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IEC 60601-2-27

IEC 60601-2-27:2011
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
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.
BASE PUBLICATION
English/French

Technical committee

TC 62/SC 62D Particular medical equipment, software, and systems
Publication typeInternational Standard
Publication date2011-03-30
Edition3.0
ICS

11.040.55

Stability date2024
ISBN number9782832242742
Pages149
File size1.79 MB
EditionDatePublicationEditionStatus
  • Ensure healthy lives and promote well-being for all

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