Igihe cy'umutekano cyo gukora ku ruhu n'udusimba twa silicone two mu mabere

I. Ibipimo by'ingenzi ku gihe cy'umutekano: Gushyiraho imipaka ukurikije uko ubuvuzi buhagaze

Nubwo nta gipimo ntarengwa cy’igihe uruhu rumara rukora nezauduce tw'amabere twa siliconeUbushakashatsi mu by'ubuvuzi n'isuzuma ry'ubuvuzi byashyizeho igipimo cy'ubwumvikane. Inzego zemewe nka Xiaohe Medical Encyclopedia zivuga neza ko igihe gisabwa cyo kwambara ibitambaro bya silicone ku mabere y'abantu bazima kidakwiye kurenza amasaha 8. Iri hame rishingiye ku bintu bibiri:
* **Ibikenewe ku mubiri w'uruhu:** Nubwo silicone irakomera, ntabwo ihumeka neza. Kuyipfuka buri gihe mu gihe kirenga amasaha 8 bishobora gutuma ibyuya byiyongera, bigatera ubushuhe bwinshi mu gice cya corneum, bikangiza imikorere y'uruhu. 15% by'abayikoresha buri gihe bashobora kugira uduheri tw'ubushyuhe cyangwa folliculitis.

* **Ingaruka zo Kurakara mu Binyabutabire:** Esters za acrylic ziri mu gice cy’agace k’igituza gishobora gutera ubwivumbure butinze. Iyo igihe kirekire kirenze amasaha 12, ibyago byo kurwara ubwivumbure byiyongera inshuro eshatu, bikagaragaza ibimenyetso bya dermatitis yo mu bwoko bwa contact nka erythema na papules ku nkengero z’agace k’igituza. Umubare wihariye w’abantu ukeneye kugenzura cyane igihe cyo gukoresha: Abagore batwite, bitewe n’impinduka mu misemburo zituma uruhu rworoshye, bagirwa inama yo kwambara uduce tw’igituza mu gihe kitarenze amasaha 6 buri gihe, kandi bagomba gukoresha agace k’igituza kadatera ubwivumbure mu rwego rw’ubuvuzi. Abantu bafite uruhu rworoshye bagomba kugabanya igihe kugeza ku masaha 4-6 no gukora isuzuma ry’uruhu ruto mbere yo gukoreshwa bwa mbere.

II. Ingaruka eshatu zikomeye zihishe zirenze imipaka y'umutekano: Ibikoresho n'amahame ni ingenzi

Ingingo y'ingenzi yo gukoresha neza igihe ntarengwa ntabwo ari ukwayo; imikorere yayo ishingira cyane ku bikoresho by'ibicuruzwa n'amahame ngenderwaho yo kubikoresha. Ingaruka eshatu z'ingenzi zihishe ku isoko ry'ubu zisaba kwitabwaho cyane n'abakiriya mpuzamahanga bagurisha ibicuruzwa:

(I) Imiterere y'urutonde rw'ubukorikori: Ingaruka zitagaragara ku buzima. Urutonde rw'ubukorikori, rugera ku ruhu, ni rwo ntandaro y'ingaruka mbi. Ubushakashatsi bwakozwe na Yangcheng Evening News bwerekana ko ibicuruzwa byinshi biboneka ku isoko bidatanga icyemezo cy'ubukorikori bwo mu rwego rw'ubuvuzi. Amwe mu mavuta adakomeye arimo formaldehyde, lisade, n'ibindi byuma bikomeye, umubiri w'umuntu udashobora gukoresha neza mu gihe kirekire. Gukoresha igihe kirekire bishobora gutera ubwivumbure bw'uruhu, kurakara mu myanya y'ubuhumekero, ndetse no kugabanuka k'ubudahangarwa bw'umubiri. Impuguke mu buvuzi zishimangira ko ingenzi mu kumenya umutekano w'urutonde rw'ubukorikori ari ukumenya niba rwaratsinze icyemezo cya muganga—urugero, gukoresha ubukorikori bushobora kwitabwaho n'abaganga buhuye n'amahame ya ISO 10993-1 bishobora kugabanya ibyago byo kurwara ubwivumbure bukagera munsi ya 0.3%. (II) Icyiciro cy'ibikoresho: Itandukaniro rikomeye hagati ya silicone yo mu rwego rw'ubuvuzi n'iyo mu rwego rusanzwe. Ubuziranenge bw'urutonde rwa silicone bugira ingaruka zitaziguye ku mutekano wo hejuru. silicone yo mu rwego rw'ubuvuzi igomba gutsinda ikizamini cya cytotoxicity level 0 (kitarimo uburozi) kandi ikagumana ubukana bwayo nyuma yo gusukura kuri 121℃. Ibikoresho byo mu mabere bikozwe muri ibi bikoresho bishobora kongera igihe cyo kwambara kugeza ku masaha 8-10. Silicone isanzwe yo mu rwego rw'inganda ishobora kuba irimo ibintu bidahagije byo gushyiramo ibintu (nk'ikaruboni karubone irimo ibyuma biremereye), bishobora gutera ububabare bw'uruhu nubwo byangirika vuba. (III) Impaka ku buryo busanzwe: Kutagira amahame ngenderwaho mu nganda Inganda zo mu mabere zihura n'ikibazo gikomeye cyo kudahuza neza: 30% by'ibicuruzwa bikoresha nabi amahame ngenderwaho y'imyenda (nka GB/T 30157-2013) kugira ngo bipime ibikoresho bya silikoni, binanirwa gukemura ibipimo by'umutekano w'uruhu; 45% by'ibigo bikoresha amahame yabyo bwite y'ubucuruzi (nka Q/HZLL 002-2004), bidafite amabwiriza asabwa; 25% gusa by'ibicuruzwa bivuga amahame ngenderwaho y'ibicuruzwa by'isuku bikoreshwa mu gihe gito, ariko ibikoresho byo mu mabere bikoreshwa kenshi, bigatera kwibaza niba ayo mahame akoreshwa. Ni ngombwa kumenya ko amahame ngenderwaho ya T/TTGA 009-2025 “Breast Patches”, yashyizwe mu bikorwa muri Mata 2025, asaba ku buryo bweruye ko phthalate ziri mu gice cy’ubudodo n’ibyuma biremereye bishobora gukurwamo bigomba kuzuza imipaka, kandi ingano ya formaldehyde n’ibindi bimenyetso bigomba kubahiriza amahame ngenderwaho ya GB 18401, bitanga icyerekezo kimwe cy’umutekano w’ibicuruzwa. III. Ingorane z’umutekano ku isoko mpuzamahanga: Amahame ngenderwaho y’ingenzi yo kohereza ibicuruzwa mu mahanga Ku bakiriya mpuzamahanga bagurisha ibicuruzwa, ibicuruzwa bigomba kuzuza amabwiriza y’isoko ryihariye. Iyi ni yo nkunga y’ibanze yo kwemeza umutekano mu gihe kirekire:

Ibipimo by'ingenzi by'isuzuma ry'ibanze ry'akarere k'isoko
EU
Amabwiriza ya REACH, RoHS
Ibibujijwe kuri siloxanes za D4/D5 zizenguruka, ingano ya lead na cadmium ≤1000ppm, kurekurwa kwa nikeli ≤0.5μg/cm²/icyumweru
Amerika
FDA 21 CFR 177.2600
Kwimuka kose ≤10mg/dm², nta kwimuka kwa pulasitiki
Ubushinwa
T / TTGA 009-2025, GB 4806.11-2016
Isuzuma ry'imbaraga zo gufata, ingano ya VOC <0.5%

Urugero, ku isoko ry’Ubumwe bw’u Burayi, uduce tw’amabere tutararenga iyandikwa ry’ibinyabutabire bigenga REACH, nubwo byaba bivuga ko “tuzambara amasaha 8,” tuzahura n’ibyago byo gufungwa by’agateganyo. Abakiriya bacuruzi baragirwa inama yo gushyira imbere ibicuruzwa byujuje icyemezo cya ISO 10993 cy’ubuhanga mu by’ibinyabuzima n’icy’ubutabire mu by’ubucuruzi kugira ngo bagabanye ibyago byo kubura imbogamizi mu bucuruzi.

IV. Amabwiriza y'umutekano mu bijyanye no kugura no gukoresha ibicuruzwa: Guha agaciro abakiriya ba nyuma

Nk'umucuruzi w'ibicuruzwa byinshi, ushobora gutanga agaciro k'umutekano no kongera icyizere cy'abakiriya binyuze mu ngamba zikurikira:

(I) Ibintu bitatu by'ingenzi mu guhitamo ibicuruzwa
* Icyemezo cy'ibikoresho: Gusaba inganda gutanga icyemezo cy'ibikoresho fatizo bya silikoni byo mu rwego rw'ubuvuzi (nk'uruhererekane rwa Dow Corning Silastic®) na raporo z'icyemezo cy'ubukorikori bwo mu rwego rw'ubuvuzi;
* Iyubahirizwa ry'Amabwiriza: Shyira imbere ibicuruzwa byubahirije amahame ya T/TTGA 009-2025 cyangwa ISO 10993, wirinde gukoresha amahame yigenga ku bigo ku giti cyabyo;
* Isuzuma ry'imikorere: Ibizamini byo gufatiraho urugero bigomba gukorwa ku bunini bw'igishishwa cy'urukuta rw'ubudodo (byemewe ≥1.5N/cm) no guhumeka neza (igipimo cyo kohereza umwuka w'amazi ≥500g/(m²・24h)) kugira ngo bihuze uburyo bwo gufata neza n'umutekano. (II) Inama ku mikoreshereze y'ibikoresho by'umukoresha
Ha abakiriya amabwiriza agenga igihe cyo gukoresha ibicuruzwa mu buryo bwihariye kugira ngo bongere ikoreshwa ry’ibicuruzwa:
Gutembera ku rugendo buri munsi: ≤amasaha 8, koresha hamwe n'ibikoresho bihumeka (nk'ibifite utwenge tw'ubuki);
Ibirori byihariye (urugero, ubukwe, ibirori): ≤ amasaha 10, ni byiza kubikuramo iminota 15 kugira ngo umwuka uhumeke;
Ubushyuhe bwinshi/Imiterere ya siporo: ≤ amasaha 4, hitamo moderi zidapfa amazi kandi zirinda ibyuya zifite ibikoresho bikonjesha mu gice gifata ubushyuhe.
Nanone, ibutsa abakoresha: Nyuma ya buri ikoreshwa, sukura urwego rwa kole ukoresheje isabune idakoresha ikoranabuhanga, ureke rumushe mu buryo bw'umwuka mbere yo kubika, kandi wirinde izuba ryinshi kugira ngo wirinde gusaza kw'ibikoresho—silicone ishaje irekura ibintu bikuramo ibintu birenga inshuro eshatu.

V. Impinduka mu nganda: Amahame y'umutekano atuma ibicuruzwa bizamuka

Bitewe n’ubwiyongere bw’ubumenyi ku buzima bw’abaguzi, gukoresha igihe neza byabaye inyungu ikomeye mu guhangana n’ibibazoibikoresho byo gusiga amabereIbigo bikomeye birimo guca mu mbogamizi z’umutekano binyuze mu guhanga udushya mu ikoranabuhanga: Mu bijyanye n’ibikoresho: Rubber ya silicone icurishwa na platine ikoreshwa aho gukoresha rubber ya silicone icurishwa na peroxide isanzwe, bigabanura ibisigazwa bya VOC kuva kuri ≤10ppm kugeza kuri ≤2ppm; Mu bijyanye n’imiterere: Iterambere ry’ibikoresho bivanze bya “silicone + membrane ihumeka” byongera ubushobozi bwo guhumeka ho 40% kandi byongera igihe cy’umutekano kugeza ku masaha 12; Mu bijyanye n’igerageza: Isuzuma rya EN 1811:2022 nickel release na ISO 18562-4 nanoparticle release tests ryarashyizweho, rikubiyemo uburyo burambuye bw’umutekano.