Historical
SIS-ISO/TR 24971:2014
Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2013, IDT) (Swedish Standard)
This Technical Report provides guidance in addressing specific areas of ISO 14971 when implementing risk management.The 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.
CONTENT PROVIDER
Swedish Standards Institute [sis]
Swedish Standards Institute [sis]