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16-Mar-2017 05:50

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We conduct a triennial review about every three years. We reviewed all comments received during the comment period and developed a five-year plan of prioritized topics.

By including additional requirements, chemical characterisation and cytotoxicity testing will be mandatory while all other toxicological endpoints will be evaluated within a toxicological risk assessment.

A major revision of ISO 10993-17 on allowable limits for leachable substances is in the works.

It is designed as a reference and an aid, not an authoritative source. Please direct your input or questions to [email protected]

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A large number of experts including Eurofins key scientists met in June 2015 in Lund, Sweden, to discuss new scientific developments and challenges to be included in the revision of the ISO 10993 standards, used in the biological evaluation of medical devices.Risk assessment approaches to use the concept of Threshold of Toxicological Concern (TTC), already established and accepted for genotoxic pharmaceutic impurities, are in discussion.If it can be shown that an impurity is below the TTC, then it is assumed that the chemical substance is of no significant risk.If you are interested in a system to protect your drinking water from pharmaceuticals or other contaminants, please contact your local Multipure Independent Builder for more information.