Standard

ISO TR 24971:2020 ED2

Jun 2020 Current

Existing or new amendments and versions must be purchased separately.

Language English

Services Online + Pdf CHF 227,00 Online CHF 195,00

There are no extended editions available for this standard

There are no available corrigendum or amendments for this standard. Any future corrigendum and amendments will be added automatically for subscribers.

Abstract

This document provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to ISO 14971:2019. The risk management process can be part of a quality management system, for example one that is based on ISO 13485:2016[24], but this is not required by ISO 14971:2019. Some requirements in ISO 13485:2016 (Clause 7 on product realization and 8.2.1 on feedback during monitoring and measurement) are related to risk management and can be fulfilled by applying ISO 14971:2019. See also the ISO Handbook: ISO 13485:2016 - Medical devices - A practical guide.

Products specifications

Standard from IEC
Published: June 16 2020
Edition: 2
Document type: TR
Pages
ISBN:

Publisher: IEC
Distributor: IEC
ICS: 11.040.01
International TC: TC 62/SC 62A

Product Relations

Revises: ISO TR 24971:2013 ED1

ISO TR 24971:2020 ED2

Create subscription