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.