A cikin dakunan aiki, asibitocin hakori, da na'urorin likitanci da ke kera dakunan tsabta, PTFE babban tef ɗin zafin jiki yana ko'ina - amma sau da yawa a ɓoye. Yana kare trays ɗin haifuwa daga mannewa, suturar riguna don kewayawa mai santsi, har ma ya zama tushen tushen dasawa na jijiyoyi.
Godiya ga rashin kuzarin sinadarai, ƙarancin juzu'i, da kwanciyar hankali na thermal, PTFE yana ɗaya daga cikin mafi yawan amfani da fluoropolymers a aikace-aikacen likita. Amma ta yaya za ku san wane tef ɗin PTFE ya dace da wace amfanin likita? Amsar ta dogara da nau'in lamba (tuntuɓar mara lafiya kai tsaye vs. kaikaice), ƙa'idodin tsari (FDA, ISO 10993), da yanayin aikace-aikacen.
Aokai PTFE ya ba da kayan PTFE don aikace-aikacen likita na shekaru. Wannan labarin yana rarraba aikace-aikacen likita ta matakin lamba, yana bayyana ainihin ƙa'idodin tsari, kuma yana ba da jagorar zaɓi mai amfani.
Matakan Aikace-aikacen Likita guda uku ta Matakin Tuntuɓi
Kashi
Yawanci Aikace-aikacen Tef na PTFE
Babban Bukatun
Mahimman aikace-aikacen likitanci (launi kai tsaye/ kai tsaye)
Suture allura (ƙananan shafi na gogayya); catheter/guidewire saman jiyya; gyare-gyaren rauni (bayan baya mara amfani); jijiyoyin bugun jini da facin zuciya (e-PTFE); warewa tushen tushen hakori
Biocompatibility (ISO 10993), daidaiton sinadarai, ƙarancin hankali, dacewa da jini
High-zazzabi juriya (≥260 ° C don haifuwa hawan keke), sunadarai lalata juriya, sauki tsaftacewa, mara sanda
Laboratory & kariyar masana'antu gabaɗaya
Chemical analyzer surface kariya; biosafety cabinet liners; na'urar likita ta rufe hatimi; bututu anti-lalata wrapping
Juriya na sinadaran, aikin rufewa, aikin kariya
Babban Aikace-aikacen Likitanci (Tsarin Majiyyaci Kai tsaye/kai tsaye)
PTFE's bioocompatibility an kafa cikin shekaru da yawa na amfani da asibiti. PTFE ta sami amincewar FDA don aikace-aikacen jijiyoyin jini a cikin 1960s -, da kuma fadada PTFE (e-PTFE) tun daga lokacin ya zama daidaitaccen abu don na'urorin da za a iya dasa.
Aikace-aikace
Takamaiman Amfani
Maɓalli na PTFE
Sutuning na tiyata
Ƙarƙashin juzu'i a kan alluran suture yana ba da damar shigar nama mai santsi
Matsakaicin ƙarancin juzu'i
Catheter & Guidewire shafi
Rufin PTFE yana rage gogayya tsakanin guidewire da bangon jirgin ruwa, yana haɓaka kewayawa ta hanyar jikin mutum mai rauni.
Ƙarƙashin ƙarfi na dindindin na dindindin; babu hydration da ake buƙata don lubricity
Tufafin rauni
Goyan bayan numfashi mara mannewa yana hana raunin nama na biyu yayin canje-canjen sutura
Ƙarƙashin ƙarfin ƙasa, ƙarfin iska
Viscular grafts & bugun zuciya
Ƙananan diamita e-PTFE tasoshin jini na wucin gadi; hadedde e-PTFE na wucin gadi na jijiyoyin jini (misali, CoreVascu) suna shiga gwaji na asibiti
PTFE membrane da aka yi amfani da shi azaman keɓewa abu a cikin tushen tushen
Biocompatibility, sinadaran kwanciyar hankali
Maɓalli mai mahimmanci: Don aikace-aikacen da za a iya dasa, PTFE ba a amfani da shi azaman tef amma azaman kayan da aka sarrafa zuwa takamaiman nau'ikan (misali, e-PTFE vascular grafts, faci). Aokai PTFE yana ba da albarkatun PTFE waɗanda masana'antun na'urar ke ƙara aiwatar da waɗannan aikace-aikacen.
Wannan shine inda tef mai zafi mai zafi kai tsaye a cikin nau'in tef ɗin sa. ake amfani da
1. Kariyar Kariyar Kayan Aikin Haihuwa
Hanyar Haifuwa
PTFE Tape Aiki
Ayyuka
Tasirin autoclave (121-134 ° C)
Kare tire da ganuwar ɗakin; hana mannewa na hatimi/gasket
Yana jure maimaita hawan hawan zafi
EtO haifuwa
Kariyar saman lokacin haifuwar iskar gas
Juriya na sinadarai; babu lalacewa
Gamma irradiation
Kariya na ɗan gajeren lokaci (dogaran kashi)
Limited - duba labarin da ya gabata akan juriya na radiation
Kaset na tushen PTFE suna tsayayya da hawan haifuwa gama gari ciki har da autoclave autoclave, EtO, da magungunan sinadarai da yawa.
2. Kunshin Hatimin zafi
A cikin marufi na blister na likita da layin rufe jakar IV, ana ɗora tef ɗin PTFE akan sandunan dumama don cimma sauri, rufewa mai tsabta ba tare da canja wurin m zuwa kayan jaka ba. Kaset ɗin fina-finai na PTFE suna kula da kwanciyar hankali mai girma da aikin thermal a fadin -73 ° C zuwa 260 ° C, yana hana canja wurin polymer yayin rufe jaka-.
3. Magani Surface Instrument
Aikace-aikace
Amfani
Rufin hannun kayan aiki
Anti-slip, ergonomic riko
Jagoran layin dogo
Motsi mai laushi mai laushi, raguwar ƙayyadaddun ƙira
Rufin lantarki don kayan aiki na ciki
Dielectric ƙarfi, thermal kwanciyar hankali
Aokai PTFE yana ba da tef mai zafi mai zafi na PTFE don kayan aikin marufi na likita da kariya ta tire. Ana samun kaset ɗin mu tare da mannen matsi na silicone, wanda ke jure maimaita sake zagayowar autoclave ba tare da ragowar mannewa ba.
Ka'idojin Gudanarwa don PTFE-Grade
1. FDA 21 CFR 177.1550 - Yarda da Gidauniyar
FDA 21 CFR 177.1550 shine tushen tushen tsarin Gudanar da Abinci da Magunguna na Amurka don resin fluoropolymer. Yardawa yana tabbatar da cewa kayan PTFE suna da aminci don maimaita amfani da su a cikin hulɗa da abinci - kuma ta tsawo, ƙa'idar tunani ce ta gama-gari don PTFE-jin lafiya.
Bambanci mai mahimmanci: FDA ba ta yarda da albarkatun kasa ba; ya amince da gamayya na'urorin likitanci. Lokacin da mai sayarwa ya bayyana cewa PTFE ta amince da 'FDA,' yawanci suna nufin cewa kayan sun cika 21 CFR 177.1550 - wanda shine ainihin ma'aunin hulɗar abinci-. Don na'urorin likitanci, amincewar ƙarshe ya dogara da cikakkiyar sallamar masana'anta ga FDA.
2. ISO 10993 - Gwajin Kwatancen Halittu
Don aikace-aikacen tuntuɓar haƙuri kai tsaye, PTFE dole ne a gwada shi ta jerin ISO 10993:
A taƙaice , tef ɗin zafi mai zafi na PTFE yana hidimar matakai uku na aikace-aikacen likita. Don ainihin aikace-aikacen likita (tuntuɓar mara lafiya kai tsaye), ana amfani da PTFE azaman albarkatun ƙasa (ba azaman tef) tare da amincewar matakin FDA na na'urar da gwajin daidaituwa na ISO 10993. Don masana'antu da sarrafa kayan aikin likita - kariya na kayan aikin haifuwa, marufi-hatimin zafi, da jiyya na kayan aiki - PTFE tef za a iya amfani da shi kai tsaye, tare da silicone PSA shawarar don yanayin autoclave.
Yarda da tsari yana farawa da FDA 21 CFR 177.1550 don amincin kayan, amma amincewar na'urar ƙarshe tana buƙatar ƙaddamar da masana'anta. Don aikace-aikacen tuntuɓar majiyyaci mai mahimmanci, koyaushe tabbatar da gwajin daidaituwa akan samfurin da aka gama, ba kawai albarkatun ƙasa ba.
Kuna buƙatar tef ɗin PTFE ko ɗanyen abu don aikace-aikacen likita? Aokai PTFE yana ba da samfuran PTFE masu darajar likita. Tuntube mu tare da cikakkun bayanan aikace-aikacenku, hanyar haifuwa da aka yi niyya, da buƙatun tsari.
Idan kuna son ƙarin sani game da cikakkun sigogi, yanayin aikace-aikacen, da mafita na musamman don kewayon samfuran mu, gami da masana'anta mai zafin jiki na PTFE, tef mai zafin jiki mai zafi, PTFE high-zazzabi raga bel, m fusing inji bel, guda-gefe PTFE masana'anta, high-zazzabi resistant masana'anta bel da high-gilashi resistant masana'anta don Allah da fiber resistant masana'anta , high-zazzabi resistant masana'anta , high-zazzabi resistant masana'anta , high-zazzabi resistant fiber .
