Testing AgenciesBecause medical devices may involve humna exposure, standards for biocompatibility have been established by various agencies, such as the United States Pharmacopeia (USP). USP has issued standards and guidelines which are classified into USP Classes 1 through V1, with V1 being the most stringent.The international Organisation for Standardization (ISO) has combined numerous international and national standards to develop the International Standard ISO 10993-1, Biological Evaluation of Medical Devices. the ISO standard groups medical devices into categories based on the severity and lenth of human exposure and offers guidelines on appropriate testing for each category. Information below summarizes the biocompatibility testing that has been conducted on BP Amoco material follwing these standards and guidelines.TEST CONDUCTED:USP intracutaneous toxicity and USP muscle implantation.RESULT: Product in compliance: Udel P-1700TEST CONDUCTED:Cytoxicity and hemolysisRESULT: Udel P-1700 Natural 11MG. Udel P-1700 White 6417 MG.
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