{"id":2247,"date":"2026-07-10T12:34:21","date_gmt":"2026-07-10T05:34:21","guid":{"rendered":"https:\/\/inoxcuongthinh.com\/inox-cay-ghep-y-te-mac-thep-chuyen-dung-va-tieu-chuan-quoc-te\/"},"modified":"2026-07-10T12:34:21","modified_gmt":"2026-07-10T05:34:21","slug":"inox-cay-ghep-y-te-mac-thep-chuyen-dung-va-tieu-chuan-quoc-te","status":"publish","type":"post","link":"https:\/\/inoxcuongthinh.com\/inox-cay-ghep-y-te-mac-thep-chuyen-dung-va-tieu-chuan-quoc-te\/","title":{"rendered":"Inox c\u1ea5y gh\u00e9p y t\u1ebf: M\u00e1c th\u00e9p chuy\u00ean d\u1ee5ng v\u00e0 ti\u00eau chu\u1ea9n qu\u1ed1c t\u1ebf"},"content":{"rendered":"\n\n<div class=\"kk-star-ratings kksr-auto kksr-align-left kksr-valign-top\"\n    data-payload='{&quot;align&quot;:&quot;left&quot;,&quot;id&quot;:&quot;2247&quot;,&quot;slug&quot;:&quot;default&quot;,&quot;valign&quot;:&quot;top&quot;,&quot;ignore&quot;:&quot;&quot;,&quot;reference&quot;:&quot;auto&quot;,&quot;class&quot;:&quot;&quot;,&quot;count&quot;:&quot;0&quot;,&quot;legendonly&quot;:&quot;&quot;,&quot;readonly&quot;:&quot;&quot;,&quot;score&quot;:&quot;0&quot;,&quot;starsonly&quot;:&quot;&quot;,&quot;best&quot;:&quot;5&quot;,&quot;gap&quot;:&quot;5&quot;,&quot;greet&quot;:&quot;\u0110\u00e1nh gi\u00e1&quot;,&quot;legend&quot;:&quot;0\\\/5 - (0 b\u00ecnh ch\u1ecdn)&quot;,&quot;size&quot;:&quot;24&quot;,&quot;title&quot;:&quot;Inox c\u1ea5y gh\u00e9p y t\u1ebf: M\u00e1c th\u00e9p chuy\u00ean d\u1ee5ng v\u00e0 ti\u00eau chu\u1ea9n qu\u1ed1c t\u1ebf&quot;,&quot;width&quot;:&quot;0&quot;,&quot;_legend&quot;:&quot;{score}\\\/{best} - ({count} {votes})&quot;,&quot;font_factor&quot;:&quot;1.25&quot;}'>\n            \n<div class=\"kksr-stars\">\n    \n<div class=\"kksr-stars-inactive\">\n            <div class=\"kksr-star\" data-star=\"1\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"2\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"3\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"4\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"5\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n    <\/div>\n    \n<div class=\"kksr-stars-active\" style=\"width: 0px;\">\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n    <\/div>\n<\/div>\n                \n\n<div class=\"kksr-legend\" style=\"font-size: 19.2px;\">\n            <span class=\"kksr-muted\">\u0110\u00e1nh gi\u00e1<\/span>\n    <\/div>\n    <\/div>\n<div class=\"custom-toc\">\n<h3>N\u1ed9i dung ch\u00ednh<\/h3>\n<ul>\n<li><a href=\"#toc-0-vi-sao-inox-van-la-vat-lieu-quan-trong-cho-implant\">V\u00ec sao inox v\u1eabn l\u00e0 v\u1eadt li\u1ec7u quan tr\u1ecdng cho implant?<\/a><\/li>\n<li><a href=\"#toc-1-cac-mac-inox-cay-ghep-chuyen-dung\">C\u00e1c m\u00e1c inox c\u1ea5y gh\u00e9p chuy\u00ean d\u1ee5ng<\/a><\/li>\n<li><a href=\"#toc-2-hinh-dang-san-pham-va-pham-vi-su-dung\">H\u00ecnh d\u1ea1ng s\u1ea3n ph\u1ea9m v\u00e0 ph\u1ea1m vi s\u1eed d\u1ee5ng<\/a><\/li>\n<li><a href=\"#toc-3-tieu-chuan-va-thu-nghiem-bat-buoc-khi-dung-inox-ch\">Ti\u00eau chu\u1ea9n v\u00e0 th\u1eed nghi\u1ec7m b\u1eaft bu\u1ed9c khi d\u00f9ng inox cho implant<\/a><\/li>\n<li><a href=\"#toc-4-316l-y-te-vs-316l-cong-nghiep-khac-nhau-o-dau\">316L y t\u1ebf vs 316L c\u00f4ng nghi\u1ec7p: kh\u00e1c nhau \u1edf \u0111\u00e2u?<\/a><\/li>\n<li><a href=\"#toc-5-huong-dan-xu-ly-be-mat-de-toi-uu-chong-an-mon-va-m\">H\u01b0\u1edbng d\u1eabn x\u1eed l\u00fd b\u1ec1 m\u1eb7t \u0111\u1ec3 t\u1ed1i \u01b0u ch\u1ed1ng \u0103n m\u00f2n v\u00e0 m\u1ecfi<\/a><\/li>\n<li><a href=\"#toc-6-thiet-ke-va-gia-cong-nhung-rui-ro-thuong-gap\">Thi\u1ebft k\u1ebf v\u00e0 gia c\u00f4ng: nh\u1eefng r\u1ee7i ro th\u01b0\u1eddng g\u1eb7p<\/a><\/li>\n<li><a href=\"#toc-7-checklist-chon-va-dat-hang-inox-cay-ghep\">Checklist ch\u1ecdn v\u00e0 \u0111\u1eb7t h\u00e0ng inox c\u1ea5y gh\u00e9p<\/a><\/li>\n<li><a href=\"#toc-8-cau-hoi-thuong-gap\">C\u00e2u h\u1ecfi th\u01b0\u1eddng g\u1eb7p<\/a><\/li>\n<li><a href=\"#toc-9-ung-dung-thuc-te-va-khuyen-nghi-chon-mac\">\u1ee8ng d\u1ee5ng th\u1ef1c t\u1ebf v\u00e0 khuy\u1ebfn ngh\u1ecb ch\u1ecdn m\u00e1c<\/a><\/li>\n<li><a href=\"#toc-10-nguon-tham-khao\">Ngu\u1ed3n tham kh\u1ea3o<\/a><\/li>\n<li><a href=\"#toc-11-ket-luan\">K\u1ebft lu\u1eadn<\/a><\/li>\n<\/ul>\n<\/div>\n<p>Inox d\u00f9ng cho c\u1ea5y gh\u00e9p trong c\u01a1 th\u1ec3 ng\u01b0\u1eddi l\u00e0 m\u1ed9t ph\u00e2n kh\u00fac r\u1ea5t \u0111\u1eb7c th\u00f9 c\u1ee7a \u201cInox trong C\u00f4ng nghi\u1ec7p S\u1ea1ch\u201d n\u01a1i y\u00eau c\u1ea7u v\u1ec1 an to\u00e0n sinh h\u1ecdc, ch\u1ed1ng \u0103n m\u00f2n trong m\u00f4i tr\u01b0\u1eddng clorua sinh l\u00fd, \u0111\u1ed9 b\u1ec1n m\u1ecfi v\u00e0 truy xu\u1ea5t ngu\u1ed3n g\u1ed1c nghi\u00eam ng\u1eb7t h\u01a1n h\u1eb3n so v\u1edbi inox c\u00f4ng nghi\u1ec7p th\u00f4ng th\u01b0\u1eddng. B\u00e0i vi\u1ebft n\u00e0y t\u1ed5ng h\u1ee3p c\u00e1c m\u00e1c th\u00e9p kh\u00f4ng g\u1ec9 (inox) chuy\u00ean d\u1ee5ng cho implant, ti\u00eau chu\u1ea9n qu\u1ed1c t\u1ebf \u0111i k\u00e8m, t\u00ednh ch\u1ea5t v\u1eadt li\u1ec7u v\u00e0 l\u01b0u \u00fd th\u1ef1c t\u1ebf khi l\u1ef1a ch\u1ecdn, gia c\u00f4ng.<\/p>\n<h2 id=\"toc-0-vi-sao-inox-van-la-vat-lieu-quan-trong-cho-implant\">V\u00ec sao inox v\u1eabn l\u00e0 v\u1eadt li\u1ec7u quan tr\u1ecdng cho implant?<\/h2>\n<p>&#8211; T\u00ednh t\u01b0\u01a1ng th\u00edch sinh h\u1ecdc t\u1ed1t khi \u0111\u1ea1t chu\u1ea9n, \u0111\u1eb7c bi\u1ec7t v\u1edbi m\u00e1c austenitic \u00edt t\u1eeb t\u00ednh (316L\/316LVM).<br \/>\n&#8211; D\u1ec5 gia c\u00f4ng, t\u1ea1o h\u00ecnh d\u00e2y, \u0111inh v\u00edt, n\u1eb9p x\u01b0\u01a1ng, d\u00e2y bu\u1ed9c x\u01b0\u01a1ng \u1ee9c, d\u1ee5ng c\u1ee5 c\u1ed1 \u0111\u1ecbnh t\u1ea1m th\u1eddi.<br \/>\n&#8211; Gi\u00e1 th\u00e0nh h\u1ee3p l\u00fd h\u01a1n h\u1ee3p kim titan ho\u1eb7c cobalt-chromium trong nhi\u1ec1u ch\u1ec9 \u0111\u1ecbnh.<br \/>\n&#8211; T\u00ednh n\u0103ng c\u01a1 h\u1ecdc \u0111\u1ee7 d\u00f9ng cho nhi\u1ec1u implant ch\u1ecbu t\u1ea3i v\u1eeba\u2013cao, \u0111\u1eb7c bi\u1ec7t khi c\u00e1n ngu\u1ed9i t\u0103ng b\u1ec1n.<\/p>\n<p>L\u01b0u \u00fd: v\u1edbi c\u1ea5y gh\u00e9p v\u0129nh vi\u1ec5n ch\u1ecbu t\u1ea3i r\u1ea5t cao ho\u1eb7c c\u1ea7n t\u01b0\u01a1ng th\u00edch h\u00ecnh \u1ea3nh t\u1ed1t h\u01a1n, v\u1eadt li\u1ec7u nh\u01b0 titan (Ti-6Al-4V) hay Co-Cr c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c \u01b0u ti\u00ean. Tuy nhi\u00ean inox y t\u1ebf v\u1eabn chi\u1ebfm th\u1ecb ph\u1ea7n l\u1edbn \u1edf n\u1eb9p\u2013v\u00edt x\u01b0\u01a1ng, d\u00e2y cerclage, d\u00e2y bu\u1ed9c x\u01b0\u01a1ng \u1ee9c, tr\u1ee5 c\u1ed1 \u0111\u1ecbnh t\u1ea1m th\u1eddi.<\/p>\n<h2 id=\"toc-1-cac-mac-inox-cay-ghep-chuyen-dung\">C\u00e1c m\u00e1c inox c\u1ea5y gh\u00e9p chuy\u00ean d\u1ee5ng<\/h2>\n<h3>1) 316L\/316LVM \u2013 ti\u00eau chu\u1ea9n v\u00e0ng cho nhi\u1ec1u implant<\/h3>\n<p>&#8211; T\u00ean g\u1ecdi\/\u0111\u1ecbnh danh: 316L y t\u1ebf (UNS S31673) th\u01b0\u1eddng \u0111\u01b0\u1ee3c luy\u1ec7n ch\u00e2n kh\u00f4ng VIM\/VAR, c\u00f2n g\u1ecdi 316LVM (Vacuum Melt).<br \/>\n&#8211; Ti\u00eau chu\u1ea9n ch\u00ednh:<br \/>\n  \u2022 ASTM F138 (thanh v\u00e0 d\u00e2y inox austenitic cho c\u1ea5y gh\u00e9p)<br \/>\n  \u2022 ASTM F139 (t\u1ea5m\/l\u00e1\/strip inox austenitic cho c\u1ea5y gh\u00e9p)<br \/>\n  \u2022 ISO 5832-1 (v\u1eadt li\u1ec7u kim lo\u1ea1i \u2013 inox r\u00e8n cho implant)<br \/>\n&#8211; Th\u00e0nh ph\u1ea7n \u0111i\u1ec3n h\u00ecnh (tham kh\u1ea3o d\u1ea3i ti\u00eau chu\u1ea9n): C \u2264 0,03%; Cr ~17\u201319%; Ni ~12\u201315%; Mo ~2\u20133%; N \u2264 0,10%; P, S r\u1ea5t th\u1ea5p. 316LVM ki\u1ec3m so\u00e1t ch\u1eb7t t\u1ea1p ch\u1ea5t, bao g\u1ed3m l\u01b0u hu\u1ef3nh\/inclusion.<br \/>\n&#8211; C\u01a1 t\u00ednh \u0111i\u1ec3n h\u00ecnh (tr\u1ea1ng th\u00e1i \u1ee7 theo ASTM F138\/ISO 5832-1):<br \/>\n  \u2022 \u0110\u1ed9 b\u1ec1n k\u00e9o t\u1ed1i thi\u1ec3u \u2265 485 MPa<br \/>\n  \u2022 Gi\u1edbi h\u1ea1n ch\u1ea3y 0,2% \u2265 170 MPa<br \/>\n  \u2022 \u0110\u1ed9 gi\u00e3n d\u00e0i \u2265 40%<br \/>\n  C\u00e1n ngu\u1ed9i c\u00f3 th\u1ec3 n\u00e2ng UTS > 700 MPa cho d\u00e2y\/\u0111inh v\u00edt.<br \/>\n&#8211; \u1ee8ng d\u1ee5ng: n\u1eb9p\u2013v\u00edt x\u01b0\u01a1ng, d\u00e2y bu\u1ed9c x\u01b0\u01a1ng \u1ee9c, thanh n\u1eb9p, v\u00edt nha khoa t\u1ea1m, stent th\u1ebf h\u1ec7 \u0111\u1ea7u (ng\u00e0y nay stent \u01b0u ti\u00ean Co-Cr\/NiTi).<\/p>\n<p>\u0110i\u1ec3m kh\u00e1c bi\u1ec7t so v\u1edbi 316L c\u00f4ng nghi\u1ec7p: quy c\u00e1ch luy\u1ec7n (VIM\/VAR), d\u1ea3i th\u00e0nh ph\u1ea7n h\u1eb9p h\u01a1n, t\u1ea1p ch\u1ea5t v\u00e0 inclusion th\u1ea5p, gi\u1edbi h\u1ea1n ferrite g\u1ea7n nh\u01b0 b\u1eb1ng 0, ki\u1ec3m so\u00e1t b\u1ec1 m\u1eb7t v\u00e0 ch\u1ee9ng ch\u1ec9 y t\u1ebf \u0111\u1ea7y \u0111\u1ee7.<\/p>\n<h3>2) 316LN v\u00e0 c\u00e1c inox austenitic t\u0103ng b\u1ec1n b\u1eb1ng nit\u01a1 (HNSS)<\/h3>\n<p>&#8211; Kh\u00e1i ni\u1ec7m: Th\u00eam nit\u01a1 (N ~0,15\u20130,40%) \u0111\u1ec3 t\u0103ng b\u1ec1n, t\u0103ng ch\u1ed1ng r\u1ed7 (PREN t\u0103ng) v\u00e0 gi\u1ea3m khuynh h\u01b0\u1edbng t\u1eeb t\u00ednh.<br \/>\n&#8211; Ti\u00eau chu\u1ea9n li\u00ean quan:<br \/>\n  \u2022 ISO 5832-9 (High Nitrogen Stainless Steel \u2013 inox austenitic gi\u00e0u nit\u01a1 r\u00e8n cho implant)<br \/>\n  \u2022 M\u1ed9t s\u1ed1 m\u00e1c t\u01b0\u01a1ng \u0111\u01b0\u01a1ng theo ASTM d\u00e0nh cho d\u00e2y\/thanh t\u0103ng b\u1ec1n nit\u01a1 d\u00f9ng trong implant (t\u00f9y nh\u00e0 s\u1ea3n xu\u1ea5t c\u00f4ng b\u1ed1, v\u00ed d\u1ee5 ASTM F2229 cho inox austenitic t\u0103ng b\u1ec1n b\u1eb1ng nit\u01a1).<br \/>\n&#8211; T\u00ednh n\u0103ng:<br \/>\n  \u2022 \u0110\u1ed9 b\u1ec1n k\u00e9o v\u00e0 m\u1ecfi cao h\u01a1n 316L \u1edf c\u00f9ng \u0111i\u1ec1u ki\u1ec7n gia c\u00f4ng.<br \/>\n  \u2022 Ch\u1ed1ng r\u1ed7\/khe t\u1ed1t h\u01a1n trong m\u00f4i tr\u01b0\u1eddng NaCl sinh l\u00fd v\u00e0 huy\u1ebft t\u01b0\u01a1ng.<br \/>\n&#8211; \u1ee8ng d\u1ee5ng: d\u00e2y cerclage, c\u00e1p x\u01b0\u01a1ng, v\u00edt\/\u0111inh ch\u1ecbu t\u1ea3i cao, thanh n\u1eb9p m\u1ecfng c\u1ea7n \u0111\u1ed9 b\u1ec1n v\u00e0 m\u1ecfi t\u1ed1t.<\/p>\n<h3>3) Inox austenitic \u201cnickel-th\u1ea5p\u201d\/kh\u00f4ng nickel (t\u00f9y m\u00e1c)<\/h3>\n<p>&#8211; M\u1ed9t s\u1ed1 h\u1ec7 inox austenitic d\u00f9ng Mn+N \u0111\u1ec3 \u1ed5n \u0111\u1ecbnh n\u1ec1n austenit, nh\u1eb1m gi\u1ea3m\/lo\u1ea1i nickel \u2013 ph\u1ee5c v\u1ee5 b\u1ec7nh nh\u00e2n c\u00f3 nguy c\u01a1 qu\u00e1 m\u1eabn Ni.<br \/>\n&#8211; Quy chi\u1ebfu: th\u01b0\u1eddng \u0111\u01b0\u1ee3c chu\u1ea9n h\u00f3a trong c\u00e1c ph\u1ea7n c\u1ee7a ISO 5832 (v\u00ed d\u1ee5 nh\u00f3m HNSS), k\u00e8m c\u00f4ng b\u1ed1 d\u1eef li\u1ec7u \u0111\u1ed9c t\u00ednh v\u00e0 \u0103n m\u00f2n c\u1ee7a nh\u00e0 s\u1ea3n xu\u1ea5t v\u1eadt li\u1ec7u.<br \/>\n&#8211; L\u01b0u \u00fd: \u0110\u00e1nh \u0111\u1ed5i c\u00f3 th\u1ec3 l\u00e0 t\u00ednh gia c\u00f4ng ho\u1eb7c \u0111\u1ed9 d\u1ebbo; c\u1ea7n th\u1ea9m \u0111\u1ecbnh theo ISO 10993 v\u00e0 th\u1eed \u0103n m\u00f2n (ASTM F2129).<\/p>\n<h2 id=\"toc-2-hinh-dang-san-pham-va-pham-vi-su-dung\">H\u00ecnh d\u1ea1ng s\u1ea3n ph\u1ea9m v\u00e0 ph\u1ea1m vi s\u1eed d\u1ee5ng<\/h2>\n<p>&#8211; D\u00e2y (wire): cerclage, bu\u1ed9c x\u01b0\u01a1ng \u1ee9c, c\u00e1p c\u1ed1 \u0111\u1ecbnh; y\u00eau c\u1ea7u b\u1ec1 m\u1eb7t b\u00f3ng, kh\u00f4ng s\u01b0\u1edbc, \u0111\u1ed9 b\u1ec1n m\u1ecfi cao.<br \/>\n&#8211; Thanh (bar\/rod): gia c\u00f4ng v\u00edt, ch\u1ed1t, \u0111inh n\u1ed9i t\u1ee7y; y\u00eau c\u1ea7u c\u1ea5p s\u1ea1ch luy\u1ec7n ch\u00e2n kh\u00f4ng, sai s\u1ed1 k\u00edch th\u01b0\u1edbc ch\u1eb7t.<br \/>\n&#8211; T\u1ea5m\/strip: n\u1eb9p x\u01b0\u01a1ng t\u1ea1o h\u00ecnh, l\u00e1 \u0111\u1ec7m; y\u00eau c\u1ea7u b\u1ec1 m\u1eb7t 2B\/BA ho\u1eb7c \u0111i\u1ec7n h\u00f3a, \u0111\u1ed9 d\u00e0y \u0111\u1ed3ng \u0111\u1ec1u.<br \/>\n&#8211; \u1ed0ng m\u1ea3nh\/thanh m\u1ea3nh: kim c\u1ed1 \u0111\u1ecbnh t\u1ea1m th\u1eddi, guidewires; y\u00eau c\u1ea7u kh\u1eed ba via, b\u00e1n k\u00ednh m\u00e9p, \u0111\u1ed9 th\u1eb3ng v\u00e0 \u0111\u1ed9 nh\u1eb5n b\u1ec1 m\u1eb7t.<\/p>\n<h2 id=\"toc-3-tieu-chuan-va-thu-nghiem-bat-buoc-khi-dung-inox-ch\">Ti\u00eau chu\u1ea9n v\u00e0 th\u1eed nghi\u1ec7m b\u1eaft bu\u1ed9c khi d\u00f9ng inox cho implant<\/h2>\n<h3>1) Th\u00e0nh ph\u1ea7n \u2013 c\u01a1 t\u00ednh \u2013 vi c\u1ea5u tr\u00fac<\/h3>\n<p>&#8211; ASTM F138\/F139, ISO 5832-1: n\u00eau r\u00f5 d\u1ea3i h\u00f3a h\u1ecdc, y\u00eau c\u1ea7u c\u01a1 t\u00ednh t\u1ed1i thi\u1ec3u, gi\u1edbi h\u1ea1n t\u1ea1p ch\u1ea5t.<br \/>\n&#8211; Ki\u1ec3m so\u00e1t vi c\u1ea5u tr\u00fac: austenit g\u1ea7n nh\u01b0 ho\u00e0n to\u00e0n; ferrite\/delta-ferrite c\u1ef1c th\u1ea5p; inclusion oxit\/sulfid theo m\u1ee9c \u0111\u1ed9 ch\u1ea5p nh\u1eadn (th\u01b0\u1eddng \u0111\u00e1nh gi\u00e1 theo ASTM E45 \u2013 do nh\u00e0 s\u1ea3n xu\u1ea5t v\u1eadt li\u1ec7u th\u1ef1c hi\u1ec7n).<br \/>\n&#8211; Ch\u1ee9ng ch\u1ec9 l\u00f4: EN 10204 3.1 ho\u1eb7c t\u01b0\u01a1ng \u0111\u01b0\u01a1ng, truy xu\u1ea5t heat\/lot \u0111\u1ea7y \u0111\u1ee7.<\/p>\n<h3>2) \u0102n m\u00f2n v\u00e0 ho\u00e0n thi\u1ec7n b\u1ec1 m\u1eb7t<\/h3>\n<p>&#8211; ASTM F86: quy tr\u00ecnh l\u00e0m s\u1ea1ch, th\u1ee5 \u0111\u1ed9ng h\u00f3a v\u00e0 \u0111\u00e1nh d\u1ea5u b\u1ec1 m\u1eb7t implant kim lo\u1ea1i (\u01b0u ti\u00ean cho implant h\u01a1n so v\u1edbi ASTM A967\/A380).<br \/>\n&#8211; ASTM F2129: th\u1eed ph\u00e2n c\u1ef1c \u0111\u1ed9ng chu k\u1ef3 \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 xu h\u01b0\u1edbng r\u1ed7\/khe trong dung d\u1ecbch gi\u1ea3 l\u1eadp sinh l\u00fd.<br \/>\n&#8211; Y\u00eau c\u1ea7u th\u1ef1c h\u00e0nh:<br \/>\n  \u2022 Th\u1ee5 \u0111\u1ed9ng h\u00f3a b\u1eb1ng axit nitric\/citric theo F86; s\u00fac r\u1eeda DI k\u1ef9; tr\u00e1nh clo d\u01b0.<br \/>\n  \u2022 \u0110i\u1ec7n h\u00f3a (electropolishing) gi\u00fap h\u1ea1 Ra, t\u0103ng Cr2O3, c\u1ea3i thi\u1ec7n ch\u1ed1ng \u0103n m\u00f2n v\u00e0 m\u1ecfi.<br \/>\n  \u2022 Tr\u00e1nh b\u1ec1 m\u1eb7t k\u1ebd\/ren s\u1eafc t\u1ea1o khe h\u1edf; qu\u1ea3n l\u00fd c\u1ea1nh v\u00e1t, b\u00e1n k\u00ednh.  <\/p>\n<h3>3) T\u01b0\u01a1ng th\u00edch sinh h\u1ecdc v\u00e0 qu\u1ea3n tr\u1ecb r\u1ee7i ro<\/h3>\n<p>&#8211; ISO 10993 (chu\u1ed7i): \u0111\u00e1nh gi\u00e1 sinh h\u1ecdc v\u1eadt li\u1ec7u\/thi\u1ebft b\u1ecb y t\u1ebf (\u0111\u1ed9c t\u00ednh t\u1ebf b\u00e0o, nh\u1ea1y c\u1ea3m, k\u00edch \u1ee9ng, h\u00f2a tan kim lo\u1ea1i&#8230;).<br \/>\n&#8211; ISO 13485: h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng l\u0129nh v\u1ef1c thi\u1ebft b\u1ecb y t\u1ebf.<br \/>\n&#8211; ISO 14971: qu\u1ea3n tr\u1ecb r\u1ee7i ro cho thi\u1ebft b\u1ecb y t\u1ebf.<br \/>\n&#8211; Quy \u0111\u1ecbnh th\u1ecb tr\u01b0\u1eddng: FDA 21 CFR 820 (QSR) v\u00e0\/ho\u1eb7c EU MDR 2017\/745; t\u1ea1i Vi\u1ec7t Nam, tu\u00e2n th\u1ee7 qu\u1ea3n l\u00fd c\u1ee7a B\u1ed9 Y t\u1ebf \u0111\u1ed1i v\u1edbi thi\u1ebft b\u1ecb c\u1ea5y gh\u00e9p.<\/p>\n<h2 id=\"toc-4-316l-y-te-vs-316l-cong-nghiep-khac-nhau-o-dau\">316L y t\u1ebf vs 316L c\u00f4ng nghi\u1ec7p: kh\u00e1c nhau \u1edf \u0111\u00e2u?<\/h2>\n<p>&#8211; Luy\u1ec7n kim: 316LVM (VIM\/VAR) lo\u1ea1i b\u1ecf kh\u00ed\/oxy\/t\u1ea1p ch\u1ea5t t\u1ed1t h\u01a1n so v\u1edbi luy\u1ec7n th\u01b0\u1eddng; gi\u1ea3m inclusion g\u00e2y n\u1ee9t m\u1ecfi\/kh\u1edfi ph\u00e1t r\u1ed7.<br \/>\n&#8211; H\u00f3a h\u1ecdc v\u00e0 t\u1ea1p ch\u1ea5t: d\u1ea3i h\u1eb9p h\u01a1n; P, S th\u1ea5p; ki\u1ec3m so\u00e1t N; Ni, Mo n\u1eb1m v\u00f9ng t\u1ed1i \u01b0u ch\u1ed1ng r\u1ed7.<br \/>\n&#8211; Vi c\u1ea5u tr\u00fac: austenit \u0111\u1ed3ng nh\u1ea5t; delta-ferrite c\u1ef1c th\u1ea5p; kh\u00f4ng c\u00f3 carbide bi\u00ean h\u1ea1t.<br \/>\n&#8211; B\u1ec1 m\u1eb7t: y\u00eau c\u1ea7u l\u00e0m s\u1ea1ch\/th\u1ee5 \u0111\u1ed9ng h\u00f3a \u0111\u1eb7c th\u00f9 y t\u1ebf; \u0111\u1ed9 nh\u00e1m th\u1ea5p; kh\u00f4ng nhi\u1ec5m Fe ngo\u1ea1i lai.<br \/>\n&#8211; Ch\u1ee9ng ch\u1ec9: b\u1eaft bu\u1ed9c c\u00f3 ch\u1ee9ng ch\u1ec9 implant-grade theo ASTM\/ISO t\u01b0\u01a1ng \u1ee9ng, k\u00e8m b\u00e1o c\u00e1o th\u1eed nghi\u1ec7m \u0103n m\u00f2n\/c\u01a1 t\u00ednh l\u00f4.<\/p>\n<p>K\u1ebft lu\u1eadn: 316L c\u00f4ng nghi\u1ec7p (UNS S31603) kh\u00f4ng th\u1ec3 thay th\u1ebf tr\u1ef1c ti\u1ebfp cho 316L y t\u1ebf (UNS S31673\/316LVM) trong c\u1ea5y gh\u00e9p.<\/p>\n<h2 id=\"toc-5-huong-dan-xu-ly-be-mat-de-toi-uu-chong-an-mon-va-m\">H\u01b0\u1edbng d\u1eabn x\u1eed l\u00fd b\u1ec1 m\u1eb7t \u0111\u1ec3 t\u1ed1i \u01b0u ch\u1ed1ng \u0103n m\u00f2n v\u00e0 m\u1ecfi<\/h2>\n<p>&#8211; Ti\u1ec1n x\u1eed l\u00fd: t\u1ea9y d\u1ea7u, si\u00eau \u00e2m, tr\u00e1nh b\u00e0n ch\u1ea3i th\u00e9p carbon; ch\u1ec9 d\u00f9ng d\u1ee5ng c\u1ee5 d\u00e0nh ri\u00eang cho inox y t\u1ebf.<br \/>\n&#8211; T\u1ea9y g\u1ec9 &#038; th\u1ee5 \u0111\u1ed9ng h\u00f3a: theo ASTM F86 (dung d\u1ecbch nitric\/citric quy \u0111\u1ecbnh); ki\u1ec3m ch\u1ee9ng s\u1ea1ch ion clorua.<br \/>\n&#8211; \u0110i\u1ec7n h\u00f3a: \u00e1p d\u1ee5ng cho d\u00e2y\/\u0111inh\/n\u1eb9p c\u00f3 b\u1ec1 m\u1eb7t l\u00e0m vi\u1ec7c; m\u1ee5c ti\u00eau Ra th\u1ea5p v\u00e0 b\u1ec1 m\u1eb7t gi\u00e0u Cr.<br \/>\n&#8211; L\u00e0m s\u1ea1ch cu\u1ed1i: n\u01b0\u1edbc DI\/RO, s\u1ea5y s\u1ea1ch; \u0111\u00f3ng g\u00f3i m\u00f4i tr\u01b0\u1eddng s\u1ea1ch \u0111\u1ec3 tr\u00e1nh h\u1ea1t b\u1ee5i g\u00e2y vi\u00eam.<br \/>\n&#8211; Ki\u1ec3m tra: th\u1eed \u0103n m\u00f2n c\u1ee5c b\u1ed9 (F2129) theo l\u00f4 \u0111i\u1ec3n h\u00ecnh cho chi ti\u1ebft quan tr\u1ecdng.<\/p>\n<h2 id=\"toc-6-thiet-ke-va-gia-cong-nhung-rui-ro-thuong-gap\">Thi\u1ebft k\u1ebf v\u00e0 gia c\u00f4ng: nh\u1eefng r\u1ee7i ro th\u01b0\u1eddng g\u1eb7p<\/h2>\n<p>&#8211; Khe k\u1ebd\/gh\u00e9p ch\u1ed3ng: t\u0103ng nguy c\u01a1 \u0103n m\u00f2n k\u1ebd; gi\u1ea3m b\u1eb1ng h\u00e0n k\u00edn ho\u1eb7c thi\u1ebft k\u1ebf tho\u00e1t d\u1ecbch.<br \/>\n&#8211; C\u1eb7p \u0111i\u1ec7n h\u00f3a: tr\u00e1nh gh\u00e9p inox v\u1edbi h\u1ee3p kim kh\u00e1c trong m\u00f4i tr\u01b0\u1eddng sinh l\u00fd n\u1ebfu kh\u00f4ng c\u00f3 c\u00e1ch \u0111i\u1ec7n.<br \/>\n&#8211; \u1ee8ng su\u1ea5t k\u00e9o d\u01b0: g\u00e2y n\u1ee9t m\u1ecfi\/\u0103n m\u00f2n \u1ee9ng su\u1ea5t; c\u1ea7n x\u1eed l\u00fd c\u01a1\u2013nhi\u1ec7t ph\u00f9 h\u1ee3p, bo b\u00e1n k\u00ednh, \u0111\u00e1nh b\u00f3ng.<br \/>\n&#8211; H\u00e0n: n\u1ebfu b\u1eaft bu\u1ed9c, d\u00f9ng quy tr\u00ecnh nhi\u1ec7t th\u1ea5p, filler t\u01b0\u01a1ng th\u00edch; th\u1ee5 \u0111\u1ed9ng h\u00f3a sau h\u00e0n.<br \/>\n&#8211; T\u1ea1p nhi\u1ec5m Fe: qu\u1ea3n l\u00fd d\u1ee5ng c\u1ee5, \u0111\u1ed3 g\u00e1; ki\u1ec3m tra b\u1ec1 m\u1eb7t b\u1eb1ng test Fe nhanh n\u1ebfu c\u1ea7n.<\/p>\n<h2 id=\"toc-7-checklist-chon-va-dat-hang-inox-cay-ghep\">Checklist ch\u1ecdn v\u00e0 \u0111\u1eb7t h\u00e0ng inox c\u1ea5y gh\u00e9p<\/h2>\n<p>&#8211; M\u00e1c th\u00e9p: 316LVM theo ASTM F138\/F139 ho\u1eb7c HNSS theo ISO 5832-9 (theo ch\u1ec9 \u0111\u1ecbnh c\u01a1\u2013\u0103n m\u00f2n).<br \/>\n&#8211; H\u00ecnh th\u1ee9c v\u00e0 tr\u1ea1ng th\u00e1i: d\u00e2y\/thanh\/t\u1ea5m; \u1ee7 hay c\u00e1n ngu\u1ed9i; \u0111\u1ed9 b\u1ec1n m\u1ee5c ti\u00eau.<br \/>\n&#8211; Quy c\u00e1ch b\u1ec1 m\u1eb7t: BA\/EP; y\u00eau c\u1ea7u Ra; kh\u00f4ng khuy\u1ebft t\u1eadt b\u1ec1 m\u1eb7t.<br \/>\n&#8211; Luy\u1ec7n kim: y\u00eau c\u1ea7u VIM\/VAR; gi\u1edbi h\u1ea1n inclusion; khai b\u00e1o ferrite.<br \/>\n&#8211; Ki\u1ec3m \u0111\u1ecbnh: ch\u1ee9ng ch\u1ec9 EN 10204 3.1; k\u1ebft qu\u1ea3 c\u01a1 t\u00ednh; h\u00f3a h\u1ecdc; n\u1ebfu c\u00f3, d\u1eef li\u1ec7u F2129 \u0111\u1ea1i di\u1ec7n.<br \/>\n&#8211; \u0110\u00f3ng g\u00f3i: m\u00f4i tr\u01b0\u1eddng s\u1ea1ch, ch\u1ed1ng tr\u1ea7y; nh\u1eadn di\u1ec7n lot\/heat r\u00f5 r\u00e0ng.<br \/>\n&#8211; Tu\u00e2n th\u1ee7 h\u1ec7 th\u1ed1ng: ISO 13485 nh\u00e0 s\u1ea3n xu\u1ea5t linh ki\u1ec7n; k\u1ebf ho\u1ea1ch \u0111\u00e1nh gi\u00e1 ISO 10993 cho s\u1ea3n ph\u1ea9m cu\u1ed1i.<\/p>\n<h2 id=\"toc-8-cau-hoi-thuong-gap\">C\u00e2u h\u1ecfi th\u01b0\u1eddng g\u1eb7p<\/h2>\n<p>&#8211; C\u00f3 th\u1ec3 d\u00f9ng 304 cho implant?<br \/>\n  \u2022 Kh\u00f4ng khuy\u1ebfn ngh\u1ecb cho c\u1ea5y gh\u00e9p v\u0129nh vi\u1ec5n do ch\u1ed1ng r\u1ed7 k\u00e9m v\u00e0 nguy c\u01a1 gi\u1ea3i ph\u00f3ng Ni cao h\u01a1n; 316L\/316LVM l\u00e0 ti\u00eau chu\u1ea9n t\u1ed1i thi\u1ec3u.<br \/>\n&#8211; 316L c\u00f3 t\u1eeb t\u00ednh kh\u00f4ng?<br \/>\n  \u2022 Austenitic v\u1ec1 b\u1ea3n ch\u1ea5t l\u00e0 kh\u00f4ng t\u1eeb ho\u1eb7c t\u1eeb t\u00ednh r\u1ea5t th\u1ea5p; gia c\u00f4ng ngu\u1ed9i n\u1eb7ng c\u00f3 th\u1ec3 t\u0103ng t\u1eeb d\u01b0 nh\u1eb9 nh\u01b0ng v\u1eabn \u0111\u00e1p \u1ee9ng y\u00eau c\u1ea7u l\u00e2m s\u00e0ng th\u00f4ng th\u01b0\u1eddng.<br \/>\n&#8211; Inox hay titan t\u1ed1t h\u01a1n?<br \/>\n  \u2022 T\u00f9y ch\u1ec9 \u0111\u1ecbnh: titan c\u00f3 t\u1ef7 tr\u1ecdng nh\u1eb9, m\u00f4 \u0111un \u0111\u00e0n h\u1ed3i th\u1ea5p h\u01a1n x\u01b0\u01a1ng, \u0103n m\u00f2n tuy\u1ec7t v\u1eddi; nh\u01b0ng inox d\u1ec5 gia c\u00f4ng, chi ph\u00ed th\u1ea5p, \u0111\u1ee7 t\u1ed1t cho nhi\u1ec1u n\u1eb9p\u2013v\u00edt v\u00e0 d\u00e2y bu\u1ed9c.<\/p>\n<h2 id=\"toc-9-ung-dung-thuc-te-va-khuyen-nghi-chon-mac\">\u1ee8ng d\u1ee5ng th\u1ef1c t\u1ebf v\u00e0 khuy\u1ebfn ngh\u1ecb ch\u1ecdn m\u00e1c<\/h2>\n<p>&#8211; D\u00e2y bu\u1ed9c x\u01b0\u01a1ng \u1ee9c\/cerclage: 316LVM c\u00e1n ngu\u1ed9i; y\u00eau c\u1ea7u \u0111i\u1ec7n h\u00f3a, Ra th\u1ea5p, ch\u1ee9ng ch\u1ec9 F138.<br \/>\n&#8211; N\u1eb9p\u2013v\u00edt x\u01b0\u01a1ng chi: 316LVM cho \u0111a s\u1ed1; n\u1ebfu \u0111\u00f2i h\u1ecfi m\u1ecfi cao v\u00e0 m\u1ecfng nh\u1eb9, c\u00e2n nh\u1eafc HNSS theo ISO 5832-9.<br \/>\n&#8211; Thanh n\u1eb9p c\u1ed9t s\u1ed1ng: 316LVM ch\u1ea5t l\u01b0\u1ee3ng cao ho\u1eb7c HNSS; ch\u00fa tr\u1ecdng m\u1ecfi\u2013\u0103n m\u00f2n v\u00e0 \u0111i\u1ec7n h\u00f3a b\u1ec1 m\u1eb7t.<br \/>\n&#8211; Implant t\u1ea1m th\u1eddi: 316LVM \u0111\u00e1p \u1ee9ng t\u1ed1t, t\u1ed1i \u01b0u chi ph\u00ed\u2013hi\u1ec7u n\u0103ng.<\/p>\n<h2 id=\"toc-10-nguon-tham-khao\">Ngu\u1ed3n tham kh\u1ea3o<\/h2>\n<p>&#8211; ASTM F138 \u2013 Standard Specification for Wrought 18Cr-14Ni-2.5Mo Stainless Steel Bar and Wire for Surgical Implants (UNS S31673).<br \/>\n&#8211; ASTM F139 \u2013 Standard Specification for Wrought 18Cr-14Ni-2.5Mo Stainless Steel Sheet and Strip for Surgical Implants.<br \/>\n&#8211; ISO 5832-1 \u2013 Implants for surgery \u2014 Metallic materials \u2014 Part 1: Wrought stainless steel.<br \/>\n&#8211; ISO 5832-9 \u2013 Implants for surgery \u2014 Metallic materials \u2014 Part 9: Wrought high nitrogen stainless steel.<br \/>\n&#8211; ASTM F86 \u2013 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants.<br \/>\n&#8211; ASTM F2129 \u2013 Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices.<br \/>\n&#8211; ISO 10993 (series) \u2013 Biological evaluation of medical devices.<br \/>\n&#8211; ISO 13485 \u2013 Medical devices \u2014 Quality management systems \u2014 Requirements for regulatory purposes.<\/p>\n<h2 id=\"toc-11-ket-luan\">K\u1ebft lu\u1eadn<\/h2>\n<p>&#8211; 316L\/316LVM theo ASTM F138\/F139 v\u00e0 ISO 5832-1 l\u00e0 l\u1ef1a ch\u1ecdn n\u1ec1n t\u1ea3ng, \u0111\u00e3 \u0111\u01b0\u1ee3c ki\u1ec3m ch\u1ee9ng cho nhi\u1ec1u lo\u1ea1i implant.<br \/>\n&#8211; C\u00e1c m\u00e1c austenitic t\u0103ng b\u1ec1n b\u1eb1ng nit\u01a1 (ISO 5832-9) mang l\u1ea1i b\u1ec1n m\u1ecfi v\u00e0 ch\u1ed1ng r\u1ed7 cao h\u01a1n, ph\u00f9 h\u1ee3p chi ti\u1ebft m\u1ea3nh, t\u1ea3i cao.<br \/>\n&#8211; Kh\u00e1c bi\u1ec7t quy\u1ebft \u0111\u1ecbnh gi\u1eefa inox y t\u1ebf v\u00e0 inox c\u00f4ng nghi\u1ec7p n\u1eb1m \u1edf luy\u1ec7n kim (VIM\/VAR), ki\u1ec3m so\u00e1t t\u1ea1p ch\u1ea5t, ho\u00e0n thi\u1ec7n b\u1ec1 m\u1eb7t theo ASTM F86 v\u00e0 ch\u1ee9ng ch\u1ec9 \u0111\u1ea7y \u0111\u1ee7.<br \/>\n&#8211; L\u1ef1a ch\u1ecdn \u0111\u00fang m\u00e1c, ti\u00eau chu\u1ea9n v\u00e0 quy tr\u00ecnh b\u1ec1 m\u1eb7t s\u1ebd gi\u1ea3m thi\u1ec3u r\u1ee7i ro \u0103n m\u00f2n, gi\u1ea3i ph\u00f3ng ion v\u00e0 h\u1ecfng m\u1ecfi, \u0111\u1ea3m b\u1ea3o an to\u00e0n l\u00e2m s\u00e0ng v\u00e0 tu\u00e2n th\u1ee7 ph\u00e1p l\u00fd.<\/p>\n<p>C\u1ea7n t\u01b0 v\u1ea5n m\u00e1c inox c\u1ea5y gh\u00e9p, ti\u00eau chu\u1ea9n v\u00e0 ch\u1ee9ng ch\u1ec9 c\u1ee5 th\u1ec3 cho d\u1ef1 \u00e1n c\u1ee7a b\u1ea1n? Li\u00ean h\u1ec7 Inox C\u01b0\u1eddng Th\u1ecbnh \u0111\u1ec3 \u0111\u01b0\u1ee3c t\u01b0 v\u1ea5n v\u00e0 b\u00e1o gi\u00e1 t\u1ed1t nh\u1ea5t. Hotline: 0343.417.281. Email: inoxcongnghiep.cuongthinh@gmail.com<\/p>\n","protected":false},"excerpt":{"rendered":"<p>T\u1ed5ng h\u1ee3p m\u00e1c inox c\u1ea5y gh\u00e9p (316L\/316LVM, HNSS), ti\u00eau chu\u1ea9n ASTM\/ISO \u00e1p d\u1ee5ng, t\u00ednh ch\u1ea5t, x\u1eed l\u00fd b\u1ec1 m\u1eb7t v\u00e0 checklist ch\u1ecdn v\u1eadt li\u1ec7u an to\u00e0n cho implant.<\/p>\n","protected":false},"author":7,"featured_media":1006,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[23],"tags":[],"class_list":["post-2247","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-tin-tuc"],"acf":[],"_links":{"self":[{"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/posts\/2247","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/comments?post=2247"}],"version-history":[{"count":0,"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/posts\/2247\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/media\/1006"}],"wp:attachment":[{"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/media?parent=2247"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/categories?post=2247"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/inoxcuongthinh.com\/inct\/wp\/v2\/tags?post=2247"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}