NEN - NPR-ISO/IEC GUIDE 63
Guide to the development and inclusion of safety aspects in International Standards for medical devices
active, Most Current
| Organization: | NEN |
| Publication Date: | 1 January 2012 |
| Status: | active |
| Page Count: | 30 |
| ICS Code (Quality and environmental management in health care): | 11.020.01 |
scope:
This Guide 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. This Guide is intended to be read in conjunction with ISO/IEC Guide 51 and ISO 14971.
Document History
NPR-ISO/IEC GUIDE 63
January 1, 2012
Guide to the development and inclusion of safety aspects in International Standards for medical devices
This Guide 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...