{"id":8010,"date":"2026-08-25T14:46:36","date_gmt":"2026-08-25T06:46:36","guid":{"rendered":"https:\/\/rysilicone.com\/?p=8010"},"modified":"2026-08-27T14:52:59","modified_gmt":"2026-08-27T06:52:59","slug":"biocompatibility-silicone","status":"publish","type":"post","link":"https:\/\/rysilicone.com\/tr\/biocompatibility-silicone\/","title":{"rendered":"Silikonun Biyouyumlulu\u011fu: Testler, Standartlar ve \u00dcretim Riskleri"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Silikon, esnekli\u011fi, kimyasal kararl\u0131l\u0131\u011f\u0131 ve s\u0131k\u0131 kontrol alt\u0131nda tutulan form\u00fclasyonlarda bulunmas\u0131 nedeniyle s\u0131kl\u0131kla t\u0131bbi cihazlar i\u00e7in tercih edilir. Sorun \u015fu ki... <a href=\"https:\/\/rysilicone.com\/tr\/medical-grade-silicone\/\">t\u0131bbi s\u0131n\u0131f silikon<\/a> Bu durum s\u0131kl\u0131kla bitmi\u015f \u00fcr\u00fcn onay\u0131 olarak de\u011ferlendirilir. Ancak \u00f6yle de\u011fildir. Pigmentler, k\u00fcrleme, son k\u00fcrleme, temizlik, sterilizasyon ve temas ko\u015fullar\u0131 biyolojik riski de\u011fi\u015ftirebilir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Silikonun biyolojik uyumlulu\u011fu, do\u011fu\u015ftan gelen bir ge\u00e7me\/kalma \u00f6zelli\u011fi de\u011fildir. Bu, form\u00fclasyonu, \u00fcretim s\u00fcreci, v\u00fccutla temas t\u00fcr\u00fc ve maruz kalma s\u00fcresi dikkate al\u0131narak de\u011ferlendirilen, belirli bir nihai cihaz\u0131n biyolojik g\u00fcvenli\u011fidir.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Bu ayr\u0131m, yayg\u0131n bir tedarik hatas\u0131n\u0131 \u00f6nler: kal\u0131planm\u0131\u015f par\u00e7ay\u0131 ve ger\u00e7ek kullan\u0131m ko\u015fullar\u0131n\u0131 de\u011ferlendirmeden malzeme sertifikas\u0131n\u0131 onaylamak.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Silikonun Biyouyumlulu\u011fu Ne Anlama Geliyor?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Biyouyumluluk, bir cihaz\u0131n tan\u0131mlanm\u0131\u015f kullan\u0131m ko\u015fullar\u0131 alt\u0131nda kabul edilemez bir biyolojik tepkiye neden olmadan ama\u00e7lanan i\u015flevini yerine getirmesi anlam\u0131na gelir. Bu, malzemenin biyolojik olarak g\u00f6r\u00fcnmez oldu\u011fu anlam\u0131na gelmez.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Silikon elastomerler esas olarak organik yan gruplara sahip bir siloksan omurgas\u0131na dayanmaktad\u0131r. Bunlar <a href=\"https:\/\/rysilicone.com\/tr\/properties-of-silicone\/\">silikon kau\u00e7u\u011fun \u00f6zellikleri<\/a> Esneklik, termal kararl\u0131l\u0131k ve bir\u00e7ok sulu ortama kar\u015f\u0131 diren\u00e7 sa\u011flarlar. Silikonun neden kullan\u0131ld\u0131\u011f\u0131n\u0131 a\u00e7\u0131klarlar. <a href=\"https:\/\/rysilicone.com\/tr\/silicone-tubing-manufacturer\/\">silikon boru<\/a>, Contalar, solunum bile\u015fenleri, yara ile temas eden \u00fcr\u00fcnler ve implante edilebilir cihazlar.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Her uygulama i\u00e7in g\u00fcvenli\u011fi kan\u0131tlamazlar. Ciltle temas eden bir conta, s\u0131v\u0131 yolu t\u00fcp\u00fc ve uzun s\u00fcreli bir implant, v\u00fccudu farkl\u0131 yollarla riske atar. Gerekli kan\u0131t, cihaza g\u00f6re de\u011fi\u015fmelidir.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Silikon, t\u0131bbi cihazlarda neden yayg\u0131n olarak kullan\u0131l\u0131r?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Silikon, mekanik ve kimyasal \u00f6zelliklerinin bir\u00e7ok organik elastomeri bozan ko\u015fullar alt\u0131nda bile istikrarl\u0131 kalabilmesi nedeniyle kullan\u0131\u015fl\u0131d\u0131r.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Tipik avantajlar \u015funlard\u0131r:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>geni\u015f bir s\u0131cakl\u0131k aral\u0131\u011f\u0131nda esneklik;<\/li>\n\n\n\n<li>Neme ve bir\u00e7ok yayg\u0131n kimyasala kar\u015f\u0131 diren\u00e7li;<\/li>\n\n\n\n<li>Form\u00fclasyonun do\u011frulanmas\u0131na ba\u011fl\u0131 olarak, \u00e7e\u015fitli sterilizasyon y\u00f6ntemleriyle uyumludur;<\/li>\n\n\n\n<li>D\u00fc\u015f\u00fck y\u00fczey enerjisi ve kal\u0131ptan kolayca \u00e7\u0131kar\u0131labilme \u00f6zelli\u011fi;<\/li>\n\n\n\n<li>Y\u00fcksek k\u0131vaml\u0131 kau\u00e7uk (HCR) ve s\u0131v\u0131 silikon kau\u00e7uk (LSR) olarak mevcuttur.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Ayn\u0131 y\u00fczey kimyas\u0131 s\u0131n\u0131rlamalar da yarat\u0131r. A <a href=\"https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC8788510\/\" target=\"_blank\" rel=\"noopener\">Biyomedikal m\u00fchendisli\u011finde PDMS&#039;nin incelenmesi<\/a> Do\u011fal PDMS&#039;nin hidrofobik oldu\u011funu ve protein adsorpsiyonunun biyolojik uygulamalarda tekrar eden bir s\u0131n\u0131rlama oldu\u011funu belirtmektedir. Kanla temas eden cihazlar i\u00e7in, <a href=\"https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC10469978\/\" target=\"_blank\" rel=\"noopener\">Malzemenin hemouyumlulu\u011funun incelenmesi<\/a> Adsorbe edilmi\u015f plazma proteinlerinin nas\u0131l konformasyon de\u011fi\u015ftirebilece\u011fini, trombosit yap\u0131\u015fmas\u0131n\u0131 ve aktivasyonunu nas\u0131l destekleyebilece\u011fini ve p\u0131ht\u0131la\u015fmaya ve tromb\u00fcs olu\u015fumuna nas\u0131l katk\u0131da bulunabilece\u011fini a\u00e7\u0131klar. Silikon ayr\u0131ca mikrobiyal kolonizasyona kar\u015f\u0131 otomatik olarak diren\u00e7li de\u011fildir: <a href=\"https:\/\/doi.org\/10.1021\/acsomega.1c00560\" target=\"_blank\" rel=\"noopener\">ACS Omega&#039;n\u0131n silikon idrar kateteri malzemeleri \u00fczerine yapt\u0131\u011f\u0131 \u00e7al\u0131\u015fma<\/a> g\u00f6zlemlendi <em>P. mirabilis<\/em> Geleneksel silikon y\u00fczeylerde yap\u0131\u015fma ve biyofilm geli\u015fimini incelerken, y\u00fczey modifikasyonunun sonucu de\u011fi\u015ftirdi\u011fini de g\u00f6stermi\u015ftir. Bu nedenle &quot;etkisiz&quot; ifadesi, tam bir biyolojik de\u011ferlendirme de\u011fil, kullan\u0131\u015fl\u0131 bir k\u0131saltmad\u0131r.<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"576\" src=\"https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-02_protein-adsorption-platelet-adhesion-publish-1024x576.jpg\" alt=\"\" class=\"wp-image-20828\" srcset=\"https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-02_protein-adsorption-platelet-adhesion-publish-1024x576.jpg 1024w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-02_protein-adsorption-platelet-adhesion-publish-300x169.jpg 300w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-02_protein-adsorption-platelet-adhesion-publish-768x432.jpg 768w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-02_protein-adsorption-platelet-adhesion-publish-1536x864.jpg 1536w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-02_protein-adsorption-platelet-adhesion-publish-18x10.jpg 18w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-02_protein-adsorption-platelet-adhesion-publish-600x338.jpg 600w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-02_protein-adsorption-platelet-adhesion-publish.jpg 1672w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">T\u0131bbi s\u0131n\u0131f silikon otomatik olarak biyolojik olarak uyumlu mudur?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Hay\u0131r. &quot;T\u0131bbi s\u0131n\u0131f&quot; terimi normalde, izlenebilirlik ve se\u00e7ilmi\u015f test verileriyle desteklenen, tedarik\u00e7i taraf\u0131ndan kontrol edilen bir form\u00fclasyonu tan\u0131mlar. Bitmi\u015f cihaz\u0131n de\u011ferlendirilmesinin yerini almaz.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/store.astm.org\/f2038-18.html\" target=\"_blank\" rel=\"noopener\">ASTM F2038<\/a>, T\u0131bbi uygulamalarda kullan\u0131lan silikon form\u00fclasyonlar\u0131n\u0131 kapsayan y\u00f6netmelik, biyolojik uygunlu\u011fun nihayetinde ama\u00e7lanan kullan\u0131ma g\u00f6re de\u011ferlendirilmesi gerekti\u011fini belirtmektedir. Bu, do\u011fru tedarik s\u0131n\u0131r\u0131d\u0131r.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Daha \u00f6nce test edilmi\u015f bir silikon, a\u015fa\u011f\u0131daki de\u011fi\u015fikliklerden herhangi birinden sonra farkl\u0131 bir risk profili g\u00f6sterebilir:<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>De\u011fi\u015ftirmek<\/th><th>Biyolojik olarak neler de\u011fi\u015febilir?<\/th><\/tr><\/thead><tbody><tr><td>Pigment veya ana kar\u0131\u015f\u0131m<\/td><td>Form\u00fclasyona yeni renklendiriciler, ta\u015f\u0131y\u0131c\u0131lar veya safs\u0131zl\u0131klar giriyor.<\/td><\/tr><tr><td>\u0130yile\u015fme d\u00f6ng\u00fcs\u00fc<\/td><td>Kalan reaktif t\u00fcrler veya eksik \u00e7apraz ba\u011flama art\u0131\u015f\u0131na neden olabilir.<\/td><\/tr><tr><td>Tedavi sonras\u0131<\/td><td>U\u00e7ucu kal\u0131nt\u0131lar ve ekstrakte edilebilir profil de\u011fi\u015febilir.<\/td><\/tr><tr><td>Kal\u0131p ay\u0131r\u0131c\u0131 madde<\/td><td>Y\u00fczey kal\u0131nt\u0131lar\u0131 olu\u015fabilir.<\/td><\/tr><tr><td>Temizleme i\u015flemi<\/td><td>Deterjan kal\u0131nt\u0131lar\u0131 veya partik\u00fcl kirlili\u011fi kalabilir.<\/td><\/tr><tr><td>Sterilizasyon<\/td><td>EtO, radyasyon, buhar veya tekrarlanan d\u00f6ng\u00fclerden sonra polimer \u00f6zellikleri veya \u00e7\u00f6z\u00fcnebilir maddeler de\u011fi\u015febilir.<\/td><\/tr><tr><td>Tedarik\u00e7i veya \u00fcretim tesisi<\/td><td>Hammadde kontrolleri ve kirlenme yollar\u0131 de\u011fi\u015febilir.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" width=\"1024\" height=\"576\" src=\"https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-03_manufacturing-biological-risk-publish-1024x576.jpg\" alt=\"\" class=\"wp-image-20829\" srcset=\"https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-03_manufacturing-biological-risk-publish-1024x576.jpg 1024w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-03_manufacturing-biological-risk-publish-300x169.jpg 300w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-03_manufacturing-biological-risk-publish-768x432.jpg 768w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-03_manufacturing-biological-risk-publish-1536x864.jpg 1536w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-03_manufacturing-biological-risk-publish-18x10.jpg 18w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-03_manufacturing-biological-risk-publish-600x338.jpg 600w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-03_manufacturing-biological-risk-publish.jpg 1672w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Bu nedenle, hammadde tedarik\u00e7isinden al\u0131nan sertifika, nihai \u00fcr\u00fcn\u00fcn sonucu de\u011fil, destekleyici bir kan\u0131tt\u0131r.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Platin ve peroksit k\u00fcrleme i\u015flemleri silikonun biyolojik uyumlulu\u011funu nas\u0131l etkiler?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The <a href=\"https:\/\/rysilicone.com\/tr\/platinum-cured-vs-peroxide-cured-silicone\/\">platin ve peroksit k\u00fcrleme sistemleri<\/a> Kal\u0131nt\u0131 kontrol\u00fcn\u00fc etkilerler, ancak biyolojik uyumlulu\u011fu kendi ba\u015flar\u0131na belirlemezler. Do\u011frulanm\u0131\u015f bir peroksit k\u00fcrlemeli bile\u015fen uygun olabilirken, k\u00f6t\u00fc i\u015flenmi\u015f bir platin k\u00fcrlemeli bile\u015fen yine de biyolojik veya kimyasal de\u011ferlendirmeden ge\u00e7emeyebilir.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Fakt\u00f6r<\/th><th>Platin k\u00fcrlenmi\u015f silikon<\/th><th>Peroksitle k\u00fcrlenmi\u015f silikon<\/th><\/tr><\/thead><tbody><tr><td>Ana reaksiyon<\/td><td>Hidrosililasyon yoluyla ilave k\u00fcrleme<\/td><td>Serbest radikal \u00e7apraz ba\u011flama<\/td><\/tr><tr><td>Reaksiyon yan \u00fcr\u00fcnleri<\/td><td>Stokiyometrik reaksiyon yan \u00fcr\u00fcn\u00fc yok.<\/td><td>Peroksit ayr\u0131\u015fma \u00fcr\u00fcnleri kalabilir.<\/td><\/tr><tr><td>Tipik kal\u0131nt\u0131 endi\u015fesi<\/td><td>Tepkimeye girmemi\u015f d\u00fc\u015f\u00fck molek\u00fcl a\u011f\u0131rl\u0131kl\u0131 t\u00fcrler, kataliz\u00f6rle ilgili safs\u0131zl\u0131klar, i\u015flem kaynakl\u0131 kirlenme<\/td><td>U\u00e7ucu bozunma \u00fcr\u00fcnleri, koku ve kal\u0131nt\u0131 peroksit ile ilgili t\u00fcrler<\/td><\/tr><tr><td>Tedavi sonras\u0131 karar<\/td><td>Uygulamaya ve form\u00fclasyona ba\u011fl\u0131<\/td><td>Genellikle u\u00e7ucu kal\u0131nt\u0131lar\u0131 azaltmak ve \u00f6zellikleri stabilize etmek i\u00e7in kullan\u0131l\u0131r.<\/td><\/tr><tr><td>Se\u00e7im mant\u0131\u011f\u0131<\/td><td>Genellikle d\u00fc\u015f\u00fck ekstraksiyon oran\u0131na sahip s\u0131v\u0131 yollar\u0131 ve s\u0131k\u0131 kontrol alt\u0131nda tutulan t\u0131bbi kal\u0131plama i\u015flemleri i\u00e7in tercih edilir.<\/td><td>Form\u00fclasyonun ve k\u00fcrleme sonras\u0131 i\u015flemin do\u011fruland\u0131\u011f\u0131 durumlarda uygun olmaya devam edebilir.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" width=\"1024\" height=\"576\" src=\"https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-04_platinum-peroxide-curing-comparison-publish-1024x576.jpg\" alt=\"\" class=\"wp-image-20830\" srcset=\"https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-04_platinum-peroxide-curing-comparison-publish-1024x576.jpg 1024w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-04_platinum-peroxide-curing-comparison-publish-300x169.jpg 300w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-04_platinum-peroxide-curing-comparison-publish-768x432.jpg 768w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-04_platinum-peroxide-curing-comparison-publish-1536x864.jpg 1536w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-04_platinum-peroxide-curing-comparison-publish-18x10.jpg 18w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-04_platinum-peroxide-curing-comparison-publish-600x338.jpg 600w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-04_platinum-peroxide-curing-comparison-publish.jpg 1672w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u00dcretimdeki sorun sadece &quot;platin mi yoksa peroksit mi?&quot; sorusu de\u011fil; k\u00fcrleme s\u0131cakl\u0131\u011f\u0131, s\u00fcresi, par\u00e7a kal\u0131nl\u0131\u011f\u0131, f\u0131r\u0131n y\u00fcklemesi, hava ak\u0131\u015f\u0131 ve k\u00fcrleme sonras\u0131 maruz kalman\u0131n kontrol edilip edilmemesi ve belgelenmesidir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Kal\u0131n kesitler, ince test plakalar\u0131ndan farkl\u0131 \u015fekilde \u0131s\u0131n\u0131r ve havalan\u0131r. Laboratuvar ortam\u0131nda test edilen bir son k\u00fcrleme i\u015fleminin, karma\u015f\u0131k kal\u0131planm\u0131\u015f bir bile\u015fenden u\u00e7ucu maddeleri ayn\u0131 oranda uzakla\u015ft\u0131rd\u0131\u011f\u0131 varsay\u0131lamaz. Ekipler bunu s\u0131kl\u0131kla g\u00f6zden ka\u00e7\u0131r\u0131r \u00e7\u00fcnk\u00fc malzeme sertifikas\u0131 bile\u015fi\u011fi tan\u0131mlar ancak bitmi\u015f par\u00e7an\u0131n termal ge\u00e7mi\u015fini kaydetmez.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">ISO 10993-1:2025 Standard\u0131na G\u00f6re Silikonun Biyouyumlulu\u011fu Nas\u0131l De\u011ferlendirilir?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/www.iso.org\/standard\/84512.html\" target=\"_blank\" rel=\"noopener\">ISO 10993-1:2025<\/a> Biyolojik g\u00fcvenli\u011fi, ISO 14971 ile uyumlu bir risk y\u00f6netimi s\u00fcreci olarak ele al\u0131r. Her silikon cihaz\u0131n tamamlamas\u0131 gereken sabit bir test listesi de\u011fildir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ABD&#039;ye yap\u0131lacak ba\u015fvurular i\u00e7in, <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfStandards\/detail.cfm?standard__identification_no=47116\" target=\"_blank\" rel=\"noopener\">FDA, 2025 bask\u0131s\u0131n\u0131 k\u0131smen tan\u0131d\u0131.<\/a> 25 May\u0131s 2026&#039;da y\u00fcr\u00fcrl\u00fc\u011fe girecektir. Bu tan\u0131ma, belirli h\u00fck\u00fcmleri hari\u00e7 tutmakta ve 1 Temmuz 2029&#039;da sona erecek bir ge\u00e7i\u015f d\u00f6nemi boyunca 2018 s\u00fcr\u00fcm\u00fcne uygunluk beyanlar\u0131n\u0131 kabul etmeye devam etmektedir. Bu nedenle, ISO s\u00fcr\u00fcm\u00fcn\u00fcn yay\u0131nlanmas\u0131, her maddenin FDA taraf\u0131ndan otomatik olarak kabul edildi\u011fi anlam\u0131na gelmez.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">De\u011ferlendirme d\u00f6rt girdiyle ba\u015flar:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>Malzemenin tamam\u0131 ve form\u00fclasyonu;<\/li>\n\n\n\n<li>\u00dcretim ve sterilizasyon s\u00fcre\u00e7leri;<\/li>\n\n\n\n<li>V\u00fccut temas\u0131n\u0131n niteli\u011fi;<\/li>\n\n\n\n<li>\u0130leti\u015fimin s\u00fcresi.<\/li>\n<\/ol>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"576\" src=\"https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-05_iso-10993-biological-evaluation-workflow-publish-1024x576.jpg\" alt=\"\" class=\"wp-image-20831\" srcset=\"https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-05_iso-10993-biological-evaluation-workflow-publish-1024x576.jpg 1024w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-05_iso-10993-biological-evaluation-workflow-publish-300x169.jpg 300w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-05_iso-10993-biological-evaluation-workflow-publish-768x432.jpg 768w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-05_iso-10993-biological-evaluation-workflow-publish-1536x864.jpg 1536w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-05_iso-10993-biological-evaluation-workflow-publish-18x10.jpg 18w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-05_iso-10993-biological-evaluation-workflow-publish-600x338.jpg 600w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-05_iso-10993-biological-evaluation-workflow-publish.jpg 1672w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Mevcut \u00e7er\u00e7eve, cihazlar\u0131 y\u00fczey temas\u0131, harici ileti\u015fim veya implantasyon gibi temas yollar\u0131na g\u00f6re s\u0131n\u0131fland\u0131r\u0131r. Temas s\u00fcresi ve cihaza \u00f6zg\u00fc tehlikeler daha sonra hangi biyolojik sonu\u00e7lar\u0131n ele al\u0131nmas\u0131 gerekti\u011fini belirler.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The <a href=\"https:\/\/www.fda.gov\/medical-devices\/biocompatibility-assessment-resource-center\/biocompatibility-evaluation-endpoints-device-category\" target=\"_blank\" rel=\"noopener\">FDA son nokta \u00e7er\u00e7evesi<\/a> ABD planlamas\u0131 i\u00e7in yararl\u0131 bir referans olmaya devam ediyor, ancak FDA&#039;n\u0131n Eyl\u00fcl 2023 k\u0131lavuzuna dayan\u0131yor. U\u00e7 nokta tablolar\u0131 bir \u00e7er\u00e7eve niteli\u011finde olup, bir test kontrol listesi de\u011fildir. Bu k\u0131lavuz, FDA&#039;n\u0131n 2025 s\u00fcr\u00fcm\u00fcn\u00fcn k\u0131smi tan\u0131nmas\u0131 ve cihaza \u00f6zg\u00fc gereksinimler aras\u0131ndaki herhangi bir fark, ba\u015fvuru i\u00e7in \u00e7\u00f6z\u00fclmelidir; bir u\u00e7 noktay\u0131 ele almak i\u00e7in mevcut veriler, kimyasal karakterizasyon, testler veya bilimsel bir gerek\u00e7e kullan\u0131labilir.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Hangi ISO 10993 Testleri Uygulanabilir?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Uygulanabilir u\u00e7 noktalar cihaza ba\u011fl\u0131d\u0131r. Yayg\u0131n referanslar \u015funlard\u0131r:<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>De\u011ferlendirme alan\u0131<\/th><th>Ortak standart<\/th><th>Ele ald\u0131\u011f\u0131 konu<\/th><\/tr><\/thead><tbody><tr><td>Sitotoksisite<\/td><td>ISO 10993-5<\/td><td>K\u00fclt\u00fcrlenmi\u015f h\u00fccreler \u00fczerinde olumsuz etkiler<\/td><\/tr><tr><td>Cilt hassasiyeti<\/td><td>ISO 10993-10:2021<\/td><td>Duyarl\u0131l\u0131\u011fa neden olma potansiyeli<\/td><\/tr><tr><td>Tahri\u015f<\/td><td>ISO 10993-23:2021<\/td><td>\u0130lgili temas yollar\u0131 i\u00e7in tahri\u015f potansiyeli<\/td><\/tr><tr><td>Kimyasal karakterizasyon<\/td><td><a href=\"https:\/\/www.iso.org\/standard\/64750.html\" target=\"_blank\" rel=\"noopener\">ISO 10993-18:2020<\/a> \u2022 <a href=\"https:\/\/www.iso.org\/standard\/82241.html\" target=\"_blank\" rel=\"noopener\">Amd 1:2022<\/a><\/td><td>Cihaz bile\u015fenlerinin ve ekstrakte edilebilir maddelerin tan\u0131mlanmas\u0131 ve nicel olarak belirlenmesi<\/td><\/tr><tr><td>Toksikolojik risk de\u011ferlendirmesi<\/td><td><a href=\"https:\/\/www.iso.org\/standard\/75323.html\" target=\"_blank\" rel=\"noopener\">ISO 10993-17:2023<\/a> \u2022 <a href=\"https:\/\/www.iso.org\/standard\/88201.html\" target=\"_blank\" rel=\"noopener\">AMD 1:2025<\/a><\/td><td>Belirlenen bile\u015fenlerin toksikolojik de\u011ferlendirmesi<\/td><\/tr><tr><td>Hemouyumluluk<\/td><td>ISO 10993-4<\/td><td>Kanla etkile\u015fimler<\/td><\/tr><tr><td>\u0130mplantasyon yan\u0131t\u0131<\/td><td>ISO 10993-6<\/td><td>\u0130mplantasyon sonras\u0131 lokal doku yan\u0131t\u0131<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">Sitotoksisite, duyarl\u0131l\u0131k ve tahri\u015f s\u0131kl\u0131kla de\u011ferlendirilir, ancak bunlar evrensel bir &quot;\u00fc\u00e7 testten ge\u00e7me&quot; kriteri de\u011fildir. Kanla temas eden bir t\u00fcp, hem uyumluluk kan\u0131t\u0131 gerektirebilir. Uzun s\u00fcreli bir implant, implantasyon, kronik toksisite, genotoksisite ve di\u011fer sonu\u00e7 noktalar\u0131n\u0131 gerektirebilir. Cihaz kategorisi plan\u0131 belirler.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Kimyasal Karakterizasyon Neden Di\u011fer Testlerden \u00d6nce Gelir?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Kimyasal karakterizasyon, bitmi\u015f cihazdan nelerin s\u0131zabilece\u011fini belirlemeye yard\u0131mc\u0131 olur. Malzeme ad\u0131n\u0131n gizledi\u011fi sorunlar\u0131 ortaya \u00e7\u0131karabilir: d\u00fc\u015f\u00fck molek\u00fcl a\u011f\u0131rl\u0131kl\u0131 siloksanlar, kataliz\u00f6r kal\u0131nt\u0131lar\u0131, pigmentler, katk\u0131 maddeleri, temizlik kal\u0131nt\u0131lar\u0131 veya sterilizasyonla ilgili bile\u015fikler.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Pratik bir s\u0131ralama \u015fu \u015fekildedir:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>Form\u00fclasyonu ve t\u00fcm i\u015fleme yard\u0131mc\u0131lar\u0131n\u0131 belgeleyin;<\/li>\n\n\n\n<li>Klinik a\u00e7\u0131dan \u00f6nemli \u00e7ekim ko\u015fullar\u0131n\u0131 tan\u0131mlay\u0131n;<\/li>\n\n\n\n<li>ISO 10993-18:2020\/Amd 1:2022 standard\u0131na g\u00f6re ekstrakte edilebilir maddeleri tan\u0131mlay\u0131n ve nicelendirin;<\/li>\n\n\n\n<li>ISO 10993-17:2023\/Amd 1:2025 standard\u0131na g\u00f6re toksikolojik riski de\u011ferlendirin;<\/li>\n\n\n\n<li>Kalan veri bo\u015fluklar\u0131n\u0131 biyolojik testleri gerek\u00e7elendirmek i\u00e7in kullan\u0131n.<\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\">Bu yakla\u015f\u0131m, test etmeyi otomatik olarak ortadan kald\u0131rmaz. Ekiplerin cihaz\u0131n i\u00e7eri\u011fini anlamadan \u00f6nce standart bir panel \u00e7al\u0131\u015ft\u0131rmas\u0131n\u0131 engeller.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Test edilecek numune ayn\u0131 zamanda \u00fcretim s\u00fcrecini de temsil etmelidir. Ticari par\u00e7alar sonradan k\u00fcrlenmi\u015f, temizlenmi\u015f, monte edilmi\u015f, paketlenmi\u015f ve sterilize edilmi\u015fse, sterilize edilmemi\u015f bir malzeme plakas\u0131 genellikle zay\u0131f bir alternatiftir. Biyolojik de\u011ferlendirme, hastan\u0131n maruziyetini de\u011fi\u015ftirebilecek s\u00fcre\u00e7leri kapsamal\u0131d\u0131r.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">USP S\u0131n\u0131f VI Neyi Kan\u0131tl\u0131yor?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">USP S\u0131n\u0131f VI, test edilen polimerik malzemenin tan\u0131mlanan biyolojik reaktivite gereksinimlerini kar\u015f\u0131lad\u0131\u011f\u0131n\u0131 g\u00f6stermektedir. <a href=\"https:\/\/doi.usp.org\/USPNF\/USPNF_M98834_01_01.html\" target=\"_blank\" rel=\"noopener\">USP Genel B\u00f6l\u00fcm &lt;88&gt;<\/a>. Program, belirtilen ekstraksiyon ko\u015fullar\u0131 alt\u0131nda sistemik enjeksiyon, intrakutan\u00f6z ve implantasyon testlerini i\u00e7ermektedir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Bu, ISO 10993-1 standard\u0131na g\u00f6re cihaz\u0131n tam biyolojik uyumlulu\u011funu sa\u011flamaz.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u0130ddia<\/th><th>Do\u011fru yorumlama<\/th><\/tr><\/thead><tbody><tr><td>\u201cBu silikon USP S\u0131n\u0131f VI&#039;d\u0131r.\u201d<\/td><td>Belirli ko\u015fullar alt\u0131nda USP &lt;88&gt;&#039;den ge\u00e7mi\u015f, tan\u0131mlanm\u0131\u015f bir malzeme veya test maddesi.<\/td><\/tr><tr><td>\u201c&quot;\u00dcretilen cihaz biyolojik olarak uyumludur.&quot;\u201d<\/td><td>Temas t\u00fcr\u00fc, s\u00fcresi, i\u015flenmesi ve kullan\u0131m amac\u0131na ba\u011fl\u0131 olarak cihaza \u00f6zg\u00fc kan\u0131t gerektirir.<\/td><\/tr><tr><td>\u201cUSP S\u0131n\u0131f VI, t\u00fcm temas s\u00fcrelerini kapsar.\u201d<\/td><td>Yanl\u0131\u015f; USP s\u0131n\u0131fland\u0131rmas\u0131, ISO 10993 u\u00e7 nokta de\u011ferlendirmesinin yerini tutmaz.<\/td><\/tr><tr><td>\u201cTedarik\u00e7i sertifikas\u0131 yeterlidir.\u201d<\/td><td>D\u00fczenleyici strateji, nihai cihaza e\u015fde\u011ferli\u011fi hakl\u0131 \u00e7\u0131karmad\u0131\u011f\u0131 s\u00fcrece yanl\u0131\u015ft\u0131r.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">USP S\u0131n\u0131f VI, malzeme taramas\u0131 ve tedarik\u00e7i yeterlili\u011fi i\u00e7in hala faydal\u0131d\u0131r. S\u0131k yap\u0131lan hata, bu sonucun belgelenmi\u015f bir ba\u011flant\u0131 olmaks\u0131z\u0131n pigmentlere, kal\u0131plamaya, temizli\u011fe, sterilizasyona ve nihai klinik kullan\u0131ma geni\u015fletilmesidir.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">G\u0131da ile Temas Standartlar\u0131 T\u0131bbi Biyouyumlulu\u011fu Kan\u0131tl\u0131yor Mu?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">HAYIR. <a href=\"https:\/\/www.nhc.gov.cn\/sps\/c100088\/202509\/5dc5e1e2b26d4d27a7913b9e71bbe931.shtml\" target=\"_blank\" rel=\"noopener\">GB 4806.16-2025<\/a> Bu, t\u0131bbi cihaz biyouyumluluk standard\u0131 de\u011fil, silikon kau\u00e7uk i\u00e7in \u00c7in men\u015feli g\u0131da temas\u0131 standard\u0131d\u0131r. <a href=\"https:\/\/apps.fas.usda.gov\/newgainapi\/api\/Report\/DownloadReportByFileName?fileName=National+Food+Safety+Standards+for+Food+Contact+Materials_Beijing_China+-+People%27s+Republic+of_CH2025-0216.pdf\" target=\"_blank\" rel=\"noopener\">ABD Tar\u0131m Bakanl\u0131\u011f\u0131 D\u0131\u015f Tar\u0131m Servisi&#039;nin nihai standart \u00e7evirisi<\/a> 2 Eyl\u00fcl 2026 tarihinde y\u00fcr\u00fcrl\u00fc\u011fe girece\u011fini teyit eder ve Ek B kapsam\u0131nda test edilen u\u00e7ucu maddeler i\u00e7in 0,5 g\/100 g (0,5%) limiti belirler.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">G\u0131da ile temas uyumlulu\u011fu, GB\/T 16886, ISO 10993 veya cihaza \u00f6zg\u00fc NMPA gerekliliklerinin yerini almaz. Mutfak e\u015fyalar\u0131, kal\u0131plar veya besleme \u00fcr\u00fcnleri i\u00e7in elde edilen bir migrasyon sonucu, bir implant veya kanla temas eden bir cihaz i\u00e7in g\u00fcvenli\u011fi kan\u0131tlayamaz.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Test sonucunu hangi \u00fcretim kontrolleri korur?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Biyouyumluluk kan\u0131t\u0131, yaln\u0131zca test edilen konfig\u00fcrasyon kontrol alt\u0131nda kald\u0131\u011f\u0131 s\u00fcrece yeniden kullan\u0131labilir.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Malzeme ve Kar\u0131\u015ft\u0131rma Kontrolleri<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Silikon kalitesini, parti numaras\u0131n\u0131, pigment oran\u0131n\u0131, katk\u0131 maddesinin t\u00fcr\u00fcn\u00fc ve kar\u0131\u015ft\u0131rma ge\u00e7mi\u015fini kaydedin. Temel polimer de\u011fi\u015fmedi\u011fi i\u00e7in renk ana kar\u0131\u015f\u0131m\u0131n\u0131 de\u011fi\u015ftirmeyin. Ta\u015f\u0131y\u0131c\u0131 ve pigment sistemi biyolojik de\u011ferlendirmenin bir par\u00e7as\u0131 haline gelir.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">K\u00fcrleme ve K\u00fcrleme Sonras\u0131 Kontroller<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Kal\u0131p s\u0131cakl\u0131\u011f\u0131n\u0131, k\u00fcrleme s\u00fcresini, par\u00e7a kal\u0131nl\u0131\u011f\u0131 aral\u0131\u011f\u0131n\u0131, son k\u00fcrleme s\u0131cakl\u0131\u011f\u0131n\u0131, pozlama s\u00fcresini, f\u0131r\u0131n y\u00fcklemesini ve hava ak\u0131\u015f\u0131n\u0131 tan\u0131mlay\u0131n. \u00c7oklu bo\u015fluklu kal\u0131plar i\u00e7in, t\u00fcm bo\u015fluklar\u0131n e\u015fde\u011fer bir i\u015flem aral\u0131\u011f\u0131na sahip oldu\u011fundan emin olun.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Temizlik ve Kullan\u0131m Kontrolleri<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Kal\u0131p ay\u0131r\u0131c\u0131 maddeleri, deterjanlar\u0131, durulama kalitesini, eldivenleri, kaplar\u0131 ve saklama s\u00fcresini kontrol edin. Temiz bir ham madde, kal\u0131ptan \u00e7\u0131kar\u0131ld\u0131ktan sonra kirlenebilir.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Sterilizasyon Kontrolleri<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Ger\u00e7ek durumu de\u011ferlendirin. <a href=\"https:\/\/rysilicone.com\/tr\/how-do-sterilization-methods-impact-medical-silicone-performance\/\">sterilizasyon y\u00f6ntemi<\/a> ve maksimum onaylanm\u0131\u015f d\u00f6ng\u00fcler. EtO kal\u0131nt\u0131lar\u0131, radyasyon dozu ve buhar maruziyeti farkl\u0131 sorular\u0131 g\u00fcndeme getiriyor. Sterilizasyondan \u00f6nce test edilen bir cihaz, piyasaya s\u00fcr\u00fclen \u00fcr\u00fcn\u00fc temsil etmeyebilir.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">De\u011fi\u015fiklik Kontrol\u00fc<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Form\u00fclasyon, tedarik\u00e7i, tesis, ekipman, k\u00fcrleme d\u00f6ng\u00fcs\u00fc, temizlik maddesi, ambalaj, sterilizasyon y\u00f6ntemi veya ama\u00e7lanan temas de\u011fi\u015fti\u011finde biyolojik risk de\u011ferlendirmesi ba\u015flat\u0131lmal\u0131d\u0131r. Bir de\u011fi\u015fiklik her zaman her testin tekrarlanmas\u0131n\u0131 gerektirmez. Ancak belgelenmi\u015f bir de\u011ferlendirme gerektirir.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Al\u0131c\u0131lar bir silikon bile\u015fen tedarik\u00e7isinden neler talep etmelidir?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Tedarik\u00e7iye &quot;t\u0131bbi silikon&quot; sunup sunmad\u0131\u011f\u0131n\u0131 sormak yerine, k\u0131sa bir kan\u0131t paketi kullan\u0131n.\u201c<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Silikonun tam kalitesi ve \u00fcreticisi;<\/li>\n\n\n\n<li>Parti takibi ve analiz sertifikas\u0131;<\/li>\n\n\n\n<li>Gerekti\u011finde form\u00fclasyon a\u00e7\u0131klamas\u0131 veya d\u00fczenleyici ana dosya deste\u011fi;<\/li>\n\n\n\n<li>K\u00fcrleme sistemi ve do\u011frulanm\u0131\u015f k\u00fcrleme\/k\u00fcrleme sonras\u0131 parametreleri;<\/li>\n\n\n\n<li>Pigment ve katk\u0131 maddesi tan\u0131mlamas\u0131;<\/li>\n\n\n\n<li>Test edilen maddeyi de i\u00e7eren ilgili USP &lt;87&gt;\/&lt;88&gt; veya ISO 10993 raporlar\u0131;<\/li>\n\n\n\n<li>Temas yolunun gerektirdi\u011fi durumlarda, ekstrakte edilebilir ve s\u0131zd\u0131r\u0131labilir madde verileri;<\/li>\n\n\n\n<li>Planlanan y\u00f6ntem i\u00e7in sterilizasyon uyumluluk verileri;<\/li>\n\n\n\n<li>Temizlik, paketleme ve kontaminasyon kontrol\u00fc;<\/li>\n\n\n\n<li>Yaz\u0131l\u0131 de\u011fi\u015fiklik bildirim anla\u015fmas\u0131.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Rapor, e\u015fde\u011ferli\u011fi desteklemek i\u00e7in tedarik edilen par\u00e7ayla yeterince yak\u0131ndan e\u015fle\u015fmelidir. Malzeme s\u0131n\u0131f\u0131n\u0131, rengini, \u00fcretim s\u00fcrecini, sterilizasyon durumunu, ekstraksiyon ko\u015fullar\u0131n\u0131 ve rapor tarihini kontrol edin. Do\u011fru standart numaras\u0131na sahip bir rapor bile, test edilen \u00f6rnek temsili de\u011filse kullan\u0131lamaz.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">S\u0131k\u00e7a Sorulan Sorular<\/h2>\n\n\n<div id=\"rank-math-faq\" class=\"rank-math-block\">\n<div class=\"rank-math-list\">\n<div id=\"faq-question-1787813135862\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question\">Silikon ciltle temas i\u00e7in her zaman g\u00fcvenli midir?<\/h3>\n<div class=\"rank-math-answer\">\n\n<p>HAYIR. <a href=\"https:\/\/rysilicone.com\/tr\/is-silicone-safe-toxicity-chemical-safety\/\">Silikon g\u00fcvenli\u011fi<\/a> Form\u00fclasyona, i\u015fleme art\u0131klar\u0131na, katk\u0131 maddelerine ve temas ko\u015fullar\u0131na ba\u011fl\u0131d\u0131r; nihai cihaz\u0131n kendi de\u011ferlendirmesi de gereklidir.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-question-1787813147122\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question\">T\u0131bbi cihazlar i\u00e7in platin k\u00fcrlenmi\u015f silikon gerekli midir?<\/h3>\n<div class=\"rank-math-answer\">\n\n<p>Hay\u0131r. Platin k\u00fcrleme genellikle d\u00fc\u015f\u00fck ekstraksiyonlu uygulamalar i\u00e7in tercih edilir, ancak bu gereklilik cihaz spesifikasyonundan ve biyolojik risk de\u011ferlendirmesinden kaynaklan\u0131r. Do\u011frulanm\u0131\u015f peroksit k\u00fcrlemeli bir form\u00fclasyon da uygun olabilir.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-question-1787813154718\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question\">USP S\u0131n\u0131f VI, ISO 10993 testinin yerini alabilir mi?<\/h3>\n<div class=\"rank-math-answer\">\n\n<p>Hay\u0131r. USP S\u0131n\u0131f VI, malzeme se\u00e7imini destekleyebilir. Ancak, cihaza \u00f6zg\u00fc ISO 10993-1 biyolojik de\u011ferlendirmesinin yerini almaz.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-question-1787813163726\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question\">Ham madde mi yoksa bitmi\u015f par\u00e7a m\u0131 test edilmeli?<\/h3>\n<div class=\"rank-math-answer\">\n\n<p>En g\u00fc\u00e7l\u00fc kan\u0131t, tamamlanm\u0131\u015f, i\u015flenmi\u015f cihaz veya bilimsel olarak gerek\u00e7elendirilmi\u015f temsili bir test numunesidir. Bu numune, ilgili k\u00fcrleme, temizleme, montaj, paketleme ve sterilizasyon ad\u0131mlar\u0131n\u0131 i\u00e7ermelidir.<\/p>\n\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n<h2 class=\"wp-block-heading\">Test plan\u0131n\u0131 se\u00e7meden \u00f6nce ileti\u015fim kurulacak ki\u015fiyi belirleyin.<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Bir tedarik\u00e7i, yaln\u0131zca polimer ad\u0131ndan yola \u00e7\u0131karak savunulabilir bir silikon biyouyumluluk paketi tan\u0131mlayamaz. Minimum girdiler; v\u00fccutla temas yolu, temas s\u00fcresi, cihaz geometrisi, form\u00fclasyon, i\u015fleme yard\u0131mc\u0131lar\u0131, sterilizasyon y\u00f6ntemi, hedef pazar ve par\u00e7an\u0131n bir bile\u015fen mi yoksa bitmi\u015f bir cihaz m\u0131 olarak tedarik edildi\u011fidir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Bu girdiler olmadan, &quot;ISO 10993 silikon&quot; talep etmek, sat\u0131n alma i\u015flemine yaln\u0131zca belirsiz bir gereklilik aktarmak anlam\u0131na gelir. Malzeme uygun olabilir. Ancak kan\u0131tlar yine de cihaz i\u00e7in yanl\u0131\u015f olabilir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>","protected":false},"excerpt":{"rendered":"<p>Silicone is often selected for medical devices because it is flexible, chemically stable, and available in tightly controlled formulations. The problem is that medical-grade silicone is frequently treated as a finished-device approval. It is not. Pigments, curing, post-curing, cleaning, sterilization, and contact conditions can all change the biological risk. The biocompatibility of silicone is not [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":20827,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1013],"tags":[],"class_list":["post-8010","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-silicone-properties"],"_links":{"self":[{"href":"https:\/\/rysilicone.com\/tr\/wp-json\/wp\/v2\/posts\/8010","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=8010"}],"version-history":[{"count":1,"href":"https:\/\/rysilicone.com\/tr\/wp-json\/wp\/v2\/posts\/8010\/revisions"}],"predecessor-version":[{"id":20832,"href":"https:\/\/rysilicone.com\/tr\/wp-json\/wp\/v2\/posts\/8010\/revisions\/20832"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/rysilicone.com\/tr\/wp-json\/wp\/v2\/media\/20827"}],"wp:attachment":[{"href":"https:\/\/rysilicone.com\/tr\/wp-json\/wp\/v2\/media?parent=8010"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rysilicone.com\/tr\/wp-json\/wp\/v2\/categories?post=8010"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rysilicone.com\/tr\/wp-json\/wp\/v2\/tags?post=8010"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}