3:1993E+A1:1998EN60601-2-3:1993 BSI 03-2000 2 Foreword At the request of the CENELEC Technical Committee TC62, Electrical equipment in medicalpractice, the International Standard IEC601-2-3:1991 was submitted to the C

33、ENELECUnique Acceptance Procedure (UAP) inFebruary1992 for acceptance as a European Standard. The text of the International Standard was approved by CENELEC as EN60601-2-3 on9December1992. This European Standard supersedes HD395.2.2S1:1985. The following dates were fixed: For products which have com

34、plied with HD395.2.3 S1:1985 before1993-09-15, as shown by the manufacturer or by a certification body, this previous standard may continue to apply for production until1998-09-15. Annexes designated “normative” are part of the body of the standard. In this standard, Annex ZA is normative. Foreword

35、to amendment A1 The text of document62D/292/FDIS, future amendment1 to IEC60601-2-3:1991, prepared by SC62D, Electromedical equipment, of IED TC62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as amendment A1 to EN60601-2-3:1993

36、 on1998-10-01. The following dates were fixed: Annexes designated “normative” are part of the body of the standard. In this standard, Annex ZA isnormative. Annex ZA has been added by CENELEC. Endorsement notice The text of amendment1:1998 to the InternationalStandard IEC60601-2-3:1991 was approved b

37、y CENELEC as an amendment to the European Standard without any modification. latest date of publication ofan identical national standard (dop) 1993-09-15 latest date of withdrawal ofconflicting national standards (dow) 1993-09-15 latest date by which the amendment has to be implemented at national l

38、evel by publication of an identical national standard or by endorsement (dop) 1999-07-01 latest date by which the national standards conflicting with the amendment have to be withdrawn (dow) 2001-07-01EN60601-2-3:1993 BSI 03-2000 3 Introduction This standard concerns the safety of short-wave therapy

39、 equipment. A first edition of this Particular Standard was published in1982, based on the first edition of the General Standard, IEC Publication601-1 (1977). The present second edition of the Particular Standard refers to the second edition (1988) of the General Standard. The revision of this secon

40、d edition concerns mainly the following: 1. Low power equipment (10W) is exempted from certain requirements as it is considered that no hazard exists. 2. Equipment with inductive applicators is dealt with in more detail. 3. Some shortcomings of the first edition detected in the application of the St

41、andard are removed. The requirements of this Particular Standard take priority over those of the General Standard. The title of the General Standard has been changed in the second edition (1988) to read: “Medical electrical equipment, Part1: General requirements for safety”. The change is reflected

42、in this Particular Standard. Where it is intended that any part of the General Standard, although possibly relevant, is not to be applied, a statement to that effect is given in this Particular Standard. The numbering of sections, clauses and sub-clauses of this Particular Standard corresponds with

43、that of the General Standard. Sub-clauses or figures which are additional to thoseof the General Standard are numbered starting from101; additional appendices are lettered AA, BB, etc., and additional items aa), bb), etc. In this Standard, the following print types are used: requirements, compliance

44、 with which can be tested, and definitions: in roman type; explanations, advice, introductions, general statements, exceptions and references: in smaller type; test specifications: in italic type; TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR THIS PARTICULAR STANDARD: SMALL CAPITALS. The requ

45、irements are followed by specifications for the relevant tests. A rationale for the more important requirements, where appropriate, is given in Appendix AA. It is considered that a knowledge of the reasons for these requirements will not only facilitate the proper application of the standard but wil

46、l, in due course, expedite any revision necessitated by changes in clinical practice or as a result of developments in technology. However, this appendix does not form part of the requirements of this Standard. The sub-clauses which have corresponding rationale statements are marked with an asterisk

47、 (*) before their number. Section 1. General 1 Scope and object This clause of the General Standard applies except as follows: 1.1 Scope Addition: This particular Standard specifies the requirements for the safety of SHORT-WAVE THERAPY EQUIPMENT as defined in sub-clause 2.1.101 hereinafter referred

48、to as EQUIPMENT having a RATED OUTPUT POWER not exceeding500W. LOW POWER EQUIPMENT as defined in subclause2.2.101 is exempted from certain requirements of this standard. 1.5 Collateral Standards Addition: The following Collateral Standards apply: IEC60601-1-1:1992, Medical electrical equipment Part1

49、: General requirements for safety1. Collateral Standard: Safety requirements for medical electrical systems. IEC60601-1-1-2:1993, Medical electrical equipment Part1: General requirements for safety 2. Collateral Standard: Electromagnetic compatibility Requirements and tests. IEC60601-1-1-4:1996, Medical electrical equipment Part1:General requirements for safety4. Programmable electrical medical systems.EN60601-2-3:1993 4 BSI 03-2000 2 Terminology and definitions This clause of the General Standard applies except as follows: