DS ISO/IEC Udhëzues 63:2012

Udhëzim për zhvillimin dhe përfshirjen e aspekteve të sigurisë në standardet ndërkombëtare për pajisjet mjekësore

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

Publication date: 25 qer 2012

General information

Current stage: 60.60 Effective date: 25 qer 2012

Originator: DPS

Owner: DPS/KT 316

Type: Guide

ICS: 11.020.01

Gjuha: anglisht

Buying

Statusi: Publikuar

PDF - 3 748 Lekë

Paper - 3 748 Lekë

CD - 3 748 Lekë

PDF and Paper - 7 496 Lekë

Language

Language in which you want to receive the document.

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
25 qer 2012

Related project

Adopted from ISO/IEC Guide 63:2012

Preview

Only informative sections of projects are publicly available. To view the full content, you will need to members of the committee. If you are a member, please log in to your account by clicking on the "Log in" button.