The paper discussed the ISO 14971 standards. ISO 14971 is an international standard for risk management specifically devised for the development of medical devices. The standard is intended to help manufacturers to establish a full risk-management process that includes the identification of hazards, the assessment of the related risks, and the implementation of risk control measures.

Chapter Contents:

• 6.1 Introduction
• 6.2 Contents
• 6.3 Risk concepts applied to medical devices
• 6.4 Examples of hazards, foreseeable sequences of events and hazardous situations
• 6.5 Risk-management methods and tools
• 6.5.1 Failure mode effects analysis
• 6.5.2 Failure mode, effects, and criticality analysis
• 6.5.3 Fault tree analysis
• 6.5.4 Hazard analysis and critical control points
• 6.5.5 Hazard operability (HAZOP) analysis
• 6.5.6 Preliminary hazard analysis
• 6.5.7 Markov analysis
• 6.6 Use of ISO 14971: 2007 in each jurisdiction

Inspec keywords: biomedical equipment; hazards; ISO standards; risk management

Other keywords: international standard; medical devices; full risk-management process; ISO 14971; risk assessment; hazard identification; risk control measures

Subjects: Standards and calibration; Management issues; Health and safety aspects