logo

Standards Manage Your Business

We Manage Your Standards

IEC

IEC 60601-2-27:2011 (EN-FR)

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

Standard Details

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.

General Information

Status : ACTIVE
Standard Type: Main
Document No: IEC 60601-2-27:2011 (EN-FR)
Document Year: 2011
Pages: 149
Edition: 3.0

Life Cycle

Currently Viewing

ACTIVE
IEC 60601-2-27:2011 (EN-FR)
Knowledge Corner

Expand Your Knowledge and Unlock Your Learning Potential - Your One-Stop Source for Information!

© Copyright 2024 BSB Edge Private Limited.

Enquire now +