- I-FDA, i-EU MDR, kunye ne-ISO 11607 zenza imfuneko yokuthobela imithetho enamanqanaba amathathu apho i-ISO 11607 isebenza njengesiseko sobugcisa esiqhelekileyo, kodwa i-FDA 21 CFR Part 820 yongeza iimfuno zokuqinisekiswa kwenkqubo kwaye i-EU MDR 2017/745 yongeza iimfuno zokhuseleko lweekhemikhali kunye nokuzinza ezingahlangabezaniyo ne-ISO 11607 yodwa.
- Eyona nto ixhaphakileyo ebangela ukulibaziseka kwe-510(k) enxulumene nokupakisha kukunganeli kwedatha yokuqinisekiswa kwesithintelo esingenazintsholongwane — ngokukodwa, uvavanyo lwamandla esitywino olufumene iisampulu zamanqaku ama-3 kuphela endaweni yovavanyo oluqhubekayo lokuxobuka kumjikelezo opheleleyo wesitywino.
- Inqaku le-EU MDR 10(9) ngoku lifuna abavelisi ukuba babhale phantsi kwaye banciphise iingozi ezivela kwizinto ezinobungozi kwizixhobo zokupakisha — imfuneko echaphazela ngokuthe ngqo ukukhethwa kwefilimu kwaye ikhetha iinkqubo zokuthintela ezingenakubola zezinto ezisetyenziswa kwindalo enye okanye ezinokubola njenge-cellulose egqunywe nge-coated.
Kutheni ukuThotyelwa kweMigangatho yoNyango kuyingxaki elawula izinto ezininzi (ayiyo ingxaki esemgangathweni omnye)
Ndilahlekelwe kukwazi ukuba bangaphi oosomashishini bezixhobo zonyango abathe kum, "Ifilimu yethu yokupakisha ihambelana ne-ISO 11607, ngoko ke sikulungele ukuphawulwa kwe-FDA kunye ne-CE." Le ngxelo ityhila ukungaqondani okubalulekileyo endifuna ukukulungisa ngoko nangoko: Ukuthobela i-ISO 11607 kuyimfuneko kodwa akwanelanga kwimvume ye-FDA okanye uphawu lwe-EU MDR CE - kuyahlangabezana neemfuno zokuqinisekiswa kobuchwephesha ezikhankanywa ngabalawuli bobabini, kodwa akukho namnye kubo ojonga ukuthobela i-ISO 11607 njengobungqina bokuba inkqubo yakho yokuthintela intsholongwane iyahlangabezana neemfuno zayo zomthetho.
Indawo yokuthobela imithetho yeefilimu zokupakisha zonyango ngo-2026 ngumceli mngeni onamajukujuku amathathu ofuna ukuba abavelisi bezixhobo zonyango bahlangabezane nezi zinto zilandelayo: (1) Umgaqo weNkqubo yoMgangatho we-FDA 21 CFR Icandelo 820 wezixhobo ezithengiswa eMelika, (2) Umgaqo weZixhobo zonyango ze-EU 2017/745 wezixhobo ezithengiswa kwi-European Union, kunye (3) I-ISO 11607-1:2019 kunye ne-ISO 11607-2:2019 njengomgangatho wobugcisa ohambelanayo osetyenziswa ngabalawuli bobabini njengomlinganiselo wokuqinisekiswa kwenkqubo yokuthintela engenazintsholongwane. Ngenxa yokuba i-FDA's Quality System Regulation iyalela ulawulo loyilo kunye nokuqinisekiswa kwenkqubo okungaphaya kobubanzi be-ISO 11607, kwaye i-EU MDR yongeza iimfuno zokhuseleko lweekhemikhali phantsi kwe-Annex I General Safety and Performance Requirements (GSPR) ezingajonganiyo ne-FDA okanye ne-ISO 11607, ifilimu yokupakisha eqinisekiswe kuphela kwiindlela zovavanyo ze-ISO 11607 isenokungaphumeleli kwisaziso se-FDA sangaphambi kwemarike okanye uphononongo lwamaxwebhu obuchwephesha e-EU MDR.
Apha kwi-XIADE, sigcina imatrix yokulandelela ukuthobela imithetho echaza imfuneko nganye evela kuyo Inxalenye 820 ye-FDA 21 CFR kwaye I-EU MDR 2017/745 ngokuchasene neendlela zovavanyo ezifanelekileyo ezivela I-ISO 11607. Le matrix iqulethe iimfuno ezingama-47 ezahlukeneyo — apho i-ISO 11607 ijongana ngqo ne-28 (60%), iCandelo le-FDA 820 longeza ezinye iimfuno ezili-11, kwaye i-EU MDR yongeza iimfuno ezisi-8 ezingagutyungelwa yi-FDA okanye yi-ISO 11607. Eli nqaku lihamba ngenkqubo nganye yomthetho emithathu ngokwembono yomthengisi wefilimu yokupakisha oxhase ukuhanjiswa kwezixhobo zonyango ezingama-23 ze-510(k) kunye neepakeji zobuchwephesha zokumakisha ze-8 CE, kwaye ichonga izikhewu ezithile zokuthobela imithetho esizibona rhoqo kwiidosi zokuqinisekisa izithintelo ezingabalulekanga zabathengi bethu.
I-FDA 21 CFR Icandelo 820 — Oko Iinkampani Zezixhobo Zezonyango Zikufunayo Kwiifilimu Zokupakisha
Umgaqo-nkqubo woMgangatho we-FDA, obhalwe kwi Inxalenye ye-21 CFR 820, ayinalo icandelo "lokupakisha" elizinikeleyo. Endaweni yoko, iimfuno zomqobo ongeyintsholongwane zisasazwa kwiinxalenye ezintathu: §820.30 Ulawulo loYilo, §820.70 Ulawulo lweMveliso kunye neNkqubo, kunye ne-§820.130 Ukupakisha izixhobo. Indlela ye-FDA yokuqinisekisa ukupakisha igxile kwinkqubo kunokuba igxile kwizinto eziphathekayo — ifuna ubungqina obubhaliweyo bokuba inkqubo yakho yokupakisha (kubandakanya ukukhethwa kwefilimu, iiparameter zokuvala, kunye nomjikelo wokubulala iintsholongwane) ivelisa umqobo ongenazintsholongwane ohlangabezana neemfuno zoyilo, endaweni yokufuna ukuba izinto zefilimu ngokwazo zithwale isiqinisekiso esithile.
Intsingiselo esebenzayo kubavelisi bezixhobo zonyango kukuba ukuthenga ifilimu yokupakisha ehambelana ne-ISO 11607 kwi-XIADE okanye nakweyiphi na enye inkampani kukuqala komsebenzi wakho wokuthobela i-FDA, hayi ukuphela. Phantsi kwe-§820.30 Design Controls, kufuneka umisele iimfuno zokufaka uyilo lwenkqubo yakho yokuthintela intsholongwane equka: (1) indlela yokubulala iintsholongwane kunye neeparamitha zomjikelo, (2) ubomi beshelufu obucwangcisiweyo, (3) indawo yokusasazwa kunye nokugcinwa (ububanzi bobushushu, uluhlu lomswakama, uluhlu loxinzelelo lomoya lokuthutha umoya), kunye (4) neendlela zokwamkelwa kokuthembeka kwetywina. Phantsi kwe-§820.70, kufuneka uqinisekise yonke indibaniselwano yeparameter yenkqubo yokutywina kunye nesiqinisekiso sokufakelwa (IQ), isiqinisekiso sokusebenza (OQ), kunye nesiqinisekiso sokusebenza (PQ) esithathwa yi-FDA njengelingana nokuqinisekiswa kwenkqubo ye-ISO 11607-2 - kodwa abahloli be-FDA endithethe nabo ngexesha lophononongo lwe-510(k) bahlala becela enye idatha eyongezelelweyo i-ISO 11607-2 engayifuniyo: idatha yamandla okutywina kulo lonke ibhendi yokunyamezela ubushushu epheleleyo yezixhobo zakho zokutywina, kungekhona nje kwindawo ebekiweyo.
Ngowama-2024, i-FDA ikhuphe isilungiso soMgaqo-nkqubo woMgangatho esihambelana neCandelo 820 ngokusondeleyo ne-ISO 13485:2016, endisibona njengophuhliso oluhle kuba Ukulungelelaniswa kwe-FDA QSR kunye ne-ISO 13485 kunciphisa umthwalo woxwebhu kubavelisi abakhonza iimarike zase-US nase-EU — inkqubo enye yolawulo lomgangatho ngoku inokwanelisa zombini abalawuli, ukuba nje iimfuno zokhuseleko lweekhemikhali ze-MDR kunye novavanyo lweklinikhi ze-EU zijongwa ngokwahlukeneyo. Utshintsho oluphambili olunxulumene nokupakishwa kwi-QSR ehambelanayo yimfuneko ecacileyo yamaxwebhu olawulo lomngcipheko ngokwe-ISO 14971 ejongana ngokukodwa neendlela zokungaphumeleli kwezithintelo ezingengomqobo, ezazichazwe ngaphambili kodwa zingachazwanga ngokucacileyo kwiCandelo 820.
I-EU MDR 2017/745 — Iimfuneko zeNkqubo yoMqobo oyiNgcali eziBamba iiNkampani zingalindelanga
Ukuba iCandelo le-FDA 820 ligxile kwinkqubo, i-EU MDR 2017/745 igxile kumngcipheko — kwaye ibeka iimfuno zenkqubo yokuthintela engenazintsholongwane ezidlula kakhulu oko kuboniswa kukuqinisekiswa kwe-ISO 11607 kuphela. I-EU MDR Annex I, Iimfuneko zoKhuseleko kunye nokusebenza ngokubanzi (GSPR) Icandelo 11.4 lifuna ukuba izixhobo eziziswa zikwimeko yokungasebenzi kakuhle kufuneka "zipakishwe kwinkqubo egcina ukungasebenzi kakuhle phantsi kweemeko zokugcina, ukuthuthwa, kunye nokuphathwa ezichazwe ngumvelisi," kwaye iCandelo 10.4 lifuna ukuba izixhobo zokupakisha "zingakhuphi izinto ezinokuphazamisa ukhuseleko okanye ukusebenza kwesixhobo" - imfuneko yokhuseleko lweekhemikhali engenakuthelekiswa ngokuthe ngqo nomgaqo we-FDA okanye i-ISO 11607.
Ndibone uphononongo lwemibhalo yobuchwephesha emithathu yokumakisha i-CE lukhatywa ngokukodwa ngenxa yokungahambelani kwe-GSPR okunxulumene nokupakishwa. Eyokuqala: umenzi owayeqinisekisile isikhwama sakhe se-PE/EVOH/PE ngokweemfuno ze-ISO 11607 ze-microbial barrier kodwa engakhange anike idatha yokuvavanya izinto ezikhutshwayo kunye neziphumayo ngokwe-ISO 10993-18 ukubonisa ukuba izongezo zokucubungula umaleko we-EVOH azizange zifudukele kwisixhobo ngexesha lokubulala iintsholongwane ze-EO kunye nobomi beshelufu beminyaka emi-3. Eyesibini: umenzi we-spinal implant osebenzise isikhwama se-foil composite esaphumelela zonke iimvavanyo zokusebenza ze-ISO 11607 kodwa umaleko we-aluminium wakhe waphawulwa ngumvavanyi we-Notified Body phantsi kwe-GSPR 10.4 kuba umenzi wayengabhalanga indlela yokuphinda kusetyenziswe i-aluminium okanye wayechaza isizathu sokuba i-laminate yezinto ezininzi ezingaphinda zisetyenziswe yayiyimfuneko kukhuseleko lwesixhobo. Eyesithathu — kwaye le isandicaphukisa — ayizange ivunywe kuba umthengisi wefilimu yokupakisha yomenzi (hayi i-XIADE) wayengenakukwazi ukubonelela ngeSibhengezo sokuVumelana neMithetho yoQhagamshelwano lokutya ye-EU (EC) 1935/2004, nto leyo umvavanyi weNotified Body ayibone ifanelekile phantsi komgaqo wokhuseleko nangona izixhobo zonyango zingalawulwa ngokuthe ngqo phantsi komthetho woqhagamshelwano lokutya.
Inqaku le-EU MDR 10(9) lifuna abavelisi ukuba baseke, babhale phantsi, basebenzise, kwaye bagcine inkqubo yolawulo lomngcipheko ejongana ngqo neengozi ezinxulumene nezinto eziyingozi kwizixhobo - kwaye ngo-2028, isilungiso sePackaging and Packaging Waste Directive (PPWD) 2018/851 kulindeleke ukuba songeze iimfuno ezithile zokusebenziseka kwakhona okanye zokubola kwezinto eziphilayo kwiipakethe zonyango ezithengiswa kwimarike ye-EU. Le vektha yokulawula yeyona inamandla kakhulu kwisakhiwo sayo kwiinkqubo zokuthintela ezisekelwe kwi-cellulose nakwezinye izinto ezibolayo endizibonileyo kwiminyaka yam eli-17 yomsebenzi, kwaye ndilindele ukuba itshintshe ngokusisiseko imakethi yefilimu yokupakisha yezonyango phakathi kowama-2026 nowama-2030.
I-ISO 11607 Deep Dive — Umgangatho woBugcisa ohlangabezana ne-FDA kunye ne-EU MDR
I-ISO 11607-1: 2019 imisela iimfuno zokusebenza kwezixhobo, iinkqubo zokuthintela ezingenakubola ezenziwe kwangaphambili, kunye neenkqubo zokupakisha zezixhobo zonyango ezicociweyo ezingabulaliyo. Yibhulorho yobugcisa phakathi kolindelo lwenkqubo ye-FDA kunye nesakhelo solawulo lomngcipheko se-EU MDR. I-ISO 11607-1 ifuna iindidi ezintlanu zobungqina bokuqinisekiswa kwenkqubo yokuthintela intsholongwane: (1) iipropati zokuthintela iintsholongwane — ixabiso elincinci lokunciphisa iilog ezi-6 kwi-ASTM F1608 nganye kwizinto ezineembobo okanye kwi-ASTM F2638 nganye kwizinto ezingenazo iimbobo, (2) amandla okutywina ≥ 1.5 N/15mm nganye kwi-ASTM F88 kunye nokuhlolwa okubonakalayo kweziphene zesiteshi ngokwe-ASTM F1886, (3) ukuhambelana kwezinto nenkqubo yokubulala intsholongwane — akukho kudilika kweempawu zokuthintela okanye amandla emva kokuvezwa kwidosi ephezulu yokubulala intsholongwane, (4) ukuhambelana kwezinto eziphilayo ngokwe-ISO 10993-1 efanelekileyo kudidi loqhagamshelwano lwesigulana sesixhobo, kunye (5) ukuzinza — idatha yokwaluphala yexesha langempela kunye nekhawulezileyo ebonisa ukugcinwa kweempawu zokuthintela intsholongwane ngexesha lokuphelelwa lixesha.
Oko i-ISO 11607 INGAKUFUNIYO — kwaye lo ngumsantsa obamba iinkampani ngexesha lophononongo lomthetho — bubungqina bokhuseleko lweekhemikhali (i-EU MDR GSPR 10.4), uvavanyo lwempembelelo kokusingqongileyo (iimfuno ze-EU ezivelayo phantsi kwe-PPWD), okanye amaxwebhu okulandelela uthotho lweenkonzo (okufunwa kakhulu ziikhontrakthi ze-GPO zesibhedlele). Ndicebisa wonke umthengi wezixhobo zonyango kwi-XIADE ukuba aphathe ukuthotyelwa kwe-ISO 11607 njengesiseko, ukuqinisekiswa kwenkqubo ye-FDA Part 820 njengeendonga, kunye namaxwebhu e-EU MDR GSPR njengophahla — uyazidinga zonke ezi zintathu, kwaye nganye ijongana nenkalo eyahlukileyo yokuthotyelwa kwenkqubo yezithintelo ezingenazintsholongwane ezingagutyungelwanga zezinye.
Indlela Yokwakha I-Compliance Matrix: Ukuthelekisa iiMarike zakho eziJongiweyo novavanyo olufunekayo
Le matrix ilandelayo yokuthobela imithetho ishwankathela iimfuno ezili-12 ezibalulekileyo ezinxulumene nokupakisha kwi-FDA, i-EU MDR, kunye ne-ISO 11607, kunye neendlela ezithile zovavanyo kunye nemigangatho yokwamkelwa endiyibonileyo abahlaziyi beyamkela kwiingxelo ezingama-31 zomthetho kule minyaka ilishumi idlulileyo.
| Imfuneko | I-ISO 11607 | Icandelo le-FDA 820 | I-EU MDR 2017/745 | Indlela yoVavanyo |
|---|---|---|---|---|
| Umqobo weentsholongwane | Imfuneko (LRV ≥ 6.0) | Ifuneka ngoLawulo loYilo | Ifuneka nge-GSPR 11.4 | I-ASTM F1608 / F2638 |
| Amandla okutywina | ≥ 1.5 N/15mm | Idatha epheleleyo yebhendi yokunyamezelana | ≥ 1.5 N/15mm | I-ASTM F88 + F1886 |
| Ukuhambelana kokubulala iintsholongwane | Kufuneka | Ifuneka ngoLawulo lweNkqubo | Kufuneka | Indlela nganye yokubulala iintsholongwane |
| Ukuhambelana kwezinto eziphilayo | Ye-ISO 10993-1 | Ngokwesixokelelwano ngasinye | Ngokwe-GSPR 10.2 | Uthotho lwe-ISO 10993 |
| Uzinzo / Ubomi beShelufu | Ixesha langempela + likhawulezisiwe | Ixesha langempela + likhawulezisiwe | Ixesha langempela + likhawulezisiwe | I-ASTM F1980 |
| Ukhuseleko lweeKhemikhali | Ayifuneki | Ayifuneki ngokuthe ngqo | Iyimfuneko (GSPR 10.4) | I-ISO 10993-18 |
| Izinto ezikhutshwayo kunye nezinto eziphumayo | Ayifuneki | Ayifuneki | Iyimfuneko (GSPR 10.4) | I-ISO 10993-18 |
| Impembelelo kwiNdalo | Ayifuneki | Ayifuneki | Evelayo (PPWD) | I-LCA ye-ISO 14040 |
| Ukuqinisekiswa kwenkqubo (IQ/OQ/PQ) | Okufunekayo (Icandelo lesi-2) | Kufuneka (§820.70) | Iyimfuneko (GSPR 11.4) | Ngomenzi wezixhobo ngamnye |
| Ulawulo lwengozi | Isalathiso | Kufuneka (uHlengahlengiso lwe-QSR.) | Kufuneka (Isihlomelo I) | I-ISO 14971 |
| Isiqinisekiso soMboneleli | Ayifuneki | Kufuneka (§820.50) | Okufunekayo (Inqaku 10) | Ngokwenkqubo yeQMS nganye |
| Uhlolo lwasemva kweMarike | Ayifuneki | Kufuneka (iingxelo ze-MDR) | Kufuneka (Ukuqapha) | Ngokwenkqubo yeQMS nganye |
Ndicebisa ukuba wonke umenzi wezixhobo zonyango akhe inguqulelo yale matrix ngokwendlela yakhe yokwahlulahlula izixhobo, indlela yokubulala iintsholongwane, kunye neemarike ekujoliswe kuzo. Kwi-XIADE, sibonelela abathengi bethu befilimu yokupakisha yezonyango ngephakheji yedatha yokuthobela imithetho equka iingxelo zovavanyo ezithile kunye nezatifikethi abazidingayo kwiseli nganye yale matrix - kuba ndifunde ukuba ababoneleli befilimu yokupakisha abathumela nje umqulu wefilimu kunye nesatifikethi sohlalutyo abancedi abathengi babo ukuba bafumane imvume yomthetho; bathumela ngaphandle eyona nxalenye inzima yomsebenzi wokuthobela imithetho kubantu abangengabo oososayensi bezinto kwaye abasenokungazi ukuba loluphi uvavanyo abalucelayo.
Iingxaki Eziqhelekileyo Zokuthobela Imithetho Ezikhokelela Ekulibazisekeni kwe-510(k) okanye Ukungavunywa Kwe-CE Mark
Kwiminyaka eli-17 ndixhasa ukungeniswa kwemithetho, ndidwelise ukusilela okuqhelekileyo kokuthobela imithetho elishumi okunxulumene nokupakisha. Nazi ezine eziphambili, kuba zibangela i-78% yazo zonke iindlela zokungavunyelwa kwenkqubo yokuthintela ezingenakutyiwa endizibonileyo:
Ingxaki 1: Uvavanyo lokuqina kwetywina olunemida emithathu endaweni yokuxobuka okuqhubekayo okujikelezayo okupheleleyo. I-ASTM F88 ivumela ukufunyaniswa kwesampuli yamanqaku amathathu kunye nomyinge ochazwe njengamandla esitywino - kwaye abahloli be-FDA kunye ne-EU MDR bobabini bayala le ndlela yokuqinisekiswa kwesithintelo esingenazintsholongwane kuba indawo enye ebandayo ecaleni kwebha yesitywino ye-800mm inokuvelisa amandla esitywino akufutshane angaphantsi kwe-1.0 N/15mm ngelixa umyinge wamanqaku amathathu uxela i-2.4 N/15mm. Zonke izithintelo ezingenakubola endizikhusele ngempumelelo zifuna uvavanyo oluqhubekayo lokuxobuka kwizithuba ze-10mm kuyo yonke imida yesitywina - kungengenxa yokuba umgangatho ufuna njalo, kodwa ngenxa yokuba abahlaziyi bafunde ukuba ukusampula kwamanqaku amathathu kufihla iziphene zesitishi sesitywina ngokucwangcisiweyo.
Ingxaki yesi-2: Ukuqinisekisa kuphela kwiiparameter zesitywina ezimiselweyo ngaphandle kwebhendi yokunyamezelana. Ndibone ukuhanjiswa kwe-510(k) kulibaziseka ngeenyanga ezili-11 kuba umenzi uqinisekisile inkqubo yabo yokutywina isikhwama sefoyile kwi-155°C ± 0°C, kodwa izixhobo zabo zokutywina imveliso bezinotshintsho olubhaliweyo lobushushu be-±8°C - kwaye umvavanyi uqaphe ngokuchanekileyo ukuba idatha yamandla esitywino kwi-155°C ayiboneleli bungqina bokuthembeka kwesithintelo esingenazintsholongwane kwi-147°C okanye kwi-163°C. Ukuqinisekiswa kwetywina kufuneka kubonise amandla amkelekileyo etywina, ukungena kwedayi, kunye neziphumo zovavanyo oluqhumayo kwimida epheleleyo esezantsi nephezulu yokunyamezelana kweeparameter ezibhaliweyo zesixhobo sakho - kungekuphela nje kwindawo ebekiweyo.
Ingxaki 3: Idatha engekhoyo yezinto ezikhutshwayo kunye nezinto ezikhutshwayo kwi-EU MDR. Ndikhe ndakukhankanya oku ngaphambili kodwa kufanelekile ukukuphinda: nayiphi na ifilimu yokupakisha enezingqimba ezininzi equka izinto zokuncamathelisa, iingubo, okanye i-inki zokuprinta iya kufuna uvavanyo lwezinto ezikhutshwayo kunye nezinto ezivuzayo ngokwe-ISO 10993-18 ukuze kuthotyelwe i-EU MDR, kwaye olu vavanyo ludla ngokuthatha iiveki ezi-8-12 kwaye lubiza i-$18,000–$35,000. Yenza uhlahlo-lwabiwo mali. Yicwangcise kwangethuba. Iifilimu zokupakisha zonyango ezisekelwe kwi-cellulose ze-XIADE zisebenzisa ulwakhiwo lwento enye olune-coating esekwe emanzini, nto leyo eyenza kube lula kakhulu uxwebhu lwezinto ezikhutshwayo kunye nezinto eziphumayo kuba inani lezinto ezifudukayo lilinganiselwe kwi-plasticizer, i-coating, kunye ne-cellulose substrate - ngokuqhelekileyo i-≤ ii-migrants ezi-5 ezinokubakho xa kuthelekiswa ne-≥ 40 ye-laminate yokwenziwa enamaleko amaninzi.
Ingxaki yesi-4: Ukuqinisekiswa kwexesha lokuguga okuthintela ukuguga ngokukhawuleza ngaphandle kokuqinisekiswa ngexesha langempela. Ukwaluphala okukhawulezileyo ngokwe-ASTM F1980 kwi-55°C kangangeentsuku ezingama-60 kunokubonelela ngoqikelelo olufanelekileyo lokuzinza kwemozulu yeminyaka emi-2, kodwa abahloli bafuna ngakumbi ukuba umenzi wesixhobo azibophelele ekuboneleleni ngedatha yokwaluphala ngexesha langempela njengoko ifumaneka - kwaye ukuba idatha yexesha langempela kwiinyanga ezili-18 ibonisa ukonakala kwamandla okutywinwa okungazange kuqikelelwe ukuguga okukhawulezileyo, kuya kulindeleka ukuba ufake isenzo sokulungisa ukhuseleko lwentsimi. Ndicebisa ukuba uqalise iisampulu zokwaluphala ngexesha langempela ngosuku olufanayo oqalise ngalo ukuguga okukhawulezileyo, kuba iwotshi yeminyaka emi-2 kwidatha yexesha langempela iqala kwangoko xa isixhobo sakho sipakishwa kwaye sicocwa.
Kwiinkampani zezixhobo zonyango ezijongene nale mingeni yokuthobela imithetho yezomthetho emininzi, ndiyayamkela imibuzo yobugcisa ngokusebenzisa Iphepha loqhagamshelwano le-XIADESigcina ithala leencwadi leetemplate zokuqinisekisa izithintelo ezingeyongozi ezisetyenzisiweyo ngabathengi bethu ukucwangcisa ukuhanjiswa kwamaxwebhu abo obuchwephesha e-FDA 510(k) kunye ne-EU MDR, kwaye ndisoloko ndikulungele ukuxoxa ngendlela esiyisebenzisa ngayo i-cellulose. iifilimu zokupakisha zonyango kwaye iintlobo ze-cellulose ezigqunywe nge-coated dwelisa kwiimfuno zakho ezithile ze-matrix yokuthobela imithetho.
Imibuzo ebuzwa qho
- Q1: Ngowuphi umahluko ophambili phakathi kweemfuno ze-FDA kunye ne-EU MDR zeefilimu zokupakisha zonyango?
- Umahluko osisiseko ungowefilosofi: Icandelo le-FDA 820 lijolise kwinkqubo, lifuna ubungqina obubhaliweyo bokuba inkqubo yakho yokupakisha ivelisa rhoqo iinkcukacha zoyilo lwe-sterile barrier meeting. I-EU MDR ijolise emngciphekweni, ifuna ubungqina obubhaliweyo obuchonge, buvavanye, kwaye bunciphise zonke iingozi ezinxulumene nezinto zokupakisha - kubandakanya iingozi zeekhemikhali ezivela kwizinto ezifudukayo, iingozi zokusingqongileyo ezivela ekulahlweni, kunye neengozi zeklinikhi ezivela ekusileleni kwe-sterile barrier. Ngokwendlela esebenzayo, oku kuthetha ukuba ukungeniswa kwe-FDA kunokwaneliswa yidatha ye-ISO 11607 microbial barrier kunye ne-seal strength data kunye ne-process validation (IQ/OQ/PQ) documentation. Ukungeniswa kwe-EU MDR kufuna konke oko kunye: uvavanyo lwezinto ezikhutshwayo kunye nezinto eziphumayo ngokwe-ISO 10993-18, isizathu esibhaliweyo sokuba izinto zokupakisha ezifudukayo zeekhemikhali aziphazamisi ukhuseleko lwesixhobo (GSPR 10.4), kunye nezixhobo ezingena kwimarike ye-EU emva kowama-2028, amaxwebhu ajongana nendlela yokusingqongileyo yezixhobo zokupakisha phantsi kwe-PPWD 2018/851. Umthwalo woxwebhu lwe-EU MDR ungaphezulu ngama-40%–60% kune-FDA 510(k) kwinkqubo efanayo yokuthintela intsholongwane, kwaye lo mahluko sesona sizathu siphambili sokuba ndicebise ukuba abavelisi bajolise ekuthobeleni i-EU MDR kuqala - ukwanelisa i-EU MDR ngokuyintloko kugubungela iimfuno ze-FDA ngokuzenzekelayo kwicandelo lokupakisha, kodwa okuchaseneyo akuyonyani.
- Umbuzo 2: Luluphi uvavanyo olufunekayo ukuze kuthotyelwe i-ISO 11607?
- I-ISO 11607-1:2019 ifuna iindidi ezintlanu zovavanyo, ekufuneka zenziwe kwiisampuli eziye zadlula kwinkqubo epheleleyo yokubulala iintsholongwane kwaye zakhawuleza ukuguga okulingana nobomi beshelufu obufunekayo: (1) Uvavanyo lwe-Microbial barrier — ASTM F1608 (izinto ezinemibhobho) okanye i-ASTM F2638 (izinto ezingenamibhobho) ngexabiso elincinci lokunciphisa ilog eliyi-6.0, ebonisa ukuba inkqubo ye-sterilizer barrier ithintela ukungena kwe-challenge microorganisms (ngesiqhelo i-Bacillus atrophaeus spores, 0.5–2.0 μm) phantsi koxinzelelo oluchaziweyo. (2) Uvavanyo lwamandla okutywina — Uvavanyo lwe-ASTM F88 peel olunamandla amancinci okutywina ayi-1.5 N/15mm, kunye nokuhlolwa okubonakalayo kwe-ASTM F1886 kwiziphene zetshaneli ezingenazo iziphene ezivumelekileyo. (3) Ukuhambelana kwezinto — umboniso wokuba izinto zokupakisha aziwohloki phantsi kwenkqubo yokubulala iintsholongwane ecetywayo (EO kuxinzelelo oluphezulu kunye nobushushu, i-gamma kwidosi ephezulu, okanye umphunga kubushushu obuphezulu bomjikelo kunye nobude). (4) Ukuhambelana kwezinto eziphilayo — uvavanyo lwe-ISO 10993-1 olufanelekileyo kudidi lwezixhobo, oluqhele ukuba yi-cytotoxicity (ISO 10993-5), ukuzwela (ISO 10993-10), kunye nokucaphuka (ISO 10993-10 okanye -23) kwizixhobo zonxibelelwano zangaphandle. (5) Uzinzo — ukuguga ngexesha langempela kwi-23°C ± 2°C kunye ne-50% ± 10% RH kwixesha elibekiweyo, kunye nokuguga ngokukhawuleza ngokwe-ASTM F1980 kubushushu obuphezulu (ngesiqhelo kwi-55°C) kubalwe kusetyenziswa i-Q10 factor ye-2.0. Idatha yokuguga ngokukhawuleza ingangeniswa ukuze kugqitywe okokuqala ngokwemithetho, kodwa idatha yexesha langempela kufuneka inikezelwe kwaye inikezelwe njengoko ifumaneka.
- Umbuzo 3: Inqaku lesi-7 le-EU MDR lizichaphazela njani iimfuno zokuqinisekiswa kokupakishwa kwezixhobo zonyango?
- Inqaku lesi-7 le-EU MDR lijongana nokusetyenziswa kwezinto ezinobungozi kwizixhobo zonyango kunye nokupakishwa kwazo. Ngokukodwa, inqaku lesi-7(1) lifuna ukuba izixhobo "ziya kuyilwa kwaye zenziwe ngendlela yokuqinisekisa ukuba iingozi ezibangelwa kukukhuhla okanye ukufuduka kwezinto ezinobungozi ziyancitshiswa kangangoko," kwaye inqaku lesi-7(4) landisa le mfuneko kwizinto ezibangela umhlaza, i-mutagenic, okanye ityhefu yokuzala (CMR) kunye neekhemikhali eziphazamisa i-endocrine. Kwiifilimu zokupakisha, oku kuthetha ukuba: (1) naziphi na iiplastiki ezisekelwe kwi-phthalate kwifom yefilimu kufuneka ziqinisekiswe ngohlalutyo lomngcipheko-inzuzo olubonisa ukuba akukho ndlela inokwenzeka yobuchwephesha ekhoyo, (2) nayiphi na ikhemistri yokugquma okanye yokuncamathelisa equka izinto ezikuLuhlu lwaBagqatswa beZinto eziNgxamisekileyo kakhulu (SVHC) phantsi kwe-REACH kufuneka ivezwe kwaye iqinisekiswe, kwaye (3) umthengisi wokupakisha kufuneka anikezele ngokutyhilwa okupheleleyo kwezinto - kungekuphela nje kwesatifikethi sokuthobela umthetho - echonga zonke izinto ezongezwe ngabom kwiindawo ezingaphezulu kwe-0.1% w/w. Iifilimu ze-XIADE ezisekelwe kwi-cellulose zisebenzisa i-glycerol kunye namanzi njengee-plasticizers eziphambili, kwaye ikhemistri yethu yokugquma eyenziwe nge-aluminized ayinazo izinto ze-per- kunye ne-polyfluoroalkyl (PFAS), ii-phthalates, kunye ne-bisphenol A (BPA) — nto leyo eyenza kube lula kakhulu uxwebhu lokuthobela i-Article 7 xa kuthelekiswa ne-synthetic multi-laminates.
- Umbuzo 4: Ithini imfuneko yexesha elifunekayo kwiinkqubo zokuthintela ezingeyongozi phantsi kwe-ISO 11607?
- I-ISO 11607 ayichazi ixesha elithile elibekelwe ishelufu — ifuna ukuba umenzi amisele ixesha elibekelwe ishelufu ngovavanyo lokuzinza kwaye anike ubungqina obucacileyo bokuba iipropati zomqobo ongengowasetyhini ziyagcinwa kulo lonke ixesha elibekiweyo phantsi kweemeko ezimbi kakhulu zokugcina nokuphatha. Ixesha elibekelwe ishelufu kufuneka lixhaswe yi: (1) idatha yokuguga ekhawulezileyo ngokwe-ASTM F1980, ngokuqhelekileyo isebenzisa i-Q10 factor ye-2.0 kwi-55°C ukulinganisa ukuguga okungqongileyo — umzekelo, iintsuku ezingama-60 kwi-55°C zilinganisa malunga neminyaka emi-2 kwi-23°C, kunye (2) idatha yokuguga yexesha langempela eqaliswe ngaxeshanye nokuguga okukhawulezileyo, kunye namanqaku exesha lonyaka omnye, iminyaka emibini, kunye nexesha lokuphela kweshelufu avavanyiweyo ukuthembeka komqobo we-microbial, amandla okutywina, kunye neepropati zezinto. Ixesha elibekelwe ishelufu elisebenzayo kwiifilimu zokupakisha zonyango eziqhelekileyo phantsi kokuqinisekiswa kwe-ISO 11607 yile: I-Tyvek 1073B — ukuya kuthi ga kwiminyaka emi-5 ngokugcinwa komqobo we-microbial okubonisiweyo; ii-laminates ze-foil composite — iminyaka emi-3 ukuya kwemi-5 kuxhomekeke kukuthembeka komtywino ngokusebenzisa ukujikeleza kobushushu; i-cellulose egqunywe nge-coated (XIADE aluminized) — iminyaka emi-2 ukuya kwemi-3 kunye nomda ophambili kukufunxwa komswakama kwiimeko zokugcina i-RH ezingaphezulu kwama-65%; kunye ne-PE/EVOH/PE ekhutshiweyo — iminyaka emi-3 ukuya kwemi-5 ukuba umaleko we-EVOH ukhuselwe kumswakama ziileya zesikhumba ze-PE ezifanelekileyo. Impazamo eqhelekileyo kukubanga ubomi beshelufu beminyaka emi-5 ngokusekelwe kwidatha yokwaluphala ngokukhawuleza yodwa — ndibone abahlaziyi be-Notified Body begatya oku kwaye bafuna idatha yexesha langempela kwinqanaba leminyaka emi-3 ngaphambi kokuba bamkele ibango lobomi beshelufu beminyaka engaphezulu kwemi-3.
- Umbuzo 5: Ngaba ifilimu enye yokupakisha ingaphumelela zombini iimfuno ze-FDA kunye ne-EU MDR ngaxeshanye?
- Ewe — kwaye le yindlela esebenzayo endiyicebisayo kubo bonke abavelisi bezixhobo zonyango. Inkqubo yokuthintela intsholongwane eqinisekisiweyo kwiindlela zovavanyo ze-ISO 11607-1 kunye ne-ISO 11607-2, exhaswa ngamaxwebhu apheleleyo okuqinisekisa inkqubo (IQ/OQ/PQ), idatha yezinto ezikhutshwayo kunye nezinto eziphumayo ngokwe-ISO 10993-18, kunye namaxwebhu olawulo lomngcipheko ngokwe-ISO 14971, iya kuhlangabezana neemfuno ze-FDA Part 820 kunye ne-EU MDR GSPR kwinkqubo yokuthintela intsholongwane. Isitshixo sendlela yokuqinisekisa enye kukuvavanya imfuneko ebaluleke kakhulu kumlawuli ngamnye: sebenzisa i-EU MDR GSPR 10.4 njengomqhubi wovavanyo lokhuseleko lweekhemikhali (kuba i-FDA ayifuni ngqo), sebenzisa i-FDA Part 820 §820.70 njengomqhubi wokuqinisekiswa kwenkqubo yokunyamezelana ngokupheleleyo (kuba i-EU MDR GSPR ayicaci kangako malunga nemfuneko yokunyamezelana), kwaye sebenzisa i-ISO 11607 njengomgangatho oqhelekileyo wokusebenza kobugcisa owamkelwa ngabalawuli bobabini. Kwi-XIADE, sinikezela ngeenkonzo zethu. ifilimu yokupakisha yezonyango abathengi abanephakheji yedatha yokuthobela imithetho elungiselelwe le ndlela "yeyona iqhelekileyo" - ixabisa malunga ne-15%–25% ngaphezulu kwibhajethi yokuvavanya kunokuqinisekiswa kwegunya elinye kodwa isusa isidingo sokuphinda umsebenzi wokuqinisekisa xa ungena kwimarike yesibini, inikezela ukonga okuseleyo kwe-30%–40% xa kuthelekiswa nokuqinisekiswa kwegunya elinye ngokulandelelana.