International Standard
ISO 14971:2019
Medical devices — Application of risk management to medical devices
Reference number
ISO 14971:2019
Edition 3
2019-12
© ISO 2024
International Standard
Read sample
Published (Edition 3, 2019)

ISO 14971:2019

Language
Format
CHF 173
Convert Swiss francs (CHF) to your currency

Abstract

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].

In bundle

Bundle
Medical devices - the basics

This bundle combines essential ISO standards to provide a robust framework for quality management and risk management in the medical device industry.

  • ISO 13485:2016
  • ISO 13485:2016 A practical guide
  • ISO 14971:2019
  • ISO/TR 24971:2020
English | PDF
CHF 658

General information

  • Status
     : Published
    Publication date
     : 2019-12
    Stage
    : International Standard published [60.60]
  • Edition
     : 3
    Number of pages
     : 36
  • Technical Committee :
    ISO/TC 210
    ICS :
    11.040.01 
  • RSS updates

Life cycle

Got a question?

Check out our Help and Support

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)

  2. Store
  3. Standards catalogue
  4. ICS
  5. 11
  6. 11.040
  7. 11.040.01
  8. ISO 14971:2019