En Iso 14971 2012
Medical devices. Application of risk management to medical devices (British Standard)
Available for SubscriptionsAvailable in Packages- BS EN ISO 14971 / BS EN 62366 - Medical Devices Package
- BS EN 62366 / BS EN ISO 14971 / BS EN 1041 / ISO 10993-1 - Medical Devices Package
- BS EN 980 / BS EN 1041 / BS EN ISO 14971 / BS EN ISO 13485 Medical Devices Package
- BS EN ISO 13485 / BS EN ISO 14971 - Risk and Quality Management Medical Devices Package
- BS EN ISO 14971 / BS EN 980 - Symbols and Risk Management of Medical Devices Package
- BS EN ISO 14971 / IEC 60601-1-2 - Risk Management of Medical Electrical Equipment Package
- BS EN ISO 14971 / BS EN ISO 11607 - Medical Devices Package
Content Provider
British Standards Institution [BSI]
BS EN ISO 14971 is a key standard specifying a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
En Iso 14971 2012 Annex Z
BS EN ISO 13485 / BS EN ISO 14971 - Risk and Quality Management Medical Devices Package; BS EN ISO 14971 / BS EN 980 - Symbols and Risk Management of Medical Devices Package; BS EN ISO 14971 / IEC 60601-1-2 - Risk Management of Medical Electrical Equipment Package; BS EN ISO 14971 / BS EN ISO 11607 - Medical Devices Package. The entire medical device regulatory world has accepted ISO 14971 as THE standard for risk management. ISO 14971 is also a significant aspect of the revised ISO as the accepted methodology for risk-based QMS and decision-making processes. I've seen many companies use a hybrid FMEA that incorporates a hazard analysis very effectively. What is BS EN ISO? BS EN ISO 14971 is a key standard specifying a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
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