1. Tsarin Rarraba Kauri Mai Girman Baki 4

Tsarin rarrabuwar kauri mai kauri 4 don daidaitaccen tsiri na bakin karfe ya ƙunshi daidaiton haƙuri na Class 1 (±0.02 mm), daidaiton haƙuri na Class 2 (±0.03 mm), juriya na kasuwanci na Class 3 (±0.05 mm), da haƙurin injin niƙa na Class 4 (±0.10 mm). Tsarin mai rukuni 4 shine ƙayyadaddun siyayya na yau da kullun ga masana'antar kayan aikin likitanci, mai ƙera tambarin daidai, da kuma bita na injinan micro wanda ke buƙatar kauri mai daidaito don tsarin samarwa na ƙasa. Ƙungiyar injiniyan WowStainless tana ba da takaddun tsarin mai rukuni 4 tare da tabbatar da ƙarfin injin niƙa na kowane aji. Don ambaton samfuran da aka nuna na WowStainless da ƙayyadaddun haƙuri na kowane samfuri, dubasamfuran da aka fi soshafi.

Juriyar daidaito ta Aji 1 (±0.02 mm) ita ce ƙungiyar farko da ya kamata ta tantance don samar da na'urorin likitanci. Juriyar Aji 1 tana goyan bayan ƙimar ƙin samarwa daga 0.5% zuwa 1% don kayan aikin tiyata da aikace-aikacen na'urar da za a iya dasawa. Juriyar Aji 1 tana buƙatar injin niƙa mai naɗewa na musamman tare da tsarin auna kauri ta X-ray ko laser akan layi. Ƙungiyar siyan ya kamata ta nemi tabbatar da ƙarfin haƙuri na Aji 1 daga mai samar da kayayyaki tare da rahoton auna kauri da aka rubuta.

Dalilai 3 na zabar rukunin haƙuri na daidaito na Aji 1 shine takamaiman tabbaci na biyu da ƙungiyar sayayya za ta tantance. Dalilai 3 sun haɗa da bin ƙa'idodin na'urorin likitanci (FDA 21 CFR 820 da tsarin ingancin ISO 13485), haɓaka yawan amfanin samarwa (rage ƙimar ƙin yarda da kashi 3% zuwa 5% idan aka kwatanta da haƙurin kasuwanci na Aji 3), da kuma daidaiton tsarin da ke ƙasa (tambari, zane mai zurfi, da aikin injina na ƙananan na'urori). Ƙungiyar sayayya ya kamata ta ƙayyade haƙurin Aji 1 bisa ga bin ƙa'idodin na'urorin likita da kuma manufar yawan amfanin samarwa.

Dalilai 3 na zabar rukunin haƙuri na injin niƙa na Aji 4 shine takamaiman tabbaci na uku da ƙungiyar sayayya za ta tantance. Dalilai 3 sun haɗa da rage farashi (ƙasa da kashi 15% zuwa 25% na farashin kowace kg idan aka kwatanta da haƙuri na Aji 1), rage lokacin jagora (kwana 5 zuwa 10 ya fi guntu bisa ga jadawalin injin niƙa na yau da kullun), da kuma samuwar maki (dukkan ma'aunin da suka haɗa da 304, 316L, 430, da 17-7PH a cikin rukunin haƙuri na injin niƙa). Ƙungiyar sayayya ya kamata ta ƙayyade haƙuri na Aji 4 bisa ga aikace-aikacen gabaɗaya na masana'antu da aikace-aikacen da ke da sauƙin farashi.

2. Kwatanta Zaren Daidaito da Zaren Jiki Mai Sanyi

Tsarin ƙarfe mai daidaito shine mafi girman nau'in tsiri mai sanyi wanda aka yi da bakin ƙarfe mai naɗewa tare da injin niƙa na musamman da kuma ma'aunin kauri a cikin layi. Tsarin daidai yawanci yana shiga cikin madaurin haƙuri na aji 1 (±0.02 mm) zuwa aji 3 (±0.05 mm). Tsarin gabaɗaya mai sanyi yawanci yana shiga cikin madaurin haƙuri na aji 3 (±0.05 mm) zuwa aji 4 (±0.10 mm). Ƙungiyar siyan ya kamata ta bambanta madaurin daidaito daga madaurin gabaɗaya don aikace-aikacen na'urar likita.

ASTM A480 da kuma ma'aunin EN 10088 su ne takaddun tabbatarwa na biyu da ƙungiyar masu sayayya za ta buƙata. Ma'aunin ASTM A480 ya bayyana ma'aunin haƙuri ga farantin ƙarfe mai faɗi, takardar, da kuma tsiri. Ma'aunin EN 10088 ya bayyana ma'aunin ƙarfe na Turai da kuma haƙurin girma. Ƙungiyar masu sayayya ya kamata ta nemi takaddun bin ƙa'idodi daga mai samar da kayayyaki tare da tabbatar da ma'aunin haƙuri.

3. Tasirin Ƙimar ƙin amincewa ta Nau'in Na'urar Lafiya

Tasirin ƙimar ƙin yarda da nau'in na'urar likitanci shine takamaiman tabbaci na uku da ƙungiyar sayayya za ta tantance. Juriyar daidaito ta Aji 1 (±0.02 mm) yawanci tana goyan bayan ƙimar ƙin yarda da samarwa daga 0.5% zuwa 1% don kayan aikin tiyata da aikace-aikacen na'urar da za a iya dasawa. Kayan aikin tiyata suna buƙatar daidaiton haƙuri don gefen yankewa, saman mannewa, da haɗin gwiwa mai haɗawa. Na'urar da za a iya dasawa tana buƙatar daidaiton haƙuri don kammala saman, hulɗar nama, da daidaiton shigarwa a cikin jiki.

Daidaitaccen haƙuri na Aji 2 (±0.03 mm) shine takamaiman tabbatarwa na huɗu don kayan aikin bincike da na'urar sa ido. Kayan aikin bincike yawanci suna tallafawa ƙimar ƙin yarda na 1% zuwa 2% a kowace zaɓin rukunin haƙuri. Na'urar sa ido yawanci tana goyan bayan ƙimar ƙin yarda na 1% zuwa 2% a kowace haƙurin haɗuwar kewaye. Daidaitaccen haƙuri na kasuwanci na Aji 3 (±0.05 mm) yawanci yana goyan bayan ƙimar ƙin yarda na 2% zuwa 5% ga na'urar likitanci ta masu amfani da kayan aikin dakin gwaje-gwaje.

Rarraba na'urorin likitanci ta FDA da tsarin MDR na EU shine takaddar tabbatarwa ta biyar da ƙungiyar sayayya za ta tantance. FDA ta rarraba na'urar likitanci zuwa Aji na I (ƙananan haɗari, misali, bandeji mai roba, safar hannu ta gwaji), Aji na II (matsakaicin haɗari, misali, kayan aikin tiyata, famfon jiko), da Aji na III (babban haɗari, misali, na'urar bugun zuciya da za a iya dasawa, bawul ɗin zuciya). EU MDR ta rarraba na'urar lafiya zuwa Aji na I (ƙananan haɗari), Aji na IIa (ƙananan haɗari zuwa matsakaici), Aji na IIb (matsakaicin haɗari zuwa babban haɗari), da Aji na III (babban haɗari). Matsakaicin tsiri da zaɓin band na haƙuri ya kamata ya dace da rarrabuwar na'urorin likita bisa ga tsarin FDA da EU MDR.

4. Zaɓin Nauyin Karfe Mai Bakin Karfe don Na'urar Lafiya

Zaɓin matakin ƙarfe na bakin ƙarfe don aikace-aikacen na'urar likitanci na daidaitacce shine takaddar tabbatarwa ta biyar da ƙungiyar masu sayayya za ta tantance. Karfe mai bakin ƙarfe 304 shine matakin da aka saba amfani da shi don kayan aikin likita na gabaɗaya da kayan aikin bincike tare da abun da ke cikin chromium 18% da nickel 8%. Karfe mai bakin ƙarfe 316L shine ƙarfe mai matakin likita don kayan aikin tiyata da kuma na'urar da za a iya dasawa tare da ƙarancin abun ciki na carbon (≤0.03%) don walda da juriya ga tsatsa. Karfe mai bakin ƙarfe 430 shine matakin ferritic don na'urar likitanci ta mabukaci da kayan aikin dakin gwaje-gwaje tare da abun ciki na chromium 16 zuwa 18%.

Karfe mai kauri 17-7PH shine matakin taurarewar hazo don bazara da kuma amfani da na'urorin likitanci masu ƙarfi tare da chromium 17%, nickel 7%, da 1% aluminum. Matsayin 17-7PH yana tallafawa ƙarfin yawan amfanin ƙasa (har zuwa 1500 MPa) tare da maganin zafi mai taurare shekaru. Ƙungiyar masu siyan ya kamata ta nemi takamaiman maki daga mai samar da kayayyaki tare da takaddun da suka dace da ƙimar ASTM / EN.

Zaɓin maki da aikace-aikacen na'urar likita ya yi shi ne takamaiman tabbaci na shida da ƙungiyar sayayya za ta tantance. Matakin 304 yana tallafawa kayan aikin likita na gabaɗaya, kayan aikin bincike, da kayan da ake amfani da su a dakin gwaje-gwaje a matakin farashi na kowace kg. Matakin 316L yana tallafawa kayan aikin tiyata, na'urar da za a iya dasawa, da na'urar likitanci mai jituwa da halittu a matakin farashi na 30% zuwa 50% idan aka kwatanta da mataki na 304. Matakin 430 yana tallafawa na'urar likitanci ta mabukaci da na'urar likita mai amsawa da maganadisu a matakin farashi na 15% zuwa 25% idan aka kwatanta da mataki na 304. Ƙungiyar sayayya ya kamata ta nemi takaddun matakin farashi na kowane mataki daga mai samar da kayayyaki.

5. Tsarin Auna Kauri akan Layi

Tsarin auna kauri ta yanar gizo shine takaddar tabbatarwa ta shida da ƙungiyar masu saye za ta buƙata. Ma'aunin watsa X-ray yana goyan bayan kewayon kauri daga 0.10 zuwa 6.0 mm tare da daidaiton ±0.001 mm. Ma'aunin triangulation na laser yana goyan bayan kewayon kauri daga 0.05 zuwa 1.0 mm tare da daidaiton ±0.005 mm. Ma'aunin watsa beta-ray yana goyan bayan kewayon kauri daga 0.005 zuwa 0.10 mm tare da daidaiton ±0.001 mm. Tsarin mayar da martani na ƙarfin birgima yana goyan bayan sarrafa kauri madauki mai rufewa tare da daidaiton ±0.005 mm.

Mitar daidaita tsarin aunawa ita ce takamaimai ta bakwai da ƙungiyar masu sayayya za ta tantance. Daidaita ma'aunin X-ray yawanci yana faɗi tsakanin watanni 6 zuwa 12. Daidaita ma'aunin laser yawanci yana faɗi tsakanin watanni 3 zuwa 6. Daidaita ma'aunin beta-ray yawanci yana faɗi tsakanin watanni 6 zuwa 12. Ƙungiyar masu sayayya ya kamata ta nemi takaddun daidaitawa na kowane ma'auni daga mai samar da kayayyaki tare da bin diddigin ma'auni da aka rubuta.

Tsarin kula da kauri na madauri da aka rufe shi ne takamaiman tabbaci na takwas da ƙungiyar sayayya za ta tantance. Tsarin madauri da aka rufe yawanci yana amfani da martanin ƙarfin birgima, martanin saurin birgima, da kuma martanin tashin hankali don kiyaye kauri da aka yi niyya. Tsarin madauri da aka rufe yana goyan bayan bambancin kauri na ±0.005 mm akan tsawon naɗin mita 1000. Ƙungiyar sayayya ya kamata ta nemi takaddun tsarin madauri da aka rufe daga mai samar da kayayyaki tare da lokacin amsawar madauri da aka rubuta.

6. Takamaiman Ƙarewar Sama don Na'urar Lafiya

Takaddun ƙarshe na saman aikace-aikacen na'urar likitanci na tsiri daidai shine takaddar tabbatarwa ta takwas da ƙungiyar sayayya za ta tantance. Saman 2B (wanda aka naɗe da sanyi + wanda aka yi amfani da shi don cire fata + wanda aka yi amfani da shi don cire acid) yana goyan bayan na'urar likita ta yau da kullun tare da saman santsi da haske. Saman BA (wanda aka yi amfani da shi don cire fata mai haske) yana goyan bayan kayan aikin tiyata da tsiri na bincike tare da madubi da saman haske mai yawa. Saman No.4 (wanda aka yi amfani da shi don cire fata) yana goyan bayan wurin da na'urar likita ke zaune tare da tsarin goga mai layi. Saman No.8 (wanda aka yi amfani da madubi) yana goyan bayan na'urar lafiya mai tsayi tare da saman haske mai haske. Don tunani akan ƙayyadaddun ƙarewar saman WowStainless da jagorar zaɓin kowane-ƙarshe, dubaShafin farko na WowStainless.

Ma'aunin tsatsa a saman shine takaddar tabbatarwa ta tara da ƙungiyar masu sayayya za ta buƙata. Ma'aunin tsatsa a saman da aka saba amfani da shi yana amfani da ma'aunin Ra (ma'aunin lissafi). Ma'aunin 2B yawanci yana goyan bayan Ra 0.1 zuwa 0.3 μm. Ma'aunin BA yawanci yana goyan bayan Ra 0.05 zuwa 0.10 μm. Ma'aunin 4 yawanci yana goyan bayan Ra 0.3 zuwa 0.5 μm. Ma'aunin 8 yawanci yana goyan bayan Ra 0.02 zuwa 0.05 μm. Ƙungiyar masu sayayya ya kamata ta nemi takaddun tsatsa a saman da aka saba daga mai samar da kayayyaki.

7. Kewayon Kauri ta Amfani da Na'urorin Lafiya

Kauri da aka yi amfani da na'urar likitanci shine takaddar tabbatarwa ta goma da ƙungiyar masu saye za ta tantance. Ana amfani da tsiri mai siriri sosai (0.05 zuwa 0.20 mm) don kayan aikin tiyata na ƙananan ƙwayoyin cuta da kuma kayan da za a iya dasawa tare da juriyar daidaiton Class 1. Ana amfani da tsiri mai siriri (0.20 zuwa 0.50 mm) don tsiri mai ganewar asali, kayan da ake amfani da su a dakin gwaje-gwaje, da kuma hulɗar bazara tare da haƙurin Class 1 ko Class 2. Ana amfani da tsiri mai matsakaici (0.50 zuwa 1.0 mm) don kayan aikin tiyata da kuma kayan aikin likita tare da juriyar Class 2 ko Class 3. Ana amfani da tsiri mai daidaito (1.0 zuwa 1.5 mm) don firam ɗin na'urar likita da kuma dashen orthopedic tare da haƙurin Class 3 ko Class 4.

Zaɓin kauri da aikace-aikacen na'urar likita ya yi shine takamaiman tabbaci na sha ɗaya da ƙungiyar masu saye za ta tantance. Kayan aikin tiyatar ƙananan yawanci suna buƙatar kauri daga 0.10 zuwa 0.30 mm tare da haƙurin Class 1. Tsarin ganewar asali yawanci yana buƙatar kauri daga 0.20 zuwa 0.50 mm tare da haƙurin Class 1 ko Class 2. Kayan aikin tiyata yawanci yana buƙatar kauri daga 0.50 zuwa 1.0 mm tare da haƙurin Class 2. Tsarin na'urar likita yawanci yana buƙatar kauri daga 1.0 zuwa 1.5 mm tare da haƙurin Class 3. Tsarin dashen orthopedic yawanci yana buƙatar kauri daga 1.0 zuwa 2.0 mm tare da haƙurin Class 3 ko Class 4.

8. Faɗi da Bayyana Yanayin Gefen

Faɗin da yanayin gefen shine takamaiman bayani na sha biyu na tabbatarwa da ƙungiyar masu sayayya za ta tantance. Matsakaicin faɗin layin daidaitacce yana tsakanin mm 5 zuwa 600 mm. Ana amfani da ƙaramin faɗin layin (5 zuwa 50 mm) don na'urar ƙananan likitoci da kuma kayan daki. Ana amfani da matsakaicin faɗin layin (50 zuwa 200 mm) don layin bincike da kayan aikin tiyata. Ana amfani da faɗin layin (200 zuwa 600 mm) don wurin da na'urar likita ke zaune da kuma firam ɗin dashen ƙashi. Yanayin gefen da aka saba amfani da shi ya haɗa da gefen niƙa (gefen halitta), gefen tsagewa (tsagewa daidai), da gefen da aka cire (gefen da aka zagaye). Ƙungiyar masu sayayya ya kamata ta nemi takaddun yanayin gefen da aka ƙayyade daga mai samar da kaya.

9. Jerin Abubuwan da Ake Bukata na Sayen Tsarin Haƙuri na BOFU Mataki 5

Ga masu kera na'urorin likitanci, masu kera na'urorin tantance daidai, da kuma ƙananan na'urori da ke shirye don tantance madaidaicin tsiri na bakin karfe tare da rarrabuwar juriya ta rukuni 4, jerin abubuwan da ke tafe na matakai 5 yana haɗa ƙayyadaddun bayanai na tabbatarwa daga sassan da suka gabata zuwa takardar takamaiman sayayya guda ɗaya.

1. A ƙayyade ma'aunin haƙuri (Aji 1 ±0.02mm / Aji 2 ±0.03mm / Aji 3 ±0.05mm / Aji 4 ±0.10mm) bisa ga maƙasudin ƙimar ƙin yarda da na'urar likita.
2. Zaɓi matakin ƙarfe mai bakin ƙarfe (304 / 316L / 430 / 17-7PH) bisa ga aikace-aikacen na'urar likita da buƙatun jituwa ta halitta.
3. A fayyace kewayon kauri (mai matuƙar siriri 0.05 zuwa 0.20 mm / siriri 0.20 zuwa 0.50 mm / matsakaici 0.50 zuwa 1.0 mm / daidaitaccen 1.0 zuwa 1.5 mm) bisa ga tsarin na'urar likita.
4. Nemi takardar kammala saman (2B / BA / Lamba 4 / Lamba 8) da kuma takardar ƙaiƙayin saman (Ra) daga mai samar da kaya.
5. Yi bayanin faɗin, yanayin gefen, MOQ, da lokacin jagora tare da jadawalin samarwa na kowane takamaiman lokaci.

Ga masu kera na'urorin likitanci da ƙungiyoyin siyan na'urorin tantancewa daidai waɗanda ke samo madaidaicin tsiri na bakin ƙarfe, albarkatun masana'antu masu zuwa suna ba da bayanai kan ma'aunin juriyar bakin ƙarfe da tsarin bin ƙa'idodin kayan aikin likita.ASTM ta Duniyayana buga ma'aunin ASTM A480 don jure wa farantin ƙarfe na bakin ƙarfe, takardar, da tsiri.Ƙungiyar Ƙasa da Ƙasa don Daidaitawa (ISO)yana buga ma'aunin ISO 9445 don haƙurin girman bakin ƙarfe mai faɗi da kuma jerin ISO 5832 don ƙayyadaddun kayan dashen tiyata.Kwamitin Tsarin Ma'auni na Turai (CEN)yana buga ma'aunin EN 10088 don matakin ƙarfe na Turai da kuma ma'aunin EN 10029 don haƙurin girma mai faɗi.Hukumar Abinci da Magunguna ta Amurka (FDA)yana wallafa jagorar daidaiton kayan aikin likitanci da kuma ƙa'idar tsarin ingancin FDA 21 CFR 820.Dandalin Masu Kula da Na'urorin Lafiya na Duniya (IMDRF)yana buga rarrabuwar kayan na'urorin likitanci da tsarin daidaitawa na ƙa'idoji.

Ga masu kera na'urorin likitanci, masu kera na'urorin tantance daidai, da kuma bita kan ƙananan injina waɗanda ke shirye don tantance madaidaicin tsiri na bakin ƙarfe tare da rarrabuwar juriyar band 4, ƙungiyar injiniyan WowStainless za ta iya samar da tabbacin ƙarfin band, ƙayyadaddun maki, rahoton auna kauri na kowane gefe, da kuma takaddun kammalawa na kowane gefe. Ƙungiyar injiniyan WowStainless ta tallafa wa masana'antun na'urorin likitanci tare da jigilar takardu a duk faɗin Tarayyar Turai, Arewacin Amurka, Japan, da kasuwannin Kudu maso Gabashin Asiya. Yi bitar WowStainlesskundin samfura shafi na 3don layin samfurin tsiri daidai da ƙayyadaddun haƙuri, ko ziyarciShafin farko na WowStainlessdon cikakken fayil ɗin samfurin.

Tambayoyin da Ake Yawan Yi