DS ISO/IEC Udhëzues 63:2012

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

Publication date: Jun 25, 2012

General information

Current stage: 60.60 Effective date: Jun 25, 2012

Originator: DPS

Owner: DPS/KT 316

Type: Guide

ICS: 11.020.01

Languages: English

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Status: Published

PDF - ALL 3,748

Paper - ALL 3,748

CD - ALL 3,748

PDF and Paper - ALL 7,496

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Scope

ISO/IEC Guide 63:2012 provides guidance to standards writers on how to include safety aspects in the development of medical device safety standards intended to be used within the risk management framework established in ISO 14971. It expands on the concepts developed in ISO/IEC Guide 51 to include safety-related performance and usability.
ISO/IEC Guide 63:2012 is intended to be read in conjunction with ISO/IEC Guide 51 and ISO 14971.

Life cycle

NOW

PUBLISHED
DS ISO/IEC Udhëzues 63:2012
60.60 Standard published
Jun 25, 2012

Related project

Adopted from ISO/IEC Guide 63:2012

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