International Standards and Conformity Assessment for all electrical, electronic and related technologies

SC 62A

Common aspects of electrical equipment used in medical practice

 

Detail

Committee
Working Groups
Project Leader

Current

Status

Frcst Pub

Date

Stability

Date

SC 62AJMT 1 C. SidebottomPPUB2013-012022

History

Stage
Document
Downloads
Decision Date
Target Date
AMW
62A/830/RR PDF file 86 kB
2012-08-17 
CDTR
62A/831/DTR PDF file 964 kB
2012-08-182012-08
APUB
62A/841/RVC Word file 80 kB
PDF file 334 kB
2012-10-262013-01
DECPUB
2012-10-302012-12
BPUB
2012-11-022012-11
RPUB
2012-11-26 
PPUB
2012-12-122013-03
  

Abstract

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.

Project

IEC TR 62348:2012 ED2

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

 

 

Associated Documents:

62A/980/RM

PDF file 306 kB
62A/965/INF

PDF file 148 kB
62A/829/RQ

PDF file 169 kB
62A/815/Q

Word file 26 kB
PDF file 213 kB