ISO/IEC Guide 63:2019
Current
The latest, up-to-date edition.
Guide to the development and inclusion of aspects of safety in International Standards for medical devices
Hardcopy , PDF
English
12-08-2019
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.
This document is applicable to any aspect related to the safety of people, property, the environment, or a combination of these.
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.
| Committee |
ISO/TMBG
|
| DocumentType |
Guide
|
| Pages |
26
|
| ProductNote |
THIS STAMNDARD REFERS:ISO/TR 80002-1,IEC 60417,GHTF/SG1/N055,GHTF/SG1/N071
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| PD ISO/IEC GUIDE 63:2019 | Identical |
| JIS T 0063:2020 | Identical |
| ANSI/AAMI/IEC 62366-1:2015(R2021)+AMD1:2020 | Medical devices—Part 1: Application of usability engineering to medical devices, including Amendment 1 |
| ISO/DIS 18969:2025 | Clinical evaluation of medical devices |
| I.S. EN ISO 14971:2019/A11:2021 | Medical devices - Application of risk management to medical devices (ISO 14971:2019) |
| S.R. CEN ISO/TR 24971:2020 | Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020) |
| I.S. EN 62366-1:2015/A1:2020 | Medical devices - Part 1: Application of usability engineering to medical devices |
| CEI EN IEC 60601-2-37:2025 | Medical electrical equipment – Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
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