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DANSK DS/ISO/TR 24971 PDF

DANSK DS/ISO/TR 24971 PDF

Name:
DANSK DS/ISO/TR 24971 PDF

Published Date:
07/04/2013

Status:
[ Active ]

Description:

Medical devices - Guidance on the application of ISO 14971

Publisher:
Dansk Standard

Document status:
Active
Format:
Electronic (PDF)
Delivery time:
10 minutes
Delivery time (for Russian version):
200 business days
SKU:
Choose Document Language:
$19.8
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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.


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

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