IEC 62366 vs. FDA Human Factors Requirements



What part of IEC 62366 is not addressed in the FDA Human Factors Requirements?


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Mark Meer

Trusted Information Resource
As far as using IEC 62366 as a consensus standard, you can lookup the standard here, and it will tell you which parts are not recognized by the FDA.

If you lookup IEC 62366, you will get the following exceptions:
  • Clause 5.5 (USABILITY SPECIFICATION) Note 1 is not recognized
  • Table D.5 (Examples of objective USABILITY goals) is not recognized
  • Table D.6 (Examples of subjective USABILITY goals) is not recognized
  • Annex G (USABILITY goals: Illustrative example for a home parenteral infusion pump) is not recognized.
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