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ISO/IEC Guide 63:2019

Guide to the development and inclusion of aspects of safety in International Standards for medical devices
12. 8. 2019.

Опште информације

90.93     2. 9. 2025.

ISO/IEC

ISO/TMBG

Uputstvo

01.120     11.040.01  

engleski  

Kupovina

Objavljen

Jezik na kome želite da primite dokument.

Apstrakt

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.

Životni ciklus

PRETHODNO

POVUČEN
ISO/IEC Guide 63:2012

TRENUTNO

OBJAVLJEN
ISO/IEC Guide 63:2019
90.93 Odluka o potvrđivanju standarda
2. 9. 2025.