1、STD-BSI BS EN bOb01-2-5-ENGL 2001 D Lb2qbbS 0708331 827 D BRITISH STANDARD Medical electrical equipment - Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment The European Standard EN 60601-2-52000 has the status of a British Standard. IC5 11.040.60 BS EN 60601-2-5:
2、2001 NO COPYING WITHOUT BSI PERMISSION EXCEPT As PERMIITED BY COPYRIGHT LAW COPYRIGHT European Committee for Electrotechnical StandardizationLicensed by Information Handling ServicesNational foreword under the authority of the .Standarda Committee and Amd. No. comes into effect on 16 May 2001 O BSI
3、06-2001 This 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 It supersedes BS 6724-2-5:1985 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/lll, Ultrasonic diagnostic equipmen
4、t, which has the responsibility to: Date Comments - - aid enquirers to understand the text; present to the responsible internationallEuropean committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European develop
5、ments and promulgate them in the UK. - 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 o
6、f time during the change over from one numbering system to the other, publications may contain identifiers hom 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 th
7、eir corresponding 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 Britis
8、h 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 itself confer immunity from legal obligations. Summary of pages This document comprises a front
9、cover, an inside front cover, the 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. ISBN O 080 57110 7 COPYRIGHT European Committee for Electrotechnical StandardizationLicensed by Inform
10、ation Handling Services - STD-BSI BS EN bObOL-2-5-ENGL 2001 Lb24bb7 0708333 bTT m EUROPEAN STANDARD EN 60601-2-5 NORME EUROPENNE EUROPAISCHE NORM December 2000 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
11、 ultrasonic physiotherapy equipment (IEC 60601-2-512000) Appareils lectromdicaux Partie 2-5: Rgles particulires de scurit des appareils ultrasons pour physiothrapie (CE1 60601-2-5:2000) Medizinische elektrische Gerte Teil 2-5: Besondere Festlegungen fr die Sicherheit von Ultraschall- P hysiotherapie
12、gerten (IEC 60601-2-512000) This European Standard was approved by CENELEC on 2000-09-01. CENELEC members are bound to comply with the CENKENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date
13、 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 by translation under t
14、he 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, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Irel
15、and, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart
16、35, B - 1050 Brussels O 2000 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60601-2-5:2000 E COPYRIGHT European Committee for Electrotechnical StandardizationLicensed by Information Handling ServicesForeword The text of document
17、62D/361/FDIS, future edition 2 of IEC60601-2-5, prepared by SC62D, 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 on 2000-09-01. This European Standard supersedes HD 395.2.5
18、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 - latest date by which the national standards conflicting with the EN have to be withdrawn (dp) 2001-06-01 (dow) 2003-09-0
19、1 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 nomiative and annexes AA and ZB are informative. Annexes ZA and ZB have been added by CENELEC. Endorsement notice The text of the Inte
20、rnational Standard IEC 60601-2-5:2000 was approved by CENELEC as a European Standard without any modification. COPYRIGHT European Committee for Electrotechnical StandardizationLicensed by Information Handling ServicesCONTENTS Page INTRODUCTION 5 Clause 1 Scope and object 6 2 Terminology and definiti
21、ons 7 4 General requirements for tests 9 5 Classification 9 6 Identification, marking and documents 9 7 Power input . 1 O SECTION ONE - GENERAL SECTION TWO - ENVIRONMENTAL CONDITIONS SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS 13 General . 11 SECTION FOUR - PROTECTION AGAINST MECHANICA
22、L HAZARDS 21 Mechanical strength . 1 I SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION 35 Acoustical energy (including ultrasonics) 1 1 36 Electromagnetic compatibility . 12 SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES SECTION
23、SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS 42 Excessive temperatures . 12 disinfection and compatibility 13 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, SECTION EIGHT -ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOU
24、S OUTPUT 50 Accuracy of operating data 13 51 Protection against hazardous output 14 Q BSI 05-2001 COPYRIGHT European Committee for Electrotechnical StandardizationLicensed by Information Handling ServicesSTD OS1 page 4 EN 60601-2-6:2000 SECTION NINE -ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONM
25、ENTAL TESTS SECTION TEN - CONSTRUCTIONAL REQUIREMENTS 56 Components and general assembly 15 Figure 101 . 16 Appendix L 17 Annex AA - General guidance and rationale . 18 corresponding European publications 21 references of the relevant European publications . 22 Annex ZA (normative) Normative referen
26、ces to international publications with their Annex ZB (informative) Other international publications mentioned in this standard with the O BSI 05-2001 COPYRIGHT European Committee for Electrotechnical StandardizationLicensed by Information Handling Services STD-BSI BS EN bObOL-2-5-ENGL ZOOL Lb2Vbb9
27、0708337 S45 Page 5 EN 60601-2-6:2000 INTRODUCTION 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 Standar
28、d. This Particular Standard takes into account 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
29、 date with reference to the publications 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 t
30、he relevant tests. A rationale for the more 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 revisi
31、on necessitated by changes in clinical practice 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. O BSI
32、05-2001 COPYRIGHT European Committee for Electrotechnical StandardizationLicensed by Information Handling ServicesMEDICAL ELECTRICAL EQUIPMENT - Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment SECTION ONE - GENERAL The clauses and subclauses of this section of
33、the General Standard apply, except as follows: 1 Scope and object 1.1 Scope Addition: This Particular Standard specifies the requirements 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
34、 a tool is driven by ULTRASOUND (for example EQUIPMENT used in EQUIPMENT in Which focused ULTRASOUND pulSe waves are used to destroy COnglOm- IEC 60601-2-36); ULTRASONIC PHYSIOTHERAPY EQUIPMENT in which focused ULTRASOUND PulSe Waves are surgery or dentistry); erates such as stones in the kidneys or
35、 the bladder (lithotrites) (for information refer to used. - - 1.2 Object Replacement: The object of this Particular Standard is to establish particular requirements for the safety of ULTRASONIC PHYSIOTHERAPY EQUIPMENT used in medical practice, as defined in 2.1.101. 1.3 Particular Standards Additio
36、n: This Particular Standard refers to IEC 60601-1 (1988): Medical electrical equipment - fart I: General requirements for safety, as amended by its amendment 1 (1991) and amendment 2 (1 995). For brevity, Part 1 is referred to in this Particular Standard as the “General Standard“ . The numbering of
37、sections, clauses and subclauses of this Particular Standard corresponds with that of the General Standard. The changes to the text of the General Standard are specified by the use of the following words: “Replacement“ means that the clause or subclause of the General Standard is replaced completely
38、 by the text of this Particular standard. “Addition“ means that the text of this Particular Standard is additional to the requirements of the General Standard. O BSI 05-2001 COPYRIGHT European Committee for Electrotechnical StandardizationLicensed by Information Handling Services STD-BSI BS EN bOb01
39、-2-5-ENGL 2001 Lb2Libb9 0908339 018 Page 7 EN 60601-2-6:2000 “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
40、101, additional 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
41、 section, 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 requ
42、irements 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 7: General requirements for safety - S
43、ection 7 - Collateral standard: Safety requirements for medical electrical systems IEC 60601 -1-2:1993, Medical electrical equipment - Part 7: General requirements for safety - 2. Collateral Standard: Electromagnetic compatibility - Requirements and tests IEC 60601-1-4:1996, Medical electrical equip
44、ment - Part 7: General requirements for safety - 4. Collateral Standard: Programmable electrical medical systems 2 Terminology and definitions 2.1 EQUIPMENT parts, auxiliaries and ACCESSORIES Additional definitions: 2.1 .lo1 ULTRASONIC PHYSIOTHERAPY EQUIPMENT (hereinafter referred to as EQUIPMENT) E
45、QUIPMENT for the generation 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 .i 02 device capable of converting electrical energy to, mec
46、hanical energy 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. ULTRAS0 NI C TRANS DUC ER Q BSI 05-2001 COPY
47、RIGHT European Committee for Electrotechnical StandardizationLicensed by Information Handling Services2.1 .I 04 ATTACHMENT HEAD 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 Maxi
48、mum OUTPUT POWER Of the EQUIPMENT at any RATED MAINS VOLTAGE IEC61689, definition 3.321 2.1 2.1 02 acoustic oscillation 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 3.451 ULTRASOUND 2.12.1 03 beam cross-secti
49、onal area extrapolated to the front face of the TREATMENT HEAD and multiplied by a dimensionless factor according 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. EFFECTIVE RADIATING AREA 2.12.1 04 EFFECTIVE INTENSITY ratio Of the OUTPUT POWER to the EFFECTIVE RADIATING AREA. It iS expressed in Watts per Square centimetre IEC 61689, definition 3.1 8, modified 2.12.1 05 ACOUSTIC WORKING FREQU
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