Lub Sijhawm Muaj Kev Nyab Xeeb ntawm Kev Sib Chwv Tawv Nqaij nrog Silicone Mis Patches

I. Cov Qauv Tseem Ceeb rau Lub Sijhawm Muaj Kev Nyab Xeeb: Tsim Kom Muaj Kev Ciam Teb Los Ntawm Lub Zeem Muag Kho Mob

Txawm hais tias tsis muaj tus qauv tseeb rau lub sijhawm nyab xeeb ntawm kev sib cuag ntawm daim tawv nqaij nrogsilicone mis thaj ua rau thaj, kev tshawb fawb kho mob thiab kev soj ntsuam hauv tsev kho mob tau tsim kom muaj kev pom zoo. Cov platforms tso cai xws li Xiaohe Medical Encyclopedia qhia meej tias lub sijhawm hnav silicone mis uas pom zoo los ntawm cov tib neeg noj qab haus huv yuav tsum tsis pub tshaj 8 teev. Tus qauv no yog raws li ob qho kev xav:
* **Kev Xav Tau Ntawm Daim Tawv Nqaij:** Txawm hais tias silicone yog cov khoom siv uas ywj tau, nws tsis ua pa tau zoo. Kev npog tas li ntau tshaj 8 teev tuaj yeem ua rau cov hws hauv zos sib sau ua ke, ua rau cov dej noo ntau dhau hauv cov stratum corneum, ua rau lub luag haujlwm ntawm daim tawv nqaij puas tsuaj. 15% ntawm cov neeg siv tas li yuav muaj mob kub hnyiab lossis mob folliculitis.

* **Kev Pheej Hmoo Txog Kev Ua Khaus Tshuaj:** Cov acrylic esters nyob rau hauv cov txheej nplaum ntawm daim ntawv nplaum mis yuav ua rau muaj kev tsis haum tshuaj qeeb. Thaum sib chwv tas li ntau tshaj 12 teev, qhov kev pheej hmoo ntawm kev ua xua yuav nce peb npaug, qhia txog cov tsos mob ntawm kev sib chwv dermatitis xws li erythema thiab papules ntawm ntug daim ntawv nplaum. Cov pej xeem tshwj xeeb xav tau kev tswj hwm nruj dua rau lub sijhawm siv: Cov poj niam cev xeeb tub, vim muaj kev hloov pauv ntawm cov tshuaj hormones ua rau daim tawv nqaij tsis muaj zog, raug qhia kom hnav daim ntawv nplaum tsis pub dhau 6 teev tas li, thiab yuav tsum siv cov nplaum kho mob uas tsis ua rau khaus. Cov neeg uas muaj daim tawv nqaij rhiab heev yuav tsum txo lub sijhawm siv mus rau 4-6 teev thiab ua qhov kev sim me me ntawm daim tawv nqaij ua ntej siv thawj zaug.

II. Peb qhov teeb meem loj uas zais cia uas tshaj qhov ciam teb kev nyab xeeb: Cov ntaub ntawv thiab cov qauv yog qhov tseem ceeb

Lub ntsiab lus tseem ceeb rau kev siv lub sijhawm kom muaj kev nyab xeeb tsis yog cais tawm; nws qhov ua tau zoo nyob ntawm cov khoom siv thiab cov qauv kev siv. Peb qhov kev phom sij tseem ceeb hauv kev ua lag luam tam sim no xav tau kev saib xyuas ze ntawm cov neeg siv khoom lag luam wholesale thoob ntiaj teb:

(I) Cov txheej nplaum sib xyaw: Qhov txaus ntshai rau kev noj qab haus huv uas tsis pom. Cov txheej nplaum, uas kov ncaj qha rau daim tawv nqaij, yog qhov txaus ntshai tseem ceeb. Ib qho kev tshawb fawb los ntawm Yangcheng Evening News qhia tau hais tias feem ntau cov khoom lag luam muaj tsis muab daim ntawv pov thawj nplaum kho mob. Qee cov nplaum qis dua muaj formaldehyde, lead, thiab lwm yam hlau hnyav, uas tib neeg lub cev tsis tuaj yeem ua rau lub cev zom zaub mov tau zoo hauv lub sijhawm ntev. Kev siv ntev yuav ua rau ua xua rau daim tawv nqaij, ua pa tsis zoo, thiab txawm tias txo qis kev tiv thaiv kab mob. Cov kws kho mob hais tias qhov tseem ceeb rau kev txiav txim siab qhov kev nyab xeeb ntawm cov txheej nplaum yog nyob rau hauv seb nws puas tau dhau daim ntawv pov thawj kho mob - piv txwv li, siv cov nplaum kho mob uas ua tau raws li ISO 10993-1 biocompatibility tus qauv tuaj yeem txo qhov kev pheej hmoo ntawm kev ua xua rau qis dua 0.3%. (II) Qib Khoom Siv: Qhov sib txawv tseem ceeb ntawm qib kho mob thiab qib silicone zoo tib yam. Qhov huv ntawm cov khoom siv silicone ncaj qha cuam tshuam rau qhov txwv siab tshaj plaws ntawm kev nyab xeeb. Qib kho mob silicone yuav tsum dhau qib cytotoxicity 0 xeem (tsis muaj tshuaj lom) thiab khaws nws cov elasticity tom qab sterilization ntawm 121 ℃. Cov ntaub so ntswg ua los ntawm cov khoom no tuaj yeem ntev lub sijhawm hnav mus rau 8-10 teev. Cov silicone qib kev lag luam ib txwm muaj tej zaum yuav muaj cov khoom sau tsis zoo (xws li calcium carbonate nrog cov hlau hnyav ntau dhau), uas yuav ua rau khaus tawv nqaij txawm tias hnav luv luv. (III) Kev Tsis Sib Haum Xeeb ntawm Cov Qauv: Tsis Muaj Cov Qauv Kev Lag Luam Kev lag luam tam sim no ntawm daim tawv nqaij raug kev txom nyem los ntawm kev tsis sib haum xeeb ntawm cov qauv: 30% ntawm cov khoom siv tsis raug cov qauv ntaub (xws li GB / T 30157-2013) los sim cov ntaub ntawv silicone, tsis ua tiav cov cim qhia kev nyab xeeb ntawm daim tawv nqaij; 45% ntawm cov tuam txhab siv lawv tus kheej cov qauv kev lag luam tsim (xws li Q / HZLL 002-2004), tsis muaj kev txwv tsis pub ua; tsuas yog 25% ntawm cov khoom xa mus rau cov qauv khoom siv tu cev pov tseg, tab sis cov ntaub so ntswg feem ntau siv ntau zaus, tsa cov lus nug txog qhov siv tau ntawm tus qauv. Nws yog ib qho tseem ceeb uas T/TTGA 009-2025 "Cov Patches Mis" pawg qauv, tau siv rau lub Plaub Hlis 2025, qhia meej tias phthalates hauv cov txheej nplaum thiab cov hlau hnyav uas tuaj yeem rho tawm yuav tsum ua tau raws li cov kev txwv, thiab cov ntsiab lus formaldehyde thiab lwm yam ntsuas yuav tsum ua raws li GB 18401 cov qauv, muab kev siv ua ke rau kev nyab xeeb ntawm cov khoom. III. Kev Nyab Xeeb Hauv Kev Lag Luam Thoob Ntiaj Teb: Cov Qauv Tseem Ceeb Rau Kev Xa Khoom Rau cov neeg siv khoom lag luam wholesale thoob ntiaj teb, cov khoom yuav tsum ua tau raws li cov cai yuav tsum tau ua ntawm lub hom phiaj ua lag luam. Qhov no yog qhov kev txhawb nqa hauv qab rau kev ua kom muaj kev nyab xeeb rau lub sijhawm ntev:

Cov Kev Cai Tseem Ceeb ntawm Cheeb Tsam Kev Lag Luam Cov Cim Qhia Txog Kev Ntsuas Tseem Ceeb
EU
Kev Cai REACH, RoHS Cov Lus Qhia
Kev txwv rau D4/D5 cyclic siloxanes, cov hlau lead thiab cadmium cov ntsiab lus ≤1000ppm, nickel tso tawm ≤0.5μg/cm²/lub lim tiam
Tebchaws Meskas
FDA 21 CFR 177.2600
Tag nrho kev tsiv teb tsaws chaw ≤10mg/dm², tsis muaj kev tsiv teb tsaws chaw yas
Tuam Tshoj
T/TTGA 009-2025, GB 4806.11-2016
Kev ntsuam xyuas qib zog nplaum, cov ntsiab lus VOC <0.5%

Piv txwv li, hauv kev ua lag luam EU, cov ntaub qhwv mis uas tsis tau dhau REACH txoj cai sau npe tshuaj lom neeg, txawm tias lawv hais tias "muaj kev nyab xeeb hnav rau 8 teev," yuav ntsib kev pheej hmoo ntawm kev raug kaw hauv kev lis kev cai. Cov neeg yuav khoom lag luam wholesale raug qhia kom muab cov khoom uas tau dhau ISO 10993 biocompatibility daim ntawv pov thawj thiab FDA sau npe kom txo qhov kev pheej hmoo ntawm kev lag luam teeb meem.

IV. Cov Lus Qhia Txog Kev Nyab Xeeb Rau Kev Yuav Khoom Thiab Siv: Tsim Kom Muaj Nqis Rau Cov Neeg Siv Khoom Kawg

Ua ib tus neeg muag khoom lag luam wholesale, koj tuaj yeem xa cov txiaj ntsig kev nyab xeeb thiab txhim kho kev ntseeg siab ntawm cov neeg siv khoom los ntawm cov kev ntsuas hauv qab no:

(I) Peb Lub Ntsiab Lus Tseem Ceeb rau Kev Xaiv Khoom
* Daim Ntawv Pov Thawj Khoom Siv: Yuav tsum tau cov chaw tsim khoom muab pov thawj ntawm cov khoom siv silicone kho mob (xws li Dow Corning Silastic® series) thiab cov ntawv pov thawj nplaum kho mob;
* Kev Ua Raws Li Cov Qauv: Muab qhov tseem ceeb rau cov khoom uas ua raws li cov qauv T/TTGA 009-2025 lossis ISO 10993, zam kev siv cov qauv uas cov tuam txhab ib leeg tau txhais;
* Kev Ntsuas Kev Ua Tau Zoo: Yuav tsum tau kuaj cov qauv ntawm lub zog ntawm cov txheej nplaum (pom zoo ≥1.5N/cm) thiab kev ua pa tau (tus nqi kis dej pa ≥500g/(m²・24h)) kom sib npaug ntawm kev nplaum thiab kev nyab xeeb. (II) Cov Lus Qhia rau Cov Xwm Txheej Siv Rau Cov Neeg Siv Kawg
Muab cov lus qhia rau cov neeg siv khoom txog lub sijhawm siv rau qhov xwm txheej tshwj xeeb los txhim kho kev siv khoom:
Kev Mus Los Txhua Hnub: ≤8 teev, siv nrog cov khoom ua pa tau (xws li cov uas muaj qhov cua nkag los ntawm honeycomb);
Cov Sijhawm Tshwj Xeeb (piv txwv li, kab tshoob, kev noj mov): ≤10 teev, nws raug pom zoo kom tshem tawm rau 15 feeb rau kev ua pa;
Qhov Kub Siab/Kev Ua Si: ≤4 teev, xaiv cov qauv uas tsis muaj dej thiab tsis hws nrog cov neeg sawv cev txias hauv txheej nplaum.
Thiab, nco ntsoov cov neeg siv kawg: Tom qab txhua zaus siv, ntxuav cov txheej nplaum nrog cov tshuaj ntxuav tsis muaj zog, cia nws qhuav ua ntej khaws cia, thiab zam kev tshav ntuj ncaj qha kom tiv thaiv cov khoom laus - silicone laus tso tawm ntau dua 3 npaug ntawm cov tshuaj ua rau khaus.

V. Cov Qauv Kev Lag Luam: Cov Qauv Kev Nyab Xeeb Tsav Kev Txhim Kho Khoom

Nrog kev paub txog kev noj qab haus huv ntawm cov neeg siv khoom ntau ntxiv, lub sijhawm siv kom muaj kev nyab xeeb tau dhau los ua qhov zoo dua rau kev sib twcov khoom siv kho mob ntawm lub misCov tuam txhab ua lag luam loj tab tom tawg los ntawm cov teeb meem kev nyab xeeb los ntawm kev tsim kho tshiab: Hauv cov ntaub ntawv siv: Cov roj hmab silicone kho platinum siv hloov cov roj hmab silicone kho peroxide ib txwm muaj, txo cov VOC seem los ntawm ≤10ppm mus rau ≤2ppm; Hauv cov qauv: Kev tsim cov khoom sib xyaw ua ke "silicone + breathable membrane" txhim kho kev ua pa los ntawm 40% thiab txuas ntxiv lub sijhawm kev nyab xeeb mus rau 12 teev; Hauv cov nqe lus ntawm kev sim: EN 1811: 2022 kev sim tso tawm nickel thiab ISO 18562-4 kev sim tso tawm nanoparticle tau qhia, npog ntau yam kev ntsuas kev nyab xeeb.