EN 60601-1-6

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Logo of the German Institute for Standardization DIN EN 60601-1-6
Area Medical technology
title Medical electrical equipment - Part 1-6: General requirements for safety including the essential performance characteristics - Collateral standard: Usability
Latest edition 2.2016
ISO

The EN 60601-1-6 entitled "Electrical Medical Equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: usability " is part of the series of standards EN 60601 .

The DIN standard DIN EN 60601-1-6 is published by the German Institute for Standardization .

The standard is the identical European version of the international standard IEC 60601-1-6. Within the framework of the VDE standards, the standard is classified as VDE 0750-1-6 , see DIN-VDE standards part 7 .

This supplementary standard regulates general requirements for safety, tests and guidelines for usability.

validity

The German edition 2.2008 has been accepted as a German standard from the date of its publication .

  • The current version (2.2008) is to be used together with the 3rd edition of DIN EN 60601-1.
  • Edition 6.2005 is to be used together with the 2nd edition of DIN EN 60601-1.
  • Until all sub-standards applicable to the device to be tested have been adapted to the 3rd edition of EN 60601-1, the version from June 2005 must still be used.
  • A new draft was published in January 2009.

scope of application

This International Standard specifies requirements for a process for the analysis, development and design, verification and validation of the usability, insofar as the usability affects the basic safety and the essential performance characteristics of medical electrical devices. This supplementary standard covers intended use and usage errors, but does not include abnormal use.

extra information

The usability standard is a process standard. The process of developing a device with regard to its usability is examined. The development process must include usability from the start. This standard only checks the '' process '' of development that should lead to good usability.

The content of EN 60601-1-6 is very similar to EN 62366, which, however, also applies to non-electrical devices. There are therefore efforts to summarize these standards.

The following changed requirements are contained in EN 60601-1-6 (extract):