Medical na'urar bugawa karfe bugawa yana samar da daidaitattun abubuwan da aka ƙera don kayan aikin tiyata, na'urorin da za a iya dasa su, kayan bincike, da tsarin isar da ƙwayoyi - aikace-aikace inda bambancin girman 0.01 mm zai iya haifar da bambanci tsakanin na'urar mutum da nasara. Ba kamar masana'anta gabaɗaya ba, tambarin likitanci dole ne ya gamsar da buƙatun kwatancen halittu, bin diddigin ƙa'ida daga FDA da ƙungiyoyin da aka sanar, da ƙa'idodin takaddun da ke gano kowane sashi zuwa yawan zafinsa na albarkatun ƙasa.
Wannan jagorar ya ƙunshi kayan, tsarin tsari, tsammanin haƙuri, buƙatun ɗaki mai tsabta, da wajibcin ganowa waɗanda ke ayyana tambarin na'urar likita. Ko kai injiniya ne da ke zana sabon kayan aikin tiyata ko kuma manajan sayayya wanda ya cancanci mai siyar da tambari, wannan bayanin yana ba da tushen fasaha da kuke buƙata.
Menene Tambarin Na'urar Likita?
Medical na'urar karfe bugawa tsari ne na daidaici wanda ke jujjuya karafa masu dacewa zuwa kayan aikin likita, na'urorin da za'a iya dasa, da kayan aikin bincike ta amfani da ci gaba da mutuwa ko kayan aiki mai kyau. Yana buƙatar ingantattun tsarin ingancin ISO 13485, ingantattun matakai, juriya na sub-0.01 mm akan mahimman fasali, da cikakkun abubuwan ganowa daga takaddar niƙa zuwa ƙarshen ɓangaren.
Kamfanoni kamar Metal Stamping Parts Ltd kula da kayan aikin tsaftar daki, takaddun shaida, da iyawar ingantaccen tsari da ake buƙata don isar da abubuwan da aka hatimi na matakin likita.
Medical bugawa Materials: Biocompatibility and Performance
Zaɓin kayan abu a cikin tambarin likitanci ana yin sa ta farko ta hanyar daidaitawa - kayan dole ne kada ya haifar da amsa mai guba, rigakafi, ko carcinogenic lokacin da yake hulɗa da nama ko ruwaye na ɗan adam. Teburin da ke ƙasa ya kwatanta abubuwan da aka fi amfani da su na hatimi ga galoli.
| Alloy | Nazari gama gari | Ƙarfin Ƙarfin Ƙarfafa (MPa) | Biocompatibility (ISO 10993) | MRI Compatibility | Aikace-aikace na Likita |
|---|---|---|---|---|---|
| Bakin Karfe 316L | ASTM F138, ASTM F139, AISI 316LVM | 480–620 | Kyakkyawan - dogon tarihin amfani | Yanayi (kayan aikin ferromagnetic mai yuwuwa) | Kayan aikin tiyata, faranti na kashi, ma'auni, wuraren allura |
| Titanium CP Grade 2 / Grade 4 | ASTM F67 ASTM F1581 | 345–550 | Mafi kyau - abokantaka na osseointegration | Cikakken jituwa (marasa ferromagnetic) | Hakora, faranti na cranial, cages na kashin baya |
| Titanium Ti-6Al-4V ELI | ASTM F136, ISO 5832-3 | 860–965 | Madalla - daidaitaccen gami da haɓakawa | Cikakken jituwa | Ƙaƙwalwar ƙasusuwa, maye gurbin haɗin gwiwa, kayan aikin tiyata |
| MP35N | ASTM F562, UNS R30035 | 800–1,100 (shekaru) | Mafi kyau - nickel-cobalt-chromium-molybdenum | Sharadi | Maɓuɓɓugan ruwa da za a iya dasa, na'urorin gyarawa, abubuwan haɗin zuciya |
| Elgiloy (Co-Cr-Ni-Mo) | ASTM F1058, UNS R30003 | 860-1,200 (shekaru) | Kyakkyawan | Sharadi | Wayoyin jagorori, firam ɗin stent, kothodontic archwires |
| Nitinol (NiTi) | ASTM F206 | 895-1,100 (austenite) | Kyakkyawan - tarihin asibiti mai yawa | Sharadi | Stents, guidewires, orthodontic archwires, masu tace jijiyoyin jini |
| Tantalum | ASTM F560 | 200–400 | Excellent - bioinert | Cikakken jituwa | Gyaran lahani na cranial, madaukai masu alama, gidaje capacitor |
Mahimman Abubuwan Abubuwan Mahimmanci
- 316LVM (Vacuum Melted) shine kayan tushe don kayan aikin tiyata marasa dasawa da na'urori masu yawa da za'a iya dasa su. Tsarin narkewar injin yana rage haɗa abun ciki, inganta rayuwar gajiya da juriya na lalata. Shi ne zaɓin da ya fi dacewa da tsadar rayuwa don yin hatimi mai girma.
- Ti-6Al-4V ELI (Extra Low Interstitials) shine ma'aunin zinare na dindindin na ƙwanƙwasa orthopedic. Modules ɗin sa na roba (~ 110 GPa) ya fi kusa da kashi (~ 20 GPa) fiye da cobalt alloys (~ 210 GPa), yana rage garkuwar damuwa. Koyaya, titanium yana da wahalar hatimi - yana buƙatar ƙirƙirar mai zafi don hadaddun siffofi kuma yana haifar da lalacewa mai ƙarfi.
- MP35N ya haɗu da juriya na lalata na musamman tare da ƙarfi mai ƙarfi da kyakkyawar rayuwa ta gajiya. Yana da kayan zaɓi don maɓuɓɓugan ruwa da na'urorin gyarawa inda 316L ba shi da isasshen ƙarfi. Abubuwan da ke cikin nickel (35%) suna buƙatar a tsanake kimanta ƙimar haɓakar halittu ta ISO 10993.
- Nitinol yana gabatar da ƙalubalen ƙalubalen tambarin sa saboda sifar-ƙwaƙwalwarta da kaddarorinsa na superelastic. Dole ne a takura shi yayin ƙirƙirar kuma yana buƙatar daidaitaccen aiki na thermal (tsarin siffa) a 400-550 ° C don tsara tsarin lissafin da ake so.
Don hadaddun gidaje na na'urar likitanci da kewaye, zane mai zurfi yana ba da ingantacciyar hanyar ƙirƙira don abubuwan haɗin silindi da siffar akwatin a cikin bakin karfe ko titanium.
Yarda da Ka'idoji: ISO 13485, FDA 21 CFR 820, da CE MDR
Masu ba da tambarin kayan aikin likita suna aiki ƙarƙashin tsarin tsari mai nau'i-nau'i da yawa. Yarda da bin doka ba tilas ba ne - sharadi ne na doka don siyarwa cikin kasuwannin da aka tsara.
| Tsarin | Bayar da Hukumar | Yankin Geographic | Babban Bukatun | Audit Frequency |
|---|---|---|---|---|
| ISO 13485:2016 | ISO / rejista da aka amince | Duniya (an san shi a cikin ƙasashe 170+) | Tsarin Gudanar da ingancin na'urorin likitanci; sarrafawar ƙira, sarrafa haɗari (ISO 14971), CAPA, gudanarwar mai siyarwa, ingantaccen tsari, sarrafa takaddar | Sa ido na shekara; Sake shedar shekaru 3 |
| FDA 21 CFR Part 820 | Hukumar Abinci da Magunguna ta Amurka | Amurka | Tsarin Tsarin Tsarin inganci (QSR); sarrafawar ƙira, sarrafawa da sarrafawa da sarrafawa, gyarawa da ayyukan rigakafi, lakabi, rikodin | Dubawa na shekara-shekara (na yau da kullun); duba-sakamakon binciken yadda ake bukata |
| EU MDR 2017/745 | Hukumar Tarayyar Turai / Ƙungiyoyin Sanarwa | Yankin Tattalin Arziki na Turai | Takardun fasaha, kimantawa na asibiti (MEDDEV 2.7/1), sa ido na kasuwa bayan kasuwa, UDI, Shaida na Na'ura na Musamman, rajistar EUDAMED | Bisa ga jadawalin tantancewar Jiki da aka Sanarwa (yawanci na shekara-shekara) |
| MDSAP (Shirin Binciken Na'urar Likita ɗaya) | Hukumomin gudanarwa (US, Canada, Brazil, Australia, Japan) | Kasashe biyar da suka kafa mambobi | Dubawa guda ɗaya wanda ya ƙunshi buƙatun duk masu gudanarwa masu shiga; yana rage nauyin dubawa ga masu samar da kasuwa da yawa | Annual |
| ASTM F86 | ASTM International | Ana magana ta FDA da ISO | Standard for surface shiri da passivation na bakin karfe kayan aikin tiyata | Kowane kuri'a |
Abin da Wannan ke nufi don masu ba da kaya
- Ingantaccen tsari (IQ/OQ/PQ) wajibi ne. Kowane tsari na tambari wanda ke samar da abubuwan kiwon lafiya dole ne a inganta shi tare da Cancantar Shigarwa, Ƙwarewar Aiki, da ka'idojin cancantar Aiki. Ana buƙatar sabuntawa lokacin da kayan aiki, kayan aiki, ko sigogi suka canza.
- Tsarin ƙira nema idan mai yin tambari ya ba da gudummawa ga ƙirar na'urar. Ko da masu sana'ar kwangila masu tsabta dole ne su kula da fayilolin tarihin ƙira (DHF) waɗanda ke rubuta yadda ɓangaren hatimi ya dace da abubuwan ƙirar na'urar.
- CAPA (Gyara da Magani Action) Dole ne a rubuta tsarin, tare da binciken tushen tushen (misali, 8D, kashin kifi, 5-Me ya sa) da tabbatar da inganci ga kowane aikin gyara.
A Metal Stamping Parts Ltd, tsarin ingancin ingancin mu na ISO 13485 da kayan aikin FDA da aka yi wa rajista suna tabbatar da kowane ɓangaren likitancin likita ya cika ka'idodi na kasuwa na Amurka, da Amurka.
Matsayin Haƙuri don Tambarin Likita
mafi matsananci na'urar a cikin masana'antu. Inda sassan sararin samaniya suna buƙatar ± 0.025-0.050 mm, kayan aikin likitanci - musamman don na'urorin da za a iya dasa su da na'urorin tiyata - akai-akai suna buƙatar ± 0.005 mm (± 0.0002 in.) akan mahimman siffofi.
| Feature | Babban Likita | Mai Shuwa / Tiya | Bayanan kula |
|---|---|---|---|
| Ramin Diamita | ±0.025 mm | ± 0.005 mm | Mahimmanci don tsangwama mai ɗaure daidai da kwararar ruwa |
| Kaurin bango (ban da aka zana) | ± 0.050 mm | ± 0.010 mm | Yana shafar daidaiton tsari da daidaitaccen isar da magunguna |
| Lalacewar saman (kowace 25 mm) | 0.025 mm | 0.005 mm | Mahimmanci don rufe saman, mu'amalar mating |
| Haƙuri na kusurwa | ±0.5° | ±0.1° | Mahimmanci don ƙaddamar da haɗin gwiwar kayan aikin tiyata |
| Edge radius | 0.05 mm min | 0.02-0.05 mm sarrafawa | Ƙaƙƙarfan gefuna yana haifar da lalacewar nama; gefuna marasa burr dole |
| Taushin saman (Ra) | 0.8 µm | 0.2–0.4 µm | Rage ragewa da haɓaka tsaftar ƙwayoyin cuta. |
Cimma ±0.005 mm Haƙuri
Samar da stampings na likita a ± 0.005 mm yana buƙatar haɗuwa da daidaitattun kayan aiki, sarrafa tsari, da iyawar ma'auni:
- Sub-micron kayan aiki - Yanke sassan waya-EDM yanke zuwa ± 0.002 mm, madubi mai gogewa zuwa Ra 0.05 µm. Tool karfe maki kamar ASP-23 ko carbide ne daidaitattun.
- Zaɓin latsa - Matsakaicin inji ko na'ura mai aiki da karfin ruwa ± 5. Matsalolin da ke gudana na Servo suna ba da damar motsin nunin shirye-shirye don tsararrun jeri.
- Kula da muhalli - Wuraren samarwa ana sarrafa zafin jiki zuwa 20 ± 1 °C. Fadada thermal na kayan aikin karfe yana kusan 11 µm / m / ° C - canjin 3 ° C yana gabatar da kuskuren 33 µm/m, wanda ya wuce ± 0.005 mm haƙuri akan fasalin 75 mm.
- Metrology - CMMs tare da daidaiton juzu'i na 1.5 + L/333 µm ko mafi kyau. Na'urorin gani mara lamba (Laser scanners, tsarin hangen nesa) don abubuwa masu laushi waɗanda ba za a iya taɓa su ta hanyar bincike ba.
- SPC tare da babban Cpk Na'urar kiwon lafiya OEMs yawanci suna buƙatar Cpk ≥ 1.67 akan ma'auni masu mahimmanci, tare da wasu Cpk ≥ 2.0.
Bukatun Samar da Tsabtace
Yawancin kayan aikin likitanci - musamman na na'urorin da za a iya dasa, isar da magunguna, da bincike - dole ne a kera su a cikin mahalli masu sarrafawa don hana ɓarna da gurɓataccen yanayi.
Rarraba ɗaki mai tsabta
| Standard | Daidai | Matsakaicin Barbashi ≥0.5 µm/ft³ | Na Musamman Aikace-aikace |
|---|---|---|---|
| ISO 14644-1 Darasi na 7 | FED-STD-209E Class 10,000 | 352,000 | Gabaɗaya taron na'urar likitanci, kammala kayan aikin tiyata |
| ISO 14644-1 Class 8 | FED-STD-209E Class 100,000 | 3,520,000 | bugawa da forming ayyuka ga wadanda ba implantable na'urorin |
| ISO 14644-1 Darasi na 5 | FED-STD-209E Class 100 | 3,520 | fakitin na'urar da za a iya dasa, taro na ƙarshe na abubuwan hulɗar miyagun ƙwayoyi |
Cleanroom bugawa Practices
- Sadaukarwa matsi mai tsafta - Ana rufe matsi a cikin matsuguni masu tsabta tare da tace iska mai HEPA. Dole ne man shafawa ya zama matakin likitanci, mara guba, kuma mai cikakken cirewa.
- Musamman kulawa - Stamped sassa ana tsabtace ultrasonically a ingantattun tsaftacewa mafita nan da nan bayan kafa. Tabbatar da tsaftacewa yana nuna cewa ragowar ɓarna da nauyi mai rai sun haɗu da ƙayyadaddun iyaka.
- Ka'idojin Tufafi - Masu aiki suna sa tufafin ɗaki mai tsabta (riga, safofin hannu, abin rufe fuska, murfin gashi) kuma su wuce ta cikin shawan iska kafin shiga wuraren sarrafawa.
- Kula da muhalli - Ci gaba da kirga barbashi, zafin jiki, da ramin zafi. Ana adana bayanan azaman ɓangare na rikodin tarihin na'urar (DHR).
Abun Ganewa da Buƙatun UDI
Abun iya ganowa a cikin tambarin na'urar likitanci an ba da izini bisa doka kuma ana iya dubawa. Yana haɗa kowane ɓangaren hatimi zuwa tushen albarkatunsa, tsarin masana'anta, da kuma ƙarshe mai haƙuri.
Abun ganowa
- Takaddun shaida Mill dole ne su dace da ƙayyadaddun kayan abu na ASTM ko ISO (misali, ASTM F138 don 361L aikin tiyata). An ba da rahoton abun da ke tattare da sinadarai, kaddarorin injina, microstructure, da abun cikin haɗawa.
- Rarraba Lot - Yawancin albarkatun kayan da aka keɓe an ware su a zahiri kuma ana yi musu lakabi a duk lokacin samarwa. Ana ɗaukar lambobin kuri'a akan matafiya masu aiki, odar aiki, da tantance ɓangaren da aka gama.
- Sarkar tsare - Abubuwan da aka rubuta daga karɓar dubawa → ajiya → blanking → kafa → kammalawa → dubawa → marufi → jigilar kaya. Ana yin rikodin kowane canji tare da kwanan wata, mai aiki, da ma'anar kuri'a.
Ƙididdigar Na'ura ta Musamman (UDI)
Tsarin UDI na FDA (21 CFR Sashe na 830) da EU MDR ta EUDAMED bayanai suna buƙatar kowace na'urar likita don ɗaukar na'urar ganowa ta musamman wacce ke alaƙa da bayanan na'urar bayanai ta duniya.
| UDI Bangaren | Bayanin | Matsayin Tambari |
|---|---|---|
| Mai Gano Na'ura (DI) | Yana Gano samfurin na'urar da mai lakabin | samfurin iyali |
| Mai Gano Samarwa (PI) | Bayanai masu canzawa: lambar kuri'a, lambar serial, kwanan wata masana'anta, ranar karewa | Mai hatimi ko Laser-alama akan sashi ko marufin sa |
| UDI Carrier | Lambar da za a iya karanta na'ura (barcode, RFID, 2D DataMatrix) | Ana amfani da tambarin Laser, etching, ko alamar manne akan ɓangaren da aka hatimi |
Don babban juzu'i na kayan aikin likitanci (misali, ma'auni, shirye-shiryen bidiyo, wuraren allura), ana amfani da UDI yawanci a matakin marufi maimakon a kan sassa ɗaya. Don kayan aikin tiyata da za a sake amfani da su da na'urorin da za a iya dasa su, ana buƙatar alamar sashin kai tsaye (DPM) ta hanyar zanen Laser.
DFM don Tambarin Na'urar Kiwon Lafiya
Zane-don-ƙera a cikin tambarin na'urar likita dole ne a ba da lissafin tsari, daidaituwar halittu, da buƙatun aikin waɗanda ba su wanzu a wasu masana'antu.
1. Biocompatibility-Driven Surface Bukatun
Dole ne sassan da aka hati a likitanci su kasance marasa lahani na saman da zai iya ɗaukar ƙwayoyin cuta ko haifar da haushin nama. Wannan yana nufin:
- Babu wani kaifi mai kaifi ko burrs - dole ne a inganta matakan lalata.
- Rashin ƙarfi na saman da aka sarrafa zuwa Ra ≤ 0.8 µm don waɗanda ba za a iya dasa su ba da Ra ≤ 0.4 µm don wuraren da za a iya dasawa.
- Passivation ta ASTM A967 ko ASTM F86 don bakin karfe don cire baƙin ƙarfe kyauta kuma ƙara girman Layer chromium oxide.
2. Bukatun Taimakon Damuwa
Yawancin alluran likitanci (316L, Ti-6Al-4V, MP35N) suna buƙatar maganin zafi na rage damuwa bayan sanyin sanyi don hana lalata-lalata da gazawar gajiya da wuri. DFM dole ne ta daidaita sauye-sauyen girma (~ 0.05-0.10%) waɗanda ke faruwa yayin taimako na danniya.
3. Tsaftace Daidaitawa
Sashe na lissafi dole ne ya ba da damar tsaftacewa mai inganci. Aljihu masu zurfi, ramukan makafi, da kunkuntar ramuka suna tarko ragowar masana'anta da gurɓatattun halittu. DFM ya kamata rage girman irin waɗannan fasalulluka ko samar da dama ga ultrasonic tsaftacewa da kurkura shigar ruwa.
4. Matsakaicin Matsakaicin Mahimmanci
Na'urorin likitanci an haɗe su daga madaidaitan abubuwa masu yawa. Dole ne sassa masu hatimi su haɗu da injina, gyare-gyare, ko wasu abubuwan da aka hatimi tare da ƙarancin sharewa. DFM ya kamata ya haɗa da nazarin tattara tarin haƙuri a kowane ASME Y14.5 don tabbatar da dacewa da taro.
5. Alama da Ganewa
DFM dole ne ya samar da fili mai lebur ko a hankali don alamar UDI. Mafi ƙarancin yanki ya dogara da hanyar ɓoyewa - alamar 2D DataMatrix yana buƙatar kusan mm 5 × 5. Dole ne a yi wa alama ba ta ɓata mutuncin tsari ko daidaituwar halittu ba.
Don duba dabarun ƙira kayan aiki na musamman ga aikace-aikacen likita, duba mu jagorar kayan aikin hatimin ƙarfe.
Ingancin Inganci a Tambarin Na'urar Lafiya
Kula da inganci a cikin hatimin likitanci yana bin tsarin hana-gano-daidaitaccen samfurin da aka saka a cikin tsarin ingancin ISO 13485.
- Tabbatar da kayan abu mai shigowa - Tabbatar da sinadarai da injina akan ƙayyadaddun ASTM/ISO; takardar shaidar yarda (CoC) daga masana'anta.
- Tabbacin Tsari - IQ/OQ/PQ ladabi ga kowane tsari na tambari. An kulle sigogi masu inganci; duk wani canji yana haifar da sabuntawa.
- In-aiki dubawa - SPC akan ma'auni mai mahimmanci; dubawa na gani don lahani na saman; dubawar hangen nesa ta atomatik don sassa masu girma.
- Dubawa ta ƙarshe - 100 % dubawa akan mahimman abubuwan tsaro; Samfurin tushen AQL ta ISO 2859-1 don abubuwan da ba su da mahimmanci.
- Gwajin biocompatibility - Ta hanyar TS EN ISO 10993 (cytotoxicity, hankali, fushi) don sabbin kayan, sabbin masu kaya, ko canje-canjen tsari waɗanda ke shafar sinadarai na saman.
- Haɗin kai - Idan ɓangaren hatimi ya ƙare, DFM dole ne ya tabbatar da kayan da lissafi sun dace da ingantacciyar hanyar haifuwa (steam, EtO, gamma, e-beam).
Don cikakkun hanyoyin dubawa, duba jagorar mu akan karfe bugawa ingancin iko.
Likita vs. Aerospace bugawa: Maɓalli Maɓalli
Injiniyoyin da ke aiki a cikin masana'antu da aka tsara za su sami daidaici masu amfani - da bambance-bambance masu mahimmanci.
| Factor | Likita bugawa | Aerospace bugawa |
|---|---|---|
| Direba na farko | Amintaccen haƙuri + bioacompatibility | Mutuncin tsari + cancantar iska |
| Tsarin inganci | ISO 13485 / FDA 21 CFR 820 | AS9100 / Nadcap |
| haƙuri | ± 0.005-0.025 mm | ± 0.025-0.050 mm |
| buƙatun ɗaki mai tsabta | gama gari (ISO 7-8) | Rare |
| Material mayar da hankali | Abubuwan da suka dace (316L, Ti, CoCr) | Babban ƙarfi-zuwa nauyi (Al, Ti, Inconel) |
| Binciken | UDI + yawan ganowa | Lot traceability + serial |
| Haɗin kai | Ana buƙata don dasawa/mazama | N/A |
| Juzu'i | 1,000-10,000,000/shekara | 100-10,000/shekara |
Farawa da Ayyukan Tambarin Na'urar Lafiya
Idan kuna samo abubuwan hatimi don na'urar likita, bi waɗannan matakan don saita aikinku don samun nasara:
- Ƙayyade hanyar tsari - Shin na'urar ce Class I, II, ko III (FDA) ko Class I, IIa, IIb, ko III (EU MDR)? Rarraba yana ƙayyade matakin shaida da binciken binciken da ake buƙata.
- Ƙayyade abu da daraja - Yi amfani da zane-zanen ASTM ko ISO (misali, ASTM F138, ba kawai "316L") ba. Ƙayyade aikin narkewa (VAR, VIM+ESR) idan an buƙata.
- Ƙaddamar da ƙima mai mahimmanci da haƙuri - Yi amfani da GD&T kowane ASME Y14.5. Gano waɗanne fasali ne masu mahimmanci-to-aminci (CTS) vs. m-to-quality (CTQ).
- Tsare-tsare don tabbatar da tsari - Kasafin kudi don ka'idojin IQ/OQ/PQ da kuma duba labarin farko. Wannan yawanci yana ƙara makonni 4-6 zuwa lokutan samarwa na farko.
- Ƙayyade ƙayyadaddun tsaftacewa da marufi - Rago iyakoki, iyakoki na bioburden, da tsarin marufi dole ne a kafa kafin fara samarwa.
Fahimtar tushen tsarin yin tambari yana taimakawa wajen daidaita cancantar mai siyarwa. Karanta gabatarwar mu ga tambarin karfe don bango. Shirya don tattauna buƙatun buga tambarin na'urar likitan ku? Tuntuɓi Metal Stamping Parts Ltd don bita da ƙididdiga na DFM.
Tambayoyin da ake yawan yi
Wane tsarin inganci ake buƙata don tambarin ƙarfe na kayan aikin likita?
ISO 13485:2016 shine tsarin kula da ingancin inganci na duniya don masana'antun na'urorin likitanci. A cikin Amurka, masu siyarwa dole ne su bi FDA 21 CFR Sashe na 820 (Dokar Tsarin Tsarin inganci). Don kasuwannin EU, ana buƙatar bin MDR 2017/745. Yawancin masu samar da kayayyaki suna bin takaddun shaida na MDSAP don gamsar da kasuwannin tsari da yawa tare da duba guda ɗaya.
Waɗanne haƙuri za a iya samu a yin tambarin na'urar likita?
bugawa na'urar likita akai-akai yana samun ± 0.005 mm (± 0.0002 in.) akan abubuwa masu mahimmanci kamar diamita na rami, kaurin bango, da saman rufewa. Wannan yana buƙatar madaidaicin kayan aiki na ƙasa, ƙwanƙwasa servo-kore tare da ± 0.005 mm maimaitawa, yanayin samar da zafin jiki (20 ± 1 ° C), da CMM dubawa tare da daidaiton ƙananan micron.
Wadanne kayan ne suka dace da tambarin na'urar likita?
Mafi yawan amfani da biocompatible kayan hati sun hada da bakin karfe 316LVM (ASTM F138), titanium CP Grade 2 da Ti-6Al-4V ELI (ASTM F136), MP35N (ASTM F562), Elgilol (ASTM F105), da kuma Nistin F105. Duk dole ne su wuce gwajin kwatankwacin halittu na ISO 10993 (cytotoxicity, hankali, fushi) don tsawon lokacin tuntuɓar haƙuri da nau'in.
Menene UDI kuma me yasa yake da mahimmanci ga abubuwan da aka hatimi na likita?
UDI (Tsarin Na'urar Musamman) tsari ne wanda FDA (21 CFR Sashe na 830) da EU MDR suka ba da izini na musamman ga kowace na'urar likita. Don abubuwan da aka hatimi, bayanan UDI - gami da lambar ƙuri'a, lambar serial, da kwanan wata masana'anta - dole ne a iya gano su kuma ko dai a yi musu alama kai tsaye a ɓangaren (don na'urorin da za a sake amfani da su) ko a kan marufi (don zubarwa).
Menene bambanci tsakanin ISO 13485 da FDA 21 CFR 820?
ISO 13485 misali ne na kasa da kasa da aka sani a duk duniya, yayin da FDA 21 CFR 820 keɓaɓɓen ƙa'ida ce ta Amurka. Suna rufe ƙasa iri ɗaya - sarrafawar ƙira, ingantaccen tsari, CAPA, sarrafa takardu - amma sun bambanta da takamaiman buƙatu. Misali, FDA na buƙatar bayar da rahoton na'urar likita (MDR) don abubuwan da ba su da kyau, yayin da ISO 13485 ke buƙatar rahoton faɗakarwa ta kowace hukuma mai zartarwa. Yawancin masu samar da kayayyaki suna daidaita tsarin ingancin su zuwa tsarin duka biyu don hidimar kasuwannin duniya.