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DS/ISO/TR 24971

2013 Edition, July 4, 2013

Complete Document

Medical devices - Guidance on the application of ISO 14971

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Product Details:

  • Revision: 2013 Edition, July 4, 2013
  • Published Date: July 4, 2013
  • Status: Active, Most Current
  • Document Language: English
  • Published By: Dansk Standardiseringsrad (DS)
  • Page Count: 22
  • ANSI Approved: No
  • DoD Adopted: No

Description / Abstract:

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.