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

Medical devices. Guidance on the application of ISO 14971

Status : Current, Project Underway   Published : July 2013



What is this published document about?

Experience shows that manufacturers have difficulty with the practical implementation of some clauses in the medical devices risk management standard BS EN ISO 14971. This published document is the UK implementation of an international Technical Report. It supplies guidance on tackling specific clauses in the standard.  

Who is this published document for?

  • Medical device manufacturers
  • Regulators
  • Other users of BS EN ISO 14971

Why should you use this published document? 

This is not an overall guidance document on the implementation of BS EN ISO 14971, but it will help manufacturers in the development, implementation and maintenance of risk management for a wide variety medical devices including: active, non-active, implantable and non-implantable devices and in vitro diagnostic devices.

It provides guidance to help manufacturers and other users of the standard:

  • Understand the role of international product safety and process standards in risk management
  • Develop the policy for determining the criteria for risk acceptability
  • Incorporate production and post-production feedback loops into risk management
  • Differentiate between information for safety as a risk control measure and disclosure of residual risk
  • Evaluate overall residual risk It also supplies insight into the different approaches an organization can use to implement and maintain aspects of a risk management system that conforms to BS EN ISO 14971.

Standard NumberPD ISO/TR 24971:2013
TitleMedical devices. Guidance on the application of ISO 14971
StatusCurrent, Project Underway
Publication Date31 July 2013
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
International RelationshipsISO/TR 24971:2013
DescriptorsSets of data, Electrical medical equipment, Information exchange, Data processing, Medical equipment, Terminology, Data handling, Thesauri, Data representation, Data structures, Medical instruments, Databases, Classification systems, Data organization
Title in FrenchDispositifs médicaux. Directives relatives à l’ISO 14971
ISBN978 0 580 75270 4
File Size1.077 MB

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