Njengethuluzi eliyisisekelo ekuxilongweni kwezokwelapha, abacindezela ulimi basesimweni esibalulekile emakethe yemishini yezokwelapha yomhlaba wonke. Izindinganiso zabo zokusetshenziswa zithinta ngokuqondile ikhwalithi nokuphepha komkhiqizo, okubenza babe nolwazi olubalulekile kulabo abasebenza kwezohwebo lwangaphandle.
Izindinganiso zamazwe ngamazwe zokucindezelwa kolimi zihlukaniswa ngokuyinhloko ngokwemithetho yesifunda kanye{0}}nokucaciswa okubanzi komkhakha. Imakethe ye-EU idinga ukuthobela i-Medical Device Directive (MDD) noma i-Medical Device Regulation (MDR). I-TS EN 13060 ibeka ngokukhethekile izidingo zokuvala inzalo, ezidinga ukuthi imikhiqizo iphumelele ukuhlolwa kwe-bioburden kanye nokuhlolwa kwensalela ye-ethylene oxide. Imakethe yase-US ilandela imithetho yokuhlukaniswa kwe-FDA, futhi izicindezeli zolimi ngokuvamile zihlukaniswa njengamadivayisi akhululiwe Ekilasini I. Kodwa-ke, kusafanele ahlangabezane namazinga okusebenza we-21 CFR Ingxenye 880.6275, okuhlanganisa nokuhambisana kwezinto ezibonakalayo nokunemba kobukhulu. I-China isebenzisa i-GB 24457-2009, indinganiso "yeMedical Tongue Depressor", ebeka izici ezithile ezibonakalayo zokhuni nezinto zepulasitiki, ezifana nokumuncwa kwamanzi namandla okuguquguquka, futhi idinga indawo ebushelelezi, engenamaqhubu.
Ukukhethwa kwezinto kuthinta ngokuqondile ukusebenza kwezinga. Izicindezeli zolimi zokhuni kufanele zithobelane nesitifiketi sehlathi se-FSC, futhi ukukhishwa kwe-formaldehyde akumele kudlule u-0.124 mg/m³. Imikhiqizo yepulasitiki iningi lenziwe nge-polypropylene noma i-polystyrene futhi kufanele iphumelele ukuhlolwa kwe-ISO 10993 cytotoxicity. Ngokuphathelene nobukhulu, osayizi abadala ngokuvamile bangu-15-18 cm ubude, kuyilapho osayizi bezingane behliswa ku-10-12 cm. Ukubekezelela ukuqina kufanele kube phakathi kuka-±0.1 mm.
Ngokuthekelisa, kubalulekile ukunaka kakhulu izimfuneko zesitifiketi zemakethe eqondiwe. Isitifiketi se-EU CE sidinga ukubuyekezwa nguMkhandlu Owazisiwe (NB). Emakethe yase-US, kunconywa ukuthi wenze ukubonisana no-510(k) ngaphambi{3}}ngaphambi kokuthumela. Isitifiketi se-GCC samukelwa ngokuvamile eMpumalanga Ephakathi. Amalebula okupakisha kufanele afake inombolo yenqwaba yokukhiqiza, idethi yokuphelelwa isikhathi yokuvala inzalo, kanye nolwazi olubalulekile. Ibhokisi elingaphandle kufanele libhalwe ilebula lesexwayiso sokuthumela.
Ukuqonda umehluko wezindinganiso zokusetshenziswa kwe-depressor yolimi kungasiza izinkampani ukuthi zihlangabezane ngokunembile nezidingo zemakethe yamazwe ngamazwe, ukunciphisa ubungozi bokuthobela ukuhweba, futhi kuthuthukise ukuncintisana komkhiqizo.