IEC TR 62348:2012 - Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition

IEC TR 62348:2012

Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition

Status : Current   Published : December 2012

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IEC/TR 62348:2012(E) which is a technical report, provides a tool to assist users of IEC 60601-1:2005 to assess the impact of the most significant changes in Amendment 1:2012. This technical report also provides a tool to assist users of IEC 60601-1 to trace requirements between the third edition and their source in the documents that form the basis of the third edition; principally the second edition as amended. This report is intended to be used by:


- those who must align standards based on the second edition of IEC 60601-1 with the third edition as amended;


- manufacturers of medical electrical equipment or medical electrical systems; and


- health care regulatory authorities, test houses and other organizations responsible for implementing standards for medical electrical equipment and medical electrical systems. This second edition cancels and replaces the first edition published in 2006. The second edition retains the mapping that traces the requirements of IEC 60601-1:2005 and its Amendment A1:2012 (Edition 3.1) from their source in the documents that relate to IEC 60601-1:1998 and its amendments (Edition 2.2). The second edition adds an assessment of the impact of the most significant changes in Amendment 1:2012.




Standard NumberIEC TR 62348:2012
TitleAssessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition
StatusCurrent
Publication Date12 December 2012
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
ICS11.040.01
CommitteeCH/62/1
ISBN978-2-83220-548-8
PublisherIEC
FormatA4
DeliveryYes
Pages106
File Size1.479 MB
Price£264.00


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