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IEC 62366 vs. FDA Human Factors Requirements


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fda (food and drug administration), human factors, iec 62366 - medical device usability engineering, requirements and specifications
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  Post Number #1  
Old 12th January 2015, 02:50 PM
Silvertabb

 
 
Total Posts: 60
Please Help! 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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  Post Number #2  
Old 13th January 2015, 06:51 AM
Stijloor's Avatar
Stijloor

 
 
Total Posts: 15,186
Re: IEC 62366 vs. FDA Human Factors Requirements

A Quick Bump!

Can someone help?

If your questions were answered here, please consider helping others.

Thank you very much!
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  Post Number #3  
Old 13th January 2015, 10:41 PM
Mark Meer

 
 
Total Posts: 595
Re: IEC 62366 vs. FDA Human Factors Requirements

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.
Thanks to Mark Meer for your informative Post and/or Attachment!
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