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

SC 62D

Electromedical equipment

 

Detail

Committee
Working Groups
Project Leader

Current

Status

Frcst Pub

Date

Stability

Date

SC 62DMT22 Klaus NeuderPPUB2011-102020

History

Stage
Document
Downloads
Decision Date
Target Date
AMW
62D/617/MCR PDF file 81 kB
2007-07-06 
1CD
62D/618/CD PDF file 3830 kB
2007-07-072007-07
CDM
62D/652/CC Word file 700 kB
PDF file 532 kB
2007-10-262007-11
ACDV
62D/652A/CC Word file 575 kB
PDF file 436 kB
2008-12-192008-09
CCDV
62D/758/CDV PDF file 3804 kB
PDF file 3862 kB
2009-02-202009-02
AFDIS
62D/835A/RVC Word file 567 kB
PDF file 488 kB
2010-04-162009-10
DECFDIS
2011-05-192011-06
RFDIS
2011-05-252011-06
CFDIS
62D/944/FDIS

2011-07-152011-08
APUB
62D/957/RVD PDF file 90 kB
2011-09-212011-09
BPUB
2011-09-222011-09
PPUB
2011-10-192011-10
 2018-03

Abstract

IEC 60601-2-25:2011 applies to the basic safety and essential performance of electrocardiographs intended by themselves or as a part of a medical electrical system, for the production of electrocardiogram reports for diagnostic purposes. The equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician's office, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply to Medical electrical equipment for those environments of use. Not included within the scope of this particular standard are:
a) the part of Medical electrical equipment that provides vectorcardiographic loops;
b) ambulatory electrocardiographic medical electrical equipment covered by IEC 60601-2-47 where not intended for obtaining electrocardiogram reports for diagnostic purposes;
c) cardiac monitors covered by IEC 60601-2-27 where not intended for obtaining electrocardiographic reports for diagnostic purposes.
This second edition cancels and replaces the first edition of IEC 60601-2-25, published in 1993 and the first edition of IEC 60601-2-51, published in 2003. Updating the particular standards to refer to the third edition of the general standard provided the opportunity to merge the first editions of IEC 60601-2-25 and IEC 60601-2-51 into one standard. Reformatting and technical changes were both made. This second edition of IEC 60601-2-25 constitutes a technical revision of both those standards.

Project

IEC 60601-2-25:2011 ED2

Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs

 

 

Associated Documents:

62D/1521/RR

PDF file 111 kB
62D/1423/RM

PDF file 2798 kB
62D/1401A/INF

PDF file 225 kB
SMB/3860/DL

PDF file 285 kB