ISO/IEC Guide 63:2012

Name: ISO/IEC Guide 63:2012
Brand: ISO/IEC
SKU: ISO/IEC Guide 63:2012
Price: 76.23 EUR
Availability: InStock
Rating: 4 (81 reviews)

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

Publication date: Jan 10, 2012

95.99 Withdrawal of Standard Aug 12, 2019

General information

Current stage: 95.99 Withdrawal of Standard Aug 12, 2019

Originator: ISO/IEC

Owner: ISO/TMBG Technical Management Board - groups

Type: Guide

ICS: 11.020.01 Quality and environmental management in health care

Buying

Status: Withdrawn

PDF - €76.23

Languages: English Russian

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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

PREVIOUSLY

WITHDRAWN
ISO/IEC Guide 63:1999

NOW

WITHDRAWN
ISO/IEC Guide 63:2012
95.99 Withdrawal of Standard
Aug 12, 2019

REVISED BY

PUBLISHED
ISO/IEC Guide 63:2019