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HomeVestakeep® M2G, M4G, M4P Medical Grades


Vestakeep® M2G, M4G, M4P Medical Grades


The biocompatibility of a medical device depends on the part of the body (skin, blood, fatty tissue, etc.) with which it is in contact and on the duration of such contact. The biological evaluation of a medical device therefore depends on the use for which it is intended. DIN EN ISO 10993 collects together a number of international standards for biocompatibility testing and regulates the choice of tests relevant to the application in question. Biocompatibility testing must always be performed on the finished medical device because the processing and combination of the raw materials could alter their biocompatibility. Certain tests on the raw material are meaningful, however, because they provide important information on the suitability of the material for the finished product. In addition to DIN EN ISO 10993, General Chapter <88> of the US Pharmacopeia (USP) describes tests on plastics for medical devices; depending on the application, plastics are assigned to Classes I to VI, those of Class VI having to satisfy the most stringent requirements. Here again, the principle applies of ensuring the biocompatibility of the finished product rather than the raw materials.
   (VESTAKEEP-MEDICAL) Vestakeep® M2G, M4G, M4P Medical Grades
Links:
  • Vestakeep M2G Data
  • Vestakeep M4G
  • Vestakeep M4P
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