chilengedwe ndi mankhwala, zakudya ndi chikhalidwe muli zinthu zitatu zofunika za selo chikhalidwe.Pali zinthu zambiri zomwe zimakhudza kukula kwa maselo, zomwe kaya zopangira zacell fakitalezili ndi zigawo zomwe sizimayenderana ndi kukula kwa maselo ndizofunikira kwambiri.

Gulu la United States Pharmacopeia Medical Materials ndi kalasi 6, kuyambira USP kalasi I mpaka USP kalasi VI, ndi USP kalasi VI kukhala giredi apamwamba.Mogwirizana ndi malamulo a USP-NF General, mapulasitiki oyesedwa mu vivo biological reaction amagawidwa m'magulu osankhidwa apulasitiki azachipatala.Cholinga cha mayesowa ndikuwunika kuyanjana kwazinthu zamapulasitiki komanso kuyenerera kwawo pazida zamankhwala, ma implants ndi machitidwe ena.

Zopangira za fakitale yama cell ndi polystyrene ndipo API imakumana ndi muyezo wa USP Class VI.Pulasitiki yomwe idawerengedwa ngati pulasitiki yachisanu ndi chimodzi yachipatala ku United States ikutanthauza kuti kuyezetsa kokwanira komanso mwamphamvu kwakhazikitsidwa.Us Medical Equipment Level 6 tsopano ndiye muyeso wa golide wa mitundu yonse ya zida zopangira mankhwala komanso kusankha kwapamwamba kwambiri kwa opanga zida zamankhwala.Zinthu zoyezetsazo zidaphatikizapo mayeso a kawopsedwe a systemic (mbewa), kuyesa kwa intradermal reaction (akalulu) ndi kuyesa kwa implantation (akalulu).

Zida za polystyrene zokha zoyesedwa kuti zikwaniritse zofunikira za USP class VI zitha kugwiritsidwa ntchitocell fakitalekupanga.Kuphatikiza apo, zotengera zama cell zimayenera kupangidwa mu msonkhano woyeretsera kalasi ya C, mogwirizana ndi zofunikira za ISO13485 kasamalidwe kabwino, kuwongolera mosamalitsa mtundu wazinthu kuchokera pakupanga, kuti zitsimikizire kuchuluka kwazinthu zomwe zamalizidwa.