BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices

BS EN ISO 14971:2012

Medical devices. Application of risk management to medical devices

Status : Superseded, Withdrawn   Published : July 2012 Replaced By : BS EN ISO 14971:2019

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BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices

In 2011 the European Commission raised a concern around the legal text supporting presumption of conformity to the Medical Device Directives (Annexes ZA, ZB, ZC) in EN ISO 14971:2009.  The outcome was that CEN decided to publish a new edition of the standard (EN ISO 14971:2012). 

This standard has a revised Foreword and Annexes ZA, ZB and ZC, but the core text remains unchanged.

Get the most out of BS EN ISO 14971:2012

PD ISO/TR 24971:2013 Medical devices. Guidance on the application of ISO 14971

Experience indicates that manufacturers have difficulty with practical implementation of some clauses of the risk management standard ISO 14971. That’s why we’ve published PD ISO/TR 24971 to assist in the development, implementation and maintenance of risk management for medical devices.

Find out more

What is BS EN ISO 14971:2012?


BS EN ISO 14971 is a key standard specifying a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.  The requirements of this standard are applicable to all stages of the life-cycle of a medical device.

It does not apply to clinical decision making, does not specify acceptable risk levels and does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management system.


How does it work?

BS EN ISO 14971 was developed specifically for medical device/system manufacturers using established principles of risk management. For other manufacturers, e.g., in other healthcare industries, this standard could be used as informative guidance in developing and maintaining a risk management system and process. 

It deals with processes for managing risks, primarily to the patient, but also to the operator, other persons, other equipment and the environment. As a general concept, activities in which an individual, organization or government is involved can expose those or other stakeholders to hazards which can cause loss of or damage to something they value. Risk management is a complex subject because each stakeholder places a different value on the probability of harm occurring and its severity.


Who should buy it?

Organizations dealing with the design, development, production, installation or servicing of medical equipment, devices and technology.

Why BSI?

We are global, we’re independent and we’re a trusted service provider to 80,000 businesses. We operate in 147 countries and are the number one certification body in the UK and US. We created 85% of our portfolio because we know standards and we know your business. We’re leaders and we can make you one too. 




Standard NumberBS EN ISO 14971:2012
TitleMedical devices. Application of risk management to medical devices
StatusSuperseded, Withdrawn
Publication Date31 July 2012
Withdrawn Date18 December 2019
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
Replaced ByBS EN ISO 14971:2019
ReplacesBS EN ISO 14971:2009
International RelationshipsISO 14971:2007,EN ISO 14971:2012
DescriptorsRisk analysis, Management, Hazards, Risk assessment, Safety measures, Diagnosis (medical), Medical instruments, Clinical investigation instruments, Medical equipment
ICS11.040.01
Title in FrenchDispositifs médicaux. Application de la gestion des risques aux dispositifs médicaux
Title in GermanMedizinprodukte. Anwendung des Risikomanagements auf Medizinprodukte
CommitteeCH/210/4
ISBN978 0 580 79952 5
PublisherBSI
FormatA4
DeliveryYes
Pages106
File Size2.313 MB
Price£292.00


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