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Historical
Reference Language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.
Best Sellers From Health Sector
OS GSO 2017:2023
GSO 2017:2023
Omani Standard
Personal Care and Baby Wet Wipes
GSO 2017:2023
Gulf Standard
Personal Care and Baby Wet Wipes
OS GSO 2241:2023
GSO 2241:2023
Omani Standard
Cosmetic Products - Body Cleaners
GSO 2241:2023
Gulf Standard
Cosmetic Products - Body Cleaners
Recently Published from Health Sector
GSO EN 1273:2020+A1:2026
EN 1273:2020+A1:2023
Gulf Standard
Child care articles - Baby walking frames - Safety requirements and test methods
GSO CEN/TR 16467:2026
CEN/TR 16467:2013
Gulf Standard
Playground equipment accessible for all children
GSO ASTM F1816:2026
ASTM F1816:18(2024)
Gulf Standard
Standard Safety Specification for Drawstrings on Children's Upper Outerwear
GSO ASTM F2194:2026
ASTM F2194:25
Gulf Standard
Standard Consumer Safety Specification for Bassinets and Cradles