ISO/IEC GUIDE 63:2019
Guide to the development and inclusion of aspects of safety in International Standards for medical devices
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.
|TC/SC||ISO/TC 210 - Quality management and corresponding general aspects for medical devicesrss|
|ICS||11.040.01 - Medical equipment in general|
01.120 - Standardization. General rules
|File size||1366 KB|
The following test report forms are related:
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