Historical

BS EN ISO 14971:2009

Medical devices. Application of risk management to medical devices (British Standard)


ISO 14971:2007 specifies 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.

The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.


CONTENT PROVIDER
British Standards Institution [bsi]

Others Also Bought
Information supplied by the manufacturer of medical devices (British Standard)
Symbols for use in the labelling of medical devices (British Standard)
Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging ...
Included in Packages
This standard is not included in any packages.
Document History
Revised By:
Amendments & Corrections
We have no amendments or corrections for this standard.