YY/T 9706.106-2021 Medical electrical equipment—Part 1-6:General requirements for basic safety and essential performance—Collateral Standard:Usability

Scope

This section specifies the process used by manufacturers to analyze, define, design, verify, and confirm the usability related to the basic safety and basic performance of medical electrical equipment (hereinafter referred to as ME equipment).
The usability engineering process evaluates and reduces the risks caused by usability issues, such as correct or incorrect use, during normal operation. It can be used to identify risks related to abnormal use, but not to evaluate or reduce such risks.
Unless there is objective evidence showing that they are unacceptable (see 4.1.2 of YY/T 1474 - 2016), if the usability engineering process meets the requirements of this section and the acceptance criteria specified in the usability confirmation plan are satisfied (see 5.9 of YY/T 1474 - 2016), the residual risks related to usability in ME equipment, as defined in YY/T 0316, can be considered acceptable.
Note: The asterisk (*) used as the first character of a title or the beginning of a paragraph or table heading indicates that there are related guidelines or principle explanations in Appendix A.

Development Information

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