Njengesixhobo esisisiseko kuxilongo lwezonyango, abacinezeli bolwimi bakwindawo ebalulekileyo kwimakethi yezixhobo zonyango zehlabathi. Imigangatho yokuphunyezwa kwayo ichaphazela ngokuthe ngqo umgangatho wemveliso kunye nokhuseleko, ibenza babe nolwazi oluyimfuneko kwabo basebenza kurhwebo lwangaphandle.
Imigangatho yezizwe ngezizwe yoxinzelelo lolwimi ihlelwa ikakhulu ngokwemigaqo yengingqi kunye-nenkcazelo ebanzi yoshishino. Imarike ye-EU ifuna ukuthotyelwa kweMedical Device Directive (MDD) okanye iMedical Device Regulation (MDR). I-EN 13060 ichaza ngokukodwa iimfuno zokuvala inzala, ezifuna ukuba iimveliso ziphumelele uvavanyo lwe-bioburden kunye novavanyo lwentsalela ye-ethylene oxide. Imakethi yase-US ilandela imimiselo yokuhlelwa kwe-FDA, kwaye izicinezeli zolwimi zihlelwa ngokubanzi njengezixhobo ezikhululwe kwiKlasi I. Nangona kunjalo, kufuneka bahlangabezane nemigangatho yokusebenza ye-21 CFR Icandelo le-880.6275, kubandakanya i-biocompatibility yezinto kunye nokuchaneka komda. I-China isebenzisa i-GB 24457 - ngo-2009, i-"Medical Language Depressor" esemgangathweni, ebeka imilinganiselo ethile yomzimba yemithi kunye nezixhobo zeplastiki, ezifana nokufunxa kwamanzi kunye namandla okuguquguquka, kwaye ifuna indawo egudileyo, engenaburr.
Ukukhethwa kwezinto eziphathekayo kukuchaphazela ngokuthe ngqo ukusetyenziswa komgangatho. Izicinezeli zolwimi zomthi kufuneka zihambelane nesiqinisekiso sehlathi le-FSC, kwaye ukukhutshwa kwe-formaldehyde makungadluli kwi-0.124 mg/m³. Iimveliso zeplastiki ubukhulu becala zenziwe nge-polypropylene okanye i-polystyrene kwaye kufuneka ziphumelele uvavanyo lwe-cytotoxicity ye-ISO 10993. Ngokubhekiselele kwimilinganiselo, ubukhulu bomntu omdala bubude be-15-18 cm, ngelixa ubukhulu babantwana buncitshiswa ukuya kwi-10-12 cm. Ukunyamezela ukutyeba kufuneka kube phakathi kwe-±0.1 mm.
Ukuthengisa kumazwe angaphandle, kubalulekile ukunika ingqwalasela engqongqo kwiimfuno zoqinisekiso lwemarike ekujoliswe kuyo. Isiqinisekiso se-EU se-CE sifuna ukujongwa kwakhona liZiko elaziswayo (NB). Kwimakethi yase-US, kuyacetyiswa ukuba kuqhutywe 510(k) phambi{3}}ungeno-thethwano kwangaphambili. Isiqinisekiso se-GCC samkelwa ngokubanzi kuMbindi Mpuma. Ukupakishwa kweelebhile kufuneka kubandakanye inombolo yebhetshi yemveliso, umhla wokuphelelwa kokuvalwa, kunye neenkcukacha zezinto eziphathekayo. Ibhokisi yangaphandle kufuneka ibhalwe neleyibhile yokulumkisa ngenqanawa.
Ukuqonda iiyantlukwano kwimigangatho yokuphunyezwa kwe-depressor depressor kunokunceda iinkampani ukuba zihlangabezane ngokuchanekileyo neemfuno zemarike yamazwe ngamazwe, ukunciphisa umngcipheko wokuthotyelwa kwezorhwebo, kunye nokwandisa ukukhuphisana kwemveliso.