ISO 14971:2019
Current
The latest, up-to-date edition.
Medical devices — Application of risk management to medical devices
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12-10-2019
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. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of this document are applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.
The process described in this document can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle.
This document does not apply to:
— decisions on the use of a medical device in the context of any particular clinical procedure; or
— business risk management.
This document requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels.
Risk management can be an integral part of a quality management system. However, this document does not require the manufacturer to have a quality management system in place.
NOTE Guidance on the application of this document can be found in ISO/TR 24971[9].
Committee |
ISO/TC 210
|
DocumentType |
Standard
|
Pages |
39
|
ProductNote |
THIS STANDARD ALSO REFERS TO IEC/TR 60513
|
PublisherName |
International Organization for Standardization
|
Status |
Current
|
Supersedes |
Standards | Relationship |
ANSI/AAMI/ ISO 14971:2019 | Identical |
IS/ISO 14971 : 2019 | Identical |
CEI UNI EN ISO 14971:2021 | Identical |
BS EN ISO 14971:2019 | Identical |
NEN-EN-ISO 14971:2019 | Identical |
EN ISO 14971:2019 | Identical |
ÖVE/ÖNORM EN ISO 14971:2020 06 01 | Identical |
AS ISO 14971:2020 | Identical |
NS-EN ISO 14971:2019 | Identical |
DIN EN ISO 14971:2020-07 | Identical |
UNI CEI EN ISO 14971:2022 | Identical |
ÖVE/ÖNORM EN ISO 14971:2022 05 15 | Identical |
JIS T 14971:2020 | Identical |
I.S. EN ISO 14971:2019/A11:2021 | Identical |
NF EN ISO 14971:2019 | Identical |
EN ISO 14971:2019+A11:2021 | Identical |
PN-EN ISO 14971:2020-05 | Identical |
SS-EN ISO 14971:2020 | Identical |
I.S. EN ISO 14971:2019 | Identical |
UNI CEI EN ISO 14971:2020 | Identical |
CEI UNI EN ISO 14971:2020 | Identical |
SAC GB/T 42062:2022 | Identical |
UNE-EN ISO 14971:2020 | Identical |
AAMI TIR52:2014(R2022) | Environmental monitoring for terminally sterilized healthcare products |
ANSI/AAMI/ISO 10993-13:2010(R2019) | Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric devices |
ANSI/AAMI/ISO 10993-16:2020(R2022) | Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables |
AAMI/ISO TIR16775:2023 | Packaging for terminally sterilized medical devices—Guidance on the application of ISO 11607-1 and ISO 11607-2 |
AS ISO 22367:2021 | Medical laboratories - Application of risk management to medical laboratories |
SA HB 13485:2020 | AS ISO 13485:2017 - Medical devices - A practical guide |
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