1. Uhlaka Lokuhlukaniswa Kokubekezelelana Kokujiya Kwamabhendi Ama-4

Uhlaka lokuhlukaniswa kokubekezelelana kobukhulu obungamabhendi amane lomugqa wensimbi engagqwali oqondile luhlanganisa ukubekezelelana kokunemba kwe-Class 1 (± 0.02 mm), ukubekezelelana okujwayelekile kwe-Class 2 (± 0.03 mm), ukubekezelelana kwezentengiselwano kwe-Class 3 (± 0.05 mm), kanye nokubekezelelana komshini wokugaya we-Class 4 (± 0.10 mm). Uhlaka lwamabhendi amane luyincazelo ejwayelekile yokuthengwa komkhiqizi wedivayisi yezokwelapha, umenzi we-precision stamping, kanye ne-micro-machining workshop edinga ukujiya okufanayo kwenqubo yokukhiqiza engezansi. Ithimba lobunjiniyela le-WowStainless linikeza imibhalo yohlaka lwamabhendi amane ngokuqinisekiswa kwamandla omshini wokugaya we-class-class. Ukuze uthole inkomba ngemikhiqizo efakiwe ye-WowStainless kanye nencazelo yokubekezelelana komkhiqizo ngamunye, bheka ku-imikhiqizo eveleleikhasi.

Ukubekezelelana kokunemba kweKlasi 1 (± 0.02 mm) yibhande lokuqala lokubekezelelana okufanele ithimba lokuthenga lihlole ukukhiqizwa kwedivayisi yezokwelapha. Ukubekezelelana kweKlasi 1 kusekela izinga lokwenqatshwa kokukhiqiza okungu-0.5% kuya ku-1% kwethuluzi lokuhlinza kanye nokusetshenziswa kwedivayisi efakelwayo. Ukubekezelelana kweKlasi 1 kudinga umshini wokugoqa obandayo oqondile okhethekile onesistimu yokulinganisa ubukhulu be-X-ray noma i-laser online. Ithimba lokuthenga kufanele licele ukuqinisekiswa kwamandla okubekezelelana kweKlasi 1 kumhlinzeki ngombiko wokulinganisa ubukhulu obhaliwe.

Izizathu ezintathu zokukhetha ibhendi yokubekezelelana ngokunemba kweKlasi 1 yisici sesibili sokuqinisekisa okufanele ithimba lokuthenga lisihlole. Izizathu ezintathu zifaka phakathi ukuthobela imithetho yedivayisi yezokwelapha (i-FDA 21 CFR 820 kanye nohlelo lwekhwalithi lwe-ISO 13485), ukuthuthukiswa kwesivuno sokukhiqiza (ukwehliswa kwezinga lokwenqatshwa okungu-3% kuya ku-5% uma kuqhathaniswa nokubekezelelana kwezentengiselwano kweKlasi 3), kanye nokuvumelana kwenqubo engezansi (ukunyathela, ukudweba okujulile, kanye nokusebenza kwemishini emincane). Ithimba lokuthenga kufanele licacise ukubekezelelana kweKlasi 1 ngokuhambisana nemithetho yedivayisi yezokwelapha kanye nomgomo wesivuno sokukhiqiza.

Izizathu ezintathu zokukhetha ibhendi yokubekezelelana kwemishini yekilasi lesi-4 yisici sesithathu sokuqinisekisa okufanele ithimba lokuthenga lisihlole. Izizathu ezintathu zifaka phakathi ukwehliswa kwezindleko (izindleko eziphansi ngo-15% kuya ku-25% ngekhilogremu uma kuqhathaniswa nokubekezelelana kweklasi lesi-1), ukwehliswa kwesikhathi sokuhola (izinsuku ezi-5 kuya kweziyi-10 zifushane ngokwesheduli ejwayelekile yokugaya imishini), kanye nokutholakala kwebanga (wonke amamaki ajwayelekile kufaka phakathi i-304, i-316L, i-430, kanye ne-17-7PH ebhendini yokubekezelelana kwemishini yekilasi). Ithimba lokuthenga kufanele licacise ukubekezelelana kweklasi lesi-4 ngokwesicelo esijwayelekile sezimboni kanye nesicelo esibucayi.

2. Ukuqhathanisa I-Precision Strip vs Cold Rolled General Strip

I-strip yensimbi engagqwali enembile iyinhlobo ebekezelela kakhulu i-strip yensimbi engagqwali ebandayo ene-rolling mill ekhethekile kanye nokulinganisa ubukhulu obuphakathi. I-strip enembile ivame ukuwela kuma-tolerance bands e-Class 1 (±0.02 mm) kuya ku-Class 3 (±0.05 mm). I-cold rolled general strip ivame ukuwela kuma-tolerance bands e-Class 3 (±0.05 mm) kuya ku-Class 4 (±0.10 mm). Ithimba lokuthenga kufanele lihlukanise i-precision strip ne-general strip yesicelo sedivayisi yezokwelapha.

I-ASTM A480 kanye nereferensi ejwayelekile ye-EN 10088 yizincazelo zesibili zokuqinisekisa okufanele zicelwe yithimba lokuthenga. Izinga le-ASTM A480 lichaza ukubekezelelana okujwayelekile kwepuleti lensimbi engagqwali eligoqiwe eliyisicaba, ishidi, kanye nomcu. Izinga le-EN 10088 lichaza izinga lensimbi engagqwali yaseYurophu kanye nokubekezelelana kobukhulu. Ithimba lokuthenga kufanele licele imibhalo yokuthobela imigomo evela kumhlinzeki kanye nokuqinisekiswa kwebhendi yokubekezelelana.

3. Umthelela Wezinga Lokwenqatshwa Ngesigaba Sedivayisi Yezokwelapha

Umthelela wezinga lokwenqatshwa yisigaba sedivayisi yezokwelapha yisici sesithathu sokuqinisekisa okufanele ithimba lokuthenga lisihlole. Ukubekezelelana kokunemba kweKlasi 1 (± 0.02 mm) kuvame ukusekela izinga lokwenqatshwa kokukhiqiza okungu-0.5% kuya ku-1% kwethuluzi lokuhlinza kanye nokusetshenziswa kwedivayisi efakelwayo. Ithuluzi lokuhlinza lidinga ukubekezelelana okunembile komphetho osikiwe, indawo yokubamba, kanye nelungu elixhumanisayo. Idivayisi efakelwayo idinga ukubekezelelana okunembile kokuphela kwendawo, ukusebenzisana kwezicubu, kanye nokunemba kokufakwa emzimbeni.

Ukubekezelelana okujwayelekile kweKlasi 2 (±0.03 mm) kuyisici sesine sokuqinisekisa semishini yokuxilonga kanye nedivayisi yokuqapha. Imishini yokuxilonga ivame ukusekela izinga lokwenqatshwa elingu-1% kuya ku-2% ngokukhetha kwebhendi yokubekezelelana. Idivayisi yokuqapha ivame ukusekela izinga lokwenqatshwa elingu-1% kuya ku-2% ngokuvumelana kokuhlanganiswa kwe-enclosure. Ukubekezelelana kwezentengiselwano kweKlasi 3 (±0.05 mm) kuvame ukusekela izinga lokwenqatshwa elingu-2% kuya ku-5% ledivayisi yezokwelapha yabathengi kanye nemishini yelabhorethri.

Ukuhlukaniswa kwedivayisi yezokwelapha yi-FDA kanye nohlaka lwe-EU MDR kuyisici sesihlanu sokuqinisekisa okufanele ithimba lokuthenga lihlole. I-FDA ihlukanisa idivayisi yezokwelapha ibe yi-Class I (ingozi ephansi, isib., ibhandishi elinwebekayo, igilavu ​​​​lokuhlola), i-Class II (ingozi elinganiselwe, isib., ithuluzi lokuhlinza, iphampu yokufaka), kanye ne-Class III (ingozi ephezulu, isib., i-pacemaker engafakwa, i-valve yenhliziyo). I-EU MDR ihlukanisa idivayisi yezokwelapha ibe yi-Class I (ingozi ephansi), i-Class IIa (ingozi ephansi kuya kwephakathi), i-Class IIb (ingozi ephansi kuya kwephezulu), kanye ne-Class III (ingozi ephezulu). Ibanga lomugqa oqondile kanye nokukhethwa kwebhendi yokubekezelelana kufanele kuhambisane nokuhlukaniswa kwedivayisi yezokwelapha ngokwe-FDA kanye nohlaka lwe-EU MDR.

4. Ukukhethwa Kwebanga Lensimbi Engagqwali Yedivayisi Yezokwelapha

Ukukhethwa kwebanga lensimbi engagqwali kwesicelo sedivayisi yezokwelapha ye-precision strip kuyisici sesihlanu sokuqinisekisa okufanele ithimba lokuthenga lisihlole. Insimbi engagqwali engu-304 iyibanga elijwayelekile lethuluzi lezokwelapha elijwayelekile kanye nemishini yokuxilonga enokwakheka kwe-chromium engu-18% kanye ne-nickel engu-8%. Insimbi engagqwali engu-316L iyi-alloy yezinga lezokwelapha yethuluzi lokuhlinza kanye nedivayisi engafakelwa enokuqukethwe okuphansi kwekhabhoni (≤0.03%) kokushibilika kanye nokumelana nokugqwala. Insimbi engagqwali engu-430 iyibanga le-ferritic ledivayisi yezokwelapha yabathengi kanye nemishini yelabhorethri enokuqukethwe kwe-chromium okungu-16 kuya ku-18%.

Insimbi engagqwali engu-17-7PH iyizinga lokuqina kwemvula lesicelo sedivayisi yezokwelapha enamandla aphezulu enokwakheka kwe-17% chromium, 7% nickel, kanye ne-1% aluminium. Ibanga le-17-7PH lisekela amandla aphezulu okukhiqiza (kufika ku-1500 MPa) ngokwelashwa kokushisa okuqinisa ubudala. Ithimba lokuthenga kufanele licele imininingwane yebanga ngalinye kumhlinzeki ngokuhambisana nezinga le-ASTM / EN elibhalwe phansi.

Ukukhethwa kwebanga ngesicelo sedivayisi yezokwelapha kuyisici sokuqinisekisa sesithupha okufanele ithimba lokuthenga lihlole. Ibanga lama-304 lisekela ithuluzi lezokwelapha elijwayelekile, imishini yokuxilonga, kanye nelabhorethri esetshenziswayo ezingeni elijwayelekile lezindleko nge-kg. Ibanga lama-316L lisekela ithuluzi lokuhlinza, idivayisi efakelwayo, kanye nedivayisi yezokwelapha ehambisana ne-biocompatible ezingeni eliphakeme ngama-30% kuya ku-50% nge-kg uma kuqhathaniswa nebanga lama-304. Ibanga lama-430 lisekela idivayisi yezokwelapha yabathengi kanye nedivayisi yezokwelapha ezwela amandla kazibuthe ezingeni eliphansi ngama-15% kuya ku-25% nge-kg uma kuqhathaniswa nebanga lama-304. Ithimba lokuthenga kufanele licele imibhalo yezinga lentengo ngebanga kumhlinzeki.

5. Uhlelo Lokulinganisa Ubukhulu Ku-inthanethi

Uhlelo lokulinganisa ubukhulu oluku-inthanethi luyisici sesithupha sokuqinisekisa okufanele sicelwe yithimba lokuthenga. Igeyiji yokudlulisa ye-X-ray isekela ububanzi bokujiya obungu-0.10 kuya ku-6.0 mm ngokunemba okungu-±0.001 mm. Igeyiji yokulinganisa i-laser triangulation isekela ububanzi bokujiya obungu-0.05 kuya ku-1.0 mm ngokunemba okungu-±0.005 mm. Igeyiji yokudlulisa ye-beta-ray isekela ububanzi bokujiya obungu-0.005 kuya ku-0.10 mm ngokunemba okungu-±0.001 mm. Uhlelo lokuphendula ngamandla okugoqa lusekela ukulawula ukujiya kwe-loop evaliwe ngokunemba okungu-±0.005 mm.

Imvamisa yokulinganisa uhlelo lokulinganisa iyisici sokuqinisekisa sesikhombisa okufanele ithimba lokuthenga lisihlole. Ukulinganiswa kwe-X-ray gauge kuvame ukuwela phakathi kwezinyanga eziyi-6 neziyi-12. Ukulinganiswa kwe-laser gauge kuvame ukuwela phakathi kwezinyanga ezi-3 neziyi-6. Ukulinganiswa kwe-beta-ray gauge kuvame ukuwela phakathi kwezinyanga eziyi-6 neziyi-12. Ithimba lokuthenga kufanele licele imibhalo yokulinganisa nge-gauge kumhlinzeki kanye nokulandelela okubhaliwe kokulinganisa.

Uhlelo lokulawula ukujiya kwe-loop evaliwe luyisici sokuqinisekisa sesishiyagalombili okufanele ithimba lokuthenga lisihlole. Uhlelo lwe-loop evaliwe luvame ukusebenzisa impendulo yamandla okugoqa, impendulo yesivinini sokugoqa, kanye nempendulo yokucindezela ukuze kugcinwe ukujiya okuqondiwe. Uhlelo lwe-loop evaliwe lusekela ukuhlukahluka kobukhulu obungu-±0.005 mm ngaphezu kobude bekhoyili yamamitha ayi-1000. Ithimba lokuthenga kufanele licele imibhalo yesistimu ye-loop evaliwe kumhlinzeki enesikhathi sokuphendula se-loop yokulawula ebhaliwe.

6. Imininingwane Yokuqedwa Komphezulu Wedivayisi Yezokwelapha

Incazelo yokuphela kobuso besicelo sedivayisi yezokwelapha ye-precision strip iyincazelo yesishiyagalombili yokuqinisekisa okufanele ithimba lokuthenga liyihlole. Ubuso be-2B (okugoqekile okubandayo + i-skin pass + i-acid pickling) busekela idivayisi yezokwelapha ejwayelekile enobuso obubushelelezi nobukhanyayo. Ubuso be-BA (obucwebezelayo obukhanyayo) busekela ithuluzi lokuhlinza kanye nomugqa wokuxilonga ngesibuko kanye nobuso obukhanyayo obuphezulu. Ubuso be-No.4 (ukuqedwa okuxutshwe) busekela indawo yokuhlala yedivayisi yezokwelapha enephethini yebhulashi eliqondile. Ubuso be-No.8 (ukuqedwa kwesibuko) busekela idivayisi yezokwelapha ephezulu enobuso obukhanyayo obukhanyayo. Ukuze uthole inkomba ku-WowStainless finish finish specification kanye nomhlahlandlela wokukhetha ngokuphela, bheka ku-Ikhasi lasekhaya le-WowStainless.

Ukulinganiswa kobulukhuni bomphezulu kuyisici sokuqinisekisa sesishiyagalolunye okufanele sicelwe yithimba lokuthenga. Ukulinganiswa kobulukhuni bomphezulu okujwayelekile kusebenzisa ipharamitha ye-Ra (ubulukhuni obuphakathi kwezibalo). Ubuso be-2B buvame ukusekela i-Ra 0.1 kuya ku-0.3 μm. Ubuso be-BA buvame ukusekela i-Ra 0.05 kuya ku-0.10 μm. Ubuso be-No.4 buvame ukusekela i-Ra 0.3 kuya ku-0.5 μm. Ubuso be-No.8 buvame ukusekela i-Ra 0.02 kuya ku-0.05 μm. Ithimba lokuthenga kufanele licele amadokhumenti okuqeda ubulukhuni bomphezulu ngamunye kumhlinzeki.

7. Ububanzi Bokujiya Ngesicelo Sedivayisi Yezokwelapha

Ububanzi bokujiya ngesicelo sedivayisi yezokwelapha buyisici sokuqinisekisa seshumi okufanele ithimba lokuthenga lisihlole. Umucu omncane kakhulu (0.05 kuya ku-0.20 mm) usetshenziselwa ithuluzi lokuhlinzwa elincane kanye nengxenye efakwayo enokumelana okunembile kweKlasi 1. Umucu omncane (0.20 kuya ku-0.50 mm) usetshenziselwa umucu wokuxilonga, ilabhorethri esetshenziswayo, kanye nokuxhumana kwentwasahlobo nokubekezelelana kweKlasi 1 noma kweKlasi 2. Umucu ophakathi (0.50 kuya ku-1.0 mm) usetshenziselwa ithuluzi lokuhlinzwa kanye nendlu yedivayisi yezokwelapha enokumelana kweKlasi 2 noma kweKlasi 3. Umucu ojwayelekile (1.0 kuya ku-1.5 mm) usetshenziselwa uhlaka lwedivayisi yezokwelapha kanye nokufakelwa kwamathambo okunokumelana kweKlasi 3 noma kweKlasi 4.

Ukukhethwa kobukhulu yisicelo sedivayisi yezokwelapha kuyisici sokuqinisekisa seshumi nanye okufanele ithimba lokuthenga lihlole. Ithuluzi lokuhlinzwa elincane livame ukudinga ubukhulu obungu-0.10 kuya ku-0.30 mm ngokubekezelelana kweKlasi 1. I-diagnostic strip ivame ukudinga ubukhulu obungu-0.20 kuya ku-0.50 mm ngokubekezelelana kweKlasi 1 noma kweKlasi 2. Ithuluzi lokuhlinzwa livame ukudinga ubukhulu obungu-0.50 kuya ku-1.0 mm ngokubekezelelana kweKlasi 2. Uhlaka lwedivayisi yezokwelapha luvame ukudinga ubukhulu obungu-1.0 kuya ku-1.5 mm ngokubekezelelana kweKlasi 3. I-orthopedic implant ivame ukudinga ubukhulu obungu-1.0 kuya ku-2.0 mm ngokubekezelelana kweKlasi 3 noma kweKlasi 4.

8. Ububanzi kanye Nesimo Somphetho

Ububanzi kanye nesimo somphetho kuyisici sokuqinisekisa seshumi nambili okufanele ithimba lokuthenga lihlole. Ububanzi obujwayelekile bomcu wokunemba buphakathi kuka-5 mm no-600 mm. Umcu wobubanzi obuncane (5 kuya ku-50 mm) usetshenziselwa idivayisi yezokwelapha encane kanye nelebhu esetshenziswayo. Umcu wobubanzi obuphakathi (50 kuya ku-200 mm) usetshenziselwa umcu wokuhlola kanye nethuluzi lokuhlinza. Umcu wobubanzi obubanzi (200 kuya ku-600 mm) usetshenziselwa indlu yedivayisi yezokwelapha kanye nohlaka lokufakelwa kwamathambo. Isimo somphetho esijwayelekile sihlanganisa umphetho wokugaya (umphetho wemvelo), umphetho womphetho (umphetho oqondile), kanye nomphetho osuliwe (umphetho ojikeleziwe). Ithimba lokuthenga kufanele licele imibhalo yobubanzi kanye nesimo somphetho kumhlinzeki.

9. Uhlu Lokuhlola Lokuthengwa Kokubekezelelana Kwe-BOFU Precision Strip Lwezinyathelo Ezi-5

Kubakhiqizi bemishini yezokwelapha, abakhiqizi bokunyathela ngokunemba, kanye nama-workshop omshini omncane alungele ukucacisa umucu wensimbi engagqwali oqondile ngesigaba sokubekezelelana kwamabhendi ama-4, uhlu lokuhlola olulandelayo lwezinyathelo ezi-5 luhlanganisa imininingwane yokuqinisekisa evela ezigabeni zangaphambilini ibe yidokhumenti eyodwa yokuchaza ukuthenga.

1. Cacisa ibhendi yokubekezelelana (Isigaba 1 ±0.02mm / Isigaba 2 ±0.03mm / Isigaba 3 ±0.05mm / Isigaba 4 ±0.10mm) ngokwesilinganiso sokwenqatshwa kwedivayisi yezokwelapha.
2. Khetha izinga lensimbi engagqwali (304 / 316L / 430 / 17-7PH) ngokwesicelo sedivayisi yezokwelapha kanye nesidingo sokuhambisana kwezinto eziphilayo.
3. Chaza ububanzi bokujiya (okuncane kakhulu kusuka ku-0.05 kuya ku-0.20 mm / okuncane kusuka ku-0.20 kuya ku-0.50 mm / okuphakathi kusuka ku-0.50 kuya ku-1.0 mm / okujwayelekile kusuka ku-1.0 kuya ku-1.5 mm) ngokwejiyometri yedivayisi yezokwelapha.
4. Cela ukuqeda ubuso (2B / BA / No.4 / No.8) kanye nemibhalo yobukhulu bobuso (Ra) kumhlinzeki.
5. Bhala phansi ububanzi, isimo somphetho, i-MOQ, kanye nesikhathi sokuhola ngesheduli yokukhiqiza ngokwezidingo.

Kubakhiqizi bemishini yezokwelapha kanye namaqembu okuthenga izitembu ezinembile athola umucu wensimbi engagqwali onembile, izinsizakusebenza zemboni ezilandelayo zinikeza idatha ehambisanayo ngezindinganiso zokubekezelela insimbi engagqwali kanye nohlaka lokuhambisana nezinto zemishini yezokwelapha.I-ASTM Internationalishicilela indinganiso ye-ASTM A480 yepuleti lensimbi engagqwali, ishidi, kanye nokubekezelelana kobukhulu be-strip.Inhlangano Yomhlaba Wonke Yokumisa Izindinganiso (i-ISO)ishicilela indinganiso ye-ISO 9445 yokubekezelelana kwensimbi engagqwali okugoqekile okuyisicaba kanye nochungechunge lwe-ISO 5832 lwencazelo yezinto zokufakelwa kokuhlinzwa.IKomidi LaseYurophu Lokumisa Izindinganiso (i-CEN)ishicilela indinganiso ye-EN 10088 yezinga lensimbi engagqwali yaseYurophu kanye nendinganiso ye-EN 10029 yokubekezelelana okugoqekile okuyisicaba.Ukuphathwa Kwezokudla Nezidakamizwa e-US (FDA)ishicilela isiqondiso sokuhambisana kwezinto zedivayisi yezokwelapha kanye nomthethonqubo wekhwalithi wesistimu ye-FDA 21 CFR 820.Iforamu Yokulawula Amadivayisi Ezokwelapha Yomhlaba Wonke (i-IMDRF)ishicilela ukuhlukaniswa kwezinto zedivayisi yezokwelapha kanye nohlaka lokulawula ukuvumelanisa.

Kwabakhiqizi bamadivayisi ezokwelapha, abakhiqizi bokunyathela ngokunemba, kanye nama-workshop omshini omncane alungele ukucacisa umucu wensimbi engagqwali oqondile ngesigaba sokubekezelelana kwamabhendi ama-4, ithimba lobunjiniyela le-WowStainless linganikeza ukuqinisekiswa kwamandla ebhendi yokubekezelelana ngakunye, ukucaciswa kwebanga ngalinye, umbiko wokulinganisa ububanzi bokujiya ngakunye, kanye nemibhalo yokuqeda ngakunye. Ithimba lobunjiniyela le-WowStainless lisekele abakhiqizi bamadivayisi ezokwelapha ngokuthunyelwa okubhaliwe kulo lonke elase-EU, eNyakatho Melika, eJapan, kanye nasezimakethe zaseNingizimu-mpumalanga ye-Asia. Buyekeza i-WowStainlessikhasi 3 lekhathalogi yemikhiqizoukuze uthole umugqa womkhiqizo we-strip onembile kanye nencazelo yokubekezelelana, noma vakashela i-Ikhasi lasekhaya le-WowStainlessukuze uthole iphothifoliyo yomkhiqizo ephelele.

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