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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 StandardDetails 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Status : WITHDRAWN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: 1.0
  • Section Volume:
  • TC 62.SC 62A Common aspects of electrical equipment used in medical practice

Life Cycle

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ISO TR 24971:2013
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