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I-Precision Medical Device Prototyping: Indlela I-HY Metals Isekela Ngayo Ukuqamba Okusha Kwezempilo Ngokukhiqizwa Kweqoqo Elincane Elisezingeni Eliphezulu

Embonini yezokwelapha ekhula ngokushesha, isidingo seukunemba izingxenye zedivayisi yezokwelaphaikhula ngamandla. Kusukela kumathuluzi okuhlinza kuya ezintweni zokuxilonga, abakhiqizi badinga izingxenye ezinemba okuphezulu, ezihlanzekayo, nezihambisana ne-bio ezihlangabezana nezindinganiso eziqinile zokulawula. NgoI-HY Metals, sisebenza ngokukhethekile ekuhlinzekeniukwakhiwa kweshidi lensimbi yezinga lezokwelapha, CNC imishini, futhiukuguqula izinsizaukusekela ukuthuthukiswa kwezixazululo zezempilo ezisezingeni eliphezulu.

Ukwenziwa kwemishini yezokwelapha kudinga ukunemba okukhethekile, ukwethembeka, nokuhambisana ngenxa yokusetshenziswa kwayo okubalulekile ekunakekelweni kwesiguli. Ngezansi izici ezibalulekile nezimfuneko zezingxenye zebanga lezokwelapha:

 MedicalParts

1. Ukunemba Okuphezulu Okuphezulu (±0.01mm noma okuqinile)

Amathuluzi okuhlinza, izimila, nezinto zokuxilonga zidinga ukunemba kwezinga le-micron ukuze kusebenze kahle.

 

I-CNC machining kanye nokusika kwe-laser kuqinisekisa ukubekezelelana okuqinile kokuhlangana okungenamthungo.

 

2. Izinto Ezivumelanayo Nezibulala Amagciwane

Izinto ezijwayelekile:

 

Insimbi Engagqwali (316L, 17-4PH) - Imelana nokuCorrosion kumathuluzi okuhlinzwa

 

I-Titanium (iBanga lesi-2, 5, 23) – I-Lightweight & biocompatible for implants

 

I-Aluminium (6061-T6, 7075) - Izingxenye zesakhiwo zamadivayisi wokucabanga

 

Kufanele imelane ne-autoclaving ephindaphindiwe, imisebe ye-gamma, noma ukuvalwa kwamakhemikhali.

 

3. Indawo Ebushelelezi, Engenazo Izimbobo

I-Electropolishing & passivation ivimbela ukunamathela kwebhaktheriya.

 

Awekho ama-burrs noma imiphetho ebukhali ukugwema ukulimala kwezicubu.

 

I-Ra ≤ 0.4µm yokuqedwa kwendawo ukuze ihlanzeke.

 

4. Ukuhambisana Nemithetho Eqinile

I-ISO 13485 - Ukuphathwa kwekhwalithi yamadivayisi wezokwelapha

 

I-FDA 21 CFR Ingxenye 820 – Amazinga okukhiqiza amathuluzi ezokwelapha ase-US

 

Ukumakwa kwe-EU MDR/CE - Izidingo zokulawula zase-Europe

 

Ukulandeleka okuphelele kwezinto ezibonakalayo (Izitifiketi Zokugawula, RoHS, REACH).

 

5. Ukwenziwa Kwegumbi Lokuhlanza (Lapho Kudingeka)

Ukukhiqizwa okungangcolisiwe kwamagumbi okuhlanza Ekilasi 7/8.

 

Ukupakishwa okukhethekile kokugcina ubunyumba.

 

6. Ukuhlola Okuqinile Nokubhalwa Kwemibhalo

Ukuhlolwa kobukhulu (i-CMM, iziqhathanisi ze-optical)

Ukuhlolwa kwemishini (ukumelana nokukhathala, amandla aqinile)

Ukuhlolwa Kwendatshana Yokuqala (i-FAI) ibika ukuze kuqinisekiswe.

 

 Kungani Abakhiqizi Bedivayisi Yezokwelapha Bathembela Izinsimbi ze-HY

 

1. Izinto ze-Medical-Grade & Precision

- Sisebenza ngensimbi engagqwali, i-titanium, ne-aluminium alloys ehlangabezana ne-ISO 13485 kanye nezidingo ze-FDA zezicelo zezokwelapha.

- Imishini yethu ye-CNC (± 0.01mm ukubekezelelana) kanye nokugoba okunembayo kweshidi lensimbi kuqinisekisa ukuthi izingxenye zilingana ngokuphelele emibuthanweni eyinkimbinkimbi.

- Ukuphatha okuhambisana negumbi elihlanzekile kuvimbela ukungcoliswa kwemishini yokuhlinza kanye neyokufakelwa.

 

2. Ukuthayipha Okusheshayo Nokukhiqizwa Kweqoqo Elincane

- Amaqembu e-R&D yezokwelapha adingaama-prototypes aphenduka ngokusheshaukusheshisa ukuthuthukiswa komkhiqizo.

- Amakhono ethu okukhiqiza ama-batch amancane avumela ukuhlolwa okungabizi kakhulu ngaphambi kokukhiqiza ngobuningi.

- Izingxenye zezokwelapha ezijwayelekile esizikhiqizayo:

- Insimbi engagqwali ezivalekile yemishini yokucabanga

- Izikulufo zethambo le-Titanium & namathuluzi okuhlinzwa

- Abakaki be-Aluminium bemishini yelebhu

 

3. Ukuthobela & Ukulandeleka

- Izitifiketi ezigcwele zezinto ezibonakalayo (i-RoHS, i-REACH, imibiko ye-biocompatibility iyatholakala)

- Imibiko enemininingwane yokuhlolwa kwe-athikili yokuqala (FAI) yobukhulu obubalulekile

- Ukwelashwa kwendawo (i-passivation, electropolishing) ukuhlangabezana nezindinganiso zokuhlanzeka kwezokwelapha

 

Indlela Esibasiza Ngayo Abasunguli Bezokwelapha Banqobe Izinselele

 

Isivinini sokuya emakethe 

- Izikhathi zokuhola zezinsuku eziyi-7-15 zama-prototypes wedivayisi yezokwelapha

- Impendulo esheshayo ye-Design-for-manufacturability (DFM).

 

Ukuthuthukisa Izindleko 

-Isidleke esihlakaniphile sokusika i-laser yensimbi kunciphisa imfucuza yezinto ezibonakalayo

- Ukusebenzisa i-modular kwehlisa izindleko zamaqoqo amancane

 

Izibonelo: Izingxenye Zezokwelapha Sezikhiqiziwe

 

- I-Orthopedic Implant Trial Kits (Titanium, CNC milled)

- Portable Ultrasound Machine Chassis (Insimbi engagqwali, ishidi lensimbi eyenziwe)

- I-Endoscopic Tool Components (Izingxenye eziguquliwe ze-Micro CNC)

 

Hlanganyela Nochwepheshe Wezokukhiqiza Ezokwelapha

 

Njengoba inesipiliyoni seminyaka engaphezu kwe-15 sisebenzela izinkampani ze-medtech zaseYurophu nezaseMelika, i-HY Metals ihlanganisa ukunemba kwebanga lezokwelapha kanye nekhono elidingekayo ekwenzeni i-prototyping kanye nokukhiqizwa kwevolumu ephansi.

 

Xhumana nathi namuhla ukuze uxoxe ngezidingo zephrojekthi yedivayisi yakho yezokwelapha. Masisungule izixazululo ezisindisa izimpilo - ngekhwalithi nokuhambisana nezimfuno zemboni yezokunakekelwa kwempilo.

 

#MedicalMachining #CNCMedicalParts #SheetMetalMedical #PrecisionManufacturing #MedtechPrototyping


Isikhathi sokuthumela: Jun-02-2025