{"id":3331,"date":"2026-09-03T16:48:46","date_gmt":"2026-09-03T08:48:46","guid":{"rendered":"http:\/\/0"},"modified":"2026-09-04T10:14:14","modified_gmt":"2026-09-04T02:14:14","slug":"lsr-liquid-silicone-implant-guide-qualify-it-first","status":"publish","type":"post","link":"https:\/\/www.jcinjectionmolding.com\/vi\/blog\/lsr-liquid-silicone-implant-guide-qualify-it-first\/","title":{"rendered":"H\u01b0\u1edbng D\u1eabn C\u1ea5y Gh\u00e9p Silicone L\u1ecfng LSR: Ki\u1ec3m \u0110\u1ecbnh Tr\u01b0\u1edbc Ti\u00ean"},"content":{"rendered":"

C\u1ee5m t\u1eeb implant silicon l\u1ecfng LSR<\/em> c\u00f3 th\u1ec3 m\u00f4 t\u1ea3 nh\u1eefng y\u00eau c\u1ea7u k\u1ef9 thu\u1eadt r\u1ea5t kh\u00e1c nhau. M\u1ed9t chi ti\u1ebft ti\u1ebfp x\u00fac ng\u1eafn h\u1ea1n, m\u1ed9t chi ti\u1ebft c\u1ea5y gh\u00e9p v\u00e0 m\u1ed9t ph\u1ee5 ki\u1ec7n thi\u1ebft b\u1ecb \u0111\u1ec1u c\u00f3 th\u1ec3 s\u1eed d\u1ee5ng silicon, nh\u01b0ng ch\u00fang kh\u00f4ng chia s\u1ebb c\u00f9ng m\u1ed9t b\u1ed9 h\u1ed3 s\u01a1 b\u1eb1ng ch\u1ee9ng hay ti\u00eau ch\u00ed ph\u00e1t h\u00e0nh. Vi\u1ec7c l\u1ef1a ch\u1ecdn v\u1eadt li\u1ec7u ph\u1ea3i tu\u00e2n theo th\u1eddi gian ti\u1ebfp x\u00fac d\u1ef1 ki\u1ebfn, m\u00f4i tr\u01b0\u1eddng c\u01a1 th\u1ec3, ph\u01b0\u01a1ng ph\u00e1p ti\u1ec7t tr\u00f9ng v\u00e0 l\u1ed9 tr\u00ecnh ph\u00e1p l\u00fd.<\/p>\n

\u0110\u1ed1i v\u1edbi c\u00f4ng vi\u1ec7c li\u00ean quan \u0111\u1ebfn c\u1ea5y gh\u00e9p, \u00c9p phun Cao su Silicone L\u1ecfng (LSR)<\/a> t\u1ed1t nh\u1ea5t n\u00ean \u0111\u01b0\u1ee3c xem nh\u01b0 m\u1ed9t ph\u1ea7n c\u1ee7a h\u1ec7 th\u1ed1ng ph\u00e1t tri\u1ec3n s\u1ea3n ph\u1ea9m c\u00f3 ki\u1ec3m so\u00e1t. Qu\u00e1 tr\u00ecnh \u0111\u00fac c\u00f3 th\u1ec3 t\u1ea1o ra h\u00ecnh h\u1ecdc l\u1eb7p l\u1ea1i, nh\u01b0ng b\u1ea3n th\u00e2n n\u00f3 kh\u00f4ng th\u1ec3 thi\u1ebft l\u1eadp t\u00ednh an to\u00e0n sinh h\u1ecdc, t\u00ednh ph\u00f9 h\u1ee3p l\u00e2m s\u00e0ng hay s\u1ef1 tu\u00e2n th\u1ee7 quy \u0111\u1ecbnh. Nh\u1eefng k\u1ebft lu\u1eadn \u0111\u00f3 thu\u1ed9c v\u1ec1 ch\u01b0\u01a1ng tr\u00ecnh \u0111\u00e1nh gi\u00e1 n\u0103ng l\u1ef1c v\u00e0 h\u1ed3 s\u01a1 \u0111\u1ec7 tr\u00ecnh c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu thi\u1ebft b\u1ecb.<\/p>\n

X\u00e1c \u0111\u1ecbnh m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng y t\u1ebf tr\u01b0\u1edbc khi ch\u1ecdn m\u00e1c v\u1eadt li\u1ec7u<\/h2>\n

\"Medical-use-profile-review\"<\/p>\n

B\u1eaft \u0111\u1ea7u b\u1eb1ng m\u1ed9t h\u1ed3 s\u01a1 s\u1eed d\u1ee5ng b\u1eb1ng v\u0103n b\u1ea3n. H\u1ed3 s\u01a1 n\u00e0y c\u1ea7n n\u00eau r\u00f5 li\u1ec7u silicon c\u00f3 ti\u1ebfp x\u00fac v\u1edbi m\u00f4, m\u00e1u, thu\u1ed1c hay ch\u1ea5t l\u1ecfng kh\u00e1c hay kh\u00f4ng; li\u1ec7u ti\u1ebfp x\u00fac l\u00e0 t\u1ea1m th\u1eddi, k\u00e9o d\u00e0i hay v\u0129nh vi\u1ec5n; v\u00e0 li\u1ec7u chi ti\u1ebft \u0111\u01b0\u1ee3c c\u1ea5y gh\u00e9p nh\u01b0 m\u1ed9t th\u00e0nh ph\u1ea7n \u0111\u1ed9c l\u1eadp hay nh\u01b0 m\u1ed9t ph\u1ea7n c\u1ee7a c\u1ee5m l\u1eafp r\u00e1p l\u1edbn h\u01a1n. Nhi\u1ec7t \u0111\u1ed9, \u00e1p su\u1ea5t, t\u1ea3i tr\u1ecdng chu k\u1ef3 v\u00e0 tu\u1ed5i th\u1ecd b\u1ea3o qu\u1ea3n d\u1ef1 ki\u1ebfn n\u00ean \u0111\u01b0\u1ee3c ghi nh\u1eadn nh\u01b0 c\u00e1c \u0111\u1ea7u v\u00e0o thi\u1ebft k\u1ebf thay v\u00ec \u0111\u1ec3 l\u1ea1i cho m\u1ed9t cu\u1ed9c th\u1ea3o lu\u1eadn v\u1ec1 v\u1eadt li\u1ec7u sau n\u00e0y.<\/p>\n\n\n\n\n\n\n\n\n
C\u00e2u h\u1ecfi<\/th>\nT\u1ea1i sao n\u00f3 thay \u0111\u1ed5i k\u1ebf ho\u1ea1ch \u0111\u00e1nh gi\u00e1 n\u0103ng l\u1ef1c<\/th>\n<\/tr>\n<\/thead>\n
Th\u1eddi gian ti\u1ebfp x\u00fac l\u00e0 bao l\u00e2u?<\/td>\nTh\u1eddi gian ph\u01a1i nhi\u1ec5m c\u00e0ng d\u00e0i th\u01b0\u1eddng \u0111\u00f2i h\u1ecfi \u0111\u00e1nh gi\u00e1 sinh h\u1ecdc v\u00e0 l\u00e3o h\u00f3a s\u00e2u h\u01a1n.<\/td>\n<\/tr>\n
Chu tr\u00ecnh ti\u1ec7t tr\u00f9ng n\u00e0o \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng?<\/td>\nNhi\u1ec7t, b\u1ee9c x\u1ea1, kh\u00ed ho\u1eb7c c\u00e1c ph\u01b0\u01a1ng ph\u00e1p kh\u00e1c c\u00f3 th\u1ec3 \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn t\u00ednh ch\u1ea5t v\u00e0 bao b\u00ec.<\/td>\n<\/tr>\n
Ch\u1ebf \u0111\u1ed9 h\u1ecfng l\u00e0 g\u00ec?<\/td>\nM\u1ed9t ni\u00eam phong, m\u00e0ng, \u1ed1ng, ho\u1eb7c giao di\u1ec7n c\u1ea5y gh\u00e9p c\u1ea7n c\u00e1c th\u1eed nghi\u1ec7m kh\u00e1c nhau.<\/td>\n<\/tr>\n
\u0110\u01a1n v\u1ecb ph\u00e1t h\u00e0nh l\u00e0 g\u00ec?<\/td>\nK\u1ebf ho\u1ea1ch c\u00f3 th\u1ec3 y\u00eau c\u1ea7u ki\u1ec3m so\u00e1t tr\u1ef1c quan \u1edf c\u1ea5p l\u00f4, c\u1ea5p khoang, ho\u1eb7c 100%.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

T\u00e0i li\u1ec7u v\u1eadt li\u1ec7u l\u00e0 c\u1ea7n thi\u1ebft, nh\u01b0ng kh\u00f4ng \u0111\u1ee7<\/h2>\n

\"LSR-material-documentation\"<\/p>\n

Y\u00eau c\u1ea7u t\u00e0i li\u1ec7u \u0111\u1ea7y \u0111\u1ee7 v\u1ec1 c\u1ea5p v\u1eadt li\u1ec7u tr\u01b0\u1edbc khi thi\u1ebft k\u1ebf \u0111\u01b0\u1ee3c ch\u1ed1t: d\u1eef li\u1ec7u k\u1ef9 thu\u1eadt, \u0111i\u1ec1u ki\u1ec7n gia c\u00f4ng khuy\u1ebfn ngh\u1ecb, nh\u1eadn d\u1ea1ng l\u00f4, th\u00f4ng tin v\u1ec1 ch\u1ea5t t\u1ea1o m\u00e0u ho\u1eb7c ph\u1ee5 gia, v\u00e0 b\u1ea5t k\u1ef3 tuy\u00ean b\u1ed1 n\u00e0o li\u00ean quan \u0111\u1ebfn m\u1ee5c \u0111\u00edch ti\u1ebfp x\u00fac. M\u1ed9t c\u1ea5p v\u1eadt li\u1ec7u \u0111\u01b0\u1ee3c ti\u1ebfp th\u1ecb cho m\u1ee5c \u0111\u00edch y t\u1ebf kh\u00f4ng t\u1ef1 \u0111\u1ed9ng \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t cho m\u1ecdi thi\u1ebft k\u1ebf c\u1ea5y gh\u00e9p. \u1ee8ng d\u1ee5ng thi\u1ebft b\u1ecb, h\u00ecnh h\u1ecdc, l\u1ecbch s\u1eed gia c\u00f4ng, l\u00e0m s\u1ea1ch, \u0111\u00f3ng g\u00f3i v\u00e0 ti\u1ec7t tr\u00f9ng \u0111\u1ec1u \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn th\u00e0nh ph\u1ea9m.<\/p>\n

\u0110\u1eb7c bi\u1ec7t ch\u00fa \u00fd \u0111\u1ebfn s\u1ef1 kh\u00e1c bi\u1ec7t gi\u1eefa tuy\u00ean b\u1ed1 v\u1ec1 nguy\u00ean li\u1ec7u th\u00f4 v\u00e0 k\u1ebft qu\u1ea3 c\u1ee7a chi ti\u1ebft th\u00e0nh ph\u1ea9m. Chi ti\u1ebft \u0111\u00fac c\u00f3 th\u1ec3 ch\u1ee9a d\u1ea5u v\u1ebft t\u1eeb d\u1ee5ng c\u1ee5, m\u00f4i tr\u01b0\u1eddng x\u1eed l\u00fd, h\u00f3a ch\u1ea5t t\u00e1ch khu\u00f4n, h\u1ec7 th\u1ed1ng s\u1eafc t\u1ed1 ho\u1eb7c bao b\u00ec. N\u1ebfu m\u1ed9t d\u1ef1 \u00e1n y\u00eau c\u1ea7u quy tr\u00ecnh ph\u00f2ng s\u1ea1ch ho\u1eb7c h\u1eadu b\u1ea3o d\u01b0\u1ee1ng c\u00f3 ki\u1ec3m so\u00e1t, h\u00e3y x\u00e1c \u0111\u1ecbnh c\u00e1c y\u00eau c\u1ea7u \u0111\u00f3 trong \u0111\u1eb7c t\u1ea3 s\u1ea3n xu\u1ea5t v\u00e0 x\u00e1c minh ch\u00fang trong qu\u00e1 tr\u00ecnh th\u1ea9m \u0111\u1ecbnh.<\/p>\n

Thi\u1ebft k\u1ebf chi ti\u1ebft xoay quanh giao di\u1ec7n sinh h\u1ecdc v\u00e0 c\u01a1 h\u1ecdc th\u1ef1c t\u1ebf<\/h2>\n

\"Silicone-interface-design-review\"<\/p>\n

M\u1ed9t chi ti\u1ebft silicone li\u00ean quan \u0111\u1ebfn c\u1ea5y gh\u00e9p kh\u00f4ng n\u00ean ch\u1ec9 \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf t\u1eeb b\u1ec1 m\u1eb7t CAD danh ngh\u0129a. H\u00e3y xem x\u00e9t giao di\u1ec7n th\u1ef1c hi\u1ec7n ch\u1ee9c n\u0103ng l\u00e2m s\u00e0ng. M\u1ed9t g\u1edd ni\u00eam phong c\u1ea7n \u0111\u1ed9 n\u00e9n \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t m\u00e0 kh\u00f4ng t\u1eadp trung \u1ee9ng su\u1ea5t qu\u00e1 m\u1ee9c. M\u1ed9t m\u00e0ng m\u1ecfng c\u1ea7n \u0111\u1ed9 u\u1ed1n d\u1ebbo c\u00f3 th\u1ec3 d\u1ef1 \u0111o\u00e1n \u0111\u01b0\u1ee3c v\u00e0 chuy\u1ec3n ti\u1ebfp s\u1ea1ch s\u1ebd sang th\u00e0nh \u0111\u1ee1 c\u1ee7a n\u00f3. M\u1ed9t \u1ed1ng ho\u1eb7c \u1ed1ng b\u1ecdc c\u1ea7n l\u1ed7 khoan v\u1eabn ho\u1ea1t \u0111\u1ed9ng \u0111\u01b0\u1ee3c sau khi b\u1ea3o d\u01b0\u1ee1ng, th\u00e1o khu\u00f4n, ti\u1ec7t tr\u00f9ng v\u00e0 l\u01b0u tr\u1eef.<\/p>\n

    \n
  1. Lo\u1ea1i b\u1ecf c\u00e1c chuy\u1ec3n ti\u1ebfp s\u1eafc nh\u1ecdn kh\u00f4ng c\u1ea7n thi\u1ebft:<\/strong> s\u1eed d\u1ee5ng b\u00e1n k\u00ednh \u1edf nh\u1eefng n\u01a1i ch\u00fang gi\u1ea3m r\u00e1ch ho\u1eb7c \u1ee9ng su\u1ea5t c\u1ee5c b\u1ed9.<\/li>\n
  2. B\u1ea3o v\u1ec7 c\u00e1c b\u1ec1 m\u1eb7t quan tr\u1ecdng:<\/strong> gi\u1eef \u0111\u01b0\u1eddng ph\u00e2n khu\u00f4n v\u00e0 c\u1ed5ng r\u00f3t tr\u00e1nh xa c\u00e1c v\u00f9ng ti\u1ebfp x\u00fac ch\u1ee9c n\u0103ng n\u1ebfu c\u00f3 th\u1ec3.<\/li>\n
  3. L\u1eadp k\u1ebf ho\u1ea1ch th\u00e1o khu\u00f4n s\u1edbm:<\/strong> c\u00e1c chi ti\u1ebft linh ho\u1ea1t c\u00f3 th\u1ec3 bi\u1ebfn d\u1ea1ng n\u1ebfu \u0111\u01b0\u1eddng tho\u00e1t khu\u00f4n kh\u00f4ng \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t.<\/li>\n
  4. T\u00e1ch bi\u1ec7t gi\u1edbi h\u1ea1n th\u1ea9m m\u1ef9 kh\u1ecfi gi\u1edbi h\u1ea1n ch\u1ee9c n\u0103ng:<\/strong> m\u1ed9t v\u1ebft d\u1ea5u v\u00f4 h\u1ea1i v\u00e0 m\u1ed9t khuy\u1ebft t\u1eadt l\u00e0m k\u00edn kh\u00f4ng n\u00ean d\u00f9ng chung m\u1ed9t quy t\u1eafc ch\u1ea5p nh\u1eadn.<\/li>\n
  5. Ghi l\u1ea1i \u0111i\u1ec1u ki\u1ec7n \u0111o:<\/strong> th\u1eddi gian sau khi \u0111\u00f3ng r\u1eafn, nhi\u1ec7t \u0111\u1ed9 v\u00e0 h\u00ecnh h\u1ecdc \u0111\u1ed3 g\u00e1 c\u00f3 th\u1ec3 \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn k\u1ebft qu\u1ea3.<\/li>\n<\/ol>\n

    Ti\u1ec7t tr\u00f9ng v\u00e0 l\u00e3o h\u00f3a thu\u1ed9c v\u1ec1 th\u1ea9m \u0111\u1ecbnh thi\u1ebft k\u1ebf<\/h2>\n

    \"Sterilization-aging-test-fixture\"<\/p>\n

    M\u1ed9t chi ti\u1ebft \u0111\u1ea1t ki\u1ec3m tra \u1edf tr\u1ea1ng th\u00e1i v\u1eeba \u00e9p khu\u00f4n c\u00f3 th\u1ec3 h\u00e0nh x\u1eed kh\u00e1c sau chu tr\u00ecnh ti\u1ec7t tr\u00f9ng d\u1ef1 ki\u1ebfn ho\u1eb7c \u0111i\u1ec1u ki\u1ec7n l\u00e3o h\u00f3a t\u0103ng t\u1ed1c. \u0110\u00e1nh gi\u00e1 c\u00e1c \u0111\u1eb7c t\u00ednh mang ch\u1ee9c n\u0103ng l\u00e2m s\u00e0ng: k\u00edch th\u01b0\u1edbc, \u0111\u1ed9 ph\u1ee5c h\u1ed3i n\u00e9n, \u0111\u1ed9 b\u1ec1n x\u00e9, \u0111\u1ed9 gi\u00e3n d\u00e0i, hi\u1ec7u su\u1ea5t l\u00e0m k\u00edn, t\u00ecnh tr\u1ea1ng b\u1ec1 m\u1eb7t v\u00e0 m\u1ecdi \u0111\u00e1nh gi\u00e1 li\u00ean quan \u0111\u1ebfn ch\u1ea5t chi\u1ebft ho\u1eb7c ch\u1ea5t th\u00f4i nhi\u1ec5m \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh b\u1edfi ch\u01b0\u01a1ng tr\u00ecnh thi\u1ebft b\u1ecb.<\/p>\n

    Kh\u00f4ng ch\u1ecdn m\u1ed9t ph\u00e9p th\u1eed ch\u1ec9 v\u00ec n\u00f3 thu\u1eadn ti\u1ec7n. \u0110\u1ed3 g\u00e1 th\u1eed nghi\u1ec7m n\u00ean t\u00e1i hi\u1ec7n c\u00e1ch chi ti\u1ebft \u0111\u01b0\u1ee3c l\u1eafp r\u00e1p v\u00e0 ch\u1ecbu t\u1ea3i. N\u1ebfu s\u1ea3n ph\u1ea9m b\u1ecb n\u00e9n b\u00ean trong m\u1ed9t v\u1ecf, h\u00e3y th\u1eed nghi\u1ec7m n\u00f3 trong v\u1ecf \u0111\u00f3. N\u1ebfu n\u00f3 b\u1ecb k\u00e9o gi\u00e3n qua m\u1ed9t chi ti\u1ebft, h\u00e3y bao g\u1ed3m tr\u00ecnh t\u1ef1 k\u00e9o gi\u00e3n v\u00e0 th\u1ea3. K\u1ebft qu\u1ea3 ph\u1ea3i gi\u00fap tr\u1ea3 l\u1eddi li\u1ec7u chi ti\u1ebft c\u00f3 duy tr\u00ec an to\u00e0n v\u00e0 ch\u1ee9c n\u0103ng trong su\u1ed1t tu\u1ed5i th\u1ecd \u0111\u00e3 c\u00f4ng b\u1ed1 hay kh\u00f4ng.<\/p>\n

    X\u00e2y d\u1ef1ng kh\u1ea3 n\u0103ng truy xu\u1ea5t ngu\u1ed3n g\u1ed1c t\u1eeb nguy\u00ean li\u1ec7u \u0111\u1ea7u v\u00e0o \u0111\u1ebfn ph\u00e1t h\u00e0nh<\/h2>\n

    \"Medical-lot-traceability-setup\"<\/p>\n

    M\u1ed9t d\u1ef1 \u00e1n li\u00ean quan \u0111\u1ebfn c\u1ea5y gh\u00e9p \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t c\u1ea7n m\u1ed9t chu\u1ed7i nh\u1eadn d\u1ea1ng: l\u00f4 nguy\u00ean li\u1ec7u, khu\u00f4n ho\u1eb7c l\u00f2ng khu\u00f4n, thi\u1ebft l\u1eadp quy tr\u00ecnh, ng\u01b0\u1eddi v\u1eadn h\u00e0nh ho\u1eb7c t\u1ebf b\u00e0o t\u1ef1 \u0111\u1ed9ng, h\u1ed3 s\u01a1 ki\u1ec3m tra, l\u00f4 bao b\u00ec v\u00e0 quy\u1ebft \u0111\u1ecbnh x\u1eed l\u00fd. Trang ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng<\/a> l\u00e0 t\u00e0i li\u1ec7u tham kh\u1ea3o n\u1ed9i b\u1ed9 h\u1eefu \u00edch \u0111\u1ec3 t\u1ed5 ch\u1ee9c c\u00e1c c\u1ed5ng ki\u1ec3m tra, trong khi \u0111\u1eb7c t\u1ea3 d\u1ef1 \u00e1n n\u00ean x\u00e1c \u0111\u1ecbnh c\u00e1c y\u00eau c\u1ea7u l\u1ea5y m\u1eabu v\u00e0 ch\u1ea5p nh\u1eadn th\u1ef1c t\u1ebf.<\/p>\n

    M\u1ed9t danh s\u00e1ch ki\u1ec3m tra ph\u00e1t h\u00e0nh th\u1ef1c t\u1ebf bao g\u1ed3m:<\/p>\n