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ISO/TR 24971:2013

Medical devices — Guidance on the application of ISO 14971

Standard Details

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.

General Information

Status : WITHDRAWN
Standard Type: Main
Document No: ISO/TR 24971:2013
Document Year: 2013
Pages: 12
Edition: 1
  • Section Volume:
  • ISO/TC 210. Quality management and corresponding general aspects for medical devices

Life Cycle

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WITHDRAWN
ISO/TR 24971:2013
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