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Historical Reference Language
OMR 33.21

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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