Product Product ISO 14971:2007
Price Price USD 239.00
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Description Description

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.

Standard Number Standard Number ISO 14971:2007
Title Title ISO 14971:2007 Medical devices — Application of risk management to medical devices
Status Status Published
Publication Date Publication Date 28 Feb 2007
Cross References Cross References
Descriptors Descriptors
ICS ICS 11.040.01
Committee Committee ISO/TC 210 Quality management and corresponding general aspects for medical devices
Publisher Publisher PECB Store
Format Format PDF
Delivery Delivery NO
Pages Pages 82
File Size File Size KB