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

BS EN ISO 14971:2009

Medical devices. Application of risk management to medical devices

Status : Superseded, Withdrawn, Revised   Published : July 2009 Replaced By : BS EN ISO 14971:2012

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BS EN ISO 14971:2009
Application of risk management to medical devices

What is it?

BS EN ISO 14971 is the latest international risk management standard for the manufacture of medical devices. It outlines ways to identify, evaluate, control and monitor risks associated with medical device manufacturing, including in vitro diagnostic (IVD) devices. The standard applies to the medical device lifecycle, covering risks to the patient and operator as well as other people and equipment exposed to the device. Compliance with BS EN ISO 14971 medical equipment risk analysis will give healthcare organisations and practitioners greater confidence in your medical device business.

How does it work?

BS EN 14971 provides medical device manufacturers with a practical risk framework. This enables you to systematically manage hazards and put in place safety measures. The standard outlines general risk requirements for medical device manufacturing as well as management responsibilities, necessary qualifications, processes for evaluating risks and identifying appropriate risk control options. Compliance with BS EN 14971 enables you to put in place a long term risk management plan and report on medical device safety.

Who should buy it?

  • Medical device manufacturers and suppliers
  • Health and safety managers
  • Healthcare practitioners using medical devices.

What’s new?

BS EN ISO 14971 is the latest version of the standard and includes updates in line with Essential Requirements of the EU Directives 93/42/EEC (medical devices), 90/385/EEC (active implantable medical devices) and 98/79/EC (in vitro diagnostic devices).

Contents of BS EN ISO 14971 include:

  • Foreword
  • Introduction
  • Scope
  • Terms and definitions
  • General requirements for risk management
  • Risk management process
  • Management responsibilities
  • Qualification of personnel
  • Risk management plan and file
  • Risk analysis process
  • Intended use and identification of characteristics related to the safety of the medical device
  • Identification of hazards
  • Estimation of the risk(s) for each hazardous situation
  • Risk evaluation, control and reduction
  • Risk control option analysis
  • Implementation of risk control measure(s)
  • Residual risk evaluation
  • Risk/benefit analysis
  • Risks arising from risk control measures
  • Completeness of risk control
  • Evaluation of overall residual risk acceptability
  • Risk management report
  • Production and post-production information
  • Rationale for requirements
  • Overview of the risk management process for medical devices
  • Questions that can be used to identify medical device characteristics that could impact on safety
  • Risk concepts applied to medical devices
  • Examples of hazards, foreseeable sequences of events and hazardous situations
  • Risk management plan
  • Information on risk management techniques
  • Guidance on risk management for in vitro diagnostic medical devices
  • Guidance on risk analysis process for biological hazards
  • Information for safety and information about residual risk
  • Bibliography

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Standard NumberBS EN ISO 14971:2009
TitleMedical devices. Application of risk management to medical devices
StatusSuperseded, Withdrawn, Revised
Publication Date31 July 2009
Withdrawn Date31 July 2012
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)ISO 18113-1, ISO 22442, ISO 10993-1, ISO 14155-2, 98/79/EC, ISO 15189, ISO 14155-1, ISO 19001, ISO 15198, IEC 61025, IEC 61882, ISO 10993-2, ISO 10993-17, ISO 17511, IEC 62366, IEC 60601-1-8, ISO 15197, IEC 60601-1-6, EN 12442-1, 90/385/EEC, ISO 9000:2005, ISO/IEC Guide 51:1999, EN 1441:1997, IEC/TR 60513, IEC 60812, ISO 9000-3:1997, IEC 60300-3-9:1995, IEC 60601-1-4, ISO/TR 14969, ISO 13485:2003, 90/285/EEC, IEC 60601-1:2005, ISO 17593, IEC 60050-191, 93/68/EEC, 93/42/EEC, ISO/IEC Guide 2:1996, ISO 18153
Replaced ByBS EN ISO 14971:2012
ReplacesBS EN ISO 14971:2007
International RelationshipsISO 14971:2007,EN ISO 14971:2009
Amended ByCorrigendum, February 2011
DescriptorsMedical instruments, Risk analysis, Risk assessment, Clinical investigation instruments, Diagnosis (medical), Management, Hazards, Safety measures, Medical equipment
Title in FrenchDispositifs médicaux. Application de la gestion des risques aux dispositifs médicaux
Title in GermanMedizinprodukte. Anwendung des Risikomanagements auf Medizinprodukte
ISBN978 0 580 74642 0
File Size2.363 MB

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