1、BRITISH STANDARD Medical electrical equipment - Part 2.10: Particular requirements for the safety of nerve and muscle stimulators The European Standard EN 60601-2- 10:2000, with the incorporation of amendment A1:2001, has the status of a British Standard ICs 11.040.55; 11.040.60 BS EN 60601-2-10:200
2、1 Incorporating Amendment No. 1 BS 5 724-2.10:1988 Incorporating Amendment No. 1 and Amendment No. 2 (renumbers the BS as BS EN 60601-2-10:2001) e British Standards NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BS EN 60601-2-10:2001 O BSI 21 March 2003 Amd. No. Committees re
3、sponsible for this Brit ish St andar d Date of issue Comments The preparation of this British Standard was entrusted by the Health Care Standards Committee (HCC/-) to Technical Committee HCC/94, upon which the following bodies were represented: British Society for Rheumatology Chartered Society of P
4、hysiotherapy Department of Health and Social Security Electro Medical Trade Association Limited Institute of Physical Sciences in Medicine Ministry of Defence Royal Society of Medicine The following BSI references 7018 relate to the work on this standard 13086 Committee reference HCC194 Draft for co
5、mment 84152255 DC 14260 ISBN O 580 16814 X 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 October 1988 Amendments issued since publication July 1992 June 2001 Im
6、plementation of the European Standard 21 March 2003 See national foreword BS EN 60601-2-10:2001 Contents Page Committees responsible Inside front cover National foreword 11 Section 1. General 1 1 Scope and object 1 2 Terminology and definitions 1 3 General requirements 2 4 General requirements for t
7、ests 2 5 Classification 2 6 Identification, marking and documents 2 7 Powerinput 3 Section 2 Environmental conditions 5 Section 3. Protection against electric shock hazards 7 13 General 7 14 Requirements related to classification 7 19 Continuous leakage currents and patient Auxiliary current 7 20 Di
8、electric strength 7 Section 4. Protection against mechanical hazards 9 Section 5. Protection against hazards from unwanted or excessive radiation 11 Section 6. Protection against hazards of ignition of flammable anaesthetic mixtures 13 Section 7. Protection against excessive temperatures, and other
9、safety hazards 15 36 Electromagnetic compatibility 11 42 Excessive temperatures 15 46 Human errors 15 Section 8. Accuracy of operating data and protection against hazardous output 17 50 Accuracy of operating data 17 51 Protection against hazardous output 17 Section 9. Abnormal operation and fault co
10、nditions; environmental tests 19 10 Section 10. Constructional requirements 21 57 Mains Darts, components and layout 21 Appendix B deleted Appendix L References - Publications mentioned in this standard 23 Appendix AA Rationale 23 22 Figure 101 - Lay-out of test equipment Figure 102 - deleted Figure
11、 103 - deleted 22 22 i O BSI 21 March 2003 BS EN 60601-2-10:2001 National foreword This British Standard is the official English language version of EN 60601-2- 10:2000, including amendment A1:2001. It is identical with IEC 60601-2-10:1987, including amendment 1:2001 and Corrigendum February 2002. T
12、he start and finish of text introduced or altered by IEC amendment 1 is indicated in the text by tags B l. Tags indicating changes to text carry the number of the amendment. For example, text altered by IEC amendment 1 is indicated by B l. This Particular Standard amends and supplements BS EN 60601-
13、1: 1990 Medical electrical equipment - Part 1: General requirements for safety, hereinafter referred to as the General Standard. As stated in 1.3 of the General Standard, the requirements of this Particular Standard take precedence over those of the General Standard. In the 60601 series of publicati
14、ons, the Standards speciSr general requirements for safety applicable to: - a group of MEDICAL ELECTRICAL EQUIPMENT (for example, radiological equipment); - a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT not fully addressed in the General Standard (for example, Electromagnetic Compati
15、bility). The numbering of sections, clauses and subclauses of this standard corresponds with that of the General Standard. For the purposes of this British Standard, any references to IEC page numbers in the text should be ignored. In this Standard, the following print types are used: - requirements
16、, compliance with which can be tested and definitions: in roman type; - explanations, advice, general statements, exceptions and references: in smaller roman type; - test specifications: in italic type; - TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR OF THIS STANDARD: SMALL CAPITALS. IEC Corr
17、igendum February 2002 replaces the text of 4.2. An asterisk preceding a clause or subclause number signifies that there is a corresponding rationale statement in Appendix AA. The UK participation in its preparation was entrusted to Technical Committee HCC/94, which has the responsibility to: - aid e
18、nquirers to understand the text; - present to the responsible 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. A list of organiza
19、tions 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 the change over from one numbering system t
20、o the other, publications may contain identifiers from both systems. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”,
21、 or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer
22、immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, the EN title page, the EN foreword page, pages 1 to 25 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. 11
23、 O BSI 21 March 2003 EUROPEAN STANDARD EN 60601-2-10 NORME EUROPENNE November 2000 EUROPISCHE NORM + Ai November 2001 ICs 11.040.55; 11.040.60 Supersedes HD 395.2.10 S1:1989 English version Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulato
24、rs (includes amendment A1:2001) (IEC 60601-2-10:1987 + A1:2001) Appareils lectromdicaux - Partie 2- 10: Rgles particulires de scurit pour stimulateurs de nerfs et de muscles (inclut lamendement Al :2 O0 1) Medizinische elektrische Gerte - Teil 2-10: Besondere Festlegungen fr die Sicherheit von Gerte
25、n zur Stimulation von Nerven und Muskeln (enthlt nderung A1:2001) (IEC 60601-2-10:1987 + A1:2001) (CE1 60601-2-10:1987 + A1:2001) This European Standard was approved by CENELEC on 2000-04-01 and amendment Al was approved by CENELEC on 2001-11-01. CENELEC members are bound to comply with the CENICENE
26、LEC 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 application to the Central Secretariat or to any C
27、ENELEC member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsiblity of a CENELEC member into its own language and notified to the Central Secretariat has the same status as the official version
28、s. 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 Kingdom. CENELEC European Committee for Electrotec
29、hnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 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
30、60601-2-10:2000 + A1:2001 E EN 60601-2-10:2000 Foreword The text of the International Standard IEC 60601-2-10:1987, prepared by SC 62C, Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC TC 62, Electrical equipment in medical practice, was approved by CENELEC as HD 395.2.10
31、 S1 on 1988-09-13. This Harmonization Document was submitted to the formal vote for conversion into a European Standard and was approved by CENELEC as EN 60601-2-10 on 2000-04-01. The following date was fixed: - latest date by which the EN has to be implemented at national level by publication of an
32、 identical national standard or by endorsement (dop) 2001-04-01 Foreword to amendment Al The text of document 62D/413/FDIS, future amendment 1 to IEC 60601-2-10:1987, prepared by SC 62D1), Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENE
33、LEC parallel vote and was approved by CENELEC as amendment Al to EN 60601-2-10:2000 on 2001-11-01. The following dates were fixed: - latest date by which the amendment has to be implemented at national level by publication of an identical national standard or by - latest date by which the national s
34、tandards conflicting with the amendment have to be endorsement (dop) 2002-08-01 withdrawn (dow) 2004-11-01 1) The foreword of EN 60601-2-10:2000 mistakenly indicated SC 62C as the technical body that drafted the text of the International Standard. O BSI 21 March 2003 EN 60601-2-10:2000 Section 1. Ge
35、neral 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 nerve and muscle stimulators, as defined in subclause 2.1.101, for use in the practice of physical medicine, hereinafter
36、referred to as stimulator(s). The following equipment is excluded - equipment intended to be implanted or to be connected to implanted electrodes; - equipment intended for the stimulation of the brain (e.g. electroconvulsive therapy equipment); - equipment intended for neurological research; - cardi
37、ac pacemakers E (partly covered by IEC 60601-2-31) a; - body-worn equipment; - stimulators intended for use during surgical procedures; - equipment intended for averaged evoked potential diagnosis E (covered by IEC 60601-2-40) a; - equipment intended for electromyography E (covered by IEC 60601-2-40
38、) a; - equipment intended for cardiac defibrillation; - equipment intended only as a transcutaneous nerve and muscle stimulator for pain relief. E 1.3 Particular Standards This Particular Standard for NERVE AND MUSCLE STIMULATORS is to be read in conjunction with the following standard: IEC 60601- 1
39、: 1988, Medical electrical equipment - Part 1: General requirements for safety Amendment 1 (1991) Amendment 2 (1995) The requirements of this Particular Standard take priority over the above-mentioned standard and its amendments, hereinafter referred to as the General Standard. 1.5 Collateral Standa
40、rds The following Collateral Standards apply: IEC 60601-1-1:2000, Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems. IEC 60601- 1-2: 1993, Medical electrical equipment - Part 1-2: General requirements fo
41、r safety - Collateral Standard: Electromagnetic compatibility - Requirements and tests. IEC 60601- 1-4: 1996, Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems. Amendment 1 (1999) a 2 Terminology and definitions Th
42、is clause of the General Standard applies except as follows: 2.1.5 APPLIED PART Addition: the stimulator electrodes and all parts conductively connected to them Additional definitions: 2.1.101 STIMULATOR Equipment for the application of electric currents via electrodes in direct contact with the pat
43、ient for the diagnosis and/or therapy of neuromuscular disorders 1 O BSI 21 March 2003 EN 60601-2-10:2000 Section 1 2.1.102 PULSE DURATION the duration of the output pulse 2.1.103 WAVEFORM the variations in magnitude of an electrical signal (in either voltage or current) as a function of time appear
44、ing in E a PATIENT CIRCUIT il 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 E Text deleted a E 4.6 Additional Item: au) Where reference is made in test specifications to electrod
45、e cables and/or electrodes, those supplied or recommended by the manufacturer shall be used. a 5 Classification This clause of the General Standard applies except as follows: 5.1 E Text deleted a *5.2 Amendment: WAVEFORM a at 50 % of the maximum amplitude Delete TYPE B APPLIED PART a. *5.6 Amendment
46、: Delete all except continuous operation. 6 Identification, marking and documents This clause of the General Standard applies except as follows: *E 6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts a j) Power input Replacement of the fourth paragraph: The rated power input of E mains operat
47、ed a stimulators shall be the maximum power input averaged over any period of 5 s under the conditions set out in Item aa) of subclause 7.3. p) output Addition: Equipment capable of delivering output values in excess of 10 mA r.m.s. or 10 V r.m.s. averaged over any period of 5 s shall be marked near
48、 the electrode connections with the symbol No. 14 (see Appendix D, E Table D1 a of the General Standard). 6.7 Indicator lights and push-buttons Addition: See also subclause 51.103. 2 O BSI 21 March 2003 Section 1 EN 60601-2-10:2000 6.8 Accompanying documents 6.8.2 Instructions for use Additional ite
49、m: *aa) The instructions for use shall contain additionally: a) Information on the output WAVEFORM(S), including any d.c. component, pulse durations, pulse repeti- tion frequencies, maximum amplitude of output voltage andor current, and the effect of load impedance on these parameters. b) Advice on the size of electrodes to be used and the method of application for each particular type of treatment for which the stimulator is intended. c) Advice on any necessary precautions to be taken when the output contains a d.c. component. d) Advice that a patient with an
