1. Isakhelo soHlelo lokuHlela ukuNyamezelwa koBukhulu obuneBhendi ezi-4

Isakhelo sokwahlulwahlulwa kobukhulu bebhendi ezi-4 somcu wentsimbi engagqwaliyo echanekileyo sigubungela ukunyamezelana okuchanekileyo kweKlasi yoku-1 (±0.02 mm), ukunyamezelana okuqhelekileyo kweKlasi yesi-2 (±0.03 mm), ukunyamezelana okuqhelekileyo kweKlasi yesi-3 (±0.05 mm), kunye nokunyamezelana kweMill yeKlasi yesi-4 (±0.10 mm). Isakhelo sebhendi ezi-4 yinkcazo eqhelekileyo yokuthengwa komenzi wezixhobo zonyango, umenzi wesitampu esichanekileyo, kunye neworkshop ye-micro-machining efuna ubukhulu obuhambelanayo kwinkqubo yemveliso esezantsi. Iqela lobunjineli beWowStainless libonelela ngamaxwebhu esakhelo sebhendi ezi-4 kunye nokuqinisekiswa kwamandla okugaya i-rolling mill nganye. Ukuze ufumane isalathiso kwiimveliso ezivezwe yiWowStainless kunye nenkcazo yokunyamezelana kwemveliso nganye, jonga kuiveliso ezifakiweiphepha.

Ukunyamezelana okuchanekileyo kweKlasi yoku-1 (±0.02 mm) yibhendi yokuqala yokunyamezelana ekufuneka ihlolwe liqela elithengayo kwimveliso yesixhobo sezonyango. Ukunyamezelana kweKlasi yoku-1 kuxhasa izinga lokwaliwa kwemveliso eliyi-0.5% ukuya kwi-1% kwisixhobo sotyando kunye nesicelo sesixhobo esifakelwayo. Ukunyamezelana kweKlasi yoku-1 kufuna isixhobo esikhethekileyo sokuqengqeleka esibandayo esine-X-ray okanye inkqubo yokulinganisa ubukhulu be-laser online. Iqela elithengayo kufuneka licele ukuqinisekiswa kwamandla okunyamezelana kweKlasi yoku-1 kumthengisi kunye nengxelo yokulinganisa ubukhulu ebhaliweyo.

Izizathu ezi-3 zokukhetha ibhendi yokunyamezelana ngokuchaneka kweKlasi yoku-1 yinkcazo yesibini yokuqinisekisa ekufuneka ihlolwe liqela lokuthenga. Ezi zizathu zi-3 ziquka ukuthotyelwa kwezixhobo zonyango (i-FDA 21 CFR 820 kunye nenkqubo yomgangatho we-ISO 13485), ukuphucuka kwemveliso (ukuncitshiswa kwesantya sokulahlwa kwe-3% ukuya kwi-5% xa kuthelekiswa nokunyamezelwa kwezorhwebo kweKlasi yesi-3), kunye nokungaguquguquki kwenkqubo esezantsi (ukunyathela, ukutsalwa okunzulu, kunye nokusebenza koomatshini abancinci). Iqela lokuthenga kufuneka lichaze ukunyamezelwa kweKlasi yoku-1 ngokwemiqathango yezixhobo zonyango kunye nenjongo yemveliso yemveliso.

Izizathu ezi-3 zokukhetha ibhendi yokunyamezelana kwe-Class 4 mill yinkcazo yesithathu yokuqinisekisa iqela lokuthenga elifanele liyivavanye. Izizathu ezi-3 ziquka ukuncitshiswa kweendleko (ixabiso eliphantsi nge-15% ukuya kwi-25% nge-kg xa kuthelekiswa nokunyamezelana kwe-Class 1), ukuncitshiswa kwexesha elikhokelayo (iintsuku ezi-5 ukuya kwezi-10 zimfutshane ngokweshedyuli eqhelekileyo ye-rolling mill), kunye nokufumaneka kwenqanaba (zonke iibakala ezisemgangathweni kubandakanya i-304, i-316L, i-430, kunye ne-17-7PH kwibhendi yokunyamezelana kwe-mill). Iqela lokuthenga kufuneka lichaze ukunyamezeleka kwe-Class 4 ngokwesicelo ngokubanzi soshishino kunye nesicelo esinomngcipheko weendleko.

2. Uthelekiso lwe-Precision Strip vs Cold Rolled General Strip

Umcu wentsimbi engagqwaliyo echanekileyo yindlela enokunyamezeleka kakhulu yomcu wentsimbi engagqwaliyo ebandayo enesixhobo sokuqengqeleka esikhethekileyo kunye nomlinganiselo wobukhulu obungaphakathi. Umcu wentsimbi echanekileyo uhlala uwela kwiibhendi zokunyamezela zeKlasi 1 (±0.02 mm) ukuya kwiKlasi 3 (±0.05 mm). Umcu wentsimbi eqhelekileyo oqengqeleyo ebandayo uhlala uwela kwiibhendi zokunyamezela zeKlasi 3 (±0.05 mm) ukuya kwiKlasi 4 (±0.10 mm). Iqela lokuthenga kufuneka lahlule umcu wentsimbi echanekileyo kumcu wesixhobo esiqhelekileyo sesicelo sesixhobo sonyango.

I-ASTM A480 kunye nereferensi esemgangathweni ye-EN 10088 zezona nkcukacha zokuqinisekisa zesibini ekufuneka zicelwe liqela lokuthenga. Umgangatho we-ASTM A480 uchaza ukunyamezelana okuqhelekileyo kwepleyiti yentsimbi engagqwaliyo egobileyo, ishiti, kunye nomcu. Umgangatho we-EN 10088 uchaza umgangatho wentsimbi engagqwaliyo yaseYurophu kunye nokunyamezelana okulinganayo. Iqela lokuthenga kufuneka licele amaxwebhu okuthobela imigangatho kumthengisi kunye nokuqinisekiswa kwebhendi yokunyamezelana.

3. Impembelelo yezinga lokwaliwa yiCandelo leZixhobo zonyango

Impembelelo yezinga lokwaliwa yicandelo lezixhobo zonyango yinkcazo yesithathu yokuqinisekisa ekufuneka ihlolwe liqela elithengayo. Ukunyamezelana ngokuchanekileyo kweKlasi 1 (± 0.02 mm) kudla ngokuxhasa izinga lokwaliwa kwemveliso eliyi-0.5% ukuya kwi-1% kwisixhobo sotyando kunye nokusetyenziswa kwesixhobo esifakelwayo. Isixhobo sotyando sifuna ukunyamezelana ngokuchanekileyo komphetho wokusika, umphezulu wokubambelela, kunye nelungu elidibeneyo. Isixhobo esifakelwayo sifuna ukunyamezelana ngokuchanekileyo kokugqitywa komphezulu, ukusebenzisana kwezicubu, kunye nokuchaneka kokufakwa emzimbeni.

Ukunyamezelana okuqhelekileyo kweKlasi yesi-2 (±0.03 mm) sisichazi sesine sokuqinisekisa izixhobo zokuxilonga kunye nesixhobo sokubeka iliso. Izixhobo zokuxilonga zihlala zixhasa izinga lokungavumi ukusuka kwi-1% ukuya kwi-2% ngokukhetha ibhendi yokubeke iliso. Isixhobo sokubeka iliso sihlala sixhasa izinga lokungavumi ukusuka kwi-1% ukuya kwi-2% ngokunyamezelana kwendibano ebiyelweyo. Ukunyamezelana kwezorhwebo kweKlasi yesi-3 (±0.05 mm) ngokuqhelekileyo kuxhasa izinga lokungavumi ukusuka kwi-2% ukuya kwi-5% kwisixhobo sezonyango sabathengi kunye nezixhobo zelebhu.

Uhlu lwezixhobo zonyango yi-FDA kunye nesakhelo se-EU MDR luluhlu lwesihlanu lokuqinisekisa olufanele luvavanywe liqela lokuthenga. I-FDA ihlela isixhobo sezonyango kwiKlasi I (umngcipheko ophantsi, umz., ibhandishi elastiki, iglavu yovavanyo), iKlasi II (umngcipheko ophakathi, umz., isixhobo sotyando, ipompo yokufaka), kunye neKlasi III (umngcipheko ophezulu, umz., i-pacemaker efakelwayo, ivalvu yentliziyo). I-EU MDR ihlela isixhobo sezonyango kwiKlasi I (umngcipheko ophantsi), iKlasi IIa (umngcipheko ophantsi ukuya kophakathi), iKlasi IIb (umngcipheko ophakathi ukuya kophezulu), kunye neKlasi III (umngcipheko ophezulu). Udidi lwe-precision strip kunye nokukhethwa kwebhendi yokunyamezela kufuneka kuhambelane nohlu lwezixhobo zonyango ngokwesakhelo se-FDA kunye ne-EU MDR.

4. Ukukhethwa koMgangatho weSixhobo sezonyango seNtsimbi engaGciniyo

Ukukhethwa komgangatho wentsimbi engagqwaliyo kwisicelo sesixhobo sezonyango esichanekileyo yinkcazo yesihlanu yokuqinisekisa ekufuneka ihlolwe liqela elithengayo. Intsimbi engagqwaliyo engama-304 yinqanaba eliqhelekileyo lesixhobo sezonyango ngokubanzi kunye nezixhobo zokuxilonga ezine-18% ye-chromium kunye ne-8% ye-nickel. Intsimbi engagqwali engama-316L yi-alloy yomgangatho wezonyango yesixhobo sotyando kunye nesixhobo esinokufakelwa esinomxholo ophantsi wekhabhoni (≤0.03%) wokudityaniswa kunye nokumelana nokugqwala. Intsimbi engagqwali engama-430 yinqanaba le-ferritic yesixhobo sezonyango sabathengi kunye nezixhobo zelebhu ezinomxholo we-chromium oyi-16 ukuya kwi-18%.

Intsimbi engagqwaliyo ye-17-7PH yinqanaba lokuqina kwemvula kwintwasahlobo kunye nesicelo sesixhobo sezonyango esinamandla aphezulu kunye nomxube we-17% we-chromium, i-7% nickel, kunye ne-1% ye-aluminium. Inqanaba le-17-7PH lixhasa amandla aphezulu okuvelisa (ukuya kuthi ga kwi-1500 MPa) kunye nonyango lobushushu lokuqina kobudala. Iqela lokuthenga kufuneka licele iinkcukacha zebanga ngalinye kumthengisi kunye nokuthobela okubhaliweyo kwebanga le-ASTM / EN.

Ukukhethwa kwamanqaku yisicelo sesixhobo sezonyango yinkcazo yesithandathu yokuqinisekisa ekufuneka ihlolwe liqela lokuthenga. Inqanaba le-304 lixhasa isixhobo sezonyango ngokubanzi, izixhobo zokuxilonga, kunye nelebhu esetyenziswayo kwinqanaba eliqhelekileyo leendleko nge-kg. Inqanaba le-316L lixhasa isixhobo sotyando, isixhobo esifakelwayo, kunye nesixhobo sezonyango esihambelanayo ne-biocompatible kwizinga leendleko ze-30% ukuya kuma-50% eliphezulu nge-kg xa kuthelekiswa nezinga le-304. Inqanaba le-430 lixhasa isixhobo sezonyango sabathengi kunye nesixhobo sezonyango esinobunkunkqele kwizinga leendleko ze-magnetic kwizinga leendleko ze-15% ukuya kuma-25% ngaphantsi nge-kg xa kuthelekiswa nezinga le-304. Iqela lokuthenga kufuneka licele amaxwebhu enqanaba lexabiso ngebanga ngalinye kumthengisi.

5. Inkqubo yokulinganisa ubungqingqwa kwi-intanethi

Inkqubo yokulinganisa ubukhulu kwi-intanethi yeyona nkcukacha yesithandathu yokuqinisekisa iqela elithengayo ekufuneka liyicele. I-X-ray transmission gauge ixhasa uluhlu lobukhulu obuyi-0.10 ukuya kwi-6.0 mm ngokuchaneka kwe-±0.001 mm. I-laser triangulation gauge ixhasa uluhlu lobukhulu obuyi-0.05 ukuya kwi-1.0 mm ngokuchaneka kwe-±0.005 mm. I-beta-ray transmission gauge ixhasa uluhlu lobukhulu obuyi-0.005 ukuya kwi-0.10 mm ngokuchaneka kwe-±0.001 mm. Inkqubo yempendulo yamandla okuqengqeleka ixhasa ulawulo lobukhulu be-closed loop ngokuchaneka kwe-±0.005 mm.

Ubungakanani bexesha lokulinganisa inkqubo yokulinganisa yinkcazo yesixhenxe yokuqinisekisa ekufuneka iqela lokuthenga liyivavanye. Ubungakanani be-X-ray gauge buhlala buphakathi kweenyanga ezi-6 nezi-12. Ubungakanani be-laser gauge buhlala buphakathi kweenyanga ezi-3 nezi-6. Ubungakanani be-beta-ray gauge buhlala buphakathi kweenyanga ezi-6 nezi-12. Iqela lokuthenga kufuneka licele uxwebhu lokulinganisa nge-per-gauge kumthengisi oluneenkcukacha zokulandelela umlinganiselo.

Inkqubo yokulawula ubungqingqwa beluphu evaliweyo yinkcazo yesibhozo yokuqinisekisa iqela lokuthenga elifanele liyivavanye. Inkqubo yeluphu evaliweyo idla ngokusebenzisa impendulo yamandla okuqengqeleka, impendulo yesantya sokuqengqeleka, kunye nempendulo yoxinzelelo ukugcina ubukhulu ekujoliswe kubo. Inkqubo yeluphu evaliweyo ixhasa umahluko wobukhulu be-±0.005 mm kubude bekhoyili yeemitha ezili-1000. Iqela lokuthenga kufuneka licele amaxwebhu enkqubo yeluphu evaliweyo kumthengisi kunye nexesha lokuphendula leluphu yokulawula elibhaliweyo.

6. Iinkcukacha zoMphezulu woGqibo lweSixhobo sezonyango

Inkcazelo yokugqiba umphezulu wesicelo sesixhobo sezonyango esichanekileyo yinkcazo yesibhozo yokuqinisekisa ekufuneka ihlolwe liqela elithengayo. Umphezulu we-2B (ogqunyiweyo obandayo + ulusu oludlulayo + i-acid pickling) uxhasa isixhobo sezonyango esiqhelekileyo esinomphezulu ogudileyo nokhanyayo. Umphezulu we-BA (okhanyayo oqhotsiweyo) uxhasa isixhobo sotyando kunye nomphezulu wokuxilonga ngesipili kunye nomphezulu okhanyayo ophezulu. Umphezulu we-No.4 (ukugqitywa okubhrashiweyo) uxhasa indawo yokuhlala yesixhobo sezonyango enepateni yebrashi ethe tye. Umphezulu we-No.8 (ukugqitywa kwesipili) uxhasa isixhobo sezonyango esikumgangatho ophezulu esinomphezulu okhanyayo. Ukuze ufumane isalathiso kwinkcazo yokugqiba umphezulu we-WowStainless kunye nesikhokelo sokukhetha ngokugqiba, jonga kuIphepha lasekhaya leWowStainless.

Umlinganiselo woburhabaxa bomphezulu sisichazi sokuqinisekisa sesithoba iqela elithengayo ekufuneka lisicele. Umlinganiselo oqhelekileyo woburhabaxa bomphezulu usebenzisa ipharamitha yeRa (uburhabaxa obuphakathi bezibalo). Umphezulu we-2B uhlala uxhasa iRa 0.1 ukuya kwi-0.3 μm. Umphezulu we-BA uhlala uxhasa iRa 0.05 ukuya kwi-0.10 μm. Umphezulu weNombolo 4 uhlala uxhasa iRa 0.3 ukuya kwi-0.5 μm. Umphezulu weNombolo 8 uhlala uxhasa iRa 0.02 ukuya kwi-0.05 μm. Iqela elithengayo kufuneka licele uxwebhu lokugqiba uburhabaxa bomphezulu ngamnye kumthengisi.

7. Uluhlu loButyebi ngokweSicelo seSixhobo sezonyango

Uluhlu lobukhulu ngokwesicelo sesixhobo sezonyango luluhlu lweshumi lokuqinisekisa olufanele luvavanywe liqela elithengayo. Umcu obhityileyo kakhulu (0.05 ukuya ku-0.20 mm) usetyenziselwa isixhobo sotyando oluncinci kunye nenxalenye efakelwayo enokunyamezelana okuchanekileyo kweKlasi yoku-1. Umcu obhityileyo (0.20 ukuya ku-0.50 mm) usetyenziselwa umcu wokuxilonga, ilabhoratri esetyenziswayo, kunye nokudibana kwentwasahlobo nokunyamezelana kweKlasi yoku-1 okanye yeKlasi yesi-2. Umcu ophakathi (0.50 ukuya ku-1.0 mm) usetyenziselwa isixhobo sotyando kunye negumbi lesixhobo sezonyango elinokunyamezelana kweKlasi yesi-2 okanye yeKlasi yesi-3. Umcu oqhelekileyo (1.0 ukuya ku-1.5 mm) usetyenziselwa ifreyimu yesixhobo sezonyango kunye nokufakelwa kwamathambo okunokunyamezelana kweKlasi yesi-3 okanye yeKlasi yesi-4.

Ukukhethwa kobukhulu besicelo sesixhobo sezonyango yinkcazo yeshumi elinanye yokuqinisekisa ekufuneka ihlolwe liqela elithengayo. Isixhobo sotyando oluncinci sidla ngokufuna ubukhulu obuyi-0.10 ukuya kwi-0.30 mm kunye nokunyamezelana kweKlasi 1. Umcu wokuxilonga udla ngokufuna ubukhulu obuyi-0.20 ukuya kwi-0.50 mm kunye nokunyamezelana kweKlasi 1 okanye kweKlasi 2. Isixhobo sotyando sidla ngokufuna ubukhulu obuyi-0.50 ukuya kwi-1.0 mm kunye nokunyamezelana kweKlasi 2. Isakhelo sesixhobo sezonyango sidla ngokufuna ubukhulu obuyi-1.0 ukuya kwi-1.5 mm kunye nokunyamezelana kweKlasi 3. I-orthopedic implant idla ngokufuna ubukhulu obuyi-1.0 ukuya kwi-2.0 mm kunye nokunyamezelana kweKlasi 3 okanye kweKlasi 4.

8. Ububanzi kunye neNkcazelo yeMeko yoMda

Inkcazelo yobubanzi kunye nemeko yomphetho yinkcazo yeshumi elinesibini yokuqinisekisa iqela lokuthenga elifanele liyivavanye. Uluhlu lobubanzi oluqhelekileyo lomphetho ochanekileyo luphakathi kwe-5 mm kunye ne-600 mm. Umphetho omfutshane wobubanzi (5 ukuya kwi-50 mm) usetyenziselwa isixhobo sezonyango ezincinci kunye nelebhu esetyenziswayo. Umphetho ophakathi wobubanzi (50 ukuya kwi-200 mm) usetyenziselwa umphetho wokuxilonga kunye nesixhobo sotyando. Umphetho obanzi (200 ukuya kwi-600 mm) usetyenziselwa indawo yokuhlala yezixhobo zonyango kunye nesakhelo sokufakelwa kwamathambo. Imeko yomphetho oqhelekileyo ibandakanya umda wokugaya (umphetho wendalo), umda womphetho (umphetho ochanekileyo), kunye nomphetho osusiweyo (umphetho ojikeleziweyo). Iqela lokuthenga kufuneka licele uxwebhu lobubanzi kunye nemeko yomphetho kumthengisi.

9. Uluhlu lokuhlola uThengo lwe-BOFU Precision Strip Tolerance oluneNyathelo ezi-5

Kwabavelisi bezixhobo zonyango, abenzi bokunyathela ngokuchanekileyo, kunye neeworkshops zokwenza i-micro-machining ezilungele ukucacisa umgca wentsimbi engagqwaliyo ngokuchanekileyo kunye nohlelo lokunyamezelana olune-band ezi-4, olu luhlu lulandelayo lwezinyathelo ezi-5 ludibanisa iinkcukacha zokuqinisekisa ezivela kumacandelo angaphambili zibe luxwebhu olunye lweenkcukacha zokuthengwa.

1. Cacisa ibhendi yokunyamezelana (Udidi 1 ±0.02mm / Udidi 2 ±0.03mm / Udidi 3 ±0.05mm / Udidi 4 ±0.10mm) ngokwethagethi yesantya sokwaliwa kwesixhobo sonyango.
2. Khetha uhlobo lwentsimbi engagqwaliyo (304 / 316L / 430 / 17-7PH) ngokwesicelo sesixhobo sezonyango kunye nemfuneko yokuhambelana kwezinto eziphilayo.
3. Chaza uluhlu lobukhulu (obuncinci kakhulu ukusuka kwi-0.05 ukuya kwi-0.20 mm / obuncinci ukusuka kwi-0.20 ukuya kwi-0.50 mm / obuphakathi ukusuka kwi-0.50 ukuya kwi-1.0 mm / obuqhelekileyo ukusuka kwi-1.0 ukuya kwi-1.5 mm) ngokwejometri yesixhobo sonyango.
4. Cela ukugqitywa komphezulu (2B / BA / No.4 / No.8) kunye namaxwebhu oburhabaxa (Ra) kumnikezeli.
5. Bhala phantsi ububanzi, imeko yomphetho, i-MOQ, kunye nexesha lokuqalisa kunye neshedyuli yemveliso ngokweemfuno.

Kubavelisi bezixhobo zonyango kunye namaqela okuthenga izixhobo zonyango ezichanekileyo afumana umgca wentsimbi engagqwaliyo echanekileyo, ezi zixhobo zilandelayo zoshishino zibonelela ngedatha ehambelanayo kwimigangatho yokunyamezelana kwentsimbi engagqwaliyo kunye nesakhelo sokuthobela imithetho yezixhobo zonyango.I-ASTM yamazwe ngamazweipapasha umgangatho we-ASTM A480 wepleyiti yentsimbi engatyiwayo, ishiti, kunye nokunyamezelana kobukhulu bemicu.Umbutho Wezizwe Ngezizwe Wokumisela Imigangatho (ISO)ipapasha umgangatho we-ISO 9445 wokunyamezelana kwe-stainless steel flat rolled dimensional tolerance kunye nothotho lwe-ISO 5832 lweenkcukacha zezinto zokufakelwa kotyando.IKomiti yaseYurophu yoKumisa iMigangatho (i-CEN)ipapasha umgangatho we-EN 10088 womgangatho wentsimbi engagqwaliyo yaseYurophu kunye nomgangatho we-EN 10029 wokunyamezelana okugoqekileyo okuthe tyaba.Ulawulo Lokutya Neziyobisi lwase-US (FDA)ipapasha isikhokelo sokuhambelana kwezinto zesixhobo sezonyango kunye nommiselo wenkqubo yomgangatho we-FDA 21 CFR 820.Iforam yaMazwe ngaMazwe yoLawulo lweZixhobo zezoNyango (i-IMDRF)ipapasha udidi lwezinto zezixhobo zonyango kunye nesakhelo sokuvumelanisa ulawulo.

Kwabavelisi bezixhobo zonyango, abenzi bokunyathela ngokuchanekileyo, kunye neeworkshops zokwenza i-micro-machining ezilungele ukucacisa umgca wentsimbi engagqwaliyo ngokuchanekileyo kunye nohlelo lokunyamezelana kwe-4-band, iqela lobunjineli leWowStainless linokubonelela ngoqinisekiso lwamandla ebhendi yokunyamezelana ngakunye, iinkcukacha zebanga ngalinye, ingxelo yokulinganisa ububanzi bobukhulu ngakunye, kunye namaxwebhu okugqiba ngomphezulu ngakunye. Iqela lobunjineli leWowStainless lixhase abavelisi bezixhobo zonyango ngokusasazwa okubhaliweyo kulo lonke i-EU, eMntla Melika, eJapan, nakwiimarike zase-Southeast Asia. Hlaziya iWowStainlessikhathalogu yeemveliso iphepha lesi-3ukuze ufumane umgca wemveliso ye-precision strip kunye neenkcukacha zokunyamezelana, okanye undwendwele iIphepha lasekhaya leWowStainlessukuze ufumane ipotifoliyo epheleleyo yemveliso.

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