Ubume bomzimba kunye neekhemikhali, izondlo kunye nezikhongozeli zenkcubeko zizinto ezintathu ezibalulekileyo zenkcubeko yeseli.Zininzi izinto ezichaphazela ukukhula kweeseli, phakathi kwazo nokuba izinto ezikrwada zeumzi-mveliso weseliziqulathe amacandelo angathandekiyo ekukhuleni kweeseli nawo ngumba obaluleke kakhulu.

I-United States Pharmacopeia Medical Materials classifications yiklasi ye-6, ukusuka kwi-USP iklasi I ukuya kwi-USP iklasi VI, kunye ne-USP iklasi VI ibe yibakala eliphezulu.Ngokuhambelana nemithetho ye-USP-NF ngokubanzi, iiplastiki eziphantsi kovavanyo lwe-biological reaction ye-vivo ziya kuhlulwa zibe ngamabakala eplastiki yezonyango ekhethiweyo.Injongo yolu vavanyo kukuqinisekisa ukuhambelana kwe-biocompatibility yeemveliso zeplastiki kunye nokufaneleka kwazo kwizixhobo zonyango, ukufakelwa kunye nezinye iinkqubo.

Izinto eziluhlaza zefektri yeseli yi-polystyrene kwaye i-API idibana nomgangatho we-USP weClass VI.Iplastiki elinganiswe njengeplastiki yesithandathu yezonyango e-United States ithetha ukuba uvavanyo olubanzi nolungqongqo lusekiwe.Us iNqanaba lesi-6 leMathiriyeli yezonyango ngoku linqanaba legolide kuzo zonke iintlobo zemathiriyeli ekrwada yonyango kunye nomgangatho ophezulu kakhulu wokukhetha abenzi bezixhobo zonyango.Izinto zovavanyo zibandakanya uvavanyo lwe-systemic toxicity (iimpuku), uvavanyo lwe-intradermal reaction (imivundla) kunye novavanyo lokufakelwa (imivundla).

Kuphela i-polystyrene imathiriyeli ekrwada evavanyiweyo ukuhlangabezana neemfuno ze-USP yeklasi VI enokusetyenziswa kuyoumzi-mveliso weseliimveliso.Ukongezelela, izitya zenkcubeko yeeseli kufuneka ziveliswe kwi-workshop yokucoca i-C-class, ngokuhambelana neemfuno zenkqubo yokulawula umgangatho we-ISO13485, ukulawula ngokungqongqo umgangatho wemveliso ukusuka kwinkqubo yokuvelisa, ukuqinisekisa izinga elifanelekileyo leemveliso ezigqityiweyo.