Name:
DANSK DS/ISO/TR 24971 PDF
Published Date:
07/04/2013
Status:
[ Active ]
Publisher:
Dansk Standard
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.
| Edition : | 13 |
| File Size : | 1 file , 1000 KB |
| Number of Pages : | 22 |
| Product Code(s) : | DS-021, DS-021 |
| Published : | 07/04/2013 |