EN 60601-2-47

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Logo of the German Institute for Standardization DIN EN 60601-2-47
Area Medical technology
title Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
Latest edition 11.2002
ISO IEC 60601-2-47: 2001

The EN 60601-2-47 with the title "Medical electrical equipment - Part 2-47: Special stipulations for the safety including the essential performance characteristics of ambulatory electrocardiographic systems" is part of the EN 60601 series of standards . The DIN standard DIN EN 60601-2-47 is published by the German Institute for Standardization .

The standard is based on the international version IEC 60601-2-47. Within the framework of the VDE standards, the standard is classified as VDE 0750-2-47 , see DIN-VDE standards part 7 .

This supplementary standard regulates general requirements for safety, tests and guidelines for outpatient electrocardiographic systems.

validity

The German edition 11.2002 has been accepted as a German standard from the date of its publication .

  • In January 2008 a new draft was published.
  • The current version (11.2002) 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 define special safety requirements for outpatient electrocardiographic systems.

Systems of the following types are within the scope of this standard:

  • Systems that enable continuous recording or continuous analysis of the ECG and whose subsequent analysis leads to the same results. These systems can first record and save the ECG and analyze it later on a separate unit or record and analyze it simultaneously. The type of storage medium used is not relevant within this standard.
  • Systems that allow continuous analysis and partial or limited recording and do not allow subsequent analysis of the ECG.

The safety information in this standard applies to all systems that fall into one of the groups mentioned above. If ambulatory electrocardiographic systems enable automated ECG analysis, minimum requirements apply to those measurements and analysis functions. Medical electrical devices that fall within the scope of EN 60601-2-25 and EN 60601-2-27 are excluded from the scope of this standard.

This standard does not apply to systems that do not allow continuous recording and analysis of the ECG (e.g. intermittent event-related recorders).

extra information

The following changed requirements are contained in EN 60601-2-47 (excerpt):