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About This Item

 

Full Description

ISO 10993-18:2018 specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents, using a generally stepwise approach to the chemical characterization.
 

Document History

  1. ISO 10993-18:2020

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    Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process

    • Most Recent
  2. ISO 10993-18:2005


    Biological evaluation of medical devices - Part 18: Chemical characterization of materials

    • Historical Version