EN 60601-2-10-2000 en Medical electrical equipment Part 2-10 Particular requirements for the safety of nerve and muscle stimulators (Incorporates Amendment A1 2001 Remains Current).pdf
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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
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