EN 60601-1-6

EN 60601-1-6, entitled "Medical electrical equipment - Part 1-6: General requirements for safety including essential features - Supplementary standard: usability" is part of the EN 60601 series.

The German Institute for Standardization is the editor of the DIN standard DIN EN 60601-1-6

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

This supplementary standard governs general requirements for safety, tests and guidelines for suitability for use. Validity Edit the source text

The German edition 2.2008 has been adopted as a German standard from its date of appearance. Scope of Application Edit the source text

This International Standard specifies requirements for a process for the analysis, development and design, verification and validation of the usability as far as the usability affects the basic safety and the essential performance characteristics of medical electrical devices. This supplementary standard covers intended use and misuse, but does not include abnormal use. Edit additional information source text

The usability standard is a process standard. The process of the development of a device is examined with regard to its suitability for use. From the outset, the development process must include usability. This standard only examines the '' process '' of the development, which should lead to good usability.

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

The following amended requirements are contained in EN 60601-1-6 (excerpt):

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