usp class vi vs iso 10993
Evaluation and Testing recommendations outlined in ISO. Materials have passed skin sensitization and cytotoxicity tests according to ISO 10993-5 and ISO 10993-10.
Usp Class Vi Certification Presco Marking Products And Engineered Films
By ensuring that a material is non-toxic and wont result in immunological rejection biocompatibility testing ensures that a rubber is safe for use with.
. Both ISO 10993 and USP Class VI define testing requirements for biocompatibility the ability of a material to perform a desired function without causing adverse effects on the human body. Per FDAs Blue Book Memorandum G95-1 Use of International Standard ISO 10993 Biological Evaluation of Medical Devices Part 1. All the TPUs supplied by ICP DAS BMP are USP Class VI certified and compliant with the ISO 10993 international standard.
ICP DAS BMP has its own laboratories for polymerization physical properties analysis and cytotoxicity testing.
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