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Medical Engineering Technologies’ Managing Director invited to author a review of ISO 10993-18: 2020 by the British Standards Institute.


Nov 2, 2020
By M.Turner

The review explains the changes that have been made to the standard since the previous version. It was commissioned by BSI for their Compliance Navigator: https://compliancenavigator.bsigroup.com/

 

The review runs through the standard (new and old) comparing clauses, highlighting new clauses and pointing out any removed information.

Complete biocompatibility testing and consulting is provided by MET. This includes Biological Evaluation Plans and Reports; chemical characterisation and the other requirements of the ISO 10993-1 matrix; the ISO 18562 Evaluation of Breathing Gas Pathways; extractables and leachables; non-clinical biological studies and Toxicological Risk Analysis.


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