DSF/ISO/IEC DGuide 63
Guide to the development and inclusion of safety aspects in International Standards for medical devices
pending, Most Current
| Organization: | DS |
| Status: | pending |
| Page Count: | 28 |
| ICS Code (Medical sciences and health care facilities in general): | 11.020 |
| ICS Code (Standardization. General rules): | 01.120 |
scope:
This Guide provides additional guidance to standards writers for the inclusion of 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 safetyrelated performance and usability. This Guide is intended to be read in conjunction with ISO/IEC Guide 51 and ISO 14971.
Document History
DSF/ISO/IEC DGuide 63
Guide to the development and inclusion of safety aspects in International Standards for medical devices
This Guide provides additional guidance to standards writers for the inclusion of safety aspects in the development of medical device safety standards intended to be used within the risk management...