Foreword

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This document was prepared by Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices, and IEC/SC 62A, Common aspects of electrical equipment used in medical practice.

This third edition cancels and replaces the second edition (ISO 14971:2007), which has been technically revised. The main changes compared to the previous edition are as follows:

— A clause on normative references has been included, in order to respect the requirements for fixed in Clause 15 of ISO/IEC Directives, Part 2:2018.
— The defined terms are updated and many are derived from ISO/IEC Guide 63:2019. Defined terms are printed in italic to assist the reader in identifying them in the body of the document.
— Definitions of benefit, reasonably foreseeable misuse and state of the art have been introduced.
— More attention is given to the benefits that are expected from the use of the medical device. The term benefit-risk analysis has been aligned with terminology used in some regulations.
— It is explained that the process described in ISO 14971 can be used for managing risks associated with medical devices, including those related to data and systems security.
— The method for the evaluation of the overall residual risk and the criteria for its acceptability are required to be defined in the risk management plan. The method can include gathering and reviewing data and literature for the medical device and for similar medical devices and similar other products on the market. The criteria for the acceptability of the overall residual risk can be different from the criteria for acceptability of individual risks.
— The requirements to disclose residual risks have been moved and merged into one requirement, after the overall residual risk has been evaluated and judged acceptable.
— The review before commercial distribution of the medical device concerns the execution of the risk management plan. The results of the review are documented as the risk management report.
— The requirements for production and post-production activities have been clarified and restructured. More detail is given on the information to be collected and the actions to be taken when the collected information has been reviewed and determined to be relevant to safety.
— Several informative annexes are moved to the guidance in ISO/TR 24971, which has been revised in parallel. More information and a rationale for the requirements in this third edition of ISO 14971 have been provided in Annex A. The correspondence between the clauses of the second edition and those of this third edition is given in Annex B.

Any feedback or questions on this document should be directed to the user’s national standards body. A complete listing of these bodies can be found at www.iso.org/members.html.

BS EN ISO 14971:2019

Medical devices. Application of risk management to medical devices

Published:

31 Dec 2019

Withdrawn:

15 Dec 2021