BIO-, PHARMA- AND MEDICAL TECHNOLOGY
Life Science Grades (LSG)
According to ISO 10993, medical devices are divided into different categories. The categorisation is based on the type and duration of contact with the human organism.
Depending on the type and duration of contact, medical devices must undergo or pass various test procedures. Some test procedures of ISO 10993 correspond to those of the USP.
For use in medical applications with the highest risk levels, e.g. as an implant, invasive product or surgical cutlery, it must ultimately be proven that the plastic complies with the relevant laws and/or standards. For these requirements, a simple certificate of compatibility is no longer sufficient. Rather, it must be documented that the plastic has undergone and passed the relevant test procedures.
POLYTRON offers high-performance plastics which have been subjected to appropriate biocompatibility tests and whose conformity can be proven by test certificates. These materials, designated as Life Science Grades (LSG), offer continuous traceability down to the individual raw material batch.
In addition to these LSG qualities, high-performance plastics for the biotechnology, pharmaceutical and medical technology industries are available on request in special colour settings (PPSU, PEEK) or with appropriate contrast agents, so that the plastic components are visible even when X-rayed.
more ...