- FDA, EU MDR, da ISO 11607 suna ƙirƙirar buƙatar bin ƙa'idodi masu matakai uku inda ISO 11607 ke aiki a matsayin tushen fasaha na gama gari, amma FDA 21 CFR Sashe na 820 ya ƙara buƙatun tabbatar da tsari kuma EU MDR 2017/745 ya ƙara buƙatun aminci da dorewa na sinadarai waɗanda ISO 11607 kaɗai bai cika ba.
- Babban abin da ya fi jawo jinkirin 510(k) da ya shafi marufi shine rashin isasshen bayanan tabbatar da shinge mai tsafta - musamman, gwajin ƙarfin hatimi wanda ya ɗauki maki 3 kawai maimakon gwajin barewa akai-akai a duk faɗin cikakken kewayen hatimi.
- Mataki na 10(9) na EU MDR yanzu yana buƙatar masana'antun su rubuta da kuma rage haɗarin da ke tattare da abubuwa masu haɗari a cikin kayan marufi - buƙatar da ke shafar zaɓin fim kai tsaye kuma tana fifita tsarin shinge mai kariya na abu ɗaya ko wanda ba ya lalacewa kamar cellulose mai rufi.
Dalilin da Yasa Bin Dokokin Marufi na Likita Ya Zama Kalubale Mai Kula da Ma'aikata Da Yawa (Ba Matsala Daya Ba)
Na rasa adadin adadin 'yan kasuwa na kayan aikin likitanci da suka gaya mini, "Fim ɗin marufi ya cika ka'idojin ISO 11607, don haka mun shirya don yin alama da FDA da CE." Wannan bayanin ya bayyana wani mummunan fahimta da nake son magancewa nan take: Bin ƙa'idodin ISO 11607 ya zama dole amma bai isa ba don amincewa da FDA ko alamar MDR CE ta EU - yana biyan buƙatun tabbatar da fasaha da masu tsara dokoki biyu suka ambata, amma babu ɗayan masu tsara dokoki da ya ɗauki bin ƙa'idodin ISO 11607 a matsayin shaida cewa tsarin shingen ku mai tsabta ya cika buƙatun doka.
Tsarin bin ƙa'ida ga fina-finan marufi na likita a shekarar 2026 ƙalubale ne guda uku da ke buƙatar masana'antun na'urorin likitanci su cika: (1) Dokar Tsarin Inganci ta FDA 21 CFR Sashe na 820 ga na'urorin da ake sayarwa a Amurka, (2) Dokar Na'urorin Lafiya ta EU 2017/745 ga na'urorin da ake sayarwa a Tarayyar Turai, da kuma (3) ISO 11607-1:2019 da ISO 11607-2:2019 a matsayin ma'aunin fasaha mai jituwa wanda masu kula da duka biyu ke amfani da shi azaman ma'aunin tabbatar da tsarin shinge mai tsafta. Saboda Dokar Tsarin Inganci ta FDA ta ba da umarnin sarrafa ƙira da tabbatar da tsari wanda ya wuce iyakokin ISO 11607, kuma EU MDR ta ƙara buƙatun aminci na sinadarai a ƙarƙashin Annex I General Safety and Performance Bukatun (GSPR) waɗanda FDA ko ISO 11607 ba su magance su ba, fim ɗin marufi da aka tabbatar kawai bisa ga hanyoyin gwaji na ISO 11607 har yanzu zai iya kasa sanar da FDA kafin kasuwa ko sake duba takardun fasaha na EU MDR.
A XIADE, muna kula da tsarin bin diddigin bin ƙa'idodi wanda ke tsara kowane buƙata daga FDA 21 CFR Sashe na 820 kuma EU MDR 2017/745 a kan hanyoyin gwaji masu dacewa daga ISO 11607Matrix ɗin ya ƙunshi buƙatu daban-daban guda 47 - waɗanda ISO 11607 ya magance kai tsaye 28 (60%), FDA Sashe na 820 ya ƙara ƙarin buƙatu 11, kuma EU MDR ya ƙara buƙatu 8 waɗanda FDA ko ISO 11607 ba su rufe ba. Wannan labarin yana tafiya ta cikin kowanne daga cikin waɗannan tsare-tsare guda uku daga mahangar mai samar da fina-finan marufi wanda ya goyi bayan gabatarwar na'urorin likitanci 510(k) guda 23 da fakitin takaddun fasaha na alamar CE 8, kuma yana gano takamaiman gibin bin ƙa'idodi da muke gani akai-akai a cikin takardun tabbatar da shinge na abokan cinikinmu.
FDA 21 CFR Sashe na 820 — Abin da Kamfanonin Na'urorin Lafiya Ke Bukata Daga Fina-finan Marufi
Dokar Tsarin Inganci ta FDA, wadda aka tsara a cikin 21 CFR Sashe na 820, ba ya ƙunshi wani sashe na musamman na "marufi". Madadin haka, ana rarraba buƙatun shinge marasa tsafta a sassa uku: §820.30 Tsarin Kulawa, §820.70 Tsarin Kulawa da Samarwa, da §820.130 Tsarin Kulawa na Na'ura. Hanyar da FDA ta bi wajen tabbatar da ingancin marufi ta dogara ne akan tsari maimakon mayar da hankali kan kayan aiki - yana buƙatar shaidar da aka rubuta cewa tsarin marufi (gami da zaɓin fim, sigogin rufewa, da zagayowar tsaftacewa) koyaushe yana samar da shinge mai tsafta wanda ya dace da ƙayyadaddun ƙira, maimakon buƙatar kayan fim ɗin da kansa ya ɗauki takamaiman takardar shaida.
Abin da masana'antun kayan aikin likitanci ke nufi shi ne cewa siyan fim ɗin marufi mai bin ƙa'idar ISO 11607 daga XIADE ko wani mai samar da kayayyaki shine farkon aikin bin ƙa'idar FDA, ba ƙarshen ba. A ƙarƙashin §820.30 Design Controls, dole ne ku kafa buƙatun shigarwar ƙira don tsarin shingen ku mai tsabta wanda ya haɗa da: (1) hanyar tsaftacewa da sigogin zagayowar, (2) tsawon lokacin shiryayye da aka nufa, (3) yanayin rarrabawa da ajiya (zafin jiki, kewayon zafi, kewayon matsin lamba na yanayi don jigilar iska), da kuma (4) sharuɗɗan karɓar amincin hatimi. A ƙarƙashin §820.70, dole ne ku tabbatar da kowane haɗin sigogin tsarin rufewa tare da cancantar shigarwa (IQ), cancantar aiki (OQ), da cancantar aiki (PQ) wanda FDA ta ɗauka daidai da tabbatar da tsarin ISO 11607-2 - amma masu bita na FDA da na yi mu'amala da su a lokacin bita na 510(k) akai-akai suna neman ƙarin bayani guda ɗaya wanda ISO 11607-2 ba ya buƙata: bayanan ƙarfin hatimi a cikin cikakken kewayon haƙurin zafin jiki na kayan aikin hatimin ku, ba kawai a wurin da aka ƙayyade ba.
A shekarar 2024, Hukumar Abinci da Magunguna ta Amurka (FDA) ta fitar da wani gyara na Tsarin Inganci wanda ya daidaita Sashe na 820 da ISO 13485:2016, wanda nake ganin hakan a matsayin ci gaba mai kyau saboda Daidaitawar FDA QSR tare da ISO 13485 yana rage nauyin takardu akan masana'antun da ke hidimar kasuwannin Amurka da EU - tsarin kula da inganci guda ɗaya yanzu zai iya gamsar da masu kula da duka biyun, muddin an magance buƙatun takaddun aminci na sinadarai na EU da kimantawa na asibiti daban-daban. Babban canjin da ya shafi marufi a cikin QSR mai jituwa shine takamaiman buƙatar takaddun kula da haɗari bisa ga ISO 14971 wanda ke magance takamaiman yanayin gazawar shinge mara tsabta, wanda aka nuna a baya amma ba a bayyana shi a sarari a Sashe na 820 ba.
EU MDR 2017/745 — Bukatun Tsarin Shingayen Tsabtace Tsabtace da ke Kama Kamfanoni daga Tsaro
Idan Sashe na 820 na FDA ya mayar da hankali kan tsari, EU MDR 2017/745 ya mayar da hankali kan haɗari - kuma yana sanya buƙatun tsarin shinge marasa tsabta waɗanda suka wuce abin da ingancin ISO 11607 kaɗai ya nuna. Kashi na 11.4 na EU MDR Annex I, Bukatun Tsaro da Aiki na Gabaɗaya (GSPR) ya buƙaci na'urorin da aka kawo a cikin yanayin da ba shi da tsafta dole ne a "kunshe su a cikin tsarin da ke kula da rashin tsafta a ƙarƙashin yanayin ajiya, sufuri, da sarrafawa da masana'anta suka ƙayyade," kuma Sashe na 10.4 ya buƙaci cewa kayan marufi kada su "saki abubuwan da za su iya lalata aminci ko aikin na'urar" - buƙatar amincin sinadarai wanda ba shi da daidaito kai tsaye a cikin ƙa'idar FDA ko ISO 11607.
Na ga an yi watsi da sake dubawa guda uku na takardun fasaha na alamar CE musamman saboda rashin daidaiton GSPR da suka shafi marufi. Na farko: masana'anta wanda ya tabbatar da jakar PE/EVOH/PE ɗinsa bisa ga buƙatun shingen ƙwayoyin cuta na ISO 11607 amma bai bayar da bayanan gwajin abubuwan cirewa da waɗanda za a iya cirewa bisa ga ISO 10993-18 ba don nuna cewa ƙarin kayan aiki na Layer EVOH bai ƙaura zuwa cikin na'urar ba yayin tsaftacewar EO da tsawon rayuwar shiryayye na shekaru 3. Na biyu: masana'anta na dashen kashin baya wanda ya yi amfani da jakar hada-hadar foil wacce ta wuce duk gwaje-gwajen aikin ISO 11607 amma wanda mai bita na Notified Body ya yiwa layin aluminum alama a ƙarƙashin GSPR 10.4 saboda masana'anta bai rubuta hanyar sake amfani da aluminum ba ko kuma ya ba da hujjar dalilin da yasa laminate mai yawa wanda ba za a iya sake amfani da shi ba ya zama dole don amincin na'urar. Na uku — kuma wannan har yanzu yana bani haushi — an ƙi shi saboda mai samar da fina-finan marufi na masana'anta (ba XIADE ba) ba zai iya bayar da Sanarwar Yarjejeniyar Ka'idojin Amfani da Kayan Abinci na EU (EC) 1935/2004 ba, wanda mai bita na Hukumar da aka Sanar ya ɗauka yana da mahimmanci a ƙarƙashin ƙa'idar taka tsantsan duk da cewa ba a tsara na'urorin lafiya kai tsaye a ƙarƙashin dokokin hulɗa da abinci ba.
Mataki na 10(9) na EU MDR ya buƙaci masana'antun su kafa, su rubuta, aiwatarwa, da kuma kula da tsarin kula da haɗari wanda ke magance haɗarin da ke da alaƙa da abubuwa masu haɗari a cikin kayan aiki - kuma nan da 2028, ana sa ran gyaran Dokar Rubutu da Rubutu ta 2018/851 (PPWD) zai ƙara takamaiman buƙatun sake amfani da su ko lalata su don marufi na likita da ake sayarwa a kasuwar EU. Wannan tsarin kula da lafiya shine babban abin da ke haifar da tsarin garkuwar jiki mai tushen cellulose da sauran tsarin shingen da ba ya lalacewa wanda na lura a cikin shekaru 17 da na yi aiki, kuma ina tsammanin zai sake fasalin kasuwar fina-finan marufi na likita tsakanin 2026 da 2030.
ISO 11607 Nutsewa Mai Zurfi - Ma'aunin Fasaha wanda Ya Gamsar da FDA da EU MDR
ISO 11607-1:2019 yana kafa buƙatun aiki na kayan aiki, tsarin shingen da aka riga aka tsara, da tsarin marufi don na'urorin likitanci da aka yi wa tiyatar kashe gobara. Ita ce gadar fasaha tsakanin tsammanin tsarin FDA da tsarin kula da haɗari na EU MDR. ISO 11607-1 yana buƙatar nau'ikan shaida guda biyar don tabbatar da tsarin shinge mai tsafta: (1) halayen shingen ƙwayoyin cuta - mafi ƙarancin ƙimar raguwar log 6 ga kowace ASTM F1608 don kayan rami ko bisa ga ASTM F2638 don marasa rami, (2) ƙarfin hatimi ≥ 1.5 N/15mm ga kowace ASTM F88 tare da duba gani don lahani na tashoshi bisa ga ASTM F1886, (3) dacewa da kayan aiki tare da tsarin tsaftacewa - babu lalacewar shinge ko halayen ƙarfi bayan fallasa ga matsakaicin adadin tsaftacewa, (4) jituwa ta halitta bisa ga ISO 10993-1 wanda ya dace da rarrabuwar hulɗar marasa lafiya na na'urar, da (5) kwanciyar hankali - bayanai na ainihin lokaci da sauri da ke nuna kula da kaddarorin shinge mai tsafta ta tsawon lokacin da aka yi iƙirarin adanawa.
Abin da ISO 11607 ba ya buƙata - kuma wannan shine gibin da ke kama kamfanoni yayin bitar ƙa'idoji - shine shaidar amincin sinadarai (EU MDR GSPR 10.4), kimanta tasirin muhalli (buƙatun EU da ke tasowa a ƙarƙashin PPWD), ko takaddun bin diddigin sarkar samar da kayayyaki (wanda kwangilolin GPO na asibiti ke buƙata da yawa). Ina ba da shawara ga kowane abokin ciniki na na'urorin likitanci a XIADE da ya ɗauki bin ka'idar ISO 11607 a matsayin tushe, tabbatar da tsarin FDA Sashe na 820 a matsayin bango, da takaddun EU MDR GSPR a matsayin rufin - kuna buƙatar duka ukun, kuma kowannensu yana magance wani ɓangare daban na bin ka'idar tsarin shinge mai tsabta wanda sauran ba su rufe ba.
Yadda Ake Gina Tsarin Bin Dokoki: Daidaita Kasuwannin da Aka Yi Niyya da Gwaje-gwajen da Ake Bukata
Tsarin bin ƙa'idodi mai zuwa ya taƙaita sharuɗɗa 12 mafi mahimmanci da suka shafi marufi a faɗin FDA, EU MDR, da ISO 11607, tare da takamaiman hanyoyin gwaji da ƙa'idodin karɓuwa waɗanda na ga masu bita sun yarda da su a cikin gabatarwar ƙa'idoji 31 a cikin shekaru goma da suka gabata.
| Bukatar | ISO 11607 | FDA Sashe na 820 | EU MDR 2017/745 | Hanyar Gwaji |
|---|---|---|---|---|
| Shingen ƙwayoyin cuta | Ana buƙata (LRV ≥ 6.0) | Ana buƙata ta hanyar Kula da Zane | Ana buƙata ta hanyar GSPR 11.4 | ASTM F1608 / F2638 |
| Ƙarfin Hatimi | ≥ 1.5 N/15mm | Cikakken bayanai game da ƙungiyar haƙuri | ≥ 1.5 N/15mm | ASTM F88 + F1886 |
| Yarjejeniyar Tsaftacewa | Ana buƙata | Ana buƙata ta hanyar Sarrafa Tsarin Aiki | Ana buƙata | Kowace hanyar tsaftacewa |
| Dacewar Halitta | Don ISO 10993-1 | Rarraba kowace na'ura | Kowace GSPR 10.2 | Tsarin ISO 10993 |
| Kwanciyar hankali / Rayuwar shiryayye | Ainihin lokaci + hanzarta | Ainihin lokaci + hanzarta | Ainihin lokaci + hanzarta | ASTM F1980 |
| Tsaron Sinadarai | Ba a buƙata ba | Ba a buƙatar kai tsaye ba | Ana buƙata (GSPR 10.4) | ISO 10993-18 |
| Abubuwan Cirewa & Abubuwan da Za a Iya Cirewa | Ba a buƙata ba | Ba a buƙata ba | Ana buƙata (GSPR 10.4) | ISO 10993-18 |
| Tasirin Muhalli | Ba a buƙata ba | Ba a buƙata ba | Masu tasowa (PPWD) | LCA don ISO 14040 |
| Tabbatar da Tsarin Aiki (IQ/OQ/PQ) | Ana buƙata (Sashe na 2) | Ana buƙata (§820.70) | Ana buƙata (GSPR 11.4) | Ga kowane mai ƙera kayan aiki |
| Gudanar da Hadari | An ambata | Ana buƙata (Gyaran QSR.) | Ana buƙata (Annex I) | ISO 14971 |
| Cancantar Mai Bayarwa | Ba a buƙata ba | Ana buƙata (§820.50) | Ana buƙata (Labari na 10) | Dangane da tsarin QMS |
| Sa ido bayan Kasuwa | Ba a buƙata ba | Ana buƙata (rahotanni na MDR) | Ana buƙata (Sanya ido) | Dangane da tsarin QMS |
Ina ba da shawarar cewa kowace masana'antar kayan aikin likita ta gina wani sigar musamman ta wannan matrix don takamaiman rarrabuwar na'urorin su, hanyar tsaftacewa, da kasuwannin da aka yi niyya. A XIADE, muna ba wa abokan cinikinmu na fim ɗin fakitin likitanci fakitin bayanai na bin ƙa'ida wanda ya haɗa da takamaiman rahotannin gwaji da takaddun shaida da suke buƙata ga kowace tantanin halitta ta wannan matrix - domin na koyi cewa masu samar da fina-finan fakiti waɗanda kawai ke aika fim ɗin da takardar shaidar bincike ba sa taimaka wa abokan cinikinsu su sami izinin doka; suna ba da mafi wahalar ɓangaren aikin bin ƙa'ida ga mutanen da ba masana kimiyya ba ne kuma ƙila ba su san wace gwaji za su nema ba.
Matsalolin Biyayya da Aka Saba Yi Waɗanda Ke Haifar da Jinkirin 510(k) ko Ƙin Amincewa da Alamar CE
Fiye da shekaru 17 na goyon bayan gabatar da ƙa'idoji, na tattara jerin kurakurai goma da suka fi faruwa dangane da bin ƙa'idodi da suka shafi marufi. Ga manyan huɗu, domin su ne kashi 78% na duk ƙin amincewa da tsarin shinge mai tsabta da na gani:
Matsalar 1: Gwajin ƙarfin hatimi mai maki uku maimakon barewa mai ci gaba da cikakken kewaye. ASTM F88 yana ba da damar ɗaukar samfurin maki uku tare da matsakaicin da aka ruwaito azaman ƙarfin hatimi - kuma masu bita na FDA da EU MDR duk suna ƙin wannan hanyar don tabbatar da shinge mai tsafta saboda wuri ɗaya mai sanyi tare da sandar hatimi mai girman 800mm na iya samar da ƙarfin hatimi na gida ƙasa da 1.0 N/15mm yayin da matsakaicin maki uku ya ba da rahoton 2.4 N/15mm. Na yi nasarar kare kowace tabbatar da shingen da aka yi amfani da shi wajen gwajin barewa a tazara ta 10mm a duk faɗin kewayen hatimin — ba wai saboda ƙa'idar ta buƙaci hakan a fili ba, amma saboda masu bita sun koyi cewa samfurin maki uku yana ɓoye lahani na tashar hatimin ta hanyar tsari.
Matsalar 2: Tabbatarwa kawai a sigogin hatimi marasa suna ba tare da ƙungiyar haƙuri ba. Na ga an jinkirta gabatar da 510(k) da watanni 11 saboda masana'anta sun tabbatar da tsarin rufe jakar foil ɗinsu a 155°C ± 0°C, amma kayan aikin rufewar da suka samar suna da bambancin zafin jiki da aka rubuta na ±8°C - kuma mai bitar ya lura daidai cewa bayanan ƙarfin hatimi a 155°C ba su nuna wata shaida ta ingancin shinge mai tsabta a 147°C ko 163°C ba. Tabbatar da hatimin dole ne ya nuna ƙarfin hatimi mai karɓuwa, shigar rini, da sakamakon gwajin fashewa a ƙarƙashin ƙasa da sama na jurewar sigogin kayan aikin ku - ba kawai a wurin da aka ƙayyade ba.
Matsalar 3: Rashin bayanan da za a iya cirewa da kuma waɗanda za a iya cirewa don ƙaddamar da MDR na EU. Na ambaci wannan a baya amma ya kamata a maimaita: duk wani fim ɗin marufi mai layuka da yawa wanda ya haɗa da manne, shafi, ko tawada na bugawa zai buƙaci gwajin abubuwan da za a iya cirewa da waɗanda za a iya cirewa bisa ga ISO 10993-18 don bin ƙa'idar MDR ta EU, kuma wannan gwajin yawanci yana ɗaukar makonni 8-12 kuma yana kashe $18,000–$35,000. Kasafin kuɗi don sa. Shirya shi da wuri. Fina-finan marufi na likitanci na XIADE waɗanda aka yi da cellulose suna amfani da ginin abu ɗaya tare da rufin ruwa, wanda hakan ke sauƙaƙa takardun abubuwan da za a iya cirewa da kuma waɗanda za a iya cirewa saboda yawan abubuwan da za a iya cirewa yana iyakance ga plasticizer, shafi, da kuma cellulose substrate - yawanci ≤ 5 masu yuwuwar ƙaura idan aka kwatanta da ≥ 40 don laminate na roba mai layuka da yawa.
Matsalar 4: Tabbatar da tsawon lokacin da za a ɗauka a wurin aiki wanda ke tsayawa a lokacin tsufa ba tare da tabbatarwa ta ainihin lokaci ba. Tsarin tsufa mai sauri bisa ga ASTM F1980 a zafin jiki na 55°C na tsawon kwanaki 60 na iya samar da hasashen daidaiton yanayi na shekaru 2, amma masu bita suna ƙara buƙatar cewa masana'antar na'urar ta himmatu wajen samar da bayanan tsufa na ainihi yayin da suke samuwa - kuma idan bayanan da aka samu a cikin watanni 18 sun nuna raguwar ƙarfin hatimi wanda saurin tsufa bai annabta ba, za a sa ran ku shigar da matakin gyara lafiyar filin. Ina ba da shawarar fara samfuran tsufa na ainihi a ranar da kuka fara tsufa da sauri, saboda agogon shekaru 2 akan bayanan ainihin lokaci yana farawa da zarar an naɗe na'urar ku kuma an yi mata magani.
Ga kamfanonin na'urorin likitanci da ke bin waɗannan ƙalubalen bin ƙa'idojin shari'a da dama, ina maraba da tambayoyin fasaha ta hanyar Shafin tuntuɓa na XIADEMuna da ɗakunan ajiya na samfuran tabbatar da shinge marasa lahani waɗanda abokan cinikinmu suka yi amfani da su don tsara takardun fasaha na FDA 510(k) da EU MDR, kuma koyaushe ina shirye in tattauna yadda za mu yi amfani da cellulose ɗinmu fina-finan marufi na likita kuma bambance-bambancen cellulose masu rufi tsara takamaiman buƙatun tsarin bin ƙa'idodi.
Tambayoyin da Ake Yawan Yi
- T1: Menene manyan bambance-bambance tsakanin buƙatun FDA da EU na MDR don fina-finan marufi na likita?
- Babban bambanci shine falsafa: Sashe na 820 na FDA yana mai da hankali kan tsari, yana buƙatar takaddun shaida cewa tsarin marufi naka koyaushe yana samar da ƙayyadaddun ƙayyadaddun tsari na shinge mai tsabta. EU MDR yana mai da hankali kan haɗari, yana buƙatar takaddun shaida waɗanda suka nuna cewa kun gano, tantancewa, da kuma rage duk haɗarin da ke tattare da kayan marufi - gami da haɗarin sinadarai daga masu ƙaura daga kayan aiki, haɗarin muhalli daga zubarwa, da haɗarin asibiti daga gazawar shinge mai tsabta. A zahiri, wannan yana nufin cewa takardar FDA za a iya gamsuwa da takardar ISO 11607 ta shingen ƙwayoyin cuta da bayanan ƙarfin hatimi tare da tabbatar da tsari (IQ/OQ/PQ). Takardar MDR ta EU tana buƙatar duk waɗannan ƙari: gwajin abubuwan da za a iya cirewa da waɗanda za a iya cirewa bisa ga ISO 10993-18, hujjar da aka rubuta cewa masu ƙaura daga sinadarai na kayan marufi ba sa lalata amincin na'ura (GSPR 10.4), da kuma ga na'urorin da ke shiga kasuwar EU bayan 2028, takardu da ke magance hanyar muhalli ta ƙarshen rayuwar kayan marufi a ƙarƙashin PPWD 2018/851. Nauyin takardu na EU MDR ya kai kusan kashi 40%–60% fiye da na FDA 510(k) na tsarin shinge iri ɗaya, kuma wannan bambancin shine babban dalilin da yasa nake ba da shawarar cewa masana'antun su fara mai da hankali kan bin ƙa'idodin EU MDR - biyan buƙatun EU MDR ya shafi buƙatun FDA ta atomatik a cikin yankin marufi, amma akasin haka ba gaskiya bane.
- T2: Wane gwaji ake buƙata don bin ƙa'idodin ISO 11607?
- ISO 11607-1:2019 yana buƙatar nau'ikan gwaji guda biyar, kowannensu dole ne a yi shi akan samfuran da aka yi cikakken tsarin tsaftacewa da kuma hanzarta tsufa daidai da lokacin da aka yi iƙirarin adanawa: (1) Gwajin shingen ƙwayoyin cuta - ASTM F1608 (kayayyakin ramuka) ko ASTM F2638 (kayayyakin da ba su da ramuka) tare da mafi ƙarancin ƙimar rage gungumen itace na 6.0, yana nuna cewa tsarin shingen da ba shi da ramuka yana hana shigar ƙwayoyin cuta masu ƙalubale (yawanci Bacillus atrophaeus spores, 0.5–2.0 μm) a ƙarƙashin bambancin matsin lamba da aka ƙayyade. (2) Gwajin ƙarfin hatimi - Gwajin bawon ASTM F88 tare da ƙaramin ƙarfin hatimi na 1.5 N/15mm, tare da duba gani na ASTM F1886 don lahani na tashoshi tare da babu lahani da aka yarda da su. (3) Dacewar kayan aiki - nuna cewa kayan marufi ba ya lalacewa a ƙarƙashin tsarin tsaftacewa da aka yi niyya (EO a matsakaicin taro da zafin jiki, gamma a matsakaicin adadin, ko tururi a matsakaicin zafin zagayowar da tsawon lokaci). (4) Daidawa da Halitta — Kimantawar ISO 10993-1 da ta dace da rarrabuwar na'urar, yawanci gubar cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), da kuma ƙaiƙayi (ISO 10993-10 ko -23) ga na'urorin sadarwa na waje. (5) Kwanciyar hankali — tsufa a ainihin lokaci a 23°C ± 2°C da 50% ± 10% RH don tsawon lokacin da aka yi iƙirarin shiryayye, tare da hanzarta tsufa bisa ga ASTM F1980 a yanayin zafi mai girma (yawanci 55°C) wanda aka ƙididdige ta amfani da ma'aunin Q10 na 2.0. Ana iya ƙaddamar da bayanan tsufa masu sauri don izinin farko na ƙa'idoji, amma dole ne a sadaukar da bayanan ainihin lokaci kuma a bayar da su yayin da suke samuwa.
- T3: Ta yaya Dokar EU MDR ta 7 ke shafar buƙatun tabbatar da na'urorin likitanci?
- Mataki na 7 na EU MDR ya yi magana game da amfani da abubuwa masu haɗari a cikin na'urorin likitanci da marufinsu. Musamman ma, Mataki na 7(1) ya buƙaci a "tsara kuma a ƙera na'urori ta yadda za a tabbatar da cewa haɗarin da ke tattare da fitar da abubuwa masu haɗari ko ƙaura an rage su gwargwadon iko," kuma Mataki na 7(4) ya faɗaɗa wannan buƙatar ga abubuwan da ke haifar da cutar kansa, maye gurbi, ko guba ga haifuwa (CMR) da sinadarai masu lalata endocrine. Ga fina-finan marufi, wannan yana nufin: (1) duk wani plasticizers na phthalate da ke cikin tsarin fim dole ne a tabbatar da shi tare da nazarin fa'idar haɗari wanda ke nuna cewa babu wani madadin da za a iya samu a fasaha, (2) duk wani shafi ko manne wanda ya haɗa da abubuwa a cikin Jerin 'Yan takarar Abubuwan da ke da Damuwa sosai (SVHC) a ƙarƙashin REACH dole ne a bayyana kuma a tabbatar da shi, kuma (3) mai samar da marufi dole ne ya samar da cikakken bayanin kayan - ba kawai takardar shaidar bin ƙa'ida ba - yana gano duk abubuwan da aka ƙara da gangan a cikin taro sama da 0.1% w/w. Fina-finan da aka yi da cellulose na XIADE suna amfani da glycerol da ruwa a matsayin manyan abubuwan da ake amfani da su wajen yin filastik, kuma sinadaran da aka yi da aluminum ba su da sinadaran per- da polyfluoroalkyl (PFAS), phthalates, da bisphenol A (BPA) - wanda hakan ke sauƙaƙa takardun bin ƙa'idodin Mataki na 7 idan aka kwatanta da laminates masu launuka da yawa na roba.
- T4: Menene buƙatar tsawon rayuwar shiryayye ga tsarin shinge mai tsafta a ƙarƙashin ISO 11607?
- ISO 11607 bai tsara takamaiman tsawon lokacin shiryawa ba - yana buƙatar masana'anta su tabbatar da tsawon lokacin shiryawa ta hanyar gwajin kwanciyar hankali kuma su samar da shaida ta gaskiya cewa ana kiyaye kaddarorin shinge marasa tsabta a duk lokacin da aka yi iƙirari a ƙarƙashin yanayin ajiya da sarrafawa mafi muni. Dole ne a tallafa wa tsawon lokacin shiryawa ta hanyar: (1) bayanan tsufa masu sauri bisa ga ASTM F1980, yawanci suna amfani da factor Q10 na 2.0 a 55°C don kwaikwayon tsufa na yanayi - misali, kwanaki 60 a 55°C yana kwaikwayon kimanin shekaru 2 a 23°C, da (2) bayanan tsufa na ainihin lokaci da aka fara a lokaci guda tare da saurin tsufa, tare da gwajin maki na shekara ɗaya, shekaru biyu, da ƙarshen shiryawa don amincin shingen ƙwayoyin cuta, ƙarfin hatimi, da kaddarorin kayan aiki. Rayuwar shiryawa mai amfani don fina-finan marufi na likita a ƙarƙashin tabbatarwar ISO 11607 shine: Tyvek 1073B - har zuwa shekaru 5 tare da tabbatar da kiyaye shingen ƙwayoyin cuta; laminates masu haɗa foil - shekaru 3 zuwa 5 dangane da ingancin hatimi ta hanyar zagayowar zafi; cellulose mai rufi (XIADE aluminated) — shekaru 2 zuwa 3 tare da babban iyakancewar shine shan danshi a yanayin ajiya na RH >65%; da kuma PE/EVOH/PE mai haɗin gwiwa — shekaru 3 zuwa 5 muddin an kare Layer ɗin EVOH daga danshi ta hanyar isasshen yadudduka na fata na PE. Kuskuren da aka saba gani shine da'awar tsawon rai na shekaru 5 bisa ga bayanan tsufa da sauri kawai — Na ga masu bita na Notified Body sun ƙi wannan kuma suna buƙatar bayanai na ainihin lokaci a lokacin shekaru 3 kafin su karɓi da'awar tsawon rai na shekaru 3.
- T5: Shin fim ɗin marufi ɗaya zai iya wuce buƙatun FDA da EU MDR a lokaci guda?
- Eh — kuma wannan ita ce hanya mafi inganci da nake ba da shawara ga kowace masana'anta ta kayan aikin likita. Tsarin shinge mai tsafta wanda aka tabbatar da shi bisa ga hanyoyin gwaji na ISO 11607-1 da ISO 11607-2, wanda aka tallafa masa da cikakkun takardun tabbatar da tsari (IQ/OQ/PQ), bayanan da za a iya cirewa da kuma waɗanda za a iya cirewa bisa ga ISO 10993-18, da kuma takardun kula da haɗari bisa ga ISO 14971, zai cika buƙatun FDA Sashe na 820 da EU MDR GSPR don tsarin shinge mai tsafta. Mabuɗin hanyar tabbatarwa guda ɗaya shine gwadawa zuwa ga mafi buƙatar buƙata daga kowane mai kula da lafiya: yi amfani da EU MDR GSPR 10.4 a matsayin direba don gwajin aminci na sinadarai (tunda FDA ba ta buƙatar ta kai tsaye), yi amfani da FDA Sashe na 820 §820.70 a matsayin direba don tabbatar da cikakken tsarin haƙuri-band (tunda EU MDR GSPR ba ta bayyana sosai game da buƙatar bandakin haƙuri ba), kuma yi amfani da ISO 11607 a matsayin ma'aunin aikin fasaha na gama gari wanda masu kula da lafiya biyu suka yarda da shi. A XIADE, muna ba da namu fim ɗin marufi na likita abokan ciniki waɗanda ke da fakitin bayanai na bin ƙa'ida wanda aka tsara bisa ga wannan hanyar "mafi girman ma'auni na gama gari" - yana kashe kusan kashi 15%-25% fiye da kasafin kuɗi na gwaji fiye da tabbatar da ikon mallakar yanki ɗaya amma yana kawar da buƙatar maimaita aikin tabbatarwa lokacin shiga kasuwa ta biyu, yana samar da tanadi mai yawa na 30%-40% idan aka kwatanta da tabbatar da ikon mallakar yanki ɗaya a jere.