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For more information regarding Biocompatibility requirements, Approved sterilization processes, Safety Guidelines and datasheets, please visit our support center webpage or contact us.

 

 

[1] Evaluated according to biological testing under the procedures and provisions of EN ISO 10993-1:2018 “Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process” and FDA Guidance "Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process", dated 16 June 2016.