Nguva Yakachengeteka Yekubata Ganda NeSilicone Breast Patches
I. Zviyero Zvikuru zveNguva Yakachengeteka: Kugadza Miganhu Kubva Pamaonero Ekurapa
Kunyange hazvo pasina mwero wakazara wekuti ganda rigare kwenguva yakareba sei rakachengeteka.zvigamba zvemazamu zvesilicone, tsvakurudzo yezvekurapa uye kuongororwa kwekiriniki zvakasimbisa chiyero chekubvumirana. Mapuratifomu ane mvumo akadai seXiaohe Medical Encyclopedia anotaura zvakajeka kuti nguva inokurudzirwa yekupfeka mapete ezamu esilicone nevanhu vane hutano haifanirwe kudarika maawa masere. Mutemo uyu wakavakirwa pazvinhu zviviri:
* **Zvinodiwa Paganda:** Kunyange zvazvo silicone isingapindiki, haikwanise kufema zvakanaka. Kuvhara nguva dzose kwemaawa anopfuura masere kunogona kukonzera kuungana kwedikita munzvimbo, zvichikonzera hunyoro hwakawanda mu stratum corneum, zvichikanganisa mashandiro ekudzivirira ganda. 15% yevashandisi vanoenderera mberi vanogona kusangana nekupisa kana folliculitis.
* **Njodzi yeKutsamwiswa neKemikari:** Maester eAcrylic ari muchikamu chinonamira chezasi chezamu anogona kukonzera kushushikana kweganda kwenguva yakareba. Kana kubata kwacho nguva dzose kukadarika maawa gumi nemaviri, njodzi yekurwara neganda inowedzera katatu, zvichiratidza zviratidzo zve contact dermatitis zvakaita se erythema nemapapules pamucheto wechigamba. Mapoka akasiyana anoda kudzora zvakanyanya nguva yekushandisa: Vakadzi vane pamuviri, nekuda kwekuchinja kwemahormone kunokonzera ganda risina kusimba, vanokurudzirwa kupfeka zvigamba izvi kweasingasviki maawa matanhatu nguva dzose, uye vanofanira kushandisa chinamira chisinganyanyi kutsamwisa chekurapa. Vanhu vane ganda rinonzwa kusuruvara vanofanira kupfupisa nguva yacho kusvika maawa mana kusvika matanhatu uye voita bvunzo yeganda diki vasati vatanga kushandisa.
II. Njodzi nhatu huru dzakavanzika dzinopfuura miganhu yekuchengetedza: Zvishandiso nezvinodiwa ndizvo zvakakosha
Chinangwa chikuru chekushandisa nguva yakachengeteka hachisi chega; kushanda kwayo kunoenderana zvakanyanya nezvinhu zvakagadzirwa uye mwero wekushandiswa. Njodzi nhatu huru dziri mumusika wazvino dzinoda kutariswa zvakanyanya nevatengi vekunze kwenyika:
(I) Kuumbwa kwechikamu chinonamira: Njodzi isingaonekwe pahutano. Chikamu chinonamira, chinosangana zvakananga neganda, ndicho njodzi huru. Ongororo yakaitwa neYangcheng Evening News inoratidza kuti zvigadzirwa zvakawanda zvinowanikwa mukutengeserana hazvipe chitupa chekunamira chemhando yekurapa. Zvimwe zvinonamira zvisina kunaka zvine formaldehyde, lead, nedzimwe simbi dzinorema, izvo muviri wemunhu usingakwanise kugaya zvinobudirira kwenguva yakareba. Kushandiswa kwenguva refu kunogona kukonzera allergies yeganda, kutsamwa kwekufema, uye kunyange kudzikira kwekudzivirira muviri. Nyanzvi dzezvekurapa dzinosimbisa kuti kiyi yekuona kuchengetedzeka kwechikamu chinonamira chiri pakuti chapasa chitupa chekurapa here—semuenzaniso, kushandisa chinonamira chinonzwa kumanikidzwa kwechiremba chinosangana neISO 10993-1 biocompatibility standard kunogona kuderedza njodzi yeallergies kusvika pasi pe0.3%. (II) Grade Yezvinhu: Musiyano wakakosha pakati pesilicone yemhando yekurapa neyemhando yemazuva ose. Kuchena kwechikamu chinonamira chesilicone kunokanganisa zvakananga muganho wepamusoro wekuchengetedza. silicone yemhando yekurapa inofanira kupasa bvunzo ye cytotoxicity level 0 (isina chepfu) uye irambe yakasununguka mushure mekuvhiyiwa pa121℃. Zvigamba zvemazamu zvakagadzirwa nechinhu ichi zvinogona kuwedzera nguva yekupfeka kusvika maawa 8-10. Silicone yemhando yepamusoro yeindasitiri inogona kunge iine zvinhu zvisina kunaka zvekuzadza (zvakaita secalcium carbonate ine simbi dzinorema zvakanyanya), izvo zvinogona kukonzera ganda kushatirwa kunyangwe kana ikasakara kwenguva pfupi. (III) Kusawirirana Kwekugadzika: Kusava Nemitemo Yeindasitiri Indasitiri yezvigamba zvemazamu iripo inotambura nekusarongeka kwakakosha kwemitemo: 30% yezvigadzirwa zvinoshandisa zvisirizvo mitemo yemachira (yakadai seGB/T 30157-2013) kuyedza zvinhu zvesilicone, zvichitadza kugadzirisa zviratidzo zvekuchengetedza ganda; 45% yemakambani anoshandisa mitemo yavo yebhizinesi yakazvigadzira (yakadai seQ/HZLL 002-2004), isina zvirambidzo zvinosungirwa; 25% chete yezvigadzirwa zvinoreva mitemo yezvigadzirwa zvehutsanana zvinoraswa, asi zvigamba zvemazamu zvinonyanya kushandiswa kakawanda, zvichimutsa mibvunzo nezvekuti chiyero ichi chinoshanda sei. Zvakakosha kuziva kuti chiyero cheboka reT/TTGA 009-2025 "Breast Patches", chakatangwa muna Kubvumbi 2025, chinoda pachena kuti ma phthalates ari mu adhesive layer nesimbi dzinorema dzinobviswa anofanira kusangana nemiganhu, uye huwandu hwe formaldehyde nezvimwe zviratidzo zvinofanirwa kutevedzera GB 18401 standards, zvichipa humbowo hwakabatana hwekuchengetedzwa kwechigadzirwa. III. Zvikamu zveKuchengetedzeka Mumusika Wepasi Pose: Mitemo Yakakosha Yekutumira Kunze Kune vatengi vepasi rose vanotengesa, zvigadzirwa zvinofanirwa kusangana nemitemo inosungirwa yemusika wakatarwa. Iyi ndiyo rutsigiro rwekutanga rwekuona kuchengetedzeka kwenguva yakareba:
Zvinodiwa zveMusika weDunhu reMusika Zviratidzo Zvikuru zveKuedza
EU
Mutemo weREACH, RoHS Directive
Zvirambidzo paD4/D5 cyclic siloxanes, lead uye cadmium content ≤1000ppm, nickel release ≤0.5μg/cm²/vhiki
USA
FDA 21 CFR 177.2600
Kutama kwese ≤10mg/dm², hapana kutama kwepurasitiki
China
T/TTGA 009-2025, GB 4806.11-2016
Kuongororwa kwesimba rekunamatira, huwandu hweVOC <0.5%
Semuenzaniso, mumusika weEU, machira emazamu asina kupasa mutemo weREACH wekunyoreswa kwemakemikari, kunyangwe akati "akachengeteka kupfeka kwemaawa masere," achasangana nenjodzi yekusungwa kwemitero. Vatengi vanotengeswa vanokurudzirwa kuti vatange nekutengesa zvigadzirwa zvakapasa ISO 10993 biocompatibility certification uye FDA registration kuderedza njodzi yemikana yekutengeserana.
IV. Nhungamiro dzekuchengetedza pakutenga nekushandisa: Kugadzira kukosha kwevatengi vekupedzisira
Semutengesi wezvinhu zvakawanda, unogona kupa kukosha kwekuchengetedza uye kuwedzera kuvimba kwevatengi kuburikidza nematanho anotevera:
(I) Zvinhu Zvitatu Zvakakosha Pakusarudza Chigadzirwa
* Chitupa Chezvinhu: Inoda kuti mafekitori ape humbowo hwezvinhu zvakagadzirwa nesilicone yepamusoro-soro (zvakadai seDow Corning Silastic® series) uye mishumo yezvitupa zvekunamatira yepamusoro-soro;
* Kutevedzera Mitemo: Isa zvinhu zvinotevedzera Mitemo yeT/TTGA 009-2025 kana ISO 10993 pakutanga, uchidzivisa kushandisa mitemo yakazvitsanangura wega nemakambani ega ega;
* Kuedzwa Kwekushanda: Miedzo yekutora sampuli inofanira kuitwa zvichienderana nesimba reganda rerukoko rwekunamira (rinokurudzirwa ≥1.5N/cm) uye kugona kufema (muyero wekufambiswa kwemvura ≥500g/(m²・24h)) kuti pave nekunamira kwakaringana uye kuchengetedzeka. (II) Mazano ekushandisa kwemushandisi wekupedzisira.
Ipa vatengi nhungamiro dzenguva yekushandisa zvinoenderana nemamiriro ezvinhu kuti vawedzere kushandiswa kwechigadzirwa:
Kufamba Netsoka Zuva Nezuva: ≤ maawa masere, shandisa nezvinhu zvinofema (zvakaita sezviya zvine maburi emhepo anopinza muuchi);
Zviitiko Zvakakosha (semuenzaniso, michato, mabiko): ≤ maawa gumi, zvinokurudzirwa kubvisa kwemaminitsi gumi nemashanu kuti mweya upinde;
Mamiriro Ekupisa Kwakanyanya/Mitambo: ≤ maawa 4, sarudza mamodheru asingapindi mvura uye asingapindi ziya ane zvinotonhodza muchikamu chinonamira.
Uyewo, yeuchidzai vashandisi vekupedzisira: Mushure mekushandisa kwega kwega, chenesai jira rinonamira nesipo isina kupindira, bvumirai kuti riome nemhepo musati machengeta, uye dzivirirai chiedza chezuva zvakananga kudzivirira kukwegura kwechinhu—silicone yekukwegura inoburitsa zvinhu zvinokuvadza zvakapetwa katatu.
V. Mafambiro Eindasitiri: Mwero Yekuchengetedza Inosimudzira Kuvandudzwa Kwezvigadzirwa
Nekuwedzera kweruzivo rwehutano hwevatengi, kushandisa nguva yakachengeteka kwave mukana mukuru wekukwikwidzana kwevatengi.zvigadzirwa zvepazamuMakambani anotungamira ari kupinda mumatambudziko ekuchengetedza kuburikidza nekuvandudza tekinoroji: Panyaya yezvinhu: Rabha yesilicone yakagadziriswa neplatinum inoshandiswa panzvimbo perabha yesilicone yakagadziriswa neperoxide, zvichideredza VOC residue kubva pa ≤10ppm kusvika pa ≤2ppm; Panyaya yemaumbirwo: Kugadzirwa kwe "silicone + membrane inofema" composite material kunovandudza kufema ne40% uye kunowedzera nguva yekuchengetedza kusvika kumaawa gumi nemaviri; Panyaya yekuyedza: EN 1811:2022 nickel release test uye ISO 18562-4 nanoparticle release test zvinounzwa, zvichifukidza huwandu hwakakwana hwezviyero zvekuchengetedza.
Nguva yekutumira: Gumiguru-31-2025