Foreword

The text of ISO 14971:2007, Corrected version 2007-10-01 has been prepared by Technical Committee ISO/TC 210 “Quality management and corresponding general aspects for medical devices” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 14971:2009 by Technical Committee CEN/CLC TC 3 “Quality management and corresponding general aspects for medical devices” the secretariat of which is held by NEN.

This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by January 2010, and conflicting national standards shall be withdrawn at the latest by March 2010.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 14971:2007.

This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directives 93/42/EEC on Medical Devices, 90/385/EEC on Active Implantable Medical Devices and 98/79/EC on In Vitro Diagnostic Devices.

For relationship with EU Directives, see informative Annexes ZA, ZB and ZC, which are an integral part of this document.

The present standard can also be used to support some parts of the conformity assessment procedures described in annexes of the European medical devices directives (90/385/EEC, 93/42/EEC and (98/79/EC):

— an adequate description of: results of the risk analysis,
— an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase and to implement appropriate means to apply any necessary corrective action

NOTE: Other requirements may be applicable to this aspect

In establishing the policy for determining risk acceptability criteria, this standard allows manufacturers to choose from a range of options within those permitted by regulations (see clause 3.2). European medical devices directives require that, in selecting the most appropriate solutions for the design and construction of the devices, these solutions must conform to safety principles, taking account of the generally acknowledged state of the art, and the manufacturer must apply the following principles in the following order:

• eliminate or reduce risks as far as possible (inherently safe design and construction),
• where appropriate take adequate protection measures including alarms if necessary, in relation to risks that cannot be eliminated,
• inform users of the residual risks due to any shortcomings of the protection measures adopted.

In this context, ‘eliminating’ or ‘reducing’ risk must be interpreted and applied in such a way as to take account of technology and practice existing at the time of design and of technical and economical considerations compatible with a high level of protection of health and safety; (see also Annex D.8).

According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom.

BS EN ISO 14971:2009

Medical devices. Application of risk management to medical devices

Published:

31 Jul 2009

Withdrawn:

31 Jul 2012