2661778

DANSK DS/ISO/TR 24971 [ Active ]

Medical devices - Guidance on the application of ISO 14971

standard by Dansk Standard , 07/04/2013

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This Technical Report 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.

 

Product Details

Edition:
13
Published:
07/04/2013
Number of Pages:
22
File Size:
1 file , 1000 KB
Product Code(s):
DS-021, DS-021