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Norm
ÖVE/ÖNORM EN ISO 14971
Issue date: 2020 06 01
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medic...
Withdrawn: 2022 05 15
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 50 Pages
Language:
German
| English
| Download GER/ENG
Currently valid:
Optionally co-design standards:
ICS
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.
ÖVE/ÖNORM EN ISO 14971
2022 05 15
Medical devices - Application of risk management to medical devices (ISO 14971:2019) (consolidated v...
Norm
ÖVE/ÖNORM EN ISO 14971
2020 06 01
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
Norm
↖
ÖNORM EN ISO 14971
2013 03 01
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected versi...
Norm
ÖNORM EN ISO 14971
2009 12 15
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected versi...
Norm
ÖNORM EN ISO 14971
2007 06 01
Medical devices - Application of risk management to medical devices (ISO 14971:2007)
Norm
ÖNORM EN ISO 14971
2003 10 01
Medical devices - Application of risk management to medical devices (ISO 14971:2000, EN ISO 14971:20...
Norm
ÖNORM EN ISO 14971/A1
2003 09 01
Medical devices - Application of risk management to medical devices - Amendment 1: Rationale for req...
Norm
ÖNORM EN ISO 14971
2001 04 01
Medical devices - Application of risk management to medical devices (ISO 14971:2000)
Norm
Norm
Issue date :
2022 05 15
Medical devices - Application of risk management to medical devices (ISO 14971:2019) (consolidated version)
Norm
Issue date :
2019 12 10
Medical devices — Application of risk management to medical devices