This standard has been revised by: IEC 62366-1:2015
If the usability engineering process detailed in this International Standard has been complied with and the acceptance criteria documented in the usability validation plan have been met, then the residual risks, as defined in ISO 14971, associated with usability of a medical device are presumed to be acceptable, unless there is objective evidence to the contrary.
This International Standard does not apply to clinical decision-making relating to the use of a medical device.
Document published on: 2007-10-01 Edition: 1 (Bilingual) ICS: 11.040.01 Status: Withdrawn Stage: 95.99 (2015-02-25) TC/SC: ISO/TC 210 Number of Pages:
Revised by: IEC 62366-1:2015