Kwishishini lezonyango elikhula ngokukhawuleza, imfuno yeizinto ezichanekileyo zesixhobo sonyangoikhula ngokukhawuleza. Ukusuka kwizixhobo zotyando ukuya kwizixhobo zokuxilonga, abavelisi bafuna ukuchaneka okuphezulu, ukucoceka, kunye neendawo ezihambelana ne-biocompatible ezihlangabezana nemigangatho engqongqo yolawulo. NgeHY Metals, sisebenza ngokukhethekileyo ekuboneleleniulwakhiwo lwentsimbi yodidi lwezonyango, CNC Machining, kwayeukuguqula iinkonzoukuxhasa uphuhliso lwezisombululo zokhathalelo lwempilo ezikumgangatho ophezulu.
Ukwenziwa kwezixhobo zonyango kufuna ukuchaneka okukhethekileyo, ukuthembeka, kunye nokuthotyelwa ngenxa yokusetyenziswa kwayo okubalulekileyo kukhathalelo lwesigulana. Apha ngezantsi ziimpawu ezibalulekileyo kunye neemfuno zamacandelo ebakala lezonyango:
1. Ukuchaneka okuPhezulu okuPhezulu (± 0.01mm okanye ngqongqo)
Izixhobo zotyando, ukufakelwa, kunye nezixhobo zokuxilonga zifuna ukuchaneka kwe-micron-level yokusebenza ngokufanelekileyo.
Umatshini we-CNC kunye nokusika kwe-laser kuqinisekisa ukunyamezelana okuqinileyo kwindibano engenamthungo.
2. Izinto zeBiocompatible & Sterilizable Materials
Izixhobo eziqhelekileyo:
Isinyithi esingenasici (316L, 17-4PH) -I-Corrosion-resistant kwizixhobo zotyando
I-Titanium (iBanga lesi-2, i-5, i-23) -I-Lightweight & biocompatible for implants
I-Aluminium (6061-T6, 7075) -Iinxalenye zesakhiwo sezixhobo zokucinga
Kufuneka imelane ne-autoclaving ephindaphindiweyo, i-gamma radiation, okanye ukuvalwa kwekhemikhali.
3. Imibuso egudileyo, engenazo iiPorous
I-Electropolishing & passivation ikhusela ukunamathela kwebhaktheriya.
Akukho burrs okanye imiphetho ebukhali ukuphepha ukonakala kwezicubu.
Ra ≤ 0.4µm umphezulu wokugqiba ukucoceka.
4. Ukuthotyelwa kweMigaqo engqongqo
I-ISO 13485-Ulawulo lomgangatho wezixhobo zonyango
I-FDA 21 CFR Icandelo le-820 - imigangatho yokwenziwa kwezixhobo zonyango zase-US
Ukumakishwa kwe-EU MDR/CE – iimfuno zolawulo lwaseYurophu
Ukulandelwa kwezinto ezigcweleyo (iMill Certs, RoHS, REACH).
5. Ukwenziwa kweGumbi elicocekileyo (Xa Kufunwa)
Imveliso engangcolisekanga kumagumbi acocekileyo eKlasi 7/8.
Ukupakishwa okukhethekileyo ukugcina inzala.
6. UVavanyo olungqongqo kunye noxwebhu
Ukuhlolwa komgangatho (CMM, izithelekisi zamehlo)
Uvavanyo lomatshini (ukumelana nokudinwa, amandla okuzibamba)
Uhlolo lweNqaku lokuQala (FAI) iingxelo zokuqinisekiswa.
Kutheni abavelisi beZixhobo zezoNyango bathembela kwi-HY Metals
1. Izinto zoNyango lweBanga kunye nokuchaneka
-Sisebenza ngensimbi engenasici, i-titanium, kunye ne-aluminium alloys ehlangabezana ne-ISO 13485 kunye neemfuno ze-FDA kwizicelo zonyango.
-Ukusebenza kwethu kwe-CNC (± 0.01mm ukunyamezela) kunye nokugoba kwentsimbi echanekileyo kuqinisekisa ukuba amacandelo afaneleka ngokugqibeleleyo kwiindibano ezinzima.
-Ukuphathwa okungqongqo kwegumbi elicocekileyo elihambelanayo kuthintela ukungcoliseka kwezixhobo zotyando kunye nokufakelwa.
2. Iprotoyipu ekhawulezayo kunye neMveliso yeBatch encinci
– Amaqela eR&D yezonyango ayafunekaiiprototypes ezikhawulezayoukukhawulezisa uphuhliso lwemveliso.
-Amandla ethu okuvelisa ama-batch amancinci avumela ukuvavanywa kweendleko ngaphambi kokuveliswa kobuninzi.
-Iinxalenye zonyango eziqhelekileyo esizivelisayo:
-Iintsimbi ezivaliweyo zentsimbi yezixhobo zokucinga
-Izikrufu zamathambo e-Titanium kunye nezixhobo zotyando
-Izibiyeli zokufakwa kweAluminiyam kwizixhobo zaselebhu
3. Ukuthotyelwa nokulandeleka
-Izatifikethi zemathiriyeli ezigcweleyo (i-RoHS, i-REACH, iingxelo ze-biocompatibility ezikhoyo)
- Iingxelo ezineenkcukacha zokuhlolwa kwenqaku lokuqala (FAI) kwimilinganiselo ebalulekileyo
– Unyango oluphezulu (passivation, electropolishing) ukuhlangabezana nemigangatho yococeko lwezonyango
Sibanceda Njani Abaqambi bezoNyango ukuba boyise imingeni
✅Isantya-ukuya-kwiMakethi
-Iintsuku ezisi-7-15 zokukhokela iiprototypes zesixhobo sonyango
– Uyilo oluKhawulezayo-lokwenziwa kokwenziwayo (DFM) ingxelo
✅UPhuculo lweendleko
-I-Smart indlwane yokusika i-laser sheet sheet kunciphisa inkunkuma yezinto
-Izixhobo zemodyuli zehlisa iindleko kwiibhetshi ezincinci
Izifundo: Amacandelo ezoNyango Senziwe
-Iikhithi zoVavanyo lwe-Orthopedic Implant (Titanium, CNC milled)
-I-Portable Ultrasound Machine Chassis (intsimbi engenanto, i-sheet metal eyenziwe yenziwe)
-Amacandelo eSixhobo se-Endoscopic (iinxalenye ezincinci zeCNC ezijikiweyo)
Iqabane kunye neNgcali yoMveliso yezoNyango
Ngaphezulu kweminyaka eyi-15 yamava okusebenzela iinkampani ze-medtech zaseYurophu nezaseMelika, i-HY Metals idibanisa ukuchaneka komgangatho wezonyango kunye nobuchule obufunekayo kwiprototyping kunye nokuveliswa kwevolumu ephantsi.
Qhagamshelana nathi namhlanje ukuxoxa ngeemfuno zeprojekthi yesixhobo sakho sonyango. Masiyinjineli izisombululo ezisindisa ubomi - kunye nomgangatho kunye nokuthobela iimfuno zeshishini lezempilo.
#MedicalMachining #CNCMedicalParts #SheetMetalMedical #PrecisionManufacturing #MedtechPrototyping
Ixesha lokuposa: Jun-02-2025