Abstract
PreviewThis 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[25].
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Status: PublishedPublication date: 2020-06
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Edition: 2Number of pages: 87
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Technical Committee: ISO/TC 210 Quality management and corresponding general aspects for products with a health purpose including medical devices
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- ICS :
- 11.040.01 Medical equipment in general
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| Format | Language | |
|---|---|---|
| std 1 208 | PDF + ePub | |
| std 2 250 | PDF + ePub + Redline | |
| std 3 208 | Paper |
- CHF208
Life cycle
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Previously
WithdrawnISO/TR 24971:2013
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Now
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Reducing and managing risks related to medical devices is the objective of a key industry standard, ISO 14971. Detailed guidance to optimize its use has just been updated.
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