ISO/IEC Guide 63:2012 provides guidance to standards writers on how to include safety aspects in the development of medical device safety standards intended to be used within the risk management framework established in ISO 14971. It expands on the concepts developed in ISO/IEC Guide 51 to include safety-related performance and usability.
ISO/IEC Guide 63:2012 is intended to be read in conjunction with ISO/IEC Guide 51 and ISO 14971.
Document published on: 2012-01-15 Edition: 2 (Monolingual) ICS: 11.020; 01.120 Status: Published Stage: 90.92 (2014-11-05) TC/SC: ISO/TC 210 Number of Pages: 21
Revised by: ISO/IEC CD Guide 63
Revises: ISO/IEC Guide 63:1999
No corrigenda or amendments available