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

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BS EN ISO 14971:2012

Medical devices. Application of risk management to medical devices

Status : Current   Published : July 2012

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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?

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Standard NumberBS EN ISO 14971:2012
TitleMedical devices. Application of risk management to medical devices
StatusCurrent
Publication Date31 July 2012
Cross References93/42/EEC, 90/385/EEC, 98/79/EC, ISO/IEC Guide 2:1996, ISO/IEC Guide 51:1999, ISO 9000-3:1997, ISO 9000:2005, ISO 10993-1, ISO 10993-2, ISO 10993-17, ISO 13485:2003, ISO/TR 14969, ISO 14155-1, ISO 14155-2, ISO 15189, ISO 15197, ISO 15198, ISO 17511, ISO 17593, ISO 18153, ISO 19001, ISO 22442, IEC 60050-191, IEC 60300-3-9:1995, IEC/TR 60513, IEC 60601-1:2005, IEC 60601-1-4, IEC 60601-1-6, IEC 60601-1-8, IEC 60812, IEC 61025, IEC 61882, IEC 62366, EN 1441:1997, EN 12442-1, 90/285/EEC, 93/42/EEC, 98/79/EC, ISO 18113-1
ReplacesBS EN ISO 14971:2009
International RelationshipsEN ISO 14971:2012,ISO 14971:2007
DescriptorsMedical equipment, Medical instruments, Risk assessment, Risk analysis, Management, Hazards, Clinical investigation instruments, Safety measures, Diagnosis (medical)
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 Size2.349 MB
Price£262.00


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