\u0110i\u1ec1u quan tr\u1ecdng nh\u1ea5t l\u00e0, t\u00ednh h\u1ee3p l\u1ec7 v\u1ec1 m\u1eb7t y t\u1ebf th\u1ef1c s\u1ef1 ph\u1ee5 thu\u1ed9c v\u00e0o vi\u1ec7c tu\u00e2n th\u1ee7 c\u00e1c ti\u00eau chu\u1ea9n \u0111\u00e1nh gi\u00e1 sinh h\u1ecdc \u0111\u01b0\u1ee3c qu\u1ed1c t\u1ebf c\u00f4ng nh\u1eadn, \u0111\u1eb7c bi\u1ec7t l\u00e0 ti\u00eau chu\u1ea9n ISO 10993.<\/p>\n\n\n\n
\u0110\u1ed1i v\u1edbi c\u00e1c h\u1ec7 th\u1ed1ng b\u01a1m h\u01a1i y t\u1ebf ph\u1ea3i ti\u1ebfp x\u00fac l\u00e2u d\u00e0i v\u1edbi da ho\u1eb7c khi\u1ebfn b\u1ec7nh nh\u00e2n ti\u1ebfp x\u00fac l\u1eb7p \u0111i l\u1eb7p l\u1ea1i, vi\u1ec7c l\u1ef1a ch\u1ecdn v\u1eadt li\u1ec7u kh\u00f4ng c\u00f2n ch\u1ec9 l\u00e0 m\u1ed9t quy\u1ebft \u0111\u1ecbnh thu\u1ed9c l\u0129nh v\u1ef1c k\u1ef9 thu\u1eadt c\u01a1 kh\u00ed. \u0110\u00e2y c\u00f2n l\u00e0 m\u1ed9t quy\u1ebft \u0111\u1ecbnh li\u00ean quan \u0111\u1ebfn quy \u0111\u1ecbnh ph\u00e1p l\u00fd v\u00e0 \u0111\u1ed9c h\u1ecdc.<\/p>\n\n\n\n
Kh\u1ea3 n\u0103ng t\u01b0\u01a1ng th\u00edch sinh h\u1ecdc kh\u00f4ng ch\u1ec9 \u0111\u01a1n thu\u1ea7n l\u00e0 \u201ckh\u00f4ng \u0111\u1ed9c h\u1ea1i\u201d<\/h2>\n\n\n\n
Ti\u00eau chu\u1ea9n ISO 10993 \u0111\u1ecbnh ngh\u0129a t\u00ednh t\u01b0\u01a1ng th\u00edch sinh h\u1ecdc nh\u01b0 sau:<\/p>\n\n\n\n
\n\u201cKh\u1ea3 n\u0103ng c\u1ee7a m\u1ed9t v\u1eadt li\u1ec7u trong vi\u1ec7c t\u1ea1o ra ph\u1ea3n \u1ee9ng th\u00edch h\u1ee3p t\u1eeb v\u1eadt ch\u1ee7 trong m\u1ed9t \u1ee9ng d\u1ee5ng c\u1ee5 th\u1ec3.\u201d<\/p>\n<\/blockquote>\n\n\n\n
\u0110\u1ecbnh ngh\u0129a n\u00e0y c\u00f3 \u00fd ngh\u0129a v\u00f4 c\u00f9ng quan tr\u1ecdng b\u1edfi v\u00ec t\u00ednh t\u01b0\u01a1ng th\u00edch sinh h\u1ecdc kh\u00f4ng ph\u1ea3i l\u00e0 m\u1ed9t t\u00ednh ch\u1ea5t c\u1ed1 h\u1eefu nh\u01b0 \u0111\u1ed9 c\u1ee9ng, \u0111\u1ed9 b\u1ec1n k\u00e9o hay m\u1eadt \u0111\u1ed9. M\u1ed9t c\u00f4ng th\u1ee9c TPU ho\u1ea1t \u0111\u1ed9ng an to\u00e0n trong m\u1ed9t thi\u1ebft b\u1ecb c\u00f3 th\u1ec3 kh\u00f4ng ph\u00f9 h\u1ee3p trong m\u1ed9t \u1ee9ng d\u1ee5ng kh\u00e1c v\u1edbi c\u00e1c \u0111i\u1ec1u ki\u1ec7n ti\u1ebfp x\u00fac kh\u00e1c nhau.<\/p>\n\n\n\n
M\u1ed9t v\u1eadt li\u1ec7u ch\u1ec9 c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c coi l\u00e0 t\u01b0\u01a1ng th\u00edch sinh h\u1ecdc trong b\u1ed1i c\u1ea3nh m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng y t\u1ebf c\u1ee7a n\u00f3.<\/p>\n\n\n\n
Kh\u00f4ng ph\u1ea3i t\u1ea5t c\u1ea3 c\u00e1c lo\u1ea1i TPU \u0111\u1ec1u gi\u1ed1ng nhau: Hi\u1ec3u v\u1ec1 t\u00ednh t\u01b0\u01a1ng th\u00edch sinh h\u1ecdc v\u00e0 ti\u00eau chu\u1ea9n ISO 10993 <\/figcaption><\/figure>\n\n\n\n Ba y\u1ebfu t\u1ed1 c\u1ed1t l\u00f5i trong \u0111\u00e1nh gi\u00e1 t\u00ednh t\u01b0\u01a1ng th\u00edch sinh h\u1ecdc<\/h2>\n\n\n\n
1. B\u1ea3n ch\u1ea5t c\u1ee7a s\u1ef1 ti\u1ebfp x\u00fac c\u01a1 th\u1ec3<\/h3>\n\n\n\n
Vi\u1ec7c \u0111\u00e1nh gi\u00e1 v\u1ec1 m\u1eb7t quy \u0111\u1ecbnh ph\u1ee5 thu\u1ed9c r\u1ea5t nhi\u1ec1u v\u00e0o c\u00e1ch thi\u1ebft b\u1ecb t\u01b0\u01a1ng t\u00e1c v\u1edbi c\u01a1 th\u1ec3.<\/p>\n\n\n\n
C\u00e1c ph\u00e2n lo\u1ea1i \u0111i\u1ec3n h\u00ecnh bao g\u1ed3m:<\/p>\n\n\n\n
Lo\u1ea1i li\u00ean h\u1ec7<\/th> V\u00ed d\u1ee5 v\u1ec1 c\u00e1c \u1ee9ng d\u1ee5ng<\/th> M\u1ee9c \u0111\u1ed9 r\u1ee7i ro<\/th><\/tr><\/thead> Ti\u1ebfp x\u00fac gi\u00e1n ti\u1ebfp<\/td> V\u1ecf thi\u1ebft b\u1ecb ngo\u1ea1i vi<\/td> Th\u1ea5p h\u01a1n<\/td><\/tr> Ti\u1ebfp x\u00fac b\u1ec1 m\u1eb7t<\/td> V\u00f2ng \u0111o huy\u1ebft \u00e1p, b\u0103ng qu\u1ea5n ph\u1ee5c h\u1ed3i ch\u1ee9c n\u0103ng c\u00f3 th\u1ec3 b\u01a1m h\u01a1i<\/td> Trung b\u00ecnh<\/td><\/tr> Ti\u1ebfp x\u00fac v\u1edbi ni\u00eam m\u1ea1c<\/td> Thi\u1ebft b\u1ecb h\u00f4 h\u1ea5p ho\u1eb7c ti\u1ebft ni\u1ec7u<\/td> Cao h\u01a1n<\/td><\/tr> Ti\u1ebfp x\u00fac v\u1edbi implant<\/td> B\u00f3ng ho\u1eb7c t\u00fai ch\u1ee9a c\u00f3 th\u1ec3 c\u1ea5y gh\u00e9p<\/td> Cao nh\u1ea5t<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n H\u1ea7u h\u1ebft c\u00e1c lo\u1ea1i v\u1ea3i y t\u1ebf b\u01a1m h\u01a1i l\u00e0m t\u1eeb TPU \u0111\u1ec1u thu\u1ed9c nh\u00f3m ti\u1ebfp x\u00fac v\u1edbi b\u1ec1 m\u1eb7t, do \u0111\u00f3 v\u1eabn c\u1ea7n ph\u1ea3i ti\u1ebfn h\u00e0nh \u0111\u00e1nh gi\u00e1 sinh h\u1ecdc k\u1ef9 l\u01b0\u1ee1ng.<\/p>\n\n\n\n
2. Th\u1eddi gian ti\u1ebfp x\u00fac<\/h3>\n\n\n\n
Ti\u00eau chu\u1ea9n ISO 10993 ph\u00e2n lo\u1ea1i th\u1eddi gian ti\u1ebfp x\u00fac th\u00e0nh ba nh\u00f3m ch\u00ednh:<\/p>\n\n\n\n
Th\u1eddi gian li\u00ean l\u1ea1c<\/th> Kho\u1ea3ng th\u1eddi gian<\/th> C\u00e1c v\u00ed d\u1ee5 \u0111i\u1ec3n h\u00ecnh<\/th><\/tr><\/thead> S\u1ed1 l\u01b0\u1ee3ng c\u00f3 h\u1ea1n<\/td> Ch\u01b0a \u0111\u1ea7y 24 gi\u1edd<\/td> C\u00f2ng tay d\u00f9ng trong tr\u01b0\u1eddng h\u1ee3p kh\u1ea9n c\u1ea5p<\/td><\/tr> K\u00e9o d\u00e0i<\/td> T\u1eeb 24 gi\u1edd \u0111\u1ebfn 30 ng\u00e0y<\/td> H\u1ec7 th\u1ed1ng tr\u1ecb li\u1ec7u b\u1eb1ng \u00e1p l\u1ef1c<\/td><\/tr> D\u00e0i h\u1ea1n \/ V\u0129nh vi\u1ec5n<\/td> H\u01a1n 30 ng\u00e0y<\/td> H\u1ec7 th\u1ed1ng h\u1ed7 tr\u1ee3 ch\u0103m s\u00f3c b\u1ec7nh m\u00e3n t\u00ednh<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n Th\u1eddi gian ti\u1ebfp x\u00fac c\u1ee7a b\u1ec7nh nh\u00e2n c\u00e0ng d\u00e0i, y\u00eau c\u1ea7u v\u1ec1 x\u00e9t nghi\u1ec7m sinh h\u1ecdc c\u00e0ng tr\u1edf n\u00ean ph\u1ee9c t\u1ea1p h\u01a1n.<\/p>\n\n\n\n
3. Ch\u1ee9c n\u0103ng d\u1ef1 ki\u1ebfn c\u1ee7a thi\u1ebft b\u1ecb<\/h3>\n\n\n\n
Ch\u1ee9c n\u0103ng c\u1ee7a thi\u1ebft b\u1ecb c\u00f3 \u1ea3nh h\u01b0\u1edfng tr\u1ef1c ti\u1ebfp \u0111\u1ebfn c\u00e1c y\u00eau c\u1ea7u c\u1ee7a c\u01a1 quan qu\u1ea3n l\u00fd.<\/p>\n\n\n\n
V\u00ed d\u1ee5, m\u1ed9t v\u00f2ng b\u0103ng \u00e9p b\u01a1m h\u01a1i t\u1ea1o ra \u00e1p l\u1ef1c t\u1ea1m th\u1eddi v\u00e0 ch\u1ec9 ti\u1ebfp x\u00fac trong th\u1eddi gian ng\u1eafn. Trong khi \u0111\u00f3, m\u1ed9t khoang n\u1ec7m ch\u1ed1ng lo\u00e9t do \u00e1p l\u1ef1c c\u00f3 th\u1ec3 duy tr\u00ec ti\u1ebfp x\u00fac li\u00ean t\u1ee5c v\u1edbi b\u1ec7nh nh\u00e2n trong nhi\u1ec1u tu\u1ea7n ho\u1eb7c nhi\u1ec1u th\u00e1ng. Ngay c\u1ea3 khi c\u1ea3 hai \u0111\u1ec1u s\u1eed d\u1ee5ng v\u1ea3i b\u01a1m h\u01a1i ph\u1ee7 TPU, c\u00e1c y\u00eau c\u1ea7u v\u1ec1 \u0111\u00e1nh gi\u00e1 sinh h\u1ecdc c\u1ee7a ch\u00fang l\u1ea1i ho\u00e0n to\u00e0n kh\u00e1c nhau.<\/p>\n\n\n\n
\u0110\u00f3 l\u00e0 l\u00fd do t\u1ea1i sao t\u00ednh t\u01b0\u01a1ng th\u00edch sinh h\u1ecdc lu\u00f4n d\u1ef1a tr\u00ean m\u1ee9c \u0111\u1ed9 r\u1ee7i ro v\u00e0 ph\u1ee5 thu\u1ed9c v\u00e0o t\u1eebng \u1ee9ng d\u1ee5ng c\u1ee5 th\u1ec3.<\/p>\n\n\n\n
T\u1ea1i sao c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf b\u01a1m h\u01a1i c\u1ea7n \u0111\u01b0\u1ee3c quan t\u00e2m \u0111\u1eb7c bi\u1ec7t<\/h2>\n\n\n\n
C\u00e1c b\u1ed9 ph\u1eadn y t\u1ebf b\u01a1m h\u01a1i \u0111\u1eb7t ra nh\u1eefng th\u00e1ch th\u1ee9c \u0111\u1eb7c th\u00f9 v\u1ec1 v\u1eadt li\u1ec7u do ch\u00fang k\u1ebft h\u1ee3p:<\/p>\n\n\n\n
\n
- Ti\u1ebfp x\u00fac l\u1eb7p \u0111i l\u1eb7p l\u1ea1i v\u1edbi da<\/li>\n\n\n\n
- \u00c1p l\u1ef1c c\u01a1 h\u1ecdc v\u00e0 m\u1ecfi do u\u1ed1n<\/li>\n\n\n\n
- Ti\u1ebfp x\u00fac v\u1edbi nhi\u1ec7t \u0111\u1ed9 cao v\u00e0 \u0111\u1ed9 \u1ea9m<\/li>\n\n\n\n
- Chu k\u1ef3 thay \u0111\u1ed5i \u00e1p su\u1ea5t li\u00ean t\u1ee5c<\/li>\n\n\n\n
- Y\u00eau c\u1ea7u v\u1ec1 th\u1eddi gian \u1ee7 l\u00e2u d\u00e0i<\/li>\n\n\n\n
- C\u00e1c r\u1ee7i ro ti\u1ec1m \u1ea9n li\u00ean quan \u0111\u1ebfn s\u1ef1 di chuy\u1ec3n c\u1ee7a c\u00e1c ch\u1ea5t h\u00f3a h\u1ecdc<\/li>\n<\/ul>\n\n\n\n
Kh\u00f4ng gi\u1ed1ng nh\u01b0 c\u00e1c b\u1ed9 ph\u1eadn nh\u1ef1a c\u1ee9ng, c\u00e1c h\u1ec7 th\u1ed1ng TPU d\u1ebbo c\u00f3 th\u1ec3 ch\u1ee9a c\u00e1c ph\u00e2n \u0111o\u1ea1n m\u1ec1m, ch\u1ea5t h\u1ed7 tr\u1ee3 gia c\u00f4ng, ch\u1ea5t x\u00fac t\u00e1c, ch\u1ea5t \u1ed5n \u0111\u1ecbnh, ch\u1ea5t m\u00e0u ho\u1eb7c ch\u1ea5t k\u1ebft d\u00ednh c\u00f3 th\u1ec3 di chuy\u1ec3n trong \u0111i\u1ec1u ki\u1ec7n s\u1eed d\u1ee5ng th\u1ef1c t\u1ebf.<\/p>\n\n\n\n
V\u00ec l\u00fd do n\u00e0y, c\u00e1c c\u01a1 quan qu\u1ea3n l\u00fd ng\u00e0y c\u00e0ng ch\u00fa tr\u1ecdng v\u00e0o vi\u1ec7c ph\u00e2n t\u00edch c\u00e1c ch\u1ea5t chi\u1ebft xu\u1ea5t v\u00e0 c\u00e1c ch\u1ea5t r\u00f2 r\u1ec9 thay v\u00ec ch\u1ec9 d\u1ef1a v\u00e0o vi\u1ec7c s\u00e0ng l\u1ecdc \u0111\u1ed9c t\u00ednh c\u01a1 b\u1ea3n.<\/p>\n\n\n\n
ISO 10993: M\u1ed9t khung an to\u00e0n sinh h\u1ecdc, ch\u1ee9 kh\u00f4ng ph\u1ea3i m\u1ed9t ph\u01b0\u01a1ng ph\u00e1p th\u1eed nghi\u1ec7m duy nh\u1ea5t<\/h2>\n\n\n\n
M\u1ed9t quan ni\u1ec7m sai l\u1ea7m ph\u1ed5 bi\u1ebfn trong ng\u00e0nh l\u00e0 coi ISO 10993 nh\u01b0 m\u1ed9t ch\u1ee9ng nh\u1eadn duy nh\u1ea5t. Tr\u00ean th\u1ef1c t\u1ebf, ISO 10993 l\u00e0 m\u1ed9t h\u1ec7 th\u1ed1ng c\u00e1c ti\u00eau chu\u1ea9n bao qu\u00e1t c\u00e1c ph\u01b0\u01a1ng ph\u00e1p \u0111\u00e1nh gi\u00e1 sinh h\u1ecdc kh\u00e1c nhau.<\/p>\n\n\n\n
Ti\u00eau chu\u1ea9n n\u00e0y \u0111\u00f3ng vai tr\u00f2 l\u00e0 m\u1ed9t khung kh\u1ed5 c\u00f3 h\u1ec7 th\u1ed1ng \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 m\u1ee9c \u0111\u1ed9 an to\u00e0n c\u1ee7a thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n\n\n\n
ISO 10993-1: L\u1ed9 tr\u00ecnh ph\u00e1p l\u00fd<\/h3>\n\n\n\n
Ti\u00eau chu\u1ea9n ISO 10993-1 quy \u0111\u1ecbnh c\u00e1c ch\u1ec9 s\u1ed1 sinh h\u1ecdc n\u00e0o ph\u1ea3i \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 d\u1ef1a tr\u00ean:<\/p>\n\n\n\n
\n
- Lo\u1ea1i li\u00ean h\u1ec7<\/li>\n\n\n\n
- Th\u1eddi gian ti\u1ebfp x\u00fac<\/li>\n\n\n\n
- Lo\u1ea1i thi\u1ebft b\u1ecb<\/li>\n\n\n\n
- \u0110\u1eb7c t\u00ednh v\u1eadt li\u1ec7u<\/li>\n\n\n\n
- T\u00ecnh hu\u1ed1ng \u1ee9ng d\u1ee5ng l\u00e2m s\u00e0ng<\/li>\n<\/ul>\n\n\n\n
\u0110\u1ed1i v\u1edbi c\u00e1c lo\u1ea1i v\u1ea3i TPU b\u01a1m h\u01a1i ti\u1ebfp x\u00fac l\u00e2u d\u00e0i v\u1edbi b\u1ec1 m\u1eb7t, c\u00e1c ch\u1ec9 s\u1ed1 sinh h\u1ecdc \u0111i\u1ec3n h\u00ecnh th\u01b0\u1eddng bao g\u1ed3m:<\/p>\n\n\n\n
\n
- \u0110\u1ed9c t\u00ednh t\u1ebf b\u00e0o<\/li>\n\n\n\n
- K\u00edch \u1ee9ng da<\/li>\n\n\n\n
- Ph\u1ea3n \u1ee9ng m\u1eabn c\u1ea3m da<\/li>\n\n\n\n
- Ng\u1ed9 \u0111\u1ed9c to\u00e0n th\u00e2n c\u1ea5p t\u00ednh<\/li>\n\n\n\n
- Ph\u00e2n t\u00edch th\u00e0nh ph\u1ea7n h\u00f3a h\u1ecdc<\/li>\n\n\n\n
- \u0110\u00e1nh gi\u00e1 c\u00e1c ch\u1ea5t chi\u1ebft xu\u1ea5t v\u00e0 c\u00e1c ch\u1ea5t h\u00f2a tan<\/li>\n<\/ul>\n\n\n\n
C\u1ea5u tr\u00fac d\u1ef1a tr\u00ean r\u1ee7i ro n\u00e0y l\u00e0 y\u1ebfu t\u1ed1 c\u1ed1t l\u00f5i trong quy \u0111\u1ecbnh hi\u1ec7n \u0111\u1ea1i v\u1ec1 thi\u1ebft b\u1ecb y t\u1ebf theo h\u01b0\u1edbng d\u1eabn c\u1ee7a FDA, Quy \u0111\u1ecbnh v\u1ec1 Thi\u1ebft b\u1ecb Y t\u1ebf c\u1ee7a EU (MDR) v\u00e0 c\u00e1c khung ph\u00e1p l\u00fd qu\u1ed1c t\u1ebf kh\u00e1c.<\/p>\n\n\n\n
C\u00e1c th\u1eed nghi\u1ec7m c\u1ed1t l\u00f5i theo ti\u00eau chu\u1ea9n ISO 10993 v\u00e0 \u00fd ngh\u0129a th\u1ef1c s\u1ef1 c\u1ee7a ch\u00fangTh\u1eed nghi\u1ec7m \u0111\u1ed9c t\u00ednh t\u1ebf b\u00e0o \u2014 ISO 10993-5<\/h3>\n\n\n\n
\u0110\u00e2y th\u01b0\u1eddng l\u00e0 b\u01b0\u1edbc s\u00e0ng l\u1ecdc sinh h\u1ecdc \u0111\u1ea7u ti\u00ean.<\/p>\n\n\n\n
Th\u1eed nghi\u1ec7m n\u00e0y nh\u1eb1m \u0111\u00e1nh gi\u00e1 li\u1ec7u c\u00e1c chi\u1ebft xu\u1ea5t t\u1eeb nguy\u00ean li\u1ec7u c\u00f3 g\u00e2y t\u1ed5n th\u01b0\u01a1ng cho t\u1ebf b\u00e0o s\u1ed1ng hay kh\u00f4ng, th\u01b0\u1eddng s\u1eed d\u1ee5ng t\u1ebf b\u00e0o s\u1ee3i L929 c\u1ee7a chu\u1ed9t.<\/p>\n\n\n\n
K\u1ebft qu\u1ea3 \u0111\u1ea1t y\u00eau c\u1ea7u cho th\u1ea5y v\u1eadt li\u1ec7u n\u00e0y kh\u00f4ng g\u00e2y \u0111\u1ed9c t\u00ednh t\u1ebf b\u00e0o c\u1ea5p t\u00ednh trong \u0111i\u1ec1u ki\u1ec7n chi\u1ebft xu\u1ea5t.<\/p>\n\n\n\n
\u0110\u1ed1i v\u1edbi c\u00e1c lo\u1ea1i v\u1ea3i y t\u1ebf b\u01a1m h\u01a1i c\u00f3 l\u1edbp ph\u1ee7 TPU, th\u1eed nghi\u1ec7m \u0111\u1ed9c t\u00ednh t\u1ebf b\u00e0o gi\u00fap x\u00e1c \u0111\u1ecbnh c\u00e1c v\u1ea5n \u0111\u1ec1 li\u00ean quan \u0111\u1ebfn:<\/p>\n\n\n\n
\n
- C\u00e1c monome c\u00f2n l\u1ea1i<\/li>\n\n\n\n
- C\u00e1c d\u01b0 l\u01b0\u1ee3ng ch\u1ea5t x\u00fac t\u00e1c<\/li>\n\n\n\n
- D\u01b0 l\u01b0\u1ee3ng dung m\u00f4i<\/li>\n\n\n\n
- C\u00e1c s\u1ea3n ph\u1ea9m ph\u1ee5 c\u1ee7a qu\u00e1 tr\u00ecnh ph\u00e2n h\u1ee7y<\/li>\n\n\n\n
- C\u00e1c ch\u1ea5t ph\u1ee5 gia kh\u00f4ng \u1ed5n \u0111\u1ecbnh<\/li>\n<\/ul>\n\n\n\n
M\u1ecdi v\u1eadt li\u1ec7u TPU \u0111\u01b0\u1ee3c \u0111\u01b0a ra th\u1ecb tr\u01b0\u1eddng \u0111\u1ec3 s\u1eed d\u1ee5ng trong y t\u1ebf \u0111\u1ec1u ph\u1ea3i cung c\u1ea5p d\u1eef li\u1ec7u v\u1ec1 \u0111\u1ed9c t\u00ednh t\u1ebf b\u00e0o \u0111\u00e3 \u0111\u01b0\u1ee3c x\u00e1c nh\u1eadn t\u1eeb c\u00e1c ph\u00f2ng th\u00ed nghi\u1ec7m \u0111\u1ed9c l\u1eadp \u0111\u01b0\u1ee3c c\u00f4ng nh\u1eadn. K\u00edch \u1ee9ng da v\u00e0 ph\u1ea3n \u1ee9ng m\u1eabn c\u1ea3m \u2014 ISO 10993-10<\/p>\n\n\n\n
C\u00e1c x\u00e9t nghi\u1ec7m n\u00e0y nh\u1eb1m \u0111\u00e1nh gi\u00e1 li\u1ec7u vi\u1ec7c ti\u1ebfp x\u00fac l\u1eb7p \u0111i l\u1eb7p l\u1ea1i c\u00f3 th\u1ec3 g\u00e2y ra:<\/p>\n\n\n\n
\n
- C\u00e1c ph\u1ea3n \u1ee9ng vi\u00eam t\u1ea1i ch\u1ed7<\/li>\n\n\n\n
- Da \u0111\u1ecf ho\u1eb7c b\u1ecb k\u00edch \u1ee9ng<\/li>\n\n\n\n
- Vi\u00eam da ti\u1ebfp x\u00fac d\u1ecb \u1ee9ng<\/li>\n\n\n\n
- Ph\u1ea3n \u1ee9ng qu\u00e1 m\u1eabn ch\u1eadm<\/li>\n<\/ul>\n\n\n\n
\u0110i\u1ec1u n\u00e0y \u0111\u1eb7c bi\u1ec7t quan tr\u1ecdng \u0111\u1ed1i v\u1edbi c\u00e1c thi\u1ebft b\u1ecb nh\u01b0:<\/p>\n\n\n\n
\n
- T\u1ea5t n\u00e9n<\/li>\n\n\n\n
- Gi\u00e0y ph\u1ee5c h\u1ed3i ch\u1ee9c n\u0103ng b\u01a1m h\u01a1i<\/li>\n\n\n\n
- H\u1ec7 th\u1ed1ng n\u1ec7m<\/li>\n\n\n\n
- V\u00f2ng b\u00edt huy\u1ebft \u00e1p d\u00f9ng nhi\u1ec1u l\u1ea7n<\/li>\n<\/ul>\n\n\n\n
Do c\u00e1c s\u1ea3n ph\u1ea9m n\u00e0y ti\u1ebfp x\u00fac v\u1edbi da trong th\u1eddi gian d\u00e0i, n\u00ean ngay c\u1ea3 khi m\u1ee9c \u0111\u1ed9 di chuy\u1ec3n h\u00f3a ch\u1ea5t \u1edf m\u1ee9c th\u1ea5p c\u0169ng c\u00f3 th\u1ec3 tr\u1edf n\u00ean \u0111\u00e1ng lo ng\u1ea1i v\u1ec1 m\u1eb7t y t\u1ebf theo th\u1eddi gian.<\/p>\n\n\n\n
\u0110\u1eb7c t\u00ednh h\u00f3a h\u1ecdc v\u00e0 c\u00e1c ch\u1ea5t r\u00f2 r\u1ec9 \u2014 ISO 10993-18 v\u00e0 10993-19<\/h3>\n\n\n\n
C\u00e1c quy \u0111\u1ecbnh y t\u1ebf hi\u1ec7n \u0111\u1ea1i ng\u00e0y c\u00e0ng nh\u1ea5n m\u1ea1nh vi\u1ec7c x\u00e1c \u0111\u1ecbnh th\u00e0nh ph\u1ea7n h\u00f3a h\u1ecdc l\u00e0 n\u1ec1n t\u1ea3ng c\u1ee7a vi\u1ec7c \u0111\u00e1nh gi\u00e1 r\u1ee7i ro sinh h\u1ecdc.<\/p>\n\n\n\n
Quy tr\u00ecnh n\u00e0y nh\u1eb1m x\u00e1c \u0111\u1ecbnh v\u00e0 \u0111\u1ecbnh l\u01b0\u1ee3ng c\u00e1c ch\u1ea5t c\u00f3 th\u1ec3 di chuy\u1ec3n ra kh\u1ecfi h\u1ec7 th\u1ed1ng TPU trong \u0111i\u1ec1u ki\u1ec7n s\u1eed d\u1ee5ng th\u1ef1c t\u1ebf.<\/p>\n\n\n\n
C\u00e1c ch\u1ea5t c\u00f3 th\u1ec3 chi\u1ebft xu\u1ea5t \u0111\u01b0\u1ee3c bao g\u1ed3m:<\/p>\n\n\n\n
\n
- Diisocyanat d\u01b0<\/li>\n\n\n\n
- C\u00e1c \u0111o\u1ea1n polyol<\/li>\n\n\n\n
- Ch\u1ea5t x\u00fac t\u00e1c<\/li>\n\n\n\n
- Ch\u1ea5t ch\u1ed1ng oxy h\u00f3a<\/li>\n\n\n\n
- Ch\u1ea5t t\u1ea1o m\u00e0u<\/li>\n\n\n\n
- D\u1ea7u b\u00f4i tr\u01a1n trong qu\u00e1 tr\u00ecnh gia c\u00f4ng<\/li>\n\n\n\n
- D\u01b0 l\u01b0\u1ee3ng ch\u1ea5t k\u1ebft d\u00ednh<\/li>\n\n\n\n
- C\u00e1c s\u1ea3n ph\u1ea9m ph\u00e2n h\u1ee7y nhi\u1ec7t<\/li>\n<\/ul>\n\n\n\n
C\u00e1c \u0111i\u1ec1u ki\u1ec7n th\u1eed nghi\u1ec7m c\u00f3 th\u1ec3 m\u00f4 ph\u1ecfng:<\/p>\n\n\n\n
\n
- Nhi\u1ec7t \u0111\u1ed9 t\u0103ng cao<\/li>\n\n\n\n
- Th\u1eddi gian ti\u1ebfp x\u00fac k\u00e9o d\u00e0i<\/li>\n\n\n\n
- Ti\u1ebfp x\u00fac v\u1edbi \u0111\u1ed9 \u1ea9m<\/li>\n\n\n\n
- \u00c1p l\u1ef1c c\u01a1 h\u1ecdc<\/li>\n\n\n\n
- M\u00f4i tr\u01b0\u1eddng t\u01b0\u01a1ng t\u00e1c h\u00f3a h\u1ecdc<\/li>\n<\/ul>\n\n\n\n
Sau khi x\u00e1c \u0111\u1ecbnh, vi\u1ec7c \u0111\u00e1nh gi\u00e1 r\u1ee7i ro \u0111\u1ed9c h\u1ecdc s\u1ebd x\u00e1c \u0111\u1ecbnh xem c\u00e1c ch\u1ea5t \u0111\u01b0\u1ee3c ph\u00e1t hi\u1ec7n c\u00f3 v\u01b0\u1ee3t qu\u00e1 ng\u01b0\u1ee1ng ph\u01a1i nhi\u1ec5m cho ph\u00e9p hay kh\u00f4ng.<\/p>\n\n\n\n
Theo Quy \u0111\u1ecbnh v\u1ec1 Thi\u1ebft b\u1ecb Y t\u1ebf c\u1ee7a Li\u00ean minh Ch\u00e2u \u00c2u (EU MDR), vi\u1ec7c \u0111\u00e1nh gi\u00e1 to\u00e0n di\u1ec7n c\u00e1c ch\u1ea5t h\u00f2a tan \u0111ang tr\u1edf n\u00ean ng\u00e0y c\u00e0ng quan tr\u1ecdng \u0111\u1ed1i v\u1edbi c\u00e1c h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd.<\/p>\n\n\n\n
TPU c\u00f4ng nghi\u1ec7p so v\u1edbi TPU y t\u1ebf: S\u1ef1 kh\u00e1c bi\u1ec7t th\u1ef1c s\u1ef1<\/h2>\n\n\n\n
S\u1ef1 kh\u00e1c bi\u1ec7t gi\u1eefa TPU c\u00f4ng nghi\u1ec7p v\u00e0 TPU y t\u1ebf kh\u00f4ng ch\u1ec9 \u0111\u01a1n thu\u1ea7n n\u1eb1m \u1edf th\u01b0\u01a1ng hi\u1ec7u. N\u00f3 b\u1eaft ngu\u1ed3n t\u1eeb h\u00f3a h\u1ecdc, quy tr\u00ecnh s\u1ea3n xu\u1ea5t, h\u1ed3 s\u01a1 t\u00e0i li\u1ec7u v\u00e0 s\u1ef1 tu\u00e2n th\u1ee7 c\u00e1c quy \u0111\u1ecbnh ph\u00e1p l\u00fd.<\/p>\n\n\n\n
Kh\u00eda c\u1ea1nh<\/th> TPU c\u00f4ng nghi\u1ec7p \/ TPU th\u00f4ng d\u1ee5ng<\/th> TPU d\u00f9ng trong y t\u1ebf<\/th><\/tr><\/thead> Nguy\u00ean li\u1ec7u th\u00f4<\/td> D\u1ef1a tr\u00ean chi ph\u00ed, c\u00f3 th\u1ec3 bao g\u1ed3m nguy\u00ean li\u1ec7u th\u00f4 c\u1ea5p c\u00f4ng nghi\u1ec7p<\/td> Nguy\u00ean li\u1ec7u th\u00f4 c\u00f3 \u0111\u1ed9 tinh khi\u1ebft cao v\u00e0 \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t ch\u1eb7t ch\u1ebd<\/td><\/tr> Ph\u1ee5 gia<\/td> C\u00f3 th\u1ec3 ch\u1ee9a c\u00e1c ch\u1ea5t \u1ed5n \u0111\u1ecbnh ho\u1eb7c ch\u1ea5t l\u00e0m d\u1ebbo ch\u01b0a \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1<\/td> C\u00e1c h\u1ec7 th\u1ed1ng ph\u1ee5 gia \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 v\u1ec1 m\u1eb7t sinh h\u1ecdc<\/td><\/tr> M\u00f4i tr\u01b0\u1eddng s\u1ea3n xu\u1ea5t<\/td> C\u00e1c d\u00e2y chuy\u1ec1n s\u1ea3n xu\u1ea5t t\u1ed5ng h\u1ee3p<\/td> H\u1ec7 th\u1ed1ng s\u1ea3n xu\u1ea5t c\u00f3 ki\u1ec3m so\u00e1t<\/td><\/tr> \u0110\u1ed9 nh\u1ea5t qu\u00e1n c\u1ee7a l\u00f4<\/td> Bi\u1ebfn<\/td> \u0110\u01b0\u1ee3c ki\u1ec3m so\u00e1t ch\u1eb7t ch\u1ebd v\u00e0 c\u00f3 th\u1ec3 truy xu\u1ea5t ngu\u1ed3n g\u1ed1c<\/td><\/tr> T\u00e0i li\u1ec7u ph\u00e1p l\u00fd<\/td> T\u1ed1i gi\u1ea3n<\/td> H\u1ed7 tr\u1ee3 \u0111\u1ea7y \u0111\u1ee7 v\u1ec1 h\u1ed3 s\u01a1 k\u1ef9 thu\u1eadt<\/td><\/tr> Th\u1eed nghi\u1ec7m sinh h\u1ecdc<\/td> Th\u01b0\u1eddng kh\u00f4ng c\u00f3 s\u1eb5n<\/td> Cung c\u1ea5p d\u1ecbch v\u1ee5 th\u1eed nghi\u1ec7m theo ti\u00eau chu\u1ea9n ISO 10993<\/td><\/tr> \u0110\u1eb7c tr\u01b0ng h\u00f3a c\u00e1c ch\u1ea5t h\u00f2a tan<\/td> Hi\u1ebfm<\/td> Ng\u00e0y c\u00e0ng tr\u1edf n\u00ean ph\u1ed5 bi\u1ebfn<\/td><\/tr> H\u1ed7 tr\u1ee3 v\u1ec1 m\u1eb7t ph\u00e1p l\u00fd<\/td> S\u1ed1 l\u01b0\u1ee3ng c\u00f3 h\u1ea1n<\/td> H\u1ed7 tr\u1ee3 vi\u1ec7c n\u1ed9p h\u1ed3 s\u01a1 theo quy \u0111\u1ecbnh c\u1ee7a FDA v\u00e0 MDR<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n T\u1ea1i sao ti\u00eau chu\u1ea9n ISO 13485 l\u1ea1i quan tr\u1ecdng \u0111\u1ed1i v\u1edbi c\u00e1c nh\u00e0 cung c\u1ea5p TPU<\/h2>\n\n\n\n
M\u1ee9c \u0111\u1ed9 an to\u00e0n c\u1ee7a m\u1ed9t lo\u1ea1i v\u1eadt li\u1ec7u ch\u1ec9 \u0111\u00e1ng tin c\u1eady \u0111\u1ebfn m\u1ee9c \u0111\u1ed9 m\u00e0 h\u1ec7 th\u1ed1ng s\u1ea3n xu\u1ea5t \u0111\u1eb1ng sau n\u00f3 \u0111\u1ea3m b\u1ea3o.<\/p>\n\n\n\n
\u0110\u00f3 l\u00e0 l\u00fd do t\u1ea1i sao c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t thi\u1ebft b\u1ecb y t\u1ebf uy t\u00edn lu\u00f4n \u01b0u ti\u00ean h\u1ee3p t\u00e1c v\u1edbi c\u00e1c nh\u00e0 cung c\u1ea5p tu\u00e2n th\u1ee7 h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng ISO 13485.<\/p>\n\n\n\n
Ch\u1ee9ng nh\u1eadn ISO 13485 gi\u00fap \u0111\u1ea3m b\u1ea3o:<\/p>\n\n\n\n
\n
- T\u00ednh nh\u1ea5t qu\u00e1n c\u1ee7a quy tr\u00ecnh<\/li>\n\n\n\n
- Qu\u1ea3n l\u00fd ki\u1ec3m so\u00e1t thay \u0111\u1ed5i<\/li>\n\n\n\n
- Kh\u1ea3 n\u0103ng truy xu\u1ea5t ngu\u1ed3n g\u1ed1c v\u1eadt li\u1ec7u<\/li>\n\n\n\n
- T\u00e0i li\u1ec7u \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t<\/li>\n\n\n\n
- Gi\u1ea3m nguy c\u01a1 \u00f4 nhi\u1ec5m<\/li>\n\n\n\n
- Kh\u1ea3 n\u0103ng t\u00e1i hi\u1ec7n c\u1ee7a l\u00f4<\/li>\n<\/ul>\n\n\n\n
\u0110\u1ed1i v\u1edbi c\u00e1c lo\u1ea1i v\u1ea3i y t\u1ebf b\u01a1m h\u01a1i, t\u00ednh nh\u1ea5t qu\u00e1n trong s\u1ea3n xu\u1ea5t l\u00e0 y\u1ebfu t\u1ed1 \u0111\u1eb7c bi\u1ec7t quan tr\u1ecdng b\u1edfi v\u00ec ngay c\u1ea3 nh\u1eefng thay \u0111\u1ed5i nh\u1ecf trong c\u00f4ng th\u1ee9c c\u0169ng c\u00f3 th\u1ec3 l\u00e0m thay \u0111\u1ed5i hi\u1ec7u su\u1ea5t sinh h\u1ecdc.<\/p>\n\n\n\n
T\u1ea7m quan tr\u1ecdng ng\u00e0y c\u00e0ng t\u0103ng c\u1ee7a c\u00e1c ch\u1ea5t chi\u1ebft xu\u1ea5t v\u00e0 c\u00e1c ch\u1ea5t h\u00f2a tan (E&L)<\/h2>\n\n\n\n
Tr\u01b0\u1edbc \u0111\u00e2y, nhi\u1ec1u nh\u00e0 s\u1ea3n xu\u1ea5t ch\u1ee7 y\u1ebfu d\u1ef1a v\u00e0o c\u00e1c th\u1eed nghi\u1ec7m sinh h\u1ecdc theo ti\u00eau ch\u00ed \u201c\u0111\u1ea1t\/kh\u00f4ng \u0111\u1ea1t\u201d. C\u00e1c y\u00eau c\u1ea7u c\u1ee7a c\u01a1 quan qu\u1ea3n l\u00fd \u0111\u00e3 c\u00f3 nh\u1eefng thay \u0111\u1ed5i \u0111\u00e1ng k\u1ec3.<\/p>\n\n\n\n
Ng\u00e0y nay, c\u00e1c c\u01a1 quan ch\u1ee9c n\u0103ng ng\u00e0y c\u00e0ng mong mu\u1ed1n c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t hi\u1ec3u r\u00f5:<\/p>\n\n\n\n
\n
- C\u00f3 nh\u1eefng h\u00f3a ch\u1ea5t n\u00e0o<\/li>\n\n\n\n
- Nh\u1eefng ch\u1ea5t n\u00e0o c\u00f3 th\u1ec3 di chuy\u1ec3n<\/li>\n\n\n\n
- Trong nh\u1eefng \u0111i\u1ec1u ki\u1ec7n n\u00e0o th\u00ec hi\u1ec7n t\u01b0\u1ee3ng di c\u01b0 x\u1ea3y ra<\/li>\n\n\n\n
- M\u1ed7i ch\u1ea5t g\u00e2y ra nh\u1eefng r\u1ee7i ro \u0111\u1ed9c h\u1ecdc n\u00e0o<\/li>\n<\/ul>\n\n\n\n
S\u1ef1 thay \u0111\u1ed5i n\u00e0y \u0111\u1eb7c bi\u1ec7t r\u00f5 r\u1ec7t trong khu\u00f4n kh\u1ed5 Quy \u0111\u1ecbnh v\u1ec1 Thi\u1ebft b\u1ecb Y t\u1ebf (MDR) c\u1ee7a Li\u00ean minh Ch\u00e2u \u00c2u.<\/p>\n\n\n\n
\u0110\u1ed1i v\u1edbi c\u00e1c h\u1ec7 th\u1ed1ng b\u01a1m h\u01a1i b\u1eb1ng TPU, c\u00e1c nghi\u00ean c\u1ee9u E&L \u0111ang tr\u1edf n\u00ean thi\u1ebft y\u1ebfu b\u1edfi v\u00ec c\u00e1c lo\u1ea1i polymer d\u1ebbo v\u1ed1n ch\u1ee9a nhi\u1ec1u h\u1ee3p ch\u1ea5t h\u00f3a h\u1ecdc c\u00f3 t\u00ednh di \u0111\u1ed9ng cao h\u01a1n so v\u1edbi c\u00e1c v\u1eadt li\u1ec7u c\u1ee9ng.<\/p>\n\n\n\n
M\u1ed9t b\u00e1o c\u00e1o E&L to\u00e0n di\u1ec7n th\u01b0\u1eddng tr\u1edf th\u00e0nh m\u1ed9t trong nh\u1eefng ch\u1ec9 s\u1ed1 \u0111\u00e1ng tin c\u1eady nh\u1ea5t cho th\u1ea5y n\u1ec1n t\u1ea3ng v\u1eadt li\u1ec7u y t\u1ebf \u0111\u00e3 \u0111\u1ea1t \u0111\u1ebfn \u0111\u1ed9 ch\u00edn mu\u1ed3i.<\/p>\n\n\n\n
Nh\u1eefng d\u1ea5u hi\u1ec7u c\u1ea3nh b\u00e1o th\u01b0\u1eddng g\u1eb7p khi \u0111\u00e1nh gi\u00e1 nh\u00e0 cung c\u1ea5p v\u1eadt li\u1ec7u y t\u1ebf TPU<\/h2>\n\n\n\n
C\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t thi\u1ebft b\u1ecb y t\u1ebf n\u00ean ti\u1ebfp c\u1eadn vi\u1ec7c t\u00ecm ngu\u1ed3n cung \u1ee9ng TPU v\u1edbi s\u1ef1 c\u1ea9n tr\u1ecdng t\u01b0\u01a1ng t\u1ef1 nh\u01b0 khi \u0111\u1ed1i v\u1edbi c\u00e1c linh ki\u1ec7n \u0111i\u1ec7n t\u1eed ho\u1eb7c d\u01b0\u1ee3c ph\u1ea9m quan tr\u1ecdng.<\/p>\n\n\n\n
C\u00e1c d\u1ea5u hi\u1ec7u c\u1ea3nh b\u00e1o bao g\u1ed3m<\/h3>\n\n\n\n
C\u00e1c tuy\u00ean b\u1ed1 chung chung v\u1ec1 \u201cti\u00eau chu\u1ea9n y t\u1ebf\u201d m\u00e0 kh\u00f4ng c\u00f3 b\u00e1o c\u00e1o ch\u1ee9ng minh<\/h4>\n\n\n\n
Nh\u00e0 cung c\u1ea5p n\u00ean cung c\u1ea5p c\u00e1c b\u00e1o c\u00e1o th\u1eed nghi\u1ec7m th\u1ef1c t\u1ebf, ch\u1ee9 kh\u00f4ng ch\u1ec9 l\u00e0 nh\u1eefng tuy\u00ean b\u1ed1 qu\u1ea3ng c\u00e1o.<\/p>\n\n\n\n
Thi\u1ebfu ph\u1ea7n \u0111\u1eb7c tr\u01b0ng h\u00f3a h\u1ecdc theo ti\u00eau chu\u1ea9n ISO 10993-18<\/h4>\n\n\n\n
M\u1ed9t ph\u1ea3n h\u1ed3i m\u01a1 h\u1ed3 v\u1ec1 vi\u1ec7c \u0111\u00e1nh gi\u00e1 c\u00e1c ch\u1ea5t chi\u1ebft xu\u1ea5t v\u00e0 c\u00e1c ch\u1ea5t r\u00f2 r\u1ec9 l\u00e0 m\u1ed9t v\u1ea5n \u0111\u1ec1 \u0111\u00e1ng lo ng\u1ea1i trong b\u1ed1i c\u1ea3nh c\u00e1c y\u00eau c\u1ea7u quy \u0111\u1ecbnh hi\u1ec7n \u0111\u1ea1i.<\/p>\n\n\n\n
Ch\u01b0a c\u00f3 ch\u1ee9ng nh\u1eadn ISO 13485<\/h4>\n\n\n\n
N\u1ebfu kh\u00f4ng c\u00f3 h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng y t\u1ebf \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t, r\u1ee7i ro v\u1ec1 t\u00ednh nh\u1ea5t qu\u00e1n s\u1ebd gia t\u0103ng \u0111\u00e1ng k\u1ec3.<\/p>\n\n\n\n
Kh\u00f4ng c\u00f3 quy tr\u00ecnh ki\u1ec3m so\u00e1t thay \u0111\u1ed5i<\/h4>\n\n\n\n
Vi\u1ec7c thay \u0111\u1ed5i c\u00f4ng th\u1ee9c nguy\u00ean li\u1ec7u m\u00e0 kh\u00f4ng th\u00f4ng b\u00e1o cho kh\u00e1ch h\u00e0ng c\u00f3 th\u1ec3 l\u00e0m m\u1ea5t hi\u1ec7u l\u1ef1c c\u00e1c gi\u1ea5y ph\u00e9p qu\u1ea3n l\u00fd \u0111\u1ed1i v\u1edbi thi\u1ebft b\u1ecb.<\/p>\n\n\n\n
C\u00e1c ph\u01b0\u01a1ng ph\u00e1p x\u00e9t nghi\u1ec7m sinh h\u1ecdc \u0111\u00e3 l\u1ed7i th\u1eddi<\/h4>\n\n\n\n
C\u00e1c b\u00e0i ki\u1ec3m tra ph\u1ea3i lu\u00f4n \u0111\u01b0\u1ee3c c\u1eadp nh\u1eadt v\u00e0 ph\u00f9 h\u1ee3p v\u1edbi c\u1ea5p \u0111\u1ed9 TPU c\u1ee5 th\u1ec3 c\u0169ng nh\u01b0 c\u1ea5u h\u00ecnh s\u1ea3n ph\u1ea9m cu\u1ed1i c\u00f9ng.<\/p>\n\n\n\n
Nh\u1eefng y\u00eau c\u1ea7u m\u00e0 c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t thi\u1ebft b\u1ecb y t\u1ebf n\u00ean \u0111\u01b0a ra \u0111\u1ed1i v\u1edbi c\u00e1c nh\u00e0 cung c\u1ea5p TPU<\/h2>\n\n\n\n
Khi \u0111\u00e1nh gi\u00e1 c\u00e1c lo\u1ea1i v\u1ea3i y t\u1ebf ph\u1ee7 TPU ho\u1eb7c h\u1ec7 th\u1ed1ng b\u01a1m h\u01a1i, c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t n\u00ean y\u00eau c\u1ea7u m\u1ed9t b\u1ed9 t\u00e0i li\u1ec7u k\u1ef9 thu\u1eadt \u0111\u1ea7y \u0111\u1ee7, bao g\u1ed3m:<\/p>\n\n\n\n
Danh s\u00e1ch ki\u1ec3m tra c\u00e1c t\u00e0i li\u1ec7u c\u1ea7n thi\u1ebft<\/h3>\n\n\n\n
\n
- Ch\u1ee9ng nh\u1eadn ISO 13485<\/li>\n\n\n\n
- B\u00e1o c\u00e1o \u0111\u1ea7y \u0111\u1ee7 v\u1ec1 c\u00e1c th\u1eed nghi\u1ec7m sinh h\u1ecdc theo ti\u00eau chu\u1ea9n ISO 10993<\/li>\n\n\n\n
- B\u00e1o c\u00e1o v\u1ec1 \u0111\u1ed9c t\u00ednh t\u1ebf b\u00e0o<\/li>\n\n\n\n
- C\u00e1c b\u00e1o c\u00e1o v\u1ec1 k\u00edch \u1ee9ng v\u00e0 qu\u00e1 m\u1eabn<\/li>\n\n\n\n
- C\u00e1c nghi\u00ean c\u1ee9u v\u1ec1 c\u00e1c ch\u1ea5t chi\u1ebft xu\u1ea5t v\u00e0 c\u00e1c ch\u1ea5t r\u00f2 r\u1ec9<\/li>\n\n\n\n
- B\u1ea3ng d\u1eef li\u1ec7u an to\u00e0n h\u00f3a ch\u1ea5t<\/li>\n\n\n\n
- Th\u00f4ng tin v\u1ec1 kh\u1ea3 n\u0103ng truy xu\u1ea5t ngu\u1ed3n g\u1ed1c nguy\u00ean li\u1ec7u<\/li>\n\n\n\n
- B\u00e1o c\u00e1o x\u00e1c nh\u1eadn t\u00ednh ch\u1ea5t v\u1eadt l\u00fd<\/li>\n\n\n\n
- Ch\u00ednh s\u00e1ch th\u00f4ng b\u00e1o thay \u0111\u1ed5i<\/li>\n\n\n\n
- T\u00e0i li\u1ec7u h\u1ed7 tr\u1ee3 v\u1ec1 quy \u0111\u1ecbnh<\/li>\n<\/ul>\n\n\n\n
M\u1ed9t nh\u00e0 cung c\u1ea5p c\u00f3 kinh nghi\u1ec7m c\u0169ng c\u1ea7n th\u1ec3 hi\u1ec7n s\u1ef1 am hi\u1ec3u v\u1ec1:<\/p>\n\n\n\n
\n
- C\u00e1c y\u00eau c\u1ea7u \u0111\u1ed1i v\u1edbi h\u1ed3 s\u01a1 n\u1ed9p l\u00ean FDA<\/li>\n\n\n\n
- C\u00e1c l\u1ed9 tr\u00ecnh tu\u00e2n th\u1ee7 Quy \u0111\u1ecbnh v\u1ec1 Thi\u1ebft b\u1ecb Y t\u1ebf (MDR) c\u1ee7a EU<\/li>\n\n\n\n
- T\u00edch h\u1ee3p qu\u1ea3n l\u00fd r\u1ee7i ro<\/li>\n\n\n\n
- C\u00e1c cu\u1ed9c th\u1ea3o lu\u1eadn v\u1ec1 t\u00ednh t\u01b0\u01a1ng \u0111\u01b0\u01a1ng c\u1ee7a v\u1eadt li\u1ec7u<\/li>\n\n\n\n
- S\u1ef1 \u1ed5n \u0111\u1ecbnh trong ngu\u1ed3n cung c\u1ea5p l\u00e2u d\u00e0i<\/li>\n<\/ul>\n\n\n\n
T\u1ea1i sao kh\u1ea3 n\u0103ng truy xu\u1ea5t ngu\u1ed3n g\u1ed1c nguy\u00ean v\u1eadt li\u1ec7u \u0111ang tr\u1edf th\u00e0nh m\u1ed9t l\u1ee3i th\u1ebf c\u1ea1nh tranh<\/h2>\n\n\n\n
Trong ng\u00e0nh s\u1ea3n xu\u1ea5t thi\u1ebft b\u1ecb y t\u1ebf hi\u1ec7n \u0111\u1ea1i, kh\u1ea3 n\u0103ng truy xu\u1ea5t ngu\u1ed3n g\u1ed1c kh\u00f4ng c\u00f2n l\u00e0 \u0111i\u1ec1u t\u00f9y ch\u1ecdn n\u1eefa.<\/p>\n\n\n\n
C\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t thi\u1ebft b\u1ecb ng\u00e0y c\u00e0ng c\u00f3 nhu c\u1ea7u:<\/p>\n\n\n\n
\n
- Kh\u1ea3 n\u0103ng truy xu\u1ea5t ngu\u1ed3n g\u1ed1c nguy\u00ean v\u1eadt li\u1ec7u theo l\u00f4<\/li>\n\n\n\n
- Qu\u1ea3n l\u00fd ngu\u1ed3n cung \u1ee9ng nguy\u00ean li\u1ec7u<\/li>\n\n\n\n
- \u0110\u1ed9 \u1ed5n \u0111\u1ecbnh c\u1ee7a c\u00f4ng th\u1ee9c trong th\u1eddi gian d\u00e0i<\/li>\n\n\n\n
- H\u1ec7 th\u1ed1ng th\u00f4ng b\u00e1o thay \u0111\u1ed5i nh\u00e0 cung c\u1ea5p<\/li>\n\n\n\n
- H\u1ed3 s\u01a1 s\u1ea3n xu\u1ea5t l\u1ecbch s\u1eed<\/li>\n<\/ul>\n\n\n\n
\u0110i\u1ec1u n\u00e0y \u0111\u1eb7c bi\u1ec7t quan tr\u1ecdng \u0111\u1ed1i v\u1edbi c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf b\u01a1m h\u01a1i v\u00ec c\u00e1c s\u1ef1 c\u1ed1 c\u00f3 th\u1ec3 kh\u00f4ng xu\u1ea5t hi\u1ec7n ngay l\u1eadp t\u1ee9c. Qu\u00e1 tr\u00ecnh ph\u00e2n h\u1ee7y h\u00f3a h\u1ecdc, s\u1ef1 di chuy\u1ec3n c\u1ee7a c\u00e1c ch\u1ea5t ho\u1eb7c s\u1ef1 kh\u00f4ng \u1ed5n \u0111\u1ecbnh c\u1ee7a v\u1eadt li\u1ec7u c\u00f3 th\u1ec3 ch\u1ec9 xu\u1ea5t hi\u1ec7n sau m\u1ed9t th\u1eddi gian d\u00e0i s\u1eed d\u1ee5ng trong l\u00e2m s\u00e0ng.<\/p>\n\n\n\n
C\u00e1c nh\u00e0 cung c\u1ea5p duy tr\u00ec h\u1ec7 th\u1ed1ng truy xu\u1ea5t ngu\u1ed3n g\u1ed1c hi\u1ec7u qu\u1ea3 s\u1ebd gi\u00fap gi\u1ea3m thi\u1ec3u r\u1ee7i ro ph\u00e1p l\u00fd d\u00e0i h\u1ea1n cho c\u00e1c kh\u00e1ch h\u00e0ng l\u00e0 nh\u00e0 s\u1ea3n xu\u1ea5t thi\u1ebft b\u1ecb g\u1ed1c (OEM).<\/p>\n\n\n\n
T\u00ednh t\u01b0\u01a1ng th\u00edch sinh h\u1ecdc l\u00e0 tr\u00e1ch nhi\u1ec7m chung<\/h2>\n\n\n\n
Theo c\u00e1c khung ph\u00e1p l\u00fd y t\u1ebf hi\u1ec7n h\u00e0nh, tr\u00e1ch nhi\u1ec7m v\u1ec1 an to\u00e0n sinh h\u1ecdc \u0111\u01b0\u1ee3c chia s\u1ebb gi\u1eefa:<\/p>\n\n\n\n
\n
- Nh\u00e0 cung c\u1ea5p v\u1eadt li\u1ec7u<\/li>\n\n\n\n
- C\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t linh ki\u1ec7n<\/li>\n\n\n\n
- C\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t thi\u1ebft b\u1ecb ho\u00e0n ch\u1ec9nh<\/li>\n<\/ul>\n\n\n\n
Kh\u00f4ng c\u00f3 nh\u00e0 cung c\u1ea5p TPU n\u00e0o c\u00f3 th\u1ec3 \u0111\u1ea3m b\u1ea3o ho\u00e0n to\u00e0n vi\u1ec7c ph\u00ea duy\u1ec7t \u1edf c\u1ea5p \u0111\u1ed9 thi\u1ebft b\u1ecb, b\u1edfi v\u00ec m\u1ee9c \u0111\u1ed9 an to\u00e0n cu\u1ed1i c\u00f9ng ph\u1ee5 thu\u1ed9c v\u00e0o:<\/p>\n\n\n\n
\n
- Thi\u1ebft k\u1ebf s\u1ea3n ph\u1ea9m<\/li>\n\n\n\n
- Quy tr\u00ecnh s\u1ea3n xu\u1ea5t<\/li>\n\n\n\n
- Ph\u01b0\u01a1ng ph\u00e1p ti\u1ec7t tr\u00f9ng<\/li>\n\n\n\n
- M\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng<\/li>\n\n\n\n
- \u0110i\u1ec1u ki\u1ec7n ti\u1ebfp x\u00fac l\u00e2m s\u00e0ng<\/li>\n<\/ul>\n\n\n\n
Tuy nhi\u00ean, m\u1ed9t nh\u00e0 cung c\u1ea5p TPU \u0111\u1ee7 ti\u00eau chu\u1ea9n c\u1ea7n ph\u1ea3i cung c\u1ea5p c\u01a1 s\u1edf khoa h\u1ecdc c\u1ea7n thi\u1ebft \u0111\u1ec3 c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 th\u1ec3 ho\u00e0n th\u00e0nh vi\u1ec7c \u0111\u00e1nh gi\u00e1 r\u1ee7i ro sinh h\u1ecdc m\u1ed9t c\u00e1ch hi\u1ec7u qu\u1ea3.<\/p>\n\n\n\n
T\u01b0\u01a1ng lai c\u1ee7a v\u1eadt li\u1ec7u TPU trong y t\u1ebf<\/h2>\n\n\n\n
Ng\u00e0nh c\u00f4ng nghi\u1ec7p TPU y t\u1ebf \u0111ang ph\u00e1t tri\u1ec3n nhanh ch\u00f3ng song song v\u1edbi c\u00e1c quy \u0111\u1ecbnh to\u00e0n c\u1ea7u ng\u00e0y c\u00e0ng nghi\u00eam ng\u1eb7t v\u00e0 nh\u1eefng k\u1ef3 v\u1ecdng cao h\u01a1n v\u1ec1 an to\u00e0n cho b\u1ec7nh nh\u00e2n.<\/p>\n\n\n\n
C\u00e1c xu h\u01b0\u1edbng ch\u00ednh bao g\u1ed3m:<\/p>\n\n\n\n
\n
- T\u0103ng c\u01b0\u1eddng ch\u00fa tr\u1ecdng v\u00e0o vi\u1ec7c ph\u00e2n t\u00edch th\u00e0nh ph\u1ea7n h\u00f3a h\u1ecdc<\/li>\n\n\n\n
- C\u00f4ng th\u1ee9c kh\u00f4ng ch\u1ee9a phthalate<\/li>\n\n\n\n
- H\u1ec7 th\u1ed1ng TPU c\u00f3 h\u00e0m l\u01b0\u1ee3ng ch\u1ea5t chi\u1ebft xu\u1ea5t th\u1ea5p<\/li>\n\n\n\n
- H\u00f3a h\u1ecdc v\u1ec1 c\u00e1c ch\u1ea5t ph\u1ee5 gia l\u00e0m s\u1ea1ch<\/li>\n\n\n\n
- Kh\u1ea3 n\u0103ng ch\u1ed1ng th\u1ee7y ph\u00e2n \u0111\u01b0\u1ee3c c\u1ea3i thi\u1ec7n<\/li>\n\n\n\n
- T\u0103ng c\u01b0\u1eddng \u0111\u1ed9 \u1ed5n \u0111\u1ecbnh khi l\u00e3o h\u00f3a l\u00e2u d\u00e0i<\/li>\n\n\n\n
- Ph\u00e1t tri\u1ec3n v\u1eadt li\u1ec7u polymer y t\u1ebf b\u1ec1n v\u1eefng<\/li>\n\n\n\n
- Y\u00eau c\u1ea7u v\u1ec1 h\u1ed3 s\u01a1 MDR \u0111\u01b0\u1ee3c t\u0103ng c\u01b0\u1eddng<\/li>\n<\/ul>\n\n\n\n
Khi c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf b\u01a1m h\u01a1i ng\u00e0y c\u00e0ng tr\u1edf n\u00ean tinh vi h\u01a1n, c\u00e1c ti\u00eau chu\u1ea9n v\u1ec1 ch\u1ea5t l\u01b0\u1ee3ng v\u1eadt li\u1ec7u s\u1ebd ti\u1ebfp t\u1ee5c \u0111\u01b0\u1ee3c n\u00e2ng cao.<\/p>\n\n\n\n
Trong b\u1ed1i c\u1ea3nh Quy \u0111\u1ecbnh v\u1ec1 Thi\u1ebft b\u1ecb Y t\u1ebf c\u1ee7a Li\u00ean minh Ch\u00e2u \u00c2u (EU MDR), s\u1ef1 gi\u00e1m s\u00e1t ch\u1eb7t ch\u1ebd c\u1ee7a C\u1ee5c Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 (FDA) c\u00f9ng v\u1edbi vi\u1ec7c \u0111\u00e1nh gi\u00e1 r\u1ee7i ro sinh h\u1ecdc ng\u00e0y c\u00e0ng ph\u1ee9c t\u1ea1p, t\u00ednh t\u01b0\u01a1ng th\u00edch sinh h\u1ecdc kh\u00f4ng c\u00f2n ch\u1ec9 l\u00e0 m\u1ed9t nh\u00e3n hi\u1ec7u ti\u1ebfp th\u1ecb. \u0110\u00f3 l\u00e0 m\u1ed9t tr\u00e1ch nhi\u1ec7m \u0111\u01b0\u1ee3c ghi ch\u00e9p \u0111\u1ea7y \u0111\u1ee7, d\u1ef1a tr\u00ean k\u1ebft qu\u1ea3 th\u1eed nghi\u1ec7m v\u00e0 \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t li\u00ean t\u1ee5c.<\/p>\n\n\n\n
Vi\u1ec7c l\u1ef1a ch\u1ecdn v\u1ea3i TPU ch\u1ec9 v\u00ec n\u00f3 \u0111\u01b0\u1ee3c qu\u1ea3ng c\u00e1o l\u00e0 \u201clo\u1ea1i d\u00f9ng trong y t\u1ebf\u201d \u0111\u00e3 kh\u00f4ng c\u00f2n l\u00e0 \u0111\u1ee7. C\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t ph\u1ea3i \u0111\u00e1nh gi\u00e1 to\u00e0n b\u1ed9 h\u1ec7 th\u1ed1ng v\u1eadt li\u1ec7u, bao g\u1ed3m ki\u1ec3m so\u00e1t c\u00f4ng th\u1ee9c, h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n xu\u1ea5t, \u0111\u1eb7c t\u00ednh c\u00e1c ch\u1ea5t chi\u1ebft xu\u1ea5t, h\u1ed3 s\u01a1 tu\u00e2n th\u1ee7 quy \u0111\u1ecbnh v\u00e0 t\u00ednh \u1ed5n \u0111\u1ecbnh l\u00e2u d\u00e0i.<\/p>\n\n\n\n
TPU y t\u1ebf \u0111\u00edch th\u1ef1c kh\u00f4ng ch\u1ec9 \u0111\u01a1n thu\u1ea7n l\u00e0 m\u1ed9t lo\u1ea1i polymer. \u0110\u00e2y l\u00e0 m\u1ed9t n\u1ec1n t\u1ea3ng t\u01b0\u01a1ng th\u00edch sinh h\u1ecdc \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf chuy\u00ean bi\u1ec7t nh\u1eb1m \u0111\u1ea3m b\u1ea3o an to\u00e0n cho b\u1ec7nh nh\u00e2n, tu\u00e2n th\u1ee7 c\u00e1c quy \u0111\u1ecbnh v\u00e0 mang l\u1ea1i hi\u1ec7u qu\u1ea3 l\u00e2m s\u00e0ng.<\/p>\n\n\n\n
\u0110\u1ed1i v\u1edbi c\u00e1c s\u1ea3n ph\u1ea9m y t\u1ebf b\u01a1m h\u01a1i m\u00e0 b\u1ec7nh nh\u00e2n tin d\u00f9ng trong qu\u00e1 tr\u00ecnh \u0111i\u1ec1u tr\u1ecb, ph\u1ee5c h\u1ed3i ch\u1ee9c n\u0103ng, theo d\u00f5i v\u00e0 h\u1ed3i ph\u1ee5c, m\u1ee9c \u0111\u1ed9 \u0111\u1ea3m b\u1ea3o \u0111\u00f3 kh\u00f4ng ph\u1ea3i l\u00e0 \u0111i\u1ec1u c\u00f3 th\u1ec3 t\u00f9y ch\u1ecdn. \u0110\u00f3 l\u00e0 ti\u00eau chu\u1ea9n b\u1eaft bu\u1ed9c.<\/p>\n\n\n\n
<\/p>","protected":false},"excerpt":{"rendered":"
The Dangerous Misunderstanding Behind \u201cMedical-Grade\u201d TPU In the medical device industry, the phrase \u201cmedical-grade TPU\u201d is frequently used as a broad marketing term. In reality, the gap between a general-purpose…<\/p>","protected":false},"author":1,"featured_media":58762,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[227],"tags":[],"class_list":["post-59619","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-quality-compliance"],"acf":[],"_links":{"self":[{"href":"https:\/\/tpumedical.com\/vi\/wp-json\/wp\/v2\/posts\/59619","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/tpumedical.com\/vi\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/tpumedical.com\/vi\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/tpumedical.com\/vi\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/tpumedical.com\/vi\/wp-json\/wp\/v2\/comments?post=59619"}],"version-history":[{"count":2,"href":"https:\/\/tpumedical.com\/vi\/wp-json\/wp\/v2\/posts\/59619\/revisions"}],"predecessor-version":[{"id":59622,"href":"https:\/\/tpumedical.com\/vi\/wp-json\/wp\/v2\/posts\/59619\/revisions\/59622"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/tpumedical.com\/vi\/wp-json\/wp\/v2\/media\/58762"}],"wp:attachment":[{"href":"https:\/\/tpumedical.com\/vi\/wp-json\/wp\/v2\/media?parent=59619"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/tpumedical.com\/vi\/wp-json\/wp\/v2\/categories?post=59619"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/tpumedical.com\/vi\/wp-json\/wp\/v2\/tags?post=59619"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
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