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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].


Общая информация 

  • Текущий статус
     :  Published
    Дата публикации
     : 2019-12
  • Версия
     : 3
  • Технический комитет
     : ISO/TC 210 Quality management and corresponding general aspects for products with a health purpose including medical devices
  • ICS
     :
    11.040.01 Medical equipment in general

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  • CHF166

Приобретены также другие

  • ISO 14155:2020
    Clinical investigation of medical devices for human subjects
    Good clinical practice
  • ISO 15223-1:2016 [Отменен]
    Medical devices
    Symbols to be used with medical device labels, labelling and information to be supplied
    Part 1: General requirements
  • ISO 13485:2016
    Medical devices
    Quality management systems
    Requirements for regulatory purposes

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  3. Каталог стандартов
  4. ТК
  5. ISO/TC 210
  6. ISO 14971:2019