GSO ISO/TR 24971:2016
ISO/TR 24971:2013
Gulf Standard
Historical
·
Approved on
22 December 2016
Medical devices -- Guidance on the application of ISO 14971
GSO ISO/TR 24971:2016 Files
English
12 Pages
Historical
Reference Language
30.1 OMR
GSO ISO/TR 24971:2016 Scope
ISO/TR 24971:2013 provides guidance in addressing specific areas of ISO 14971 when implementing risk management. This guidance is intended to assist manufacturers and other users of the standard to understand the role of international product safety and process standards in risk management, develop the policy for determining the criteria for risk acceptability, incorporate production and post-production feedback loop into risk management, differentiate between "information for safety" and "disclosure of residual risk", and evaluate overall residual risk.
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