ISO TR 24971:2013 Withdrawn

Medical devices -- Guidance on the application of ISO 14971

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Abstract

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.

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Additional information

Publication typeTechnical Report
Publication date2013-06-19
Withdrawal date2020-06-16
Edition1.0
Available language(s)English, Russian
TC/SCTC 62/SC 62A - Common aspects of medical equipment, software, and systemsrss
ICS11.040.01 - Medical equipment in general
Stability date  2020
Pages12
File size584 KB

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