{"id":10267,"date":"2026-05-28T11:25:52","date_gmt":"2026-05-28T03:25:52","guid":{"rendered":"https:\/\/rysilicone.com\/?p=10267"},"modified":"2026-05-28T13:55:12","modified_gmt":"2026-05-28T05:55:12","slug":"medical-grade-silicone","status":"publish","type":"post","link":"https:\/\/rysilicone.com\/tr\/medical-grade-silicone\/","title":{"rendered":"T\u0131bbi S\u0131n\u0131f Silikon: FDA, USP S\u0131n\u0131f VI ve ISO 10993 A\u00e7\u0131klamas\u0131"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u201c&quot;T\u0131bbi s\u0131n\u0131f silikon&quot; ifadesi, B2B tedarikinde en \u00e7ok yanl\u0131\u015f kullan\u0131lan etiketlerden biridir. Ayn\u0131 ifade bebek emziklerinde, inf\u00fczyon t\u00fcplerinde ve uzun s\u00fcreli implantlarda da yer al\u0131r; ancak her biri farkl\u0131 bir standarda tabidir. \u00c7o\u011fu genel makale bu ayr\u0131m\u0131 g\u00f6z ard\u0131 eder.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>T\u0131bbi s\u0131n\u0131f silikon <a href=\"https:\/\/rysilicone.com\/tr\/platinum-vulcanization\/\" target=\"_blank\" rel=\"noreferrer noopener\">platin k\u00fcrlenmi\u015f silikon<\/a> En az bir tan\u0131nm\u0131\u015f biyolojik uyumluluk standard\u0131n\u0131 (genellikle FDA 21 CFR 177.2600 (temas), USP S\u0131n\u0131f VI (k\u0131sa s\u00fcreli t\u0131bbi kullan\u0131m) veya ISO 10993 (klinik cihaz s\u0131n\u0131fland\u0131rmas\u0131)) ge\u00e7mi\u015f olmas\u0131 gerekir. Uygulanabilir standart, silikonun kendisinden ziyade temas t\u00fcr\u00fcne ve temas s\u00fcresine ba\u011fl\u0131d\u0131r.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">E\u011fer g\u00f6reviniz, bir \u00fcr\u00fcn\u00fcn t\u0131bbi s\u0131n\u0131f malzemeye ihtiya\u00e7 duyup duymad\u0131\u011f\u0131na karar vermek ve ard\u0131ndan teklif talebi g\u00f6ndermekse, a\u015fa\u011f\u0131daki b\u00f6l\u00fcmler size s\u0131n\u0131r \u00e7izgilerini g\u00f6sterir.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">&quot;T\u0131bbi S\u0131n\u0131f Silikon&quot; Ger\u00e7ekte Ne Anlama Geliyor?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Tek bir k\u00fcresel tan\u0131m yoktur. Bir fabrika bir bile\u015fi\u011fi &quot;t\u0131bbi s\u0131n\u0131f&quot; olarak adland\u0131rd\u0131\u011f\u0131nda, genellikle \u00fc\u00e7 ko\u015ful ayn\u0131 anda kar\u015f\u0131lan\u0131r:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Platinle k\u00fcrlenmi\u015f (ilave k\u00fcrleme), peroksitle k\u00fcrlenmemi\u015f \u2014 peroksit yan \u00fcr\u00fcnleri yok, kal\u0131nt\u0131 koku yok, sararma yok.<\/li>\n\n\n\n<li>Biyouyumluluk a\u00e7\u0131s\u0131ndan kabul g\u00f6rm\u00fc\u015f bir standarda (FDA, USP veya ISO 10993) g\u00f6re test edilmi\u015f baz polimerlerden \u00fcretilmi\u015ftir.<\/li>\n\n\n\n<li>Tipik olarak kontroll\u00fc ko\u015fullar alt\u0131nda \u00fcretilir. <a href=\"https:\/\/www.iso.org\/standard\/53394.html\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">ISO 14644-1 S\u0131n\u0131f 8<\/a> Temiz oda (\u2248 S\u0131n\u0131f 100.000) veya daha kat\u0131 standartlar.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Bu \u00fc\u00e7 \u00f6zellikten birini eksik b\u0131rakan herhangi bir bile\u015fik, pazarlama ifadelerine bak\u0131lmaks\u0131z\u0131n, tedarik a\u00e7\u0131s\u0131ndan t\u0131bbi s\u0131n\u0131f olarak kabul edilmez.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u00dc\u00e7 Uyumluluk Seviyesi (ve Her Birinin Uyguland\u0131\u011f\u0131 Yerler)<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Farkl\u0131 uygulamalar farkl\u0131 sertifikalar gerektirir. Yanl\u0131\u015f seviyeyi se\u00e7mek ya malzeme i\u00e7in gere\u011finden fazla harcamaya yol a\u00e7ar ya da kay\u0131t s\u0131ras\u0131nda denetimden ge\u00e7ememeye neden olur.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th><strong>Standart<\/strong><\/th><th><strong>Kapsam<\/strong><\/th><th><strong>Tipik \u0130leti\u015fim<\/strong><\/th><th><strong>Tahmini Malzeme Maliyeti ile End\u00fcstriyel Is\u0131 Transfer Vinili Kar\u015f\u0131la\u015ft\u0131rmas\u0131<\/strong><\/th><\/tr><\/thead><tbody><tr><td><a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-B\/part-177\/subpart-C\/section-177.2600\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">FDA 21 CFR 177.2600<\/a><\/td><td>G\u0131da \/ a\u011f\u0131z yoluyla \/ cilt temas\u0131yla ilgili g\u00fcvenlik<\/td><td>Emzikler, biberon u\u00e7lar\u0131, mutfak e\u015fyalar\u0131<\/td><td>+10\u201320%<\/td><\/tr><tr><td><a href=\"https:\/\/doi.usp.org\/USPNF\/USPNF_M98834_01_01.html\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">USP S\u0131n\u0131f VI<\/a> (USP &lt;87&gt; \/ &lt;88&gt;)<\/td><td>K\u0131sa s\u00fcreli t\u0131bbi temas, \u2264 30 g\u00fcn<\/td><td>T\u00fcpler, maskeler, k\u0131sa s\u00fcreli kullan\u0131ml\u0131 kateterler<\/td><td>+30\u201350%<\/td><\/tr><tr><td><a href=\"https:\/\/www.iso.org\/standard\/68936.html\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">ISO 10993 serisi<\/a><\/td><td>Tam klinik biyolojik uyumluluk testi (sitotoksisite, duyarl\u0131l\u0131k, tahri\u015f, sistemik toksisite)<\/td><td>\u0130mplantlar, uzun s\u00fcreli temas cihazlar\u0131<\/td><td>+50\u2013100%<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-image size-full\"><img fetchpriority=\"high\" decoding=\"async\" width=\"800\" height=\"450\" src=\"https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/Three-medical-silicone-compliance-tiers-comparison.jpg\" alt=\"\u00dc\u00e7 t\u0131bbi silikon uyumluluk seviyesinin kar\u015f\u0131la\u015ft\u0131r\u0131lmas\u0131\" class=\"wp-image-16312\" srcset=\"https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/Three-medical-silicone-compliance-tiers-comparison.jpg 800w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/Three-medical-silicone-compliance-tiers-comparison-300x169.jpg 300w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/Three-medical-silicone-compliance-tiers-comparison-768x432.jpg 768w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/Three-medical-silicone-compliance-tiers-comparison-18x10.jpg 18w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/Three-medical-silicone-compliance-tiers-comparison-600x338.jpg 600w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\u00d6nemli s\u0131n\u0131r: FDA 21 CFR 177.2600, t\u0131bbi cihaz kural\u0131 de\u011fil, g\u0131da temas\u0131 kural\u0131d\u0131r. &quot;FDA onayl\u0131 silikon&quot; olarak tan\u0131mlanan bir bile\u015fik, otomatik olarak t\u0131bbi kullan\u0131m i\u00e7in onaylanm\u0131\u015f say\u0131lmaz.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">T\u0131bbi S\u0131n\u0131f \u00dcr\u00fcnlere Ger\u00e7ekten \u0130htiyac\u0131n\u0131z Oldu\u011funda<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Tedarik s\u00fcrecinde, karar \u00fcr\u00fcn kategorisi ad\u0131na de\u011fil, ileti\u015fim t\u00fcr\u00fcne ve ileti\u015fim s\u00fcresine g\u00f6re verilir.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Cilt veya a\u011f\u0131z yoluyla temas etmeyin.<\/strong> (End\u00fcstriyel contalar, d\u0131\u015f g\u00f6vdeler, yap\u0131sal par\u00e7alar): Standart HTV silikon yeterlidir. T\u0131bbi s\u0131n\u0131f silikon ise gere\u011finden fazlad\u0131r.<\/li>\n\n\n\n<li><strong>Tekrarlanan a\u011f\u0131z veya cilt temas\u0131<\/strong> (\u00d6nl\u00fckler, paspaslar, mutfak gere\u00e7leri, emzikler): FDA 21 CFR 177.2600 art\u0131 <a href=\"https:\/\/www.bfr.bund.de\/en\/product-safety\/health-assessment-of-food-contact-materials\/\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">LFGB<\/a> (AB pazar\u0131) \u00e7al\u0131\u015fma temelini olu\u015fturmaktad\u0131r. USP S\u0131n\u0131f VI, denetim avantaj\u0131 olmaks\u0131z\u0131n maliyeti art\u0131rmaktad\u0131r.<\/li>\n\n\n\n<li><strong>K\u0131sa s\u00fcreli t\u0131bbi cihaz temas\u0131<\/strong> (\u2264 30 g\u00fcn, sa\u011flam deri veya mukoza \u2014 \u00f6rne\u011fin). <a href=\"https:\/\/rysilicone.com\/tr\/silicone-tubing-manufacturer\/\" target=\"_blank\" rel=\"noreferrer noopener\">inf\u00fczyon t\u00fcp\u00fc<\/a>, (solunum maskeleri): USP S\u0131n\u0131f VI, minimum \u00e7al\u0131\u015fma standard\u0131d\u0131r.<\/li>\n\n\n\n<li><strong>\u0130mplant veya <a href=\"https:\/\/rysilicone.com\/tr\/silicone-strips-used-in-the-medical-and-pharmaceutical-fields\/\" target=\"_blank\" rel=\"noreferrer noopener\">uzun s\u00fcreli doku temas\u0131<\/a><\/strong> (&gt; 30 g\u00fcn): ISO 10993 zorunludur; <a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-submissions-selecting-and-preparing-correct-submission\/premarket-notification-510k\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">FDA 510(k)<\/a> Cihaz onay\u0131, malzeme seviyesinde de\u011fil, cihaz seviyesinde ayr\u0131 bir s\u00fcre\u00e7tir.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u00dcr\u00fcn t\u0131bbi cihaz s\u0131n\u0131r\u0131n\u0131n alt\u0131nda kal\u0131yorsa, USP S\u0131n\u0131f VI hammaddesi i\u00e7in \u00f6deme yapmak sat\u0131\u015flar\u0131 nadiren art\u0131r\u0131r ve malzeme maliyetine 30\u201350% ekler.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Fabrika Taraf\u0131nda Neler De\u011fi\u015fiyor?<\/h2>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" width=\"800\" height=\"450\" src=\"https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/ISO-Class-8-cleanroom-liquid-silicone-injection-production.jpg\" alt=\"ISO S\u0131n\u0131f 8 temiz oda s\u0131v\u0131 silikon enjeksiyon \u00fcretimi\" class=\"wp-image-16311\" srcset=\"https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/ISO-Class-8-cleanroom-liquid-silicone-injection-production.jpg 800w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/ISO-Class-8-cleanroom-liquid-silicone-injection-production-300x169.jpg 300w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/ISO-Class-8-cleanroom-liquid-silicone-injection-production-768x432.jpg 768w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/ISO-Class-8-cleanroom-liquid-silicone-injection-production-18x10.jpg 18w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/ISO-Class-8-cleanroom-liquid-silicone-injection-production-600x338.jpg 600w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">Bir proje t\u0131bbi standartlara uygun olarak kesinle\u015fti\u011finde, fiyat teklifi a\u015famas\u0131nda \u00fc\u00e7 \u015fey de\u011fi\u015fir:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Malzeme<\/strong>: peroksit k\u00fcrlemeli HTV&#039;den platin k\u00fcrlemeli HTV&#039;ye ge\u00e7i\u015f yapar veya <a href=\"https:\/\/rysilicone.com\/tr\/liquid-silicone-rubber\/\" target=\"_blank\" rel=\"noreferrer noopener\">LSR<\/a>. Hammadde fiyatlar\u0131 yakla\u015f\u0131k 25-401 trilyon dolar art\u0131yor.<\/li>\n\n\n\n<li><strong>Tak\u0131m ve hat<\/strong>\u00dcretim, temiz oda ortam\u0131nda (en az ISO 14644-1 S\u0131n\u0131f 8) ger\u00e7ekle\u015ftirilmelidir. \u00c7apraz kontaminasyon riski nedeniyle, peroksit k\u00fcrleme aletlerinin ortak kullan\u0131m\u0131 yasakt\u0131r.<\/li>\n\n\n\n<li><strong>Kur\u015fun zaman\u0131<\/strong>Malzeme analiz sertifikas\u0131, biyolojik uyumluluk test raporlar\u0131 ve parti takibi genellikle ilk \u00fcr\u00fcn onay\u0131ndan \u00f6nce 1-2 hafta daha s\u00fcrer.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Bunlar, iste\u011fe ba\u011fl\u0131 tedarik\u00e7i ek \u00fccretlerinin de\u011fil, standard\u0131n do\u011frudan sonu\u00e7lar\u0131d\u0131r.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Al\u0131nt\u0131 Yapmadan \u00d6nce Ka\u00e7\u0131nman\u0131z Gereken Yayg\u0131n Yanl\u0131\u015f Anlamalar<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u201c<a href=\"https:\/\/rysilicone.com\/tr\/food-grade-silicone\/\" target=\"_blank\" rel=\"noreferrer noopener\">G\u0131da s\u0131n\u0131f\u0131<\/a>\u201d \u2260 t\u0131bbi s\u0131n\u0131f. FDA 21 CFR 177.2600, t\u0131bbi kullan\u0131m i\u00e7in biyolojik uyumlulu\u011fu kapsamaz.<\/li>\n\n\n\n<li>\u201cYaln\u0131zca &quot;platinle k\u00fcrlenmi\u015f&quot; olmas\u0131 t\u0131bbi s\u0131n\u0131f anlam\u0131na gelmez. Bile\u015fi\u011fin ayr\u0131ca ilgili USP veya ISO 10993 test setini de ge\u00e7mesi gerekir.<\/li>\n\n\n\n<li>\u201cLSR\u201d \u2260 t\u0131bbi s\u0131n\u0131f anlam\u0131na gelmez. LSR, bir i\u015flemi (s\u0131v\u0131 silikon enjeksiyonu) tan\u0131mlar; bu i\u015flem, kullan\u0131lan bile\u015fi\u011fe ve temiz oda s\u0131n\u0131f\u0131na ba\u011fl\u0131 olarak end\u00fcstriyel veya t\u0131bbi olabilir.<\/li>\n\n\n\n<li>Malzeme CoA&#039;s\u0131 yaln\u0131zca ham silikonu kapsar. Nihai cihaz sertifikasyonu (FDA 510(k)), <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj\/eng\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">CE MDR<\/a>Bu, silikon tedarik\u00e7isinin de\u011fil, al\u0131c\u0131n\u0131n sorumlulu\u011fundad\u0131r.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">\u00dcretti\u011fimiz Tipik T\u0131bbi S\u0131n\u0131f Uygulamalar<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Teklif verdi\u011fimiz t\u0131bbi s\u0131n\u0131f \u00fcr\u00fcn taleplerinin \u00e7o\u011funu \u00fc\u00e7 \u00fcr\u00fcn grubumuz kar\u015f\u0131l\u0131yor. Her biri farkl\u0131 bir uyumluluk seviyesinde yer al\u0131yor; bu da gerekli test raporlar\u0131n\u0131, \u00fcretim hatt\u0131n\u0131 ve birim fiyat\u0131n\u0131 belirliyor.<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" width=\"800\" height=\"450\" src=\"https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/Medical-grade-silicone-product-range-overview.jpg\" alt=\"T\u0131bbi s\u0131n\u0131f silikon \u00fcr\u00fcn yelpazesine genel bak\u0131\u015f\" class=\"wp-image-16310\" srcset=\"https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/Medical-grade-silicone-product-range-overview.jpg 800w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/Medical-grade-silicone-product-range-overview-300x169.jpg 300w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/Medical-grade-silicone-product-range-overview-768x432.jpg 768w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/Medical-grade-silicone-product-range-overview-18x10.jpg 18w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/Medical-grade-silicone-product-range-overview-600x338.jpg 600w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th><strong>Uyumluluk Seviyesi<\/strong><\/th><th><strong>Tipik \u00dcr\u00fcn Yelpazesi<\/strong><\/th><th><strong>Bu kademenin neden ge\u00e7erli oldu\u011fu<\/strong><\/th><\/tr><\/thead><tbody><tr><td>FDA 21 CFR 177.2600<\/td><td><a href=\"https:\/\/rysilicone.com\/tr\/silicone-baby-pacifier\/\" target=\"_blank\" rel=\"noreferrer noopener\">Silikon bebek emzikleri<\/a> ve g\u0131da ile temas eden di\u011fer par\u00e7alar<\/td><td>Tekrarlanan a\u011f\u0131z temas\u0131, ancak kay\u0131tl\u0131 bir t\u0131bbi cihaz de\u011fil \u2014 g\u0131da s\u0131n\u0131f\u0131 uyumlulu\u011fu temel \u00e7al\u0131\u015fma \u00f6l\u00e7\u00fct\u00fcd\u00fcr.<\/td><\/tr><tr><td>USP S\u0131n\u0131f VI (\u2264 30 g\u00fcn)<\/td><td><a href=\"https:\/\/rysilicone.com\/tr\/silicone-hoses-manufacturer\/\" target=\"_blank\" rel=\"noreferrer noopener\">Silikon hortumlar<\/a> ve klinik ekipman i\u00e7in borular<\/td><td>T\u0131bbi cihazlarda y\u00fczey veya k\u0131sa s\u00fcreli s\u0131v\u0131 yolu temas\u0131; USP &lt;87&gt; \/ &lt;88&gt; sitotoksisite raporlar\u0131 gereklidir.<\/td><\/tr><tr><td>ISO 10993 (uzun s\u00fcreli \/ mukozal)<\/td><td><a href=\"https:\/\/rysilicone.com\/tr\/silicone-menstrual-cup\/\" target=\"_blank\" rel=\"noreferrer noopener\">T\u0131bbi s\u0131n\u0131f silikon adet kaplar\u0131<\/a><\/td><td>K\u00fcm\u00fclatif vajina i\u00e7i temas 30 g\u00fcnl\u00fck e\u015fi\u011fi a\u015f\u0131yor; tam ISO 10993-5 ve -10 testleri gereklidir.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">Bu tam bir katalog de\u011fil; fiyatland\u0131rmay\u0131 en do\u011frudan etkileyen uyumluluk seviyesi burada yer al\u0131yor. Di\u011fer kategoriler i\u00e7in de ayn\u0131 kural ge\u00e7erli: standard\u0131 belirleyen \u00fcr\u00fcn ad\u0131 de\u011fil, ileti\u015fim t\u00fcr\u00fc ve s\u00fcresidir.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">SSS<\/h2>\n\n\n<div id=\"rank-math-faq\" class=\"rank-math-block\">\n<div class=\"rank-math-list\">\n<div id=\"faq-question-1779947514422\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question\"><strong>FDA onayl\u0131 silikon, t\u0131bbi s\u0131n\u0131f silikonla ayn\u0131 m\u0131d\u0131r?<\/strong><\/h3>\n<div class=\"rank-math-answer\">\n\n<p>Hay\u0131r. FDA 21 CFR 177.2600 g\u0131da ile temas g\u00fcvenli\u011fini kapsar. T\u0131bbi kullan\u0131m i\u00e7in USP S\u0131n\u0131f VI veya ISO 10993 testleri gereklidir.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-question-1779947524182\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question\"><strong>T\u0131bbi ama\u00e7l\u0131 silikonun platinle k\u00fcrlenmesi gerekiyor mu?<\/strong><\/h3>\n<div class=\"rank-math-answer\">\n\n<p>Pratikte evet. Peroksit kal\u0131nt\u0131lar\u0131 USP S\u0131n\u0131f VI sitotoksisite testinden ge\u00e7emez, bu nedenle g\u00fcn\u00fcm\u00fczde \u00fcretilen t\u0131bbi s\u0131n\u0131f bile\u015fikler platinle k\u00fcrlenir.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-question-1779947533763\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question\"><strong>T\u0131bbi s\u0131n\u0131f silikon par\u00e7alar i\u00e7in tipik minimum sipari\u015f miktar\u0131 (MOQ) nedir?<\/strong><\/h3>\n<div class=\"rank-math-answer\">\n\n<p>\u00c7o\u011fu fabrika, t\u0131bbi s\u0131n\u0131f LSR i\u00e7in 5.000-10.000 adetlik sipari\u015fler veriyor \u00e7\u00fcnk\u00fc daha k\u00fc\u00e7\u00fck sipari\u015fler i\u00e7in temiz oda hatt\u0131 kurulumu ekonomik de\u011fil.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-question-1779947545615\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question\"><strong>Maliyetleri d\u00fc\u015f\u00fcrmek i\u00e7in daha sonra t\u0131bbi s\u0131n\u0131f \u00fcr\u00fcnden g\u0131da s\u0131n\u0131f\u0131 \u00fcr\u00fcne ge\u00e7ebilir miyim?<\/strong><\/h3>\n<div class=\"rank-math-answer\">\n\n<p>\u00dcr\u00fcn hi\u00e7bir zaman t\u0131bbi bir iddia i\u00e7ermiyorsa, bu durum ge\u00e7erlidir. Bir cihaz FDA 510(k) veya CE MDR kapsam\u0131nda tescil edildikten sonra, malzeme ikamesi yeniden do\u011frulama gerektirir.<\/p>\n\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Teklif talebini g\u00f6ndermeden \u00f6nce<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Kullan\u0131labilir, t\u0131bbi standartlara uygun bir fiyat teklifi almak i\u00e7in \u00f6nceden \u00fc\u00e7 bilginin teyit edilmesi gerekmektedir:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Temas t\u00fcr\u00fc ve temas s\u00fcresi (cilt \/ mukoza \/ implant; \u2264 30 g\u00fcn veya &gt; 30 g\u00fcn).<\/li>\n\n\n\n<li>Hedef pazar ve gerekli sertifikasyon (FDA 21 CFR 177.2600, USP S\u0131n\u0131f VI, ISO 10993-5 \/ -10).<\/li>\n\n\n\n<li>Al\u0131c\u0131n\u0131n cihaz kayd\u0131na (510(k) \/ CE MDR) sahip olup olmad\u0131\u011f\u0131 veya tedarik\u00e7i deste\u011fi bekleyip beklemedi\u011fi.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Bu \u00fc\u00e7 girdi olmadan, alaca\u011f\u0131n\u0131z herhangi bir &quot;t\u0131bbi standart&quot; fiyat teklifi ger\u00e7ek bir fiyat de\u011fil, sadece bir yer tutucudur.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>","protected":false},"excerpt":{"rendered":"<p>&#8220;Medical grade silicone&#8221; is one of the most misused labels in B2B procurement. The same wording appears on baby pacifiers, infusion tubing, and long-term implants \u2014 but each one is held to a different standard. Most generic articles skip that distinction. Medical-grade silicone is platinum-cured silicone that has passed at least one recognized biocompatibility standard [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":16313,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1045],"tags":[],"class_list":["post-10267","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-silicone-materials"],"_links":{"self":[{"href":"https:\/\/rysilicone.com\/tr\/wp-json\/wp\/v2\/posts\/10267","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/rysilicone.com\/tr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/rysilicone.com\/tr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/rysilicone.com\/tr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/rysilicone.com\/tr\/wp-json\/wp\/v2\/comments?post=10267"}],"version-history":[{"count":6,"href":"https:\/\/rysilicone.com\/tr\/wp-json\/wp\/v2\/posts\/10267\/revisions"}],"predecessor-version":[{"id":16321,"href":"https:\/\/rysilicone.com\/tr\/wp-json\/wp\/v2\/posts\/10267\/revisions\/16321"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/rysilicone.com\/tr\/wp-json\/wp\/v2\/media\/16313"}],"wp:attachment":[{"href":"https:\/\/rysilicone.com\/tr\/wp-json\/wp\/v2\/media?parent=10267"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rysilicone.com\/tr\/wp-json\/wp\/v2\/categories?post=10267"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rysilicone.com\/tr\/wp-json\/wp\/v2\/tags?post=10267"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}