SC 62D

Electromedical equipment

 

Detail

Committee
Working Groups
Project Leader

Current

Status

Frcst Pub

Date

Stability

Date

SC 62DMT22 Klaus NeuderPPUB2011-042021

History

Stage
Document
Downloads
Decision Date
Target Date
AMW
62D/619/MCR PDF file 81 kB
2007-07-13 
1CD
62D/620/CD PDF file 900 kB
2007-07-142007-07
ACDV
62D/716/CC Word file 687 kB
PDF file 571 kB
2008-08-222008-09
CCDV
62D/745/CDV PDF file 984 kB
PDF file 1020 kB
2009-01-162008-11
AFDIS
62D/837A/RVC Word file 1053 kB
PDF file 779 kB
2010-04-162009-09
DECFDIS
2010-10-112010-10
RFDIS
2010-10-182010-10
CFDIS
62D/900/FDIS

2011-01-072011-01
APUB
62D/913/RVD PDF file 127 kB
2011-03-152011-03
BPUB
2011-03-162011-03
PPUB
2011-03-302011-04
 2018-03

Abstract

IEC 60601-2-27:2011 applies to electrocardiographic monitoring equipments used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. This particular standard also applies to ECG telemetry systems used in a hospital environment. Electrocardiographic monitoring equipments intended for use under extreme or uncontrolled environmental conditions outside the hospital environment, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply for those environments of use. This standard is not applicable to electrocardiographic monitors for home use. However, manufacturers should consider using relevant clauses of this standard as appropriate for their intended use. Ambulatory ("Holter") monitors, fetal heart rate monitoring, pulse plethysmographic devices, and other ECG recording equipment are outside the scope of this particular standard. The aim of this third edition is to bring this particular standard up to date with reference to the third edition of the general standard through reformatting and technical changes. The contents of the corrigendum of May 2012 have been included in this copy.

Project

IEC 60601-2-27:2011 ED3

Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

 

 

Associated Documents:

62D/1521/RR

PDF file 111 kB
62D/1423/RM

PDF file 2798 kB
62D/1401A/INF

PDF file 225 kB