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Medical devices - Application of risk management to medical devices (ISO 14971:2019)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

12-26-2021

Publisher

National Standards Authority of Ireland

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US$81.03

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CONTENTS
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for risk management system
5 Risk analysis
6 Risk evaluation
7 Risk control
8 Evaluation of overall residual risk
9 Risk management review
10 Production and post-production activities
Annex A (informative) Rationale for requirements
Annex B (informative) Risk management process for medical devices
Annex C (informative) Fundamental risk concepts
Bibliography

This document specifies terminology, principles and a process for risk management of medical devices,
including software as a medical device and in vitro diagnostic medical devices.

Committee	ISO/TC 210
DocumentType	Standard
Pages	36
ProductNote	The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document. THIS STANDARD ALSO REFERS TO IEC/TR 60513.
PublisherName	National Standards Authority of Ireland
Status	Current
Supersedes	I.S. EN ISO 14971:2019

Standards	Relationship
EN ISO 14971:2019+A11:2021	Identical
ISO 14971:2019	Identical
EN ISO 14971:2019	Identical

Frequently Asked Questions

I.S. EN ISO 14971 defines or supports a lifecycle process for identifying, evaluating, controlling and monitoring medical device risks. It is an Irish standard published by National Standards Authority of Ireland (NSAI).

I.S. EN ISO 14971 is used by medical device manufacturers and developers managing product safety risk throughout the lifecycle. It is an Irish standard published by National Standards Authority of Ireland (NSAI).

I.S. EN ISO 14971 is National Standards Authority of Ireland (NSAI)'s standard for medical device risk management, while S.R. CEN ISO/TR 24971 covers medical device risk management (Requires verification). I.S. EN ISO 14971 defines or supports a lifecycle process for identifying, evaluating, controlling and monitoring medical device risks. S.R. CEN ISO/TR 24971 defines or supports a lifecycle process for identifying, evaluating, controlling and monitoring medical device risks. It supports consistent specification, verification and documented acceptance across the relevant lifecycle.

No — I.S. EN ISO 14971 is an Irish standard published by National Standards Authority of Ireland (NSAI), with its listed region as Ireland.

I.S. EN ISO 14971 defines or supports a lifecycle process for identifying, evaluating, controlling and monitoring medical device risks. In practice it is applied by medical device manufacturers and developers managing product safety risk throughout the lifecycle.

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I.S. EN ISO 14971:2019/A11:2021

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

Industry

Sub-Industry

What is the scope of I.S. EN ISO 14971?

Who is I.S. EN ISO 14971 written for?

What is the difference between I.S. EN ISO 14971 and S.R. CEN ISO/TR 24971?

Is I.S. EN ISO 14971 an Australian standard?

What is I.S. EN ISO 14971 used for?