ISO/TC 210
| Project No. | ISO/IEC Guide 63:2019 |
|---|---|
| Title | <p>This document provides requirements and recommendations to writers of medical device standards on the inclusion of aspects related to safety in International Standards, based on well-established risk management concepts and methodology.</p> <p>This document is applicable to any aspect related to the safety of people, property, the environment, or a combination of these.</p> <p>In this document, the term "product" includes a medical device or a system consisting of one or more medical devices, possibly combined with non-medical devices.</p> |
| Registration number (WIID) | 67944 |
| Scope | <p>This document provides requirements and recommendations to writers of medical device standards on the inclusion of aspects related to safety in International Standards, based on well-established risk management concepts and methodology.</p> <p>This document is applicable to any aspect related to the safety of people, property, the environment, or a combination of these.</p> <p>In this document, the term "product" includes a medical device or a system consisting of one or more medical devices, possibly combined with non-medical devices.</p> |
| Status | Atcelts |
| ICS group | 01.120 11.040.01 |