ISO TR 24971:2013

Title

Language: EN Medical devices -- Guidance on the application of ISO 14971

Abstract

Language: EN 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.

Language(s)
Language: RU
Edition
1.0
Date of issue
19.06.2013
TC 62/SC 62A
ICS Codes
11.040.01
Publication number
24971
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Price (excl. VAT)
€ 52,70 (Download and hardcopy)
Delivery format
postal download (12 Pages)

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