EN 60601-2-27

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Logo of the German Institute for Standardization DIN EN 60601-2-27
Area Medical technology
title Medical electrical equipment - Part 2-27: Particular requirements for the safety of electrocardiography monitors
Latest edition 8.2006
ISO IEC 60601-2-27: 2005

The EN 60601-2-27 with the title "Medical electrical devices - Part 2-27: Special specifications for the safety of electrocardiography monitoring devices" is part of the EN 60601 series of standards .

The DIN standard DIN EN 60601-2-27 is published by the German Institute for Standardization .

The standard is based on the international version IEC 60601-2-27. Within the framework of the VDE standards, the standard is classified as VDE 0750-2-27 , see DIN-VDE standards part 7 .

This supplementary standard regulates general requirements for the safety, tests and guidelines for electrocardiography monitoring devices .

validity

The German edition 8.2006 has been accepted as a German standard from 11.2008 .

  • In January 2008 a new draft was published.
  • The current version (8.2006) is to be used in accordance with the 2nd edition of DIN EN 60601-1 .
  • Draft 1.2008 is to be used in accordance with the 3rd edition of DIN EN 60601-1.

scope of application

These special stipulations establish special requirements for the safety, including the essential performance characteristics of electrocardiography (EKG) monitoring devices. This standard applies to devices that are used in the field of application of a hospital .

Devices that are used outside the scope of a hospital, such as in emergency vehicles and air transport, must comply with this standard. For devices that are specifically used outside the scope of a hospital, additional requirements apply.

This standard is not applicable to electrocardiographic monitors for home use. Manufacturers should, however, consider the essential clauses of this standard as far as they apply to the intended purpose. EKG telemetry monitoring devices, ambulatory monitoring devices ("Holter") and other EKG recording devices also do not fall within the scope of this particular specification.

extra information

The following changed requirements are contained in EN 60601-2-27 (extract):

  • Defibrillation resistance
  • Immunity to interference ( electromagnetic compatibility )
  • Dielectric strength
  • Accuracy of the operating data
  • software
  • Alarms