SC 62D

Electromedical equipment

 

Detail

Committee
Working Groups
Project Leader

Current

Status

Frcst Pub

Date

Stability

Date

SC 62DMT22 Klaus NeuderPPUB2012-022021

History

Stage
Document
Downloads
Decision Date
Target Date
AMW
62D/623/MCR PDF file 82 kB
2007-07-13 
1CD
62D/624/CD PDF file 459 kB
2007-07-142007-07
ACDV
62D/754/CC Word file 159 kB
PDF file 156 kB
2009-01-302008-09
CCDV
62D/769/CDV PDF file 691 kB
PDF file 922 kB
2009-04-032009-03
AFDIS
62D/839A/RVC Word file 330 kB
PDF file 303 kB
2010-04-162009-12
DECFDIS
2011-08-172011-08
RFDIS
2011-08-262011-09
CFDIS
62D/963/FDIS

2011-11-182011-11
APUB
62D/980/RVD PDF file 108 kB
2012-01-232012-01
BPUB
2012-01-242012-02
PPUB
2012-02-162012-03
 2018-03

Abstract

IEC 60601-2-47:2012 concerns the basic safety and essential performance of AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS. It amends and supplements the general standard IEC 60601-1 (third edition 2005). The requirements of this particular standard take priority over those of the general standard. Within the scope of this standard are systems of the following types:
a) systems that provide continuous recording and continuous analysis of the ECG allowing full re-analysis giving essentially similar results.
b) systems that provide continuous analysis and only partial or limited recording not allowing a full re-analysis of the ECG.
The safety aspects of this standard apply to all types of systems falling in one of the above- mentioned categories. If the AMBULATORY ELECTROCARDIOGRAPHIC SYSTEM offers automatic ECG analysis, minimal performance requirements for measurement and analysis functions apply. MEDICAL ELECTRICAL EQUIPMENT covered by IEC 60601-2-25 and IEC 60601-2-27 are excluded from the scope of this standard. This standard does not apply to systems that do not continuously record and analyse the ECG (for example, 'intermittent event recorders'). This second edition cancels and replaces the first edition published in 2001. It constitutes a technical revision. This edition was revised to align structurally with the 2005 edition of IEC 60601-1.

Project

IEC 60601-2-47:2012 ED2

Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems

 

 

Associated Documents:

62D/1521/RR

PDF file 111 kB
62D/1423/RM

PDF file 2798 kB
62D/1401A/INF

PDF file 225 kB