Medical Device Design Using Polymer Compounds
Medical Device Design Using Polymer Compounds
Medical Device Design Using Polymer Compounds
Polymer Compounds
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What is biocompatibility?
To be biocompatible, a material or device must not produce any adverse response in
the human body. Compounds used in medical devices must meet the
biocompatibility requirements of the application for which they are used. Regulatory
agencies typically require the final medical device, which might include several
different types of materials, to be tested for biocompatibility for a specific application.
Although agencies approve the device, not the materials, materials can be tested
ahead of time to validate that they are generally biocompatible.
USP General Chapter <87> “Biological Reactivity Tests, In Vitro,” describes three
tests (agar diffusion, direct contact, and elution) used to determine biological
reactivity of mammalian cell cultures in contact with polymer materials. The tests
look at cytotoxicity (i.e., if and to what extent a material is toxic to cells).
USP General Chapter <88> “Biological Reactivity Tests, In Vivo,” details tests that
can be used to classify materials into one of six classes (I to VI), based on biological
reactivity under certain conditions related to the intended end use. USP Class VI
requires the most comprehensive testing. According to US Pharmacopeia, if the
material is to be exposed to a sterilization process prior to end-use, the tests should
be conducted on specimens preconditioned under the relevant process. PVC
Compound 2222C-85 is an extrusion-grade PVC that is widely used for urological
tubing. It meets all requirements for biomedical Class VI devices.
For more information, Read a Case Study about PVC Compound ‘Animal By-Product
Free’ solutions for Medical and Dental Products.
Methods of sterilization include autoclaving, which uses saturated steam (i.e., moist
heat sterilization), and gaseous chemical sterilization. Sterilizing by irradiation with
high energy (e.g., electron beam or gamma rays) requires specially designed
compounds to withstand these conditions.
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