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Reference IEC 60601-2-27 ed3.0 withdrawn corrigendum
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Title Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
Publication date 2011-03-30
Format, price
(Swiss francs)
and language
280.- 149 pages
280.- 2163 Kb
 
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.
Technical Committee 62D - Electromedical equipment  RSS
ICS Codes
11.040.55 Diagnostic equipment
*Including medical monitoring equipment, medical thermometers and related materials
 
Replaced by
Stability date 2015
 
Work in progress
ProjectStage codeForecast publication date
No project under development--


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