BS EN 60601-2-5-2001 Medical electrical equipment Particular requirements for safety Particular requirements for the safety of ultrasonic physiotherapy equipment《医用电气设备 安全性详细要求 超声波.pdf

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1、BRITISH STANDARD BS EN 60601-2-5:2001 Medical electrical equipment Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment The European Standard EN 60601-2-5:2000 has the status of a British Standard. ICS 11.040.60 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED

2、BY COPYRIGHT LAWBS EN 60601-2-5:2001 This British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 May 2001 BSI 05-2001 ISBN 0 580 37110 7 National foreword This

3、 British Standard is the official English language version of EN 60601-2-5:2000. It is identical with IEC 60601-2-5:2000. It supersedes BS 5724-2-5:1985 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/111, Ultrasonic diagnostic equipment, which has

4、 the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. From 1 January 1997, all IEC publications have the number 60000 added to the old number. For instance, IEC 27-1 has been renumbered as IEC 60027-1. For a period of time during t

5、he change over from one numbering system to the other, publications may contain identifiers from both systems. Cross-references Attention is drawn to the fact that CEN and CENELEC Standards normally include an annex which lists normative references to international publications with their correspond

6、ing European publications. The British Standards which implement these publications may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard doe

7、s 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 itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsibl

8、e international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, t

9、he EN title page, pages 2 to 22, an inside back cover and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEAN STANDARD EN 60601-2-5 NORME EUROPENNE EUROPISCHE NORM December 200

10、0 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels 2000 CENELEC - All rights of exploitation in any form and by any means reserve

11、d worldwide for CENELEC members. Ref. No. EN 60601-2-5:2000 E ICS 11.040.60 Supersedes HD 395.2.5 S1:1986 English version Medical electrical equipment Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment (IEC 60601-2-5:2000) Appareils lectromdicaux Partie 2-5: Rgles

12、 particulires de scurit des appareils ultrasons pour physiothrapie (CEI 60601-2-5:2000) Medizinische elektrische Gerte Teil 2-5: Besondere Festlegungen fr die Sicherheit von Ultraschall- Physiotherapiegerten (IEC 60601-2-5:2000) This European Standard was approved by CENELEC on 2000-09-01. CENELEC m

13、embers 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 alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on applic

14、ation 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 by translation under the responsibility of a CENELEC member into its own language and notified to the Central Secretaria

15、t has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingd

16、om.gaPe 2 6 NE060-1-22:5000 Foreword The text of document 62D/361/FDIS, future edition 2 of IEC 60601-2-5, prepared by SC 62D, Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-5

17、on 2000-09-01. This European Standard supersedes HD 395.2.5 S1:1986. The following dates were fixed: latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2001-06-01 latest date by which the national standards con

18、flicting with the EN have to be withdrawn (dow) 2003-09-01 Annexes designated “normative“ are part of the body of the standard. Annexes designated “informative“ are given for information only. In this standard, annex ZA is normative and annexes AA and ZB are informative. Annexes ZA and ZB have been

19、added by CENELEC. _ Endorsement notice The text of the International Standard IEC 60601-2-5:2000 was approved by CENELEC as a European Standard without any modification. _ Page2 EN6060125:2000 BSI 05-2001 CONTENTS Page INTRODUCTION 5 Clause SECTION ONE GENERAL 1 Scope and object 6 2 Terminology and

20、definitions 7 4 General requirements for tests 9 5 Classification 9 6 Identification, marking and documents 9 7 Power input .10 SECTION TWO ENVIRONMENTAL CONDITIONS SECTION THREE PROTECTION AGAINST ELECTRIC SHOCK HAZARDS 13 General .11 SECTION FOUR PROTECTION AGAINST MECHANICAL HAZARDS 21 Mechanical

21、 strength.11 SECTION FIVE PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION 35 Acoustical energy (including ultrasonics)11 36 Electromagnetic compatibility.12 SECTION SIX PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES SECTION SEVEN PROTECTION AGAINST EXCESSIVE

22、 TEMPERATURESAND OTHER SAFETY HAZARDS 42 Excessive temperatures.12 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection and compatibility 13 SECTION EIGHT ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT 50 Accuracy of operating data 1

23、3 51 Protection against hazardous output 14 Page3 EN6060125:2000 BSI 05-2001 SECTION NINE ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS SECTION TEN CONSTRUCTIONAL REQUIREMENTS 56 Components and general assembly15 Figure 101.16 Appendix L17 Annex AA - General guidance and rationale.18

24、Annex ZA (normative) Normative references to international publications with their corresponding European publications 21 Annex ZB (informative) Other international publications mentioned in this standard with the references of the relevant European publications.22 Page4 EN6060125:2000 BSI 05-2001IN

25、TRODUCTION This Particular Standard specifies requirements and tests for the safety of ULTRASONIC PHYSIOTHERAPY EQUIPMENT. It amends and supplements IEC 60601-1 (second edition, 1988) including Amendments 1 and 2, hereinafter referred to as the General Standard. This Particular Standard takes into a

26、ccount IEC 60601-1-2 and IEC 61689. A first edition of this Particular Standard was published in 1984, based on the first edition (1977) of IEC 60601-1 and making reference to IEC 60150. The aim of this second edition is to bring this Particular Standard up to date with reference to the publications

27、 and documents mentioned above. The title has been changed to better reflect its scope based on developments in the therapeutic application of ultrasound and in line with changes in the above IEC standards. The requirements are followed by specifications for the relevant tests. A rationale for the m

28、ore important requirements, where appropriate, is given in annex AA. It is considered that a knowledge of the reasons for these requirements will not only facilitate the proper application of the Particular Standard but will, in due course, expedite any revision necessitated by changes in clinical p

29、ractice or as a result of developments in technology. However this annex does not form part of the requirements of this Standard. The clauses and subclauses which have corresponding rationale statements are marked with an asterisk * before their number. Page5 EN6060125:2000 BSI 05-2001 MEDICAL ELECT

30、RICAL EQUIPMENT Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment SECTION ONE GENERAL The clauses and subclauses of this section of the General Standard apply, except as follows: 1 Scope and object 1.1 Scope Addition: This Particular Standard specifies the requir

31、ements for safety of ULTRASONIC PHYSIOTHERAPY EQUIPMENT used in medical practice, as defined in 2.1.101. This Particular Standard does not apply to: EQUIPMENT in which a tool is driven by ULTRASOUND (for example EQUIPMENT used in surgery or dentistry); EQUIPMENT in which focused ULTRASOUND pulse wav

32、es are used to destroy conglom- erates such as stones in the kidneys or the bladder (lithotrites) (for information refer to IEC 60601-2-36); ULTRASONIC PHYSIOTHERAPY EQUIPMENT in which focused ULTRASOUND pulse waves are used. 1.2 Object Replacement: The object of this Particular Standard is to estab

33、lish particular requirements for the safety of ULTRASONIC PHYSIOTHERAPY EQUIPMENT used in medical practice, as defined in 2.1.101. 1.3 Particular Standards Addition: This Particular Standard refers to IEC 60601-1 (1988): Medical electrical equipment Part 1: General requirements for safety, as amende

34、d by its amendment 1 (1991) and amendment 2 (1995). For brevity, Part 1 is referred to in this Particular Standard as the “General Standard” . The numbering of sections, clauses and subclauses of this Particular Standard corresponds with that of the General Standard. The changes to the text of the G

35、eneral Standard are specified by the use of the following words: “Replacement” means that the clause or subclause of the General Standard is replaced completely by the text of this Particular Standard. “Addition” means that the text of this Particular Standard is additional to the requirements of th

36、e General Standard. Page6 EN6060125:2000 BSI 05-2001 “Amendment” means that the clause or subclause of the General Standard is amended as indicated by the text of this Particular Standard. Subclauses or figures which are additional to those of the General Standard are numbered starting from 101, add

37、itional annexes are lettered AA, BB, etc., and additional items aa), bb), etc. The term “this standard” is used to make reference to the General Standard and this Particular Standard taken together. Where there is no corresponding section, clause or subclause in this Particular Standard, the section

38、, clause or subclause of the General Standard, although possibly not relevant, applies without modification; 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 requirements

39、 of this Particular Standard take priority over those of the General Standard and Collateral Standards mentioned below. 1.5 Collateral Standards Addition: The following Collateral Standards apply: IEC 60601-1-1:1992, Medical electrical equipment Part 1: General requirements for safety Section 1 Coll

40、ateral standard: Safety requirements for medical electrical systems IEC 60601-1-2:1993, Medical electrical equipment Part 1: General requirements for safety 2. Collateral Standard: Electromagnetic compatibility Requirements and tests IEC 60601-1-4:1996, Medical electrical equipment Part 1: General r

41、equirements for safety 4. Collateral Standard: Programmable electrical medical systems 2 Terminology and definitions 2.1 EQUIPMENT parts, auxiliaries and ACCESSORIES Additional definitions: 2.1.101 ULTRASONIC PHYSIOTHERAPY EQUIPMENT (hereinafter referred to as EQUIPMENT) EQUIPMENT for the generation

42、 and application of ULTRASOUND to a PATIENT for therapeutic purposes NOTE Essentially the EQUIPMENT comprises a generator of electric high-frequency power and a transducer for converting this to ULTRASOUND. 2.1.102 ULTRASONIC TRANSDUCER device capable of converting electrical energy to mechanical en

43、ergy within the ultrasonic frequency range *2.1.103 TREATMENT HEAD assembly comprising an ULTRASONIC TRANSDUCER and associated parts for local application of ULTRASOUND to the PATIENT NOTE A TREATMENT HEAD is also referred to as an applicator. Page7 EN6060125:2000 BSI 05-2001 2.1.104 ATTACHMENT HEAD

44、 ACCESSORY intended to be attached to the TREATMENT HEAD for the purpose of modifying the ultrasonic beam characteristics 2.12 MISCELLANEOUS 2.12.101 RATED OUTPUT POWER Maximum OUTPUT POWER of the EQUIPMENT at any RATED MAINS VOLTAGE IEC 61689, definition 3.32 2.12.102 ULTRASOUND acoustic oscillatio

45、n whose frequency is above the high-frequency limit of audible sound (about 16 kHz) (see 801-21-04 of IEC 60050(801) IEC 61689, definition 3.45 2.12.103 EFFECTIVE RADIATING AREA beam cross-sectional area extrapolated to the front face of the TREATMENT HEAD and multiplied by a dimensionless factor ac

46、cording to IEC 61689 IEC 61689, definition 3.20, modified NOTE This may be thought of as the area of the face of the treatment head which contains 100% of the total mean square acoustic power. 2.12.104 EFFECTIVE INTENSITY ratio of the OUTPUT POWER to the EFFECTIVE RADIATING AREA. It is expressed in

47、watts per square centimetre IEC 61689, definition 3.18, modified 2.12.105 ACOUSTIC WORKING FREQUENCY frequency of an acoustic signal based on the observation of the output of a hydrophone placed in an acoustic field. The signal is analysed using the zero-crossing frequency technique (see 3.4.1 of IE

48、C 61102) IEC 61689, definition 3.3 2.12.106 BEAM NON-UNIFORMITY RATIO ratio of the square of the maximum r.m.s. acoustic pressure to the spatial average of the square of the r.m.s. acoustic pressure where the spatial average is taken over the EFFECTIVE RADIATING AREA, determined in accordance with I

49、EC 61689 IEC 61689, definition 3.9, modified 2.12.107 BEAM TYPE descriptive classification for the ultrasonic beam in one of three types: collimated, convergent or divergent IEC 61689, definition 3.11 2.12.108 DUTY FACTOR ratio of the PULSE DURATION to the PULSE REPETITION PERIOD (see 5.3.2.4 of IEC 60469-1) IEC 61689, definition 3.17 2.12.109 OUTPUT POWER time-average ultrasonic power radiated by a TREATMENT HEAD of EQUIPME