1、 IEC 60601-1 Edition 3.1 2012-08 INTERNATIONAL STANDARD Medical electrical equipment Part 1:General requirements for basic safety and essential performance IEC 60601-1:2005+A1:2012(E)colourinside THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2012 IEC,Geneva,Switzerland All rights reserved.Unless
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9、safety and essential performance INTERNATIONAL ELECTROTECHNICAL COMMISSION CW ICS 11.040 PRICE CODE ISBN 978-2-8322-0331-6 Registered trademark of the International Electrotechnical Commission Warning!Make sure that you obtained this publication from an authorized distributor.colourinsideApril 2008
10、Publication IEC 60601-1(Third edition 2005)I-SH 01 MEDICAL ELECTRICAL EQUIPMENT Part 1:General requirements for basic safety and essential performance INTERPRETATION SHEET 1 This interpretation sheet has been prepared by SC 62A:Common aspects of electrical equipment used in medical practice The text
11、 of this interpretation sheet is based on the following documents:ISH Report on voting 62A/599/ISH 62A/613/RVD Full information on the voting for the approval of this interpretation sheet can be found in the report on voting indicated in the above table._ Subclause 1.1 This subclause is clarified by
12、 the following:IEC 60601-1 does not apply to medical gas pipeline systems covered by ISO 7396-1,Medical gas pipeline systems Part 1:Pipeline systems for compressed medical gases and vacuum.NOTE Subclause 6.3 of ISO 7396-1 applies the requirement of IEC 60601-1-8 to certain monitoring and alarm signa
13、ls.This clarification will remain valid until a new version of IEC 60601-1 is published._ 1 January 2009 ICS 11.040 French text overleaf Publication IEC 60601-1(Third edition 2005)I-SH 02 MEDICAL ELECTRICAL EQUIPMENT Part 1:General requirements for basic safety and essential performance INTERPRETATI
14、ON SHEET 2 This interpretation sheet has been prepared by subcomittee 62A:Common aspects of electrical equipment used in medical practice,of IEC technical committee 62:Electrical equipment in medical practice.The text of this interpretation sheet is based on the following documents:ISH Report on vot
15、ing 62A/634/ISH 62A/640/RVD Full information on the voting for the approval of this interpretation sheet can be found in the report on voting indicated in the above table._ Subclause 11.3 This subclause is clarified by the following:As stated in the rationale for this subclause,fire ENCLOSURES are i
16、ntended to be used only where there is a significant likelihood of fire due to the presence of a source of ignition(as described in the subclause)and a significant source of fuel.Most materials used in the construction of ME EQUIPMENT are not considered to be such a source of fuel unless they are in the presence of an OXYGEN RICH ENVIRONMENT.MANUFACTURERS should determine,through analyses documented in the RISK MANAGEMENT FILE,whether the ME EQUIPMENT contains combustible materials(fuel)in suffi