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ISO/IEC Guide 63:2019

Current Revision

Guide to the development and inclusion of aspects of safety in International Standards for medical devices

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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.


SDO ISO: International Organization for Standardization
Document Number ISO/IEC 63
Publication Date Not Available
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TMBG
Publish Date Document Id Type View
Not Available ISO/IEC Guide 63:2019 Revision