BS EN ISO 14971:2009

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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