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  • BSI
    BS EN ISO 14971:2019 Medical devices. Application of risk management to medical devices
    Edition: 2019
    $497.46
    / user per year

Description of BS EN ISO 14971:2019 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].



Standard NumberBS EN ISO 14971:2019
TitleMedical devices. Application of risk management to medical devices
StatusWithdrawn
Publication Date2019-12-18
Withdrawn Date2021-12-15
Identical National Standard OfISO 14971:2019, EN ISO 14971:2019, EN ISO 14971:2019
DescriptorsRisk analysis, Management, Hazards, Risk assessment, Safety measures, Diagnosis (medical), Medical instruments, Clinical investigation instruments, Medical equipment
ICS11.040.01 Medical equipment in general
CommitteeCH/210/4
ISBN978 0 539 12339 5
PublisherBSI
Pages46

The following editions for this book are also available...

Format Year Publisher Type Title Annual Price
2021
BSI
Standards
 $497.46 Buy

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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