{"id":10267,"date":"2026-05-28T11:25:52","date_gmt":"2026-05-28T03:25:52","guid":{"rendered":"https:\/\/rysilicone.com\/?p=10267"},"modified":"2026-08-26T18:13:26","modified_gmt":"2026-08-26T10:13:26","slug":"medical-grade-silicone","status":"publish","type":"post","link":"https:\/\/rysilicone.com\/vi\/medical-grade-silicone\/","title":{"rendered":"Silicone y t\u1ebf: Gi\u1ea3i th\u00edch theo ti\u00eau chu\u1ea9n FDA, USP Class VI &amp; ISO 10993"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u201cSilicon y t\u1ebf\u201d l\u00e0 m\u1ed9t trong nh\u1eefng nh\u00e3n m\u00e1c b\u1ecb l\u1ea1m d\u1ee5ng nhi\u1ec1u nh\u1ea5t trong ho\u1ea1t \u0111\u1ed9ng mua s\u1eafm B2B. C\u1ee5m t\u1eeb t\u01b0\u01a1ng t\u1ef1 xu\u1ea5t hi\u1ec7n tr\u00ean n\u00fam v\u00fa gi\u1ea3 cho tr\u1ebb em, \u1ed1ng truy\u1ec1n d\u1ecbch v\u00e0 c\u00e1c thi\u1ebft b\u1ecb c\u1ea5y gh\u00e9p d\u00e0i h\u1ea1n \u2014 nh\u01b0ng m\u1ed7i lo\u1ea1i l\u1ea1i \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 theo m\u1ed9t ti\u00eau chu\u1ea9n kh\u00e1c nhau. H\u1ea7u h\u1ebft c\u00e1c b\u00e0i vi\u1ebft chung chung \u0111\u1ec1u b\u1ecf qua s\u1ef1 ph\u00e2n bi\u1ec7t n\u00e0y.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Silicone y t\u1ebf l\u00e0 <a href=\"https:\/\/rysilicone.com\/vi\/platinum-vulcanization\/\" target=\"_blank\" rel=\"noreferrer noopener\">silicon \u0111\u01b0\u1ee3c x\u1eed l\u00fd b\u1eb1ng b\u1ea1ch kim<\/a> S\u1ea3n ph\u1ea9m ph\u1ea3i \u0111\u00e1p \u1ee9ng \u00edt nh\u1ea5t m\u1ed9t ti\u00eau chu\u1ea9n t\u01b0\u01a1ng th\u00edch sinh h\u1ecdc \u0111\u01b0\u1ee3c c\u00f4ng nh\u1eadn \u2014 th\u01b0\u1eddng l\u00e0 FDA 21 CFR 177.2600 (ti\u1ebfp x\u00fac), USP Class VI (s\u1eed d\u1ee5ng y t\u1ebf ng\u1eafn h\u1ea1n) ho\u1eb7c ISO 10993 (ph\u00e2n lo\u1ea1i thi\u1ebft b\u1ecb l\u00e2m s\u00e0ng). Ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng ph\u1ee5 thu\u1ed9c v\u00e0o lo\u1ea1i ti\u1ebfp x\u00fac v\u00e0 th\u1eddi gian ti\u1ebfp x\u00fac, ch\u1ee9 kh\u00f4ng ph\u1ea3i b\u1ea3n th\u00e2n silicon.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">N\u1ebfu nhi\u1ec7m v\u1ee5 c\u1ee7a b\u1ea1n l\u00e0 quy\u1ebft \u0111\u1ecbnh xem m\u1ed9t s\u1ea3n ph\u1ea9m c\u00f3 c\u1ea7n v\u1eadt li\u1ec7u \u0111\u1ea1t ti\u00eau chu\u1ea9n y t\u1ebf hay kh\u00f4ng tr\u01b0\u1edbc khi g\u1eedi y\u00eau c\u1ea7u b\u00e1o gi\u00e1, c\u00e1c ph\u1ea7n b\u00ean d\u01b0\u1edbi s\u1ebd cung c\u1ea5p cho b\u1ea1n c\u00e1c ranh gi\u1edbi c\u1ea7n x\u00e1c \u0111\u1ecbnh.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u201cSilicon y t\u1ebf\u201d th\u1ef1c s\u1ef1 c\u00f3 ngh\u0129a l\u00e0 g\u00ec?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Kh\u00f4ng c\u00f3 m\u1ed9t \u0111\u1ecbnh ngh\u0129a to\u00e0n c\u1ea7u duy nh\u1ea5t. Khi m\u1ed9t nh\u00e0 m\u00e1y g\u1ecdi m\u1ed9t h\u1ee3p ch\u1ea5t l\u00e0 &quot;\u0111\u1ea1t ti\u00eau chu\u1ea9n y t\u1ebf&quot;, th\u01b0\u1eddng th\u00ec ba \u0111i\u1ec1u ki\u1ec7n ph\u1ea3i \u0111\u01b0\u1ee3c \u0111\u00e1p \u1ee9ng c\u00f9ng m\u1ed9t l\u00fac:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u0110\u01b0\u1ee3c x\u1eed l\u00fd b\u1eb1ng b\u1ea1ch kim (x\u1eed l\u00fd b\u1eb1ng ph\u1ea3n \u1ee9ng c\u1ed9ng), kh\u00f4ng ph\u1ea3i b\u1eb1ng peroxit \u2014 kh\u00f4ng c\u00f3 s\u1ea3n ph\u1ea9m ph\u1ee5 c\u1ee7a peroxit, kh\u00f4ng c\u00f3 m\u00f9i d\u01b0, kh\u00f4ng b\u1ecb \u1ed1 v\u00e0ng.<\/li>\n\n\n\n<li>\u0110\u01b0\u1ee3c \u0111i\u1ec1u ch\u1ebf t\u1eeb c\u00e1c polyme c\u01a1 b\u1ea3n \u0111\u00e3 \u0111\u01b0\u1ee3c ki\u1ec3m nghi\u1ec7m theo ti\u00eau chu\u1ea9n t\u01b0\u01a1ng th\u00edch sinh h\u1ecdc \u0111\u01b0\u1ee3c c\u00f4ng nh\u1eadn (FDA, USP ho\u1eb7c ISO 10993).<\/li>\n\n\n\n<li>\u0110\u01b0\u1ee3c s\u1ea3n xu\u1ea5t trong \u0111i\u1ec1u ki\u1ec7n \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t, th\u00f4ng th\u01b0\u1eddng <a href=\"https:\/\/www.iso.org\/standard\/53394.html\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">ISO 14644-1 Lo\u1ea1i 8<\/a> Ph\u00f2ng s\u1ea1ch (t\u01b0\u01a1ng \u0111\u01b0\u01a1ng c\u1ea5p \u0111\u1ed9 100.000) ho\u1eb7c nghi\u00eam ng\u1eb7t h\u01a1n.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">B\u1ea5t k\u1ef3 h\u1ee3p ch\u1ea5t n\u00e0o thi\u1ebfu m\u1ed9t trong ba th\u00e0nh ph\u1ea7n \u0111\u00f3 \u0111\u1ec1u kh\u00f4ng \u0111\u01b0\u1ee3c coi l\u00e0 \u0111\u1ea1t ti\u00eau chu\u1ea9n y t\u1ebf theo quy \u0111\u1ecbnh, b\u1ea5t k\u1ec3 c\u00e1ch d\u00f9ng t\u1eeb ng\u1eef ti\u1ebfp th\u1ecb nh\u01b0 th\u1ebf n\u00e0o.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Ba c\u1ea5p \u0111\u1ed9 tu\u00e2n th\u1ee7 (v\u00e0 ph\u1ea1m vi \u00e1p d\u1ee5ng c\u1ee7a t\u1eebng c\u1ea5p \u0111\u1ed9)<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">C\u00e1c \u1ee9ng d\u1ee5ng kh\u00e1c nhau y\u00eau c\u1ea7u c\u00e1c ch\u1ee9ng nh\u1eadn kh\u00e1c nhau. Ch\u1ecdn sai c\u1ea5p \u0111\u1ed9 c\u00f3 th\u1ec3 d\u1eabn \u0111\u1ebfn l\u00e3ng ph\u00ed v\u1eadt t\u01b0 ho\u1eb7c kh\u00f4ng v\u01b0\u1ee3t qua \u0111\u01b0\u1ee3c ki\u1ec3m to\u00e1n khi \u0111\u0103ng k\u00fd.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th><strong>Ti\u00eau chu\u1ea9n<\/strong><\/th><th><strong>Ph\u1ea1m vi<\/strong><\/th><th><strong>Li\u00ean h\u1ec7 \u0111i\u1ec3n h\u00ecnh<\/strong><\/th><th><strong>Chi ph\u00ed v\u1eadt li\u1ec7u tham kh\u1ea3o so v\u1edbi gi\u00e1 tr\u1ecb nhi\u1ec7t c\u00f4ng nghi\u1ec7p (HTV)<\/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>An to\u00e0n th\u1ef1c ph\u1ea9m \/ \u0111\u01b0\u1eddng mi\u1ec7ng \/ ti\u1ebfp x\u00fac da<\/td><td>N\u00fam v\u00fa gi\u1ea3, n\u00fam ti, \u0111\u1ed3 d\u00f9ng nh\u00e0 b\u1ebfp<\/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 L\u1edbp VI<\/a> (USP &lt;87&gt; \/ &lt;88&gt;)<\/td><td>Ti\u1ebfp x\u00fac y t\u1ebf ng\u1eafn h\u1ea1n, \u2264 30 ng\u00e0y<\/td><td>\u1ed0ng d\u1eabn, m\u1eb7t n\u1ea1, \u1ed1ng th\u00f4ng d\u00f9ng m\u1ed9t l\u1ea7n<\/td><td>+30\u201350%<\/td><\/tr><tr><td><a href=\"https:\/\/www.iso.org\/standard\/68936.html\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">B\u1ed9 ti\u00eau chu\u1ea9n ISO 10993<\/a><\/td><td>B\u1ed9 ki\u1ec3m tra sinh kh\u1ea3 d\u1ee5ng l\u00e2m s\u00e0ng \u0111\u1ea7y \u0111\u1ee7 (\u0111\u1ed9c t\u00ednh t\u1ebf b\u00e0o, m\u1eabn c\u1ea3m, k\u00edch \u1ee9ng, \u0111\u1ed9c t\u00ednh to\u00e0n th\u00e2n)<\/td><td>C\u1ea5y gh\u00e9p, thi\u1ebft b\u1ecb ti\u1ebfp x\u00fac l\u00e2u d\u00e0i<\/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=\"So s\u00e1nh ba c\u1ea5p \u0111\u1ed9 tu\u00e2n th\u1ee7 ti\u00eau chu\u1ea9n silicon y t\u1ebf\" 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\">\u0110i\u1ec3m m\u1ea5u ch\u1ed1t: Quy \u0111\u1ecbnh FDA 21 CFR 177.2600 l\u00e0 quy \u0111\u1ecbnh v\u1ec1 ti\u1ebfp x\u00fac v\u1edbi th\u1ef1c ph\u1ea9m, kh\u00f4ng ph\u1ea3i quy \u0111\u1ecbnh v\u1ec1 thi\u1ebft b\u1ecb y t\u1ebf. M\u1ed9t h\u1ee3p ch\u1ea5t \u0111\u01b0\u1ee3c m\u00f4 t\u1ea3 l\u00e0 \u201csilicone \u0111\u01b0\u1ee3c FDA ch\u1ea5p thu\u1eadn\u201d kh\u00f4ng t\u1ef1 \u0111\u1ed9ng \u0111\u01b0\u1ee3c ph\u00e9p s\u1eed d\u1ee5ng trong y t\u1ebf. \u0110\u1ec3 \u0111\u00e1nh gi\u00e1 thi\u1ebft b\u1ecb ho\u00e0n ch\u1ec9nh, xem <a href=\"https:\/\/rysilicone.com\/vi\/biocompatibility-silicone\/\">C\u00e1ch \u0111\u00e1nh gi\u00e1 kh\u1ea3 n\u0103ng t\u01b0\u01a1ng th\u00edch sinh h\u1ecdc c\u1ee7a silicone theo ti\u00eau chu\u1ea9n ISO 10993<\/a>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Khi b\u1ea1n th\u1ef1c s\u1ef1 c\u1ea7n \u0111\u1ebfn ch\u1ea5t l\u01b0\u1ee3ng y t\u1ebf<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u0110\u1ed1i v\u1edbi quy tr\u00ecnh s\u00e0ng l\u1ecdc h\u1ed3 s\u01a1 mua s\u1eafm, quy\u1ebft \u0111\u1ecbnh \u0111\u01b0\u1ee3c \u0111\u01b0a ra d\u1ef1a tr\u00ean lo\u1ea1i h\u00ecnh li\u00ean h\u1ec7 v\u00e0 th\u1eddi gian li\u00ean h\u1ec7 \u2014 ch\u1ee9 kh\u00f4ng ph\u1ea3i t\u00ean danh m\u1ee5c s\u1ea3n ph\u1ea9m.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Kh\u00f4ng ti\u1ebfp x\u00fac v\u1edbi da ho\u1eb7c mi\u1ec7ng.<\/strong> (Gio\u0103ng c\u00f4ng nghi\u1ec7p, v\u1ecf ngo\u00e0i, c\u00e1c b\u1ed9 ph\u1eadn k\u1ebft c\u1ea5u): Silicone HTV ti\u00eau chu\u1ea9n l\u00e0 \u0111\u1ee7. Lo\u1ea1i d\u00f9ng trong y t\u1ebf th\u00ec v\u01b0\u1ee3t ti\u00eau chu\u1ea9n.<\/li>\n\n\n\n<li><strong>Ti\u1ebfp x\u00fac qua \u0111\u01b0\u1eddng mi\u1ec7ng ho\u1eb7c da nhi\u1ec1u l\u1ea7n<\/strong> (y\u1ebfm \u0103n, th\u1ea3m, d\u1ee5ng c\u1ee5 nh\u00e0 b\u1ebfp, n\u00fam v\u00fa gi\u1ea3): FDA 21 CFR 177.2600 plus <a href=\"https:\/\/www.bfr.bund.de\/en\/product-safety\/health-assessment-of-food-contact-materials\/\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">LFGB<\/a> (Th\u1ecb tr\u01b0\u1eddng EU) l\u00e0 c\u01a1 s\u1edf tham kh\u1ea3o. USP Class VI l\u00e0m t\u0103ng chi ph\u00ed m\u00e0 kh\u00f4ng mang l\u1ea1i l\u1ee3i \u00edch ki\u1ec3m to\u00e1n.<\/li>\n\n\n\n<li><strong>Ti\u1ebfp x\u00fac ng\u1eafn h\u1ea1n v\u1edbi thi\u1ebft b\u1ecb y t\u1ebf<\/strong> (\u2264 30 ng\u00e0y, da ho\u1eb7c ni\u00eam m\u1ea1c c\u00f2n nguy\u00ean v\u1eb9n \u2014 v\u00ed d\u1ee5:. <a href=\"https:\/\/rysilicone.com\/vi\/silicone-tubing-manufacturer\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u1ed1ng truy\u1ec1n d\u1ecbch<\/a>, (M\u1eb7t n\u1ea1 ph\u00f2ng \u0111\u1ed9c): Ti\u00eau chu\u1ea9n USP Class VI l\u00e0 ti\u00eau chu\u1ea9n t\u1ed1i thi\u1ec3u c\u1ea7n thi\u1ebft.<\/li>\n\n\n\n<li><strong>C\u1ea5y gh\u00e9p ho\u1eb7c <a href=\"https:\/\/rysilicone.com\/vi\/silicone-strips-used-in-the-medical-and-pharmaceutical-fields\/\" target=\"_blank\" rel=\"noreferrer noopener\">ti\u1ebfp x\u00fac m\u00f4 l\u00e2u d\u00e0i<\/a><\/strong> (&gt; 30 ng\u00e0y): Ti\u00eau chu\u1ea9n ISO 10993 l\u00e0 b\u1eaft bu\u1ed9c; <a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-submissions-selecting-and-preparing-correct-submission\/premarket-notification-510k\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">FDA510(k)<\/a> Vi\u1ec7c ph\u00ea duy\u1ec7t thi\u1ebft b\u1ecb l\u00e0 m\u1ed9t quy tr\u00ecnh ri\u00eang bi\u1ec7t \u1edf c\u1ea5p \u0111\u1ed9 thi\u1ebft b\u1ecb, ch\u1ee9 kh\u00f4ng ph\u1ea3i \u1edf c\u1ea5p \u0111\u1ed9 v\u1eadt li\u1ec7u.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">N\u1ebfu s\u1ea3n ph\u1ea9m n\u1eb1m d\u01b0\u1edbi ranh gi\u1edbi c\u1ee7a thi\u1ebft b\u1ecb y t\u1ebf, vi\u1ec7c tr\u1ea3 ti\u1ec1n cho nguy\u00ean li\u1ec7u th\u00f4 USP Lo\u1ea1i VI hi\u1ebfm khi c\u1ea3i thi\u1ec7n doanh s\u1ed1 b\u00e1n h\u00e0ng v\u00e0 l\u00e0m t\u0103ng th\u00eam 30\u201350% v\u00e0o chi ph\u00ed nguy\u00ean v\u1eadt li\u1ec7u.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Nh\u1eefng thay \u0111\u1ed5i n\u00e0o di\u1ec5n ra \u1edf ph\u00eda nh\u00e0 m\u00e1y?<\/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=\"S\u1ea3n xu\u1ea5t silicon l\u1ecfng b\u1eb1ng ph\u01b0\u01a1ng ph\u00e1p \u00e9p phun trong ph\u00f2ng s\u1ea1ch \u0111\u1ea1t ti\u00eau chu\u1ea9n ISO c\u1ea5p 8\" 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\">Khi m\u1ed9t d\u1ef1 \u00e1n \u0111\u01b0\u1ee3c ch\u1ed1t \u1edf ti\u00eau chu\u1ea9n y t\u1ebf, ba \u0111i\u1ec1u s\u1ebd thay \u0111\u1ed5i \u1edf giai \u0111o\u1ea1n b\u00e1o gi\u00e1:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>V\u1eadt li\u1ec7u<\/strong>: chuy\u1ec3n t\u1eeb HTV \u0111\u01b0\u1ee3c x\u1eed l\u00fd b\u1eb1ng peroxide sang HTV \u0111\u01b0\u1ee3c x\u1eed l\u00fd b\u1eb1ng b\u1ea1ch kim ho\u1eb7c <a href=\"https:\/\/rysilicone.com\/vi\/liquid-silicone-rubber\/\" target=\"_blank\" rel=\"noreferrer noopener\">LSR<\/a>. Gi\u00e1 nguy\u00ean li\u1ec7u th\u00f4 t\u0103ng kho\u1ea3ng 25\u201340%.<\/li>\n\n\n\n<li><strong>D\u1ee5ng c\u1ee5 v\u00e0 d\u00e2y chuy\u1ec1n<\/strong>Qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t ph\u1ea3i \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n trong ph\u00f2ng s\u1ea1ch (t\u1ed1i thi\u1ec3u ISO 14644-1 Lo\u1ea1i 8). Kh\u00f4ng \u0111\u01b0\u1ee3c ph\u00e9p s\u1eed d\u1ee5ng chung d\u1ee5ng c\u1ee5 x\u1eed l\u00fd b\u1eb1ng peroxide do nguy c\u01a1 l\u00e2y nhi\u1ec5m ch\u00e9o.<\/li>\n\n\n\n<li><strong>Th\u1eddi gian d\u1eabn<\/strong>: Vi\u1ec7c ki\u1ec3m \u0111\u1ecbnh v\u1eadt li\u1ec7u (CoA), b\u00e1o c\u00e1o th\u1eed nghi\u1ec7m kh\u1ea3 n\u0103ng t\u01b0\u01a1ng th\u00edch sinh h\u1ecdc v\u00e0 truy xu\u1ea5t ngu\u1ed3n g\u1ed1c l\u00f4 h\u00e0ng th\u01b0\u1eddng m\u1ea5t th\u00eam 1-2 tu\u1ea7n tr\u01b0\u1edbc khi ph\u00ea duy\u1ec7t s\u1ea3n ph\u1ea9m m\u1eabu \u0111\u1ea7u ti\u00ean.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u0110\u00e2y l\u00e0 nh\u1eefng h\u1ec7 qu\u1ea3 tr\u1ef1c ti\u1ebfp c\u1ee7a c\u00e1c kho\u1ea3n ph\u1ee5 ph\u00ed ti\u00eau chu\u1ea9n, ch\u1ee9 kh\u00f4ng ph\u1ea3i l\u00e0 c\u00e1c kho\u1ea3n ph\u1ee5 ph\u00ed t\u00f9y ch\u1ecdn c\u1ee7a nh\u00e0 cung c\u1ea5p.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Nh\u1eefng l\u1ed7i hi\u1ec3u sai th\u01b0\u1eddng g\u1eb7p c\u1ea7n tr\u00e1nh tr\u01b0\u1edbc khi tr\u00edch d\u1eabn.<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u201c<a href=\"https:\/\/rysilicone.com\/vi\/food-grade-silicone\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u0110\u1ea1t ti\u00eau chu\u1ea9n th\u1ef1c ph\u1ea9m<\/a>\u201d \u2260 \u0111\u1ea1t ti\u00eau chu\u1ea9n y t\u1ebf. Quy \u0111\u1ecbnh FDA 21 CFR 177.2600 kh\u00f4ng \u0111\u1ec1 c\u1eadp \u0111\u1ebfn kh\u1ea3 n\u0103ng t\u01b0\u01a1ng th\u00edch sinh h\u1ecdc cho m\u1ee5c \u0111\u00edch y t\u1ebf.<\/li>\n\n\n\n<li>\u201cCh\u1ec9 ri\u00eang c\u1ee5m t\u1eeb \u201d\u0111\u01b0\u1ee3c x\u1eed l\u00fd b\u1eb1ng b\u1ea1ch kim\u201d kh\u00f4ng \u0111\u1ed3ng ngh\u0129a v\u1edbi \u0111\u1ea1t ti\u00eau chu\u1ea9n y t\u1ebf. H\u1ee3p ch\u1ea5t n\u00e0y c\u0169ng ph\u1ea3i v\u01b0\u1ee3t qua b\u1ed9 th\u1eed nghi\u1ec7m USP ho\u1eb7c ISO 10993 hi\u1ec7n h\u00e0nh.<\/li>\n\n\n\n<li>\u201cLSR\u201d kh\u00f4ng \u0111\u1ed3ng ngh\u0129a v\u1edbi c\u1ea5p \u0111\u1ed9 y t\u1ebf. LSR m\u00f4 t\u1ea3 m\u1ed9t quy tr\u00ecnh (phun silicon l\u1ecfng); d\u00e2y chuy\u1ec1n c\u00f3 th\u1ec3 l\u00e0 c\u00f4ng nghi\u1ec7p ho\u1eb7c y t\u1ebf t\u00f9y thu\u1ed9c v\u00e0o h\u1ee3p ch\u1ea5t v\u00e0 c\u1ea5p \u0111\u1ed9 ph\u00f2ng s\u1ea1ch.<\/li>\n\n\n\n<li>Gi\u1ea5y ch\u1ee9ng nh\u1eadn ph\u00e2n t\u00edch v\u1eadt li\u1ec7u (CoA) ch\u1ec9 bao g\u1ed3m silicon th\u00f4. Ch\u1ee9ng nh\u1eadn thi\u1ebft b\u1ecb cu\u1ed1i c\u00f9ng (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>(\u0110\u00f3 l\u00e0 tr\u00e1ch nhi\u1ec7m c\u1ee7a ng\u01b0\u1eddi mua, kh\u00f4ng ph\u1ea3i c\u1ee7a nh\u00e0 cung c\u1ea5p silicon).<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">C\u00e1c \u1ee9ng d\u1ee5ng y t\u1ebf ti\u00eau chu\u1ea9n \u0111i\u1ec3n h\u00ecnh m\u00e0 ch\u00fang t\u00f4i s\u1ea3n xu\u1ea5t<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Ba d\u00f2ng s\u1ea3n ph\u1ea9m bao ph\u1ee7 h\u1ea7u h\u1ebft c\u00e1c y\u00eau c\u1ea7u b\u00e1o gi\u00e1 (RFQ) d\u00e0nh cho thi\u1ebft b\u1ecb y t\u1ebf m\u00e0 ch\u00fang t\u00f4i b\u00e1o gi\u00e1. M\u1ed7i d\u00f2ng s\u1ea3n ph\u1ea9m thu\u1ed9c m\u1ed9t c\u1ea5p \u0111\u1ed9 tu\u00e2n th\u1ee7 kh\u00e1c nhau \u2014 \u0111i\u1ec1u n\u00e0y quy\u1ebft \u0111\u1ecbnh c\u00e1c b\u00e1o c\u00e1o th\u1eed nghi\u1ec7m c\u1ea7n thi\u1ebft, d\u00e2y chuy\u1ec1n s\u1ea3n xu\u1ea5t v\u00e0 gi\u00e1 \u0111\u01a1n v\u1ecb.<\/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\u1ed5ng quan v\u1ec1 d\u00f2ng s\u1ea3n ph\u1ea9m silicone y t\u1ebf\" 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>C\u1ea5p \u0111\u1ed9 tu\u00e2n th\u1ee7<\/strong><\/th><th><strong>D\u00f2ng s\u1ea3n ph\u1ea9m ti\u00eau bi\u1ec3u<\/strong><\/th><th><strong>T\u1ea1i sao c\u1ea5p \u0111\u1ed9 n\u00e0y \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng<\/strong><\/th><\/tr><\/thead><tbody><tr><td>FDA 21 CFR 177.2600<\/td><td><a href=\"https:\/\/rysilicone.com\/vi\/silicone-baby-pacifier\/\" target=\"_blank\" rel=\"noreferrer noopener\">N\u00fam v\u00fa gi\u1ea3 b\u1eb1ng silicon cho tr\u1ebb em<\/a> v\u00e0 c\u00e1c b\u1ed9 ph\u1eadn ti\u1ebfp x\u00fac v\u1edbi th\u1ef1c ph\u1ea9m kh\u00e1c<\/td><td>Ti\u1ebfp x\u00fac mi\u1ec7ng nhi\u1ec1u l\u1ea7n, nh\u01b0ng kh\u00f4ng ph\u1ea3i l\u00e0 thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c \u0111\u0103ng k\u00fd \u2014 ti\u00eau chu\u1ea9n an to\u00e0n th\u1ef1c ph\u1ea9m l\u00e0 m\u1ee9c c\u01a1 b\u1ea3n \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng.<\/td><\/tr><tr><td>USP Lo\u1ea1i VI (\u2264 30 ng\u00e0y)<\/td><td><a href=\"https:\/\/rysilicone.com\/vi\/silicone-hoses-manufacturer\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u1ed0ng silicone<\/a> v\u00e0 \u1ed1ng d\u1eabn cho thi\u1ebft b\u1ecb l\u00e2m s\u00e0ng<\/td><td>Ti\u1ebfp x\u00fac b\u1ec1 m\u1eb7t ho\u1eb7c ti\u1ebfp x\u00fac ng\u1eafn h\u1ea1n v\u1edbi \u0111\u01b0\u1eddng d\u1eabn ch\u1ea5t l\u1ecfng trong thi\u1ebft b\u1ecb y t\u1ebf; y\u00eau c\u1ea7u b\u00e1o c\u00e1o \u0111\u1ed9c t\u00ednh t\u1ebf b\u00e0o theo USP &lt;87&gt; \/ &lt;88&gt;.<\/td><\/tr><tr><td>ISO 10993 (d\u00e0i h\u1ea1n \/ ni\u00eam m\u1ea1c)<\/td><td><a href=\"https:\/\/rysilicone.com\/vi\/silicone-menstrual-cup\/\" target=\"_blank\" rel=\"noreferrer noopener\">C\u1ed1c nguy\u1ec7t san b\u1eb1ng silicon y t\u1ebf<\/a><\/td><td>T\u1ed5ng th\u1eddi gian ti\u1ebfp x\u00fac trong \u00e2m \u0111\u1ea1o v\u01b0\u1ee3t qu\u00e1 ng\u01b0\u1ee1ng 30 ng\u00e0y; c\u1ea7n ti\u1ebfn h\u00e0nh ki\u1ec3m tra \u0111\u1ea7y \u0111\u1ee7 theo ti\u00eau chu\u1ea9n ISO 10993-5 v\u00e0 -10.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\u0110\u00e2y kh\u00f4ng ph\u1ea3i l\u00e0 danh m\u1ee5c \u0111\u1ea7y \u0111\u1ee7 \u2014 m\u00e0 l\u00e0 n\u01a1i m\u00e0 c\u1ea5p \u0111\u1ed9 tu\u00e2n th\u1ee7 \u1ea3nh h\u01b0\u1edfng tr\u1ef1c ti\u1ebfp nh\u1ea5t \u0111\u1ebfn vi\u1ec7c b\u00e1o gi\u00e1. \u0110\u1ed1i v\u1edbi c\u00e1c danh m\u1ee5c kh\u00e1c, quy t\u1eafc t\u01b0\u01a1ng t\u1ef1 c\u0169ng \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng: lo\u1ea1i h\u1ee3p \u0111\u1ed3ng v\u00e0 th\u1eddi h\u1ea1n quy\u1ebft \u0111\u1ecbnh ti\u00eau chu\u1ea9n, ch\u1ee9 kh\u00f4ng ph\u1ea3i t\u00ean s\u1ea3n ph\u1ea9m.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">C\u00e2u h\u1ecfi th\u01b0\u1eddng g\u1eb7p<\/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>Silicone \u0111\u01b0\u1ee3c FDA ch\u1ea5p thu\u1eadn c\u00f3 gi\u1ed1ng v\u1edbi silicone d\u00f9ng trong y t\u1ebf kh\u00f4ng?<\/strong><\/h3>\n<div class=\"rank-math-answer\">\n\n<p>Kh\u00f4ng. Quy \u0111\u1ecbnh FDA 21 CFR 177.2600 \u0111\u1ec1 c\u1eadp \u0111\u1ebfn an to\u00e0n khi ti\u1ebfp x\u00fac v\u1edbi th\u1ef1c ph\u1ea9m. S\u1eed d\u1ee5ng trong y t\u1ebf y\u00eau c\u1ea7u ki\u1ec3m nghi\u1ec7m theo ti\u00eau chu\u1ea9n USP Class VI ho\u1eb7c ISO 10993.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-question-1779947524182\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question\"><strong>Silicone y t\u1ebf c\u00f3 c\u1ea7n ph\u1ea3i \u0111\u01b0\u1ee3c x\u1eed l\u00fd b\u1eb1ng b\u1ea1ch kim kh\u00f4ng?<\/strong><\/h3>\n<div class=\"rank-math-answer\">\n\n<p>Tr\u00ean th\u1ef1c t\u1ebf th\u00ec \u0111\u00fang v\u1eady. D\u01b0 l\u01b0\u1ee3ng peroxide kh\u00f4ng \u0111\u1ea1t ti\u00eau chu\u1ea9n ki\u1ec3m tra \u0111\u1ed9c t\u00ednh t\u1ebf b\u00e0o USP Class VI, v\u00ec v\u1eady c\u00e1c h\u1ee3p ch\u1ea5t y t\u1ebf \u0111ang \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t hi\u1ec7n nay \u0111\u1ec1u \u0111\u01b0\u1ee3c x\u1eed l\u00fd b\u1eb1ng b\u1ea1ch kim.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-question-1779947533763\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question\"><strong>S\u1ed1 l\u01b0\u1ee3ng \u0111\u1eb7t h\u00e0ng t\u1ed1i thi\u1ec3u (MOQ) th\u00f4ng th\u01b0\u1eddng cho c\u00e1c b\u1ed9 ph\u1eadn silicon y t\u1ebf l\u00e0 bao nhi\u00eau?<\/strong><\/h3>\n<div class=\"rank-math-answer\">\n\n<p>H\u1ea7u h\u1ebft c\u00e1c nh\u00e0 m\u00e1y b\u00e1o gi\u00e1 LSR c\u1ea5p y t\u1ebf t\u1eeb 5.000\u201310.000 chi\u1ebfc, v\u00ec vi\u1ec7c thi\u1ebft l\u1eadp d\u00e2y chuy\u1ec1n ph\u00f2ng s\u1ea1ch kh\u00f4ng hi\u1ec7u qu\u1ea3 v\u1ec1 m\u1eb7t kinh t\u1ebf \u0111\u1ed1i v\u1edbi c\u00e1c l\u00f4 h\u00e0ng nh\u1ecf h\u01a1n.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-question-1779947545615\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question\"><strong>T\u00f4i c\u00f3 th\u1ec3 h\u1ea1 c\u1ea5p t\u1eeb lo\u1ea1i d\u00f9ng trong y t\u1ebf xu\u1ed1ng lo\u1ea1i d\u00f9ng trong th\u1ef1c ph\u1ea9m sau n\u00e0y \u0111\u1ec3 ti\u1ebft ki\u1ec7m chi ph\u00ed \u0111\u01b0\u1ee3c kh\u00f4ng?<\/strong><\/h3>\n<div class=\"rank-math-answer\">\n\n<p>Ch\u1ec9 khi s\u1ea3n ph\u1ea9m kh\u00f4ng bao gi\u1edd c\u00f3 tuy\u00ean b\u1ed1 v\u1ec1 t\u00ednh ch\u1ea5t y t\u1ebf. Sau khi thi\u1ebft b\u1ecb \u0111\u01b0\u1ee3c \u0111\u0103ng k\u00fd theo FDA 510(k) ho\u1eb7c CE MDR, vi\u1ec7c thay th\u1ebf v\u1eadt li\u1ec7u y\u00eau c\u1ea7u ph\u1ea3i \u0111\u01b0\u1ee3c th\u1ea9m \u0111\u1ecbnh l\u1ea1i.<\/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\">Tr\u01b0\u1edbc khi b\u1ea1n g\u1eedi y\u00eau c\u1ea7u b\u00e1o gi\u00e1 (RFQ)<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u0110\u1ec3 nh\u1eadn \u0111\u01b0\u1ee3c b\u00e1o gi\u00e1 \u0111\u1ea1t ti\u00eau chu\u1ea9n y t\u1ebf, c\u1ea7n x\u00e1c nh\u1eadn tr\u01b0\u1edbc ba th\u00f4ng tin sau:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Lo\u1ea1i ti\u1ebfp x\u00fac v\u00e0 th\u1eddi gian ti\u1ebfp x\u00fac (da \/ ni\u00eam m\u1ea1c \/ c\u1ea5y gh\u00e9p; \u2264 30 ng\u00e0y ho\u1eb7c &gt; 30 ng\u00e0y).<\/li>\n\n\n\n<li>Th\u1ecb tr\u01b0\u1eddng m\u1ee5c ti\u00eau v\u00e0 ch\u1ee9ng nh\u1eadn c\u1ea7n thi\u1ebft (FDA 21 CFR 177.2600, USP Class VI, ISO 10993-5 \/ -10).<\/li>\n\n\n\n<li>Cho d\u00f9 ng\u01b0\u1eddi mua n\u1eafm gi\u1eef gi\u1ea5y ph\u00e9p \u0111\u0103ng k\u00fd thi\u1ebft b\u1ecb (510(k) \/ CE MDR) hay mong mu\u1ed1n nh\u1eadn \u0111\u01b0\u1ee3c h\u1ed7 tr\u1ee3 t\u1eeb nh\u00e0 cung c\u1ea5p.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">N\u1ebfu thi\u1ebfu ba th\u00f4ng tin \u0111\u1ea7u v\u00e0o n\u00e0y, b\u1ea5t k\u1ef3 b\u00e1o gi\u00e1 &quot;\u0111\u1ea1t ti\u00eau chu\u1ea9n y t\u1ebf&quot; n\u00e0o b\u1ea1n nh\u1eadn \u0111\u01b0\u1ee3c ch\u1ec9 l\u00e0 gi\u00e1 tham kh\u1ea3o, kh\u00f4ng ph\u1ea3i gi\u00e1 th\u1ef1c t\u1ebf.<\/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":"closed","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\/vi\/wp-json\/wp\/v2\/posts\/10267","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/rysilicone.com\/vi\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/rysilicone.com\/vi\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/rysilicone.com\/vi\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/rysilicone.com\/vi\/wp-json\/wp\/v2\/comments?post=10267"}],"version-history":[{"count":7,"href":"https:\/\/rysilicone.com\/vi\/wp-json\/wp\/v2\/posts\/10267\/revisions"}],"predecessor-version":[{"id":20802,"href":"https:\/\/rysilicone.com\/vi\/wp-json\/wp\/v2\/posts\/10267\/revisions\/20802"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/rysilicone.com\/vi\/wp-json\/wp\/v2\/media\/16313"}],"wp:attachment":[{"href":"https:\/\/rysilicone.com\/vi\/wp-json\/wp\/v2\/media?parent=10267"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rysilicone.com\/vi\/wp-json\/wp\/v2\/categories?post=10267"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rysilicone.com\/vi\/wp-json\/wp\/v2\/tags?post=10267"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}