ISO 14971:2019 Medical Devices: Application of Risk Management to Medical Devices

What this entry covers

ISO 14971 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, estimate and evaluate the associated risks, control them and monitor the effectiveness of the controls, at all stages of the device life cycle. It is published by ISO. The third edition, ISO 14971:2019, is listed by FDA as a recognized consensus standard (recognition number 5-125), with ISO/TR 24971:2020 as guidance on its application.

MyRHC indexes this framework so practitioners, auditors, and automated agents can find the authoritative primary sources in one place. This page is a navigation aid; it is not legal advice and is not a substitute for the official text.

Official documentation

• Primary official source: https://www.iso.org/standard/72704.html
• FDA recognized consensus standard entry (5-125): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/detail.cfm?standard__identification_no=41349
• ISO/TR 24971:2020 guidance: https://www.iso.org/standard/74437.html

How to use this index entry

1. Open the official link above (or the agency home if the deep link drifts).
2. Confirm edition / revision date against your program scope.
3. Map applicability by sector and jurisdiction listed in the metadata.
4. Follow related frameworks only after checking their own official sources.

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