Medical Device tëggin metal ci matris defar ay komponent yuñ defaree ci anam wu jaar yoon ngir jumtukaayi chirurgie, aparey yuñ mëna implante, jumtukaayi saytu feebar, ak sistem yuy joxe drog — aplikaasioŋ yu am njariñ ci diggante implant ak implantation mën na nekk 0. ñàkka mëna liggéey ci biir yaram wi. Defar bu wuute ak yeneen yi, tëggin medikaal dafa wara méngoo ak li ñuy laaj ci biocompatibilité, audit yu bawoo ci FDA ak mbootaay yiñ yëgal, ak sàrti dokimaa yuy toppu pàcc bu nekk ci tàngooru macceer bu bees bi.
Gis-gis bii dafay wax ci jumtukaay yi, kaadar yiñ tëral, li ñuy seentu ci muñ, li ñuy laaj ci néeg bu sell, ak wareefu toppu biy màndargaal tëggin aparey medikaal. Yaakaar naa ni ingénieur nga buy defar jumtukaayu chirurgie bu bees wala kilifa jëndkat bu yelloo furnisër buy stampe, royuwaay bii daf lay jox fondaasioŋ teknik bi nga soxla.
Luy stampu wen
Aparey medikaal tëggin wen xeetu formaasioŋ la buy soppi tóol biocompatible ci jumtukaayi medsin, aparey implantable, ak jumtukaayi diagnostic jëfandikoo matris yuy yokk, matris toxal, wala jumtukaayi fineblanking. Dafay laaj sistemu kalite bu ISO 13485 sertifiye, anam yu baax, tolerans yu néew 0.01 mm ci màndarga yu am solo, ak mëna toppu macceer bu mat sëkk daale ko ci sertifikaa moulin bi ba ci wàll wi jeex.
Sosiete yu melni Metal Stamping Parts Ltd toppatoo infrastructure cleanroom, sertifikaasioŋ yuñ yamale, ak kàttan yiñ soxla ngir mëna joxe paj miñ tampoon.
Jumtukaayi estampoŋ pajum: Dëppoo ak njariñ
Tannub jumtukaay ci tëggin medikaal mingi njëkka aju ci biocompatibilite - jumtukaay bi warul jur tontu bu toxic, immunogenic, wala carcinogenic su amee tisu nit wala ndox. Tablo bi ci suuf dafay méngale aleage tëggin yiñ gëna jëfandikoo ci wàllu pajum.
| Alloy | Tur yiñ gëna xam | Force de traction (MPa) | Dëppoo ak dundu (ISO 10993) | MRI Compatibility | Aplikaasioŋu pajum |
|---|---|---|---|---|---|
| Acier inoxydable 316L | ASTM f138, ASTM F139, AISI 316LVM | 480–620 | Baaxna — taarix bu yàgg ci jëfandikoo implant | Wareef (mën na am ay mbiri ferromagnetik) | Jumtukaayi chirurgie, plaques osseux, agrafes, moyeu à aigule |
| Titanium CP 2 / 4 | ASTM F67, ASTM F1581 | 345–550 | Dafa baax - baaxna ci boole yax yi | Fully compatible (non-ferromagnetic) | Implant dentaire, plaque cranienne, cages épinières |
| Titanium Ti-6Al-4V ELI | ASTM F136, ISO 5832-3 | 860–965 | Excellent — standard implant alloy | Fully compatible | implant orthopédique, wecci yax yi, jumtukaayi chirurgie |
| MP35N | ASTM F562, UNS R30035 | 800-1,100 (màgget) | Nikel-kobalt-krom-molibdeen | Conditional | Ressorts implantables, aparey de fixation, composants cardiaques |
| Elgiloy (co-cr-ni-mo) | ASTM F1058, UNS R30003 | 860-1,200 (am) | Xereñ | Conditional | Fiil yiy tegtal, kadre stent, arcfiil ortodontik |
| Nitinol (Niti) | ASTM f2063 | 895-1100 (austenit) | Baaxna — jaar-jaar klinik bu yaatu | Conditional | Stent, kable njiit, kable ortodontik, filtre vaskulaire |
| Tantalum | ASTM F560 | 200–400 | Baaxna — bioinert | Fully compatible | Defar fi yaxxu ci boppu bi, bande marqueur, boîtier condensateur |
Mbir yu am solo yiñ wara bàyyi xel
- 316LVM (Fous à vide) mooy jumtukaay bi ñuy jëfandikoo ngir jumtukaayi operaasioŋ yuñ mënul implante ak aparey yu bari yuñ mëna implante. Prosedur melting bi ci vide dafay wàññi limu ciy boole, gëna baaxal dundu coono ak baña yàqu. Mooy tànneef biocompatible bi gëna xéewale ngir tëggin bu bari.
- Ti-6Al-4V ELI (Interstitiel yu gëna suufe) mooy standard biñ gëna jëfandikoo ngir implant orthopédique yuy yàgg. Module elastisite bi (~110 GPa) moo gëna jege yag (~20 GPa) ak aleaasioŋ kobalt (~210 GPa), muy wàññi kaaraange stress. Waaye, titanium jafe na tampon - dafay laaj forme bu tàng ngir jëmm yu jafee xam te dafay indi màngat bu metti ci jumtukaay yi.
- MP35N dafay boole mbañeelu corrosion bu amul fenn ak doole ju bari ak dundu coono bu baax. Mooy meceer biñ gëna tann ngir ressort implantable ak aparey fixation fu 316L ñàkk doole ju doy. Nikel bi ci nekk (35%) dafay laaj ñu xoolaat bu baax ndax mën na ànd ak ISO 10993.
- Nitinol dafay wane jafe-jafe yu amul fenn ci estampoŋ ndax limu mëna fàttaliku jëmm ji ak limu mëna elastike lool. Dafa wara am ay jafe-jafe ci diir bi ñuy forme, te fàww ñu defar ko ci tàngoor bu jaar yoon (defar jëmm) ci 400 ba 550 °C ngir mëna prograam geometrie biñ soxla.
Ngir dëkkuwaayi aparey medikaal yu jaffe ak boîtier yi, tëggin bu xóot tëggin dafay joxe xeetu jëmmal bu baax ngir jëmmal jëmmu silindrik ak jëmmu boyet ci asiye inox wala titanium.
Topp sàrt yiñ tëral: ISO 13485, FDA 21 CFR 820, ak CE MDR
Furnisëru estampoŋu aparey medikaal yi ñu ngi liggéey ci biir kaadar buñ tëral bu bari ay diisaay. Regle du luñu la mëna tànn — yoon moo ko wara njëkka def ngir mëna jaay ci marse yuñ yamale.
| Kadar | Ki ko joxe | Yaatuwaayu gox | Core Matuwaay yi | Bariwaayu xool |
|---|---|---|---|---|
| ISO 13485:2016 | ISO / accredited registrar | Àdduna bi (ñu nangu ko ci 170+ réew) | Sistemu Yorandi Kalite ci aparey medikaal yi; | Wottu at mu nekk; Sàrtifikaasioŋ bu bees bu 3 at |
| FDA 21 CFR pàcc 820 | Amerique | Etats Unis | Reglemaasioŋ Sistemu Kalite (QSR); Kontrôlu jëmmal, defar ak saytu liggéey, jëf ju jub ak fàggu, etiketu, dokimaa | Saytu ñaari yoon ci at (li ñuy faral di def); saytu ndax luñu ko soxlaa |
| MDR 2017/745 | Komisoŋu Ëroop / Baŋxaas yiñ yëgle | Barabu koom-koomu Ëroop | Këyitu xarala, jàngat klinik (MEDDEV 2.7/1), wattu ginaaw marse, UDI, ràññeekaay bu benn aparey, bindu EUDAMED | Buñu sukkandikoo ci kalendriye audit bu Baŋxaas biñ yëgle (dafay am at mu nekk) |
| MDSAP (Prograamu benn xool aparey pajum) | Bañkat yiy dalal (Etats Unis, Canada, Brésil, Australie, Japon) | Juroom réew yu bokk ci mbootaay mi | Benn audit buy tënk sàrti bépp dalalkat bu ci bokk; wàññi li ñuy saytu ci furnisër yu bari | At mu nekk |
| ASTM F86 | ASTM internasional | FDA ak ISO ñoo ko jox royuwaay | Standard ngir waajal kaw suuf ak pasif jumtukaayi chirurgie asiye inox | Per lot |
Lu loolu tekki ci furnisër yiy stampe
- Liggéeyukaay yiy saytu (IQ/OQ/PQ) mënul ñàkk. Bépp liggéeyu tëggin buy defar ay komponent medikaal dañu ko wara firndeel ak protokolu Kalifikaasioŋ Instalaasioŋ, Kalifikaasioŋ Liggéey, ak Kalifikaasioŋ Performaas. Dañuy laaj ñu xoolaat bu baax sudee jumtukaay yi, macceer yi wala parametru prosedur yi dañu soppeeku.
- Kontrolu jëmmal jëfandikoo sudee furnisër biy stampe dafa bokk ci jëmmal aparey bi. Ba ci defarkati kontraa yu sell yi dañu wara tëye fichier taarixu jëmmal (DHF) yuy wane ni cër biñ tampone bi di daje ak jëmmal jëmmal aparey bi.
- CAPA (Jëf ngir saafara ak moytu) sistem yi dañu wara bind, ak jàngat root-cause (lu melni, 8D, fishbone, 5-Lu tax) ak xool njariñ li ci bépp jëf ju jub.
Ci Metal Stamping Parts Ltd, sunu sistemu kalite bu am sertifikaa ISO 13485, ak liggéeyukaay biñ bind ci FDA.
Njàngat yiñ tëral ngir tëggin pajum
Toleransu tëggin aparey medikaal bokk na ci yi gëna tar ci bépp liggéey. Fàww piyeesu aerospace yi dañuy laaj ±0.025–0.050 mm, piyeesu medsin yi - rawatina ci aparey yiñ mëna implante ak yi ñuy operate - dañuy laaj ±0.005 mm (±0.0002 in.) ci màndarga yu am solo.
| Melokaan defar | Pajum général | Implantable / Surgical | Saaga yi |
|---|---|---|---|
| Diametru pax mi | ±0.025 mm | ±0,005 mm | Critical for fastener interference fits and fluid flow |
| Mur épaisseur (pièces dessinées) | ±0,050 mm | ±0,010 mm | Dafay indi jafe-jafe ci njubteg jumtukaay bi ak ci joxe drog ci anam wu jaar yoon |
| Surface flatness (per 25 mm) | 0.025 mm | 0,005 mm | Dafay am solo ngir surface yiy tënk, interface yiy boole |
| Angular tolerance | ±0.5° | ±0.1° | Dafay am solo lool ngir boole jumtukaayi operaasioŋ yi |
| Rayon bord | 0,05 mm simili | 0.02–0.05 mm | Boor yu ñaw yi dañuy yàq tisu bi; |
| Rugosité surface (Ra) | 0.8 μm | 0.2–0.4 μm | Ra bu wàññeeku dafay wàññi adhésion bakteri yi ba noppi gëna yombal setal bi |
±0.005 mm Tolerans
Defar stamps medikaal ci ±0.005 mm dafay laaj jumtukaay yu jaar yoon, doxal liggéey bi, ak mëna natt:
- Jumtukaay yu ndaw — Dañu dagg fiil EDM ci ±0.002 mm, ñu polise ko ci seetu ba Ra 0.05 μm. Jumtukaay yu melni ASP-23 wala carbure ñooy standard.
- Bësal tànneef - Press mekanik wala hydraulique yu am njariñ ci ±0.005 mm. Press yiy dawal servo yi dañuy may tànki diapozitif yuñ mëna prograam ngir forme yu jafee toppalante.
- Xool environmaa bi - Barab yi ñuy liggéey dañuy saytu tàngoor wi ba 20 ± 1 °C. Yaatuwaayu tàngoor ci jumtukaayi asiye mingi tollu ci 11 μm/m/°C - coppite 3°C dafay indi njuumte 33 μm/m, lu ëpp ±0.005 mm tolerans ci 75 mm.
- Metrologie - CMM yu am njubte bu 1,5 + L/333 μm wala gëna. Sistem optik yu amul laal (scanner laser, sistem gis) ngir mbir yu woyof yu sonde mënu laal.
- SPC ak Cpk bu yéeg - OEM yi ci aparey medikaal yi dañuy laaj Cpk ≥ 1.67 ci dimension yu am solo, ak ñenn ñuy laaj Cpk ≥ 2.0.
Cleanroom Production Matuwaay yi
Lu bari ci aparey medikaal yi — rawatina aparey yiñ mëna implante, joxe garab yi, ak saytu feebar yi — dañu leen wara defaree ci barab buñ saytu ngir moytu particule wala contamination biologique.
Cleanroom Classifications
| Standard | Equivalent | particules yu gëna bari ≥0.5 μm/ft3 | Application typique |
|---|---|---|---|
| ISO 14644-1 Klaas 7 | FED-STD-209E Klaas 10,000 | 352,000 | Montage aparey médical général, jumtukaayi operaasioŋ |
| ISO 14644-1 Klaas 8 | FED-STD-209E Klaas 100,000 | 3,520,000 | tëggin and forming operations for non-implantable devices |
| ISO 14644-1 Class 5 | FED-STD-209E Class 100 | 3,520 | Implantable device packaging, final assembly of drug-jokkoo components |
Xeetu estampoŋ ci saal bu sell
- Dedicated cleanroom presses — Press yi dañu leen tëj ci biir néeg yu sell, am ngelaw luñu filtre HEPA. Lubrifiant yi dañu wara am grade medikaal, amul toxic, te mën nañu ko dindi lépp.
- Kontrolu particule — Piyees yiñ estampone dañu leen di raxas ci ultrason ci biir ay pexe yu setal yuñ gëm ginaaw bi ñu leen raxasee. Saytu setal bi dafay wane ni particule yi des ak bioburden yi matnañu ay yam yuñ tëral.
- Protokolu yéere — Operatër yi dañuy sol yéere yu sell (rob, gant, masku kanam, kawar) te dañuy jaar ci duusu air balaa ñuy dugg ci barab yiñ saytu.
- Xool environmaa bi — Limu particule yu wéy, tàngoor, ak bind ci niir. Done yi dañu leen di denc ci done taarixu aparey bi (DHR).
Màndarga toppu jumtukaay ak UDI
Yoon dafa santaane ñu mëna topp ci aparey medikaal yi, te mën nañu ko saytu. Dafay boole bépp cër buñ tampoon ak fiñu ko jëlee, anam wi ñu koy defaree, ak malaad bi.
Mën toppu macceer
- Mill certifications dafa wara méngoo ak tegtali jumtukaayi ASTM wala ISO (lu melni, ASTM F138 ngir grade implant chirurgikaal 361L). Composition chimique bi, màndarga mekanik yi, microstructure yi, ak ëmbiitu liñu ci boole dañu leen di xamle.
- Tàqale lu bari — Lotu macceer yu bees yi dañu leen di tàqale ci biir liggéey bi yépp, daal di leen etikete. Nimero lot yi ñu ngi leen yor ci tukkikat yi, komàndu liggéey yi ak ràññeekaay yiñ jeexal.
- Chain of custody - Documented handoffs jot ci saytu → dencukaay → fomp → forme → jeexal → saytu → emballage → yobbu. Bépp jàll dañu koy bind ak bis bi, operatër bi ak royuwaayu lot bi.
ràññeekaay aparey (UDI)
Sistem UDI bu FDA (21 CFR pàcc 830) ak base de done EUDAMED bu EU MDR dañuy laaj bépp aparey medikaal mu am benn ràññeekaay bu lëkkale ak base de done global bu leeral yi ci aparey bi.
| Àndaaleb UDI | Tegtal | tëggin Relevance |
|---|---|---|
| ràññeekaay aparey (DI) | Dafay xàmmee model/versioŋu aparey bi ak etiket bi | Dañu ko jox famiy produit biñ tampoon |
| Xammekaayu liggéey (PI) | Done yu mën soppiku: nimero lot, nimero serie, bisu defar, bisu jeex | Dañu ko tampoon wala laser ci wàll wi wala ci emballage bi |
| UDI Porteur | Kod buñ mëna jàng ci masin (kodu bar, RFID, 2D DataMatrix) | Dañu koy def ci màrku laser, gravure, wala etiket buñ tampoon |
agrafes, clips, moyeu à souilles), UDI dañu koy gëna jëfandikoo ci niveau emballage bi moo gën ñu koy jëfandikoo ci pàcc yi. Ngir jumtukaayi chirurgie yuñ mëna jëfandikoowaat ak aparey yuñ mëna implante, fàww ñu def màrku direct (DPM) jaaraleko ci gravure laser.
DFM ngir tëggin aparey médical
Nafar ngir defar ci aparey medikaal dafa wara bàyyi xel ci sàrti sàrt yi, biocompatibilité, ak sàrti liggéey yi amul ci yeneen liggéey.
1. Biocompatibilite-Driven Surface Wareef
Piyees yiñ stampe medikaal dañu wara baña am benn sikk ci kaw gi lu mëna tëye bakteri wala luy mettiloo tisu bi. Loolu dafay tekki:
– Amul benn boor bu ñaw wala ay boor — fàww ñu saytu anam yi ñuy dindi ay bour.
– Ra ≤ 0.8 μm ci surface yiñ mënul implante ak Ra ≤ 0.4 μm ci surface yiñ mëna implante.
- Pasivaasioŋ ci ASTM A967 wala ASTM F86 ngir asiye inox ngir dindi wen wu amul benn couche oxide chromium.
2. Li ñuy laaj ngir wàcce stress
Aleage medikaal yu bari (316L, Ti-6Al-4V, MP35N) dañu soxla pajum tàngoor buy wàññi stress ginaaw bi ñu forme sedd ngir moytu stress-corrosion xar xar ak coono bu teel. DFM dafa wara ànd ak coppite yi am ci dimension (~0.05–0.10%) yiy am ci diir bi ñuy wàcce stress.
3. Setluwaay buy méngoo
Geometri pàrti dafa wara may setal bu baax. Poos yu xóot yi, pax yu nëbbu yi, ak xar-xar yu sew yi dañuy jàpp residu yi ak contaminants biologik yi. DFM war na wàññi màndarga yu mel noonu wala joxe yoon ngir ultrasonic setal ak rinse duggug ndox.
4. Interfaasu montage bu jaar yoon
Aparey medikaal yi dañu leen boole ci pàcc yu bari te jaar yoon. Piyees yiñ tampoñ dañu wara ànd ak piyees yuñ defaree masin, moulé wala yeneen piyees yuñ tampoon te amul benn yar bu néew. DFM war na amaale jàngat ci dajale tolerans ci ASME Y14.5 ngir xool ndax dajale bi mën na nekk.
5. Màrk ak ràññeekaay
DFM dafa wara am surface bu dalal wala bu xawa sëgg ngir mëna màrke UDI. Barab bi gëna ndaw bi ñuy màrke mingi aju ci anam wi ñu koy enkodee — màndarga DataMatrix 2D dafay laaj lu tollu ci 5 × 5 mm ci gëna ndaw. Màrking warul yàq njubteg jumtukaay bi wala biocompatibilite bi.
xoolal sunuy jumtukaayi jëmmal metal jumtukaayi matris guide.
Xool kalite ci tëggin aparey medikaal
Kontrôlu kalite ci estampoŋ medikaal dafa topp xeetu moytu-gis-jub buñ samp ci sistemu kalite ISO 13485.
- Incoming material verification - Xam-xam chimik ak mekanik ci wàllu ASTM/ISO; sertifikaa di wane ni dañu méngoo (CoC) ci moulin bi.
- Process validation - Protokol IQ/OQ/PQ ngir bépp liggéeyu tëggin. Parametre yiñ siiwal dañu tëju; bépp coppite dafay indiwaat.
- Ci biir liggéey — SPC ci dimension yu am solo; xool ak gis-gis ngir gis ndax surface bi amul benn sikk; saytu gis-gis otomatik ngir pièce yu am volume bu rëy.
- Saytu bu mujj — 100% saytu ci man-mani kaaraange yu am solo; Échantillonnage bu sukkandiko ci AQL ci ISO 2859-1 ngir màndarga yi amul benn njariñ.
- Test biocompatibilité — Ci wàllu ISO 10993 (sitotoksisite, yëg-yëg, mer) ngir macceer yu bees, furnisër yu bees, wala coppite ci liggéey biy indi jafe-jafe ci chimie surface bi.
- Dëppoo ak sterilisasioŋ — Sudee wàll wiñ tampoon dañu ko sterilisé bamu jeex, DFM dafa wara fexe macceer bi ak geometrie bi méngoo ak njuréefi sterilisasioŋ biñ gëm (vapeur, EtO, gamma, e-beam).
Ngir xam anam yi ñuy saytoo bu baax, xoolal sunu tegtal ci tëggin metal ci matris quality control.
Pajum vs. Stampage aérospatiale: wuute yu am solo
Ingénieur yiy liggéey ci liggéeyukaay yuñ yamale dina ñu gis ay mbir yu am njariñ yuy méngoo — ak ay wuute yu am solo.
| Facteur | Medical tëggin | Aerospace tëggin |
|---|---|---|
| Dawalkat bu njëkk biy yamale | Kaaraange malaad + méngoo ak dundu | Structural integrity + airworthiness |
| Baaxaay system | ISO 13485 / FDA 21 CFR 820 | AS9100 / |
| Muñ | ±0,005–0,025 mm | ±0,025–0,050 mm |
| Cleanroom requirement | Common (ISO 7–8) | Jafe |
| Focus matériel | Biocompatible (316L, Ti, CoCr) | Al, Ti, Inconel |
| Toppu | UDI + toppu lot | Lot traceability + serial |
| Dëppoo ak sterilisasioŋ | Required for implantable/invasive | N/A |
| Volume | 1000–10000000/at | 100-10,000/at |
Tàmbali ay projet de tëggin ci aparey pajum
Sooy jënd ay komponent yuñ tampoon ngir benn aparey medikaal, toppal yii tegtali ngir mëna defar sa projet mu am ndam:
- Mandargal yoonu yamale - Ndax aparey bi Klaas I, II, wala III (FDA) wala Klaas I, IIa, IIb, wala III (UE MDR)? Xeetu xaaj bi mooy wane ni firnde yi ak saytub audit bi di doxee.
- Mandargal jumtukaay bi ak grade bi - Jëfandikool ASTM wala ISO (lu melni, ASTM F138, du "316L" kese). Mandargal anam yi ñuy jëfandikoo ngir seey (VAR, VIM+ESR) su ko jaree.
- Defar dimension yu am solo ak tolerans - Jëfandikool GD&T ci ASME Y14.5 bu nekk. Xaarandil man-man yi gëna am solo ci kaaraange (CTS) ak gëna am solo ci kalite (CTQ).
- Waajal ngir saytu liggéey bi — Budget ngir protokol IQ/OQ/PQ ak saytu xët wi njëkk. Loolu dafay yokk 4 ba 6 ayu-bis ci kalendriye liggéey bi.
- Mandargal setal ak ëmb — Dañu wara am yamaleg particule yi des, yamaleg bioburden yi, ak xeetu emballage bi laataa ñuy tàmbali liggéey bi.
Xam li gëna am solo ci anamu estampoŋ bi dina tax nga am kàttan furnisër bu yomb. Jàngaleel sunu duggal ci estampage wen ngir lëndëm. Waajal nga waxtaan ak yeen ci seeni sàrti tëggin aparey medikaal? jokkoo Metal Stamping Parts Ltd ngir jàngat DFM ak devis.
Laaj yu ñuy faral di laaj
Ban sistem kalite lañu soxla ngir stampe wen ci aparey medikaal yi?
ISO 13485:2016 mooy sistem bi gëna am solo ci àdduna bi ngir defarkati aparey medikaal yi. Ci Etats Unis, furnisër yi dañu wara topp FDA 21 CFR pàcc 820 (Sàrti Sistemu Kalite). Ci marse EU, fàww ñu topp MDR 2017/745. Furnisëer yu bari dañu topp sertifikaasioŋ MDSAP ngir mëna satisfaire marse yu bari yuñ yamale ci benn audit.
Ban tolerans lañu mëna am ci tëggin aparey medikaal?
Aparey medikaal biy stampe dafay yegg ±0.005 mm (±0.0002 in.) ci anam yu am solo yu melni diametre pax mi, yaatuwaayu miir yi, ak surface yiy tëju. Loolu dafay laaj jumtukaayi suuf yu jaar yoon, pres yu servo-driven ak ±0.005 mm repeatability, environmaa yi ñuy saytu tàngoor (20 ± 1 °C), ak saytu CMM ak sub-micron njub.
Yan mbir ñooy biocompatible ngir stampe ay aparey medikaal?
Biocompatible bi gëna bari luñu koy jëfandikoo mooy asiye 316LVM (ASTM F138), titane CP Grade 2 ak Ti-6Al-4V ELI (ASTM F136), MP35N (ASTM F562), El F2063). Ñoom ñépp dañu wara jàll test biocompatibilité ISO 10993 (cytotoxisite, sensibilisasioŋ, metit) ci diir bi ñu bëgga jëflante ak malaad bi ak xeetu malaad bi.
Luy UDI ak lu tax mu am solo ci paj miñ tampoon?
UDI (Xammekaayu Aprey bu Benn) sistem la bu FDA santaane (21 CFR Wàll 830) ak EU MDR buy jox bépp aparey medikaal benn xàmmeekaay. Ci wàllu komposant yiñ tampoon, done UDI yi - boole ci nimero lot bi, nimero serie bi, ak bisu defar bi - dañu wara mëna toppu, ñu mën ko màrke ci piis bi (ngir aparey yuñ mëna jëfandikoowaat / implantable) wala ci emballage bi (ngir aparey yuñ mëna jefandikoo).
Lan mooy wuutale ISO 13485 ak FDA 21 CFR 820?
ISO 13485 sàrt la bu àdduna bi yépp nangu, waaye FDA 21 CFR 820 sàrt la buñ jagleel Etats Unis kese. Dañuy muur suuf su noonu - njiitu jëmmal, gëmloo liggéey, CAPA, njiitu këyitu - waaye wuute ci ay sàrt yuñ laaj. Ci misaal, FDA dafay laaj rapoor ci aparey medikaal (MDR) ngir jafe-jafe yi, waaye ISO 13485 dafay laaj rapoor ci wàllu paj ci kilifa yi ko yor. Furnisëer yu bari dañuy méngale seen sistemu kalite ak ñaari kaadar yi ngir mëna jàppale marse àdduna bi.