ISO 14971

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Logo of the German Institute for Standardization DIN EN ISO 14971
Area Medical technology
title Medical Devices - Applying Risk Management to Medical Devices
Latest edition 2019-12
ISO 14971

The ISO 14971 standard (European version EN ISO 14971) regulates the application of risk management to medical devices .

The standard serves as a framework for the effective management of the risks associated with the use of medical devices in healthcare by the manufacturer .

The third edition of ISO 14971 was published in December 2019.

history

The EN ISO 14971: 2012 standard is harmonized with the European Council Directive 93/42 / EEC of June 14, 1993 on medical devices . It immediately replaced the EN ISO 14971: 2009 standard with the publication of the list of harmonized standards on August 30, 2012. There was no transition period. Before the EN ISO 14971: 2009 standard, the EN ISO 14971: 2000 standard was applicable with a transition period up to March 31, 2010. The standard EN ISO 14971: 2000 replaced the previous standard EN 1441: 1997, which was formulated in 1997 with regard to Directive 93/42 / EEC.

scope of application

The standard defines a procedure for manufacturers with which they recognize hazards associated with medical devices and their accessories, assess, evaluate and control the risks, and monitor the effectiveness of this control. The requirements of the standard apply during all phases of the product life cycle of a medical device.

Processes

The standard is based on a process-oriented approach to implementing a risk management process. A distinction is made between the following processes: risk analysis , risk assessment , risk control and information from production and production phases.

documentation

The standard requires the documentation of essential activities of the risk management process as well as their results for the respective medical device in a risk management file. The manufacturer must develop a risk management plan in accordance with his risk management process. The risk management plan is part of the risk management file. The risk management plan must contain:

  • Scope of the plan, describing the medical device and the stages of its life cycle phases
  • a plan for verification
  • Assignment of responsibilities
  • Requirements for the evaluation of the risk management activities
  • Criteria for the acceptability of risks

The results of the risk management process are to be recorded in a risk management report. The risk management report must enable traceability to the analysis and assessment of the risk for each hazard. Furthermore, there must be traceability of the implementation and verification of the risk control measures. The risk management report must contain a declaration that the residual risk (the sum of the individual residual risks) is acceptable. The risk management report is part of the risk management file.

Changes in the standard EN ISO 14971: 2012

The EN ISO 14971: 2012 standard differs from the international version ISO 14971: 2007 in particular through a modified European foreword and the modified appendices ZA, ZB and ZC. In these annexes, the relationship between the requirements of the standard and the requirements of EC Directives 93/42 / EEC (on medical devices), 90/385 / EEC (on active implantable medical devices) and 98/79 / EC (on domestic vitro diagnostics). The normative part has not been adapted compared to the previous EN ISO 14971: 2009.

Changes in the ISO 14971: 2019 standard

The third edition of the standard from 2019 differs from 14971: 2007 not only in a new chapter structure, but also in a stronger consideration of the benefit-risk ratio ("benefit-risk ratio"). For this purpose, the concept of (medical) benefit is defined. In addition, there is a stronger focus on the “information from production and production downstream phases”. Some explanations or appendices from the previous standard have been moved to ISO / TR 24971: 2019.

Sources and individual references

  1. ↑ 14: 00-17: 00: ISO 14971: 2019. Retrieved December 11, 2019 .

literature

  • DIN EN ISO 14971: 2013-04, Medical devices - Application of risk management to medical devices (ISO 14971: 2007, corrected version October 1, 2007); German version EN ISO 14971: 2012
  • DIN EN ISO 14971: 2009-10, Medical devices - Application of risk management to medical devices (ISO 14971: 2007, corrected version October 1, 2007); German version EN ISO 14971: 2009
  • DIN EN 62366: 2008-09, Medical devices - Application of usability to medical devices (IEC 62366: 2007); German version EN 62366: 2008
  • Jürgen P. Bläsing: Medical products: Risk management in the life cycle model according to ISO 14971: 2007 monitoring and reporting systems
  • U. Hölscher / W. Laurig: Ergonomics guidelines for the design of medical devices , KAN report 31, 02/2004
  • Manfred Kindler / Wolfgang Menke (Eds.): Medical Products Act , MPG: 6.1.2 Risk Management at Manufacturers of Medical Products and IvD - Duty or Opportunity, 5th Edition, ecomed Verlag, ISBN 978-3-609-51870-1