OVERVIEW of Vestakeep® M2G, M4G, M4P Medical Grades |
VESTAKEEP® grades for medical technology
We offer the grades VESTAKEEP® M2G, VESTAKEEP® M4G und VESTAKEEP® M4P for medical applications. These products have been formulated for high biocompatibility, and batch tests are conducted in vitro to test for cytotoxicity according to DIN EN 10993-5, which ensures a necessary margin of safety.
VESTAKEEP M2G and VESTAKEEP M4G meet the following requirements for medical applications:
United States Pharmacopeia Testing: <88> "Biological Reactivity Testing In Vivo" Class VI:
Acute Systemic Toxicity Test: Four different extraction media (70°C/24h);
Irritation Test — Intracutaneous Injection Test: Four different extraction media (70°C/24h);
Implantation Test: In Vivo-Implantation Test: intramuscular, seven days
United States Pharmacopeia Testing <87> ôBiological Reactivity Testing In Vitro"
Cytotoxicity Test: L929 MEM elution, according to ISO 10993-5 (37°C/24h)
VESTAKEEP M4P meets the following requirements for medical applications:
Biocompatibility Test:
United States Pharmacopoeia Testing <87> ôBiological Reactivity Testing In Vitro"
Cytotoxicity Test: L929 MEM elution, according to ISO 10993-5 (37°C/24h)
Granules made from VESTAKEEP M4P meet the following requirements:
United States Pharmacopoeia Testing: <88> "Biological Reactivity Testing In Vivo" Class VI:
Acute Systemic Toxicity Test: Four different extraction media (70°C/24h)
Irritation Test - Intracutaneous Injection Test: Four different extraction media (70°C/24h)
Implantation Test: In Vivo-Implantation Test: intramuscular, seven days
|
|
FEATURES AND BENEFITS of 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® M2g, M4g, M4p Medical Grades]( "Vestakeep® M2g, M4g, M4p Medical Grades")
|
Contact Us
Locations
About Us
Track Shipment
Register
Log In
