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Full Description

This guidance is applicable to the conduct of biological evaluation of medical devices according to the requirements of ISO 10993-1. It does not add to, or otherwise change, the requirements of ISO 10993-1. This guidance does not include requirements to be used as the basis of regulatory inspection or certification assessment activities. This guidance is applicable to all biological evaluation of all types of medical devices including active, non-active, implantable and nonimplantable medical devices.
 

Document History

  1. AAMI/ISO TIR15499:2017

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    Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process

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  2. AAMI/ISO TIR15499:2012


    Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process

    • Historical Version