{"id":85902,"date":"2025-07-08T14:53:22","date_gmt":"2025-07-08T07:53:22","guid":{"rendered":"https:\/\/tcvn.gov.vn\/?p=85902"},"modified":"2026-05-14T11:00:40","modified_gmt":"2026-05-14T04:00:40","slug":"iso-14971-chuan-hoa-quan-ly-rui-ro-cho-thiet-bi-y-te-hien-dai","status":"publish","type":"post","link":"https:\/\/tcvn.gov.vn\/iso-14971-chuan-hoa-quan-ly-rui-ro-cho-thiet-bi-y-te-hien-dai\/08\/07\/2025\/","title":{"rendered":"ISO 14971 – Chu\u1ea9n h\u00f3a qu\u1ea3n l\u00fd r\u1ee7i ro cho thi\u1ebft b\u1ecb y t\u1ebf hi\u1ec7n \u0111\u1ea1i"},"content":{"rendered":"

Ti\u00eau chu\u1ea9n ISO 14971 l\u00e0 ch\u1ee9ng nh\u1eadn cho khung qu\u1ea3n l\u00fd r\u1ee7i ro d\u00e0nh cho thi\u1ebft b\u1ecb y t\u1ebf, \u0111\u00f3ng vai tr\u00f2 quan tr\u1ecdng trong vi\u1ec7c \u0111\u1ea3m b\u1ea3o an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 c\u1ee7a c\u00e1c s\u1ea3n ph\u1ea9m y t\u1ebf hi\u1ec7n \u0111\u1ea1i. <\/em><\/strong><\/p>\n

ISO 14971 l\u00e0 ti\u00eau chu\u1ea9n qu\u1ed1c t\u1ebf v\u1ec1 \u1ee9ng d\u1ee5ng qu\u1ea3n l\u00fd r\u1ee7i ro cho c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf. Ti\u00eau chu\u1ea9n n\u00e0y ph\u00e1c th\u1ea3o m\u1ed9t ph\u01b0\u01a1ng ph\u00e1p ti\u1ebfp c\u1eadn c\u00f3 h\u1ec7 th\u1ed1ng \u0111\u1ec3 c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t \u0111\u00e1nh gi\u00e1 c\u00e1c r\u1ee7i ro li\u00ean quan \u0111\u1ebfn thi\u1ebft b\u1ecb y t\u1ebf, t\u1eeb thi\u1ebft k\u1ebf v\u00e0 ph\u00e1t tri\u1ec3n \u0111\u1ebfn s\u1ea3n xu\u1ea5t v\u00e0 gi\u00e1m s\u00e1t sau khi \u0111\u01b0a ra th\u1ecb tr\u01b0\u1eddng. B\u1ea3n ti\u00eau chu\u1ea9n n\u00e0y nh\u1ea5n m\u1ea1nh ph\u01b0\u01a1ng ph\u00e1p ti\u1ebfp c\u1eadn ch\u1ee7 \u0111\u1ed9ng v\u00e0 to\u00e0n di\u1ec7n \u0111\u1ec3 qu\u1ea3n l\u00fd c\u00e1c m\u1ed1i nguy ti\u1ec1m \u1ea9n v\u00e0 \u0111\u1ea3m b\u1ea3o an to\u00e0n cho b\u1ec7nh nh\u00e2n. \u0110i\u1ec1u n\u00e0y l\u00e0m cho ti\u00eau chu\u1ea9n n\u00e0y tr\u1edf th\u00e0nh n\u1ec1n t\u1ea3ng c\u1ee7a vi\u1ec7c tu\u00e2n th\u1ee7 quy \u0111\u1ecbnh v\u1ec1 thi\u1ebft b\u1ecb y t\u1ebf tr\u00ean to\u00e0n c\u1ea7u.<\/p>\n

Theo \u0111\u00f3, ISO 14971 h\u01b0\u1edbng d\u1eabn c\u00e1ch th\u1ee9c x\u00e1c \u0111\u1ecbnh, \u0111\u00e1nh gi\u00e1, ki\u1ec3m so\u00e1t v\u00e0 gi\u00e1m s\u00e1t c\u00e1c r\u1ee7i ro c\u00f3 th\u1ec3 ph\u00e1t sinh trong su\u1ed1t v\u00f2ng \u0111\u1eddi c\u1ee7a thi\u1ebft b\u1ecb y t\u1ebf \u2013 t\u1eeb thi\u1ebft k\u1ebf, s\u1ea3n xu\u1ea5t \u0111\u1ebfn s\u1eed d\u1ee5ng th\u1ef1c t\u1ebf. Ti\u00eau chu\u1ea9n kh\u00f4ng ch\u1ec9 t\u1eadp trung v\u00e0o r\u1ee7i ro \u0111\u1ed1i v\u1edbi b\u1ec7nh nh\u00e2n, m\u00e0 c\u00f2n m\u1edf r\u1ed9ng sang c\u1ea3 ng\u01b0\u1eddi s\u1eed d\u1ee5ng, ng\u01b0\u1eddi b\u1ea3o tr\u00ec v\u00e0 m\u00f4i tr\u01b0\u1eddng.<\/p>\n

\"\"<\/p>\n

ISO 14971: H\u01b0\u1edbng d\u1eabn to\u00e0n di\u1ec7n v\u1ec1 qu\u1ea3n l\u00fd r\u1ee7i ro trong thi\u1ebft b\u1ecb y t\u1ebf<\/strong><\/p>\n

Phi\u00ean b\u1ea3n m\u1edbi nh\u1ea5t hi\u1ec7n n\u00e0y l\u00e0 phi\u00ean b\u1ea3n n\u0103m 2019, \u0111i\u1ec3m n\u1ed5i b\u1eadt l\u00e0 nh\u1ea5n m\u1ea1nh vai tr\u00f2 c\u1ee7a \u0111\u00e1nh gi\u00e1 l\u1ee3i \u00edch \u2013 nguy c\u01a1 (benefit-risk analysis) v\u00e0 y\u00eau c\u1ea7u qu\u1ea3n l\u00fd h\u1eadu ki\u1ec3m sau khi s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c \u0111\u01b0a ra th\u1ecb tr\u01b0\u1eddng. Ngo\u00e0i ra, ti\u00eau chu\u1ea9n c\u0169ng khuy\u1ebfn kh\u00edch doanh nghi\u1ec7p duy tr\u00ec m\u1ed9t h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd r\u1ee7i ro t\u00edch h\u1ee3p v\u1edbi c\u00e1c quy tr\u00ecnh ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 tu\u00e2n th\u1ee7 ph\u00e1p l\u00fd nh\u01b0 ISO 13485 ho\u1eb7c quy \u0111\u1ecbnh MDR\/IVDR c\u1ee7a ch\u00e2u \u00c2u, FDA Hoa K\u1ef3.<\/p>\n

S\u1ef1 ph\u00f9 h\u1ee3p v\u1edbi ISO 14971 kh\u00f4ng ch\u1ec9 gi\u00fap doanh nghi\u1ec7p gi\u1ea3m thi\u1ec3u l\u1ed7i, tai bi\u1ebfn y khoa m\u00e0 c\u00f2n n\u00e2ng cao uy t\u00edn, th\u00fac \u0111\u1ea9y ph\u00ea duy\u1ec7t s\u1ea3n ph\u1ea9m t\u1ea1i nhi\u1ec1u th\u1ecb tr\u01b0\u1eddng v\u00e0 t\u0103ng kh\u1ea3 n\u0103ng c\u1ea1nh tranh to\u00e0n c\u1ea7u.<\/p>\n

Trong b\u1ed1i c\u1ea3nh c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf ng\u00e0y c\u00e0ng th\u00f4ng minh, k\u1ebft n\u1ed1i v\u00e0 t\u1ef1 \u0111\u1ed9ng h\u00f3a, ISO 14971 \u0111\u00f3ng vai tr\u00f2 nh\u01b0 m\u1ed9t \u201cla b\u00e0n\u201d gi\u00fap doanh nghi\u1ec7p \u0111\u1ecbnh h\u01b0\u1edbng ph\u00e1t tri\u1ec3n s\u1ea3n ph\u1ea9m an to\u00e0n, hi\u1ec7u qu\u1ea3 v\u00e0 tu\u00e2n th\u1ee7 ph\u00e1p l\u00fd nghi\u00eam ng\u1eb7t h\u01a1n bao gi\u1edd h\u1ebft.<\/p>\n

Qu\u1ea3n l\u00fd r\u1ee7i ro \u0111\u00e3 tr\u1edf th\u00e0nh tr\u1ecdng t\u00e2m quan tr\u1ecdng \u0111\u1ed1i v\u1edbi h\u1ea7u nh\u01b0 t\u1ea5t c\u1ea3 c\u00e1c c\u01a1 quan qu\u1ea3n l\u00fd to\u00e0n c\u1ea7u gi\u00e1m s\u00e1t thi\u1ebft b\u1ecb y t\u1ebf. C\u00e1c c\u01a1 quan nh\u01b0 FDA Hoa K\u1ef3, B\u1ed9 Y t\u1ebf Canada, C\u01a1 quan c\u00f3 th\u1ea9m quy\u1ec1n c\u1ee7a Li\u00ean minh Ch\u00e2u \u00c2u, C\u01a1 quan Qu\u1ea3n l\u00fd H\u00e0ng h\u00f3a Tr\u1ecb li\u1ec7u c\u1ee7a \u00dac (TGA) v\u00e0 B\u1ed9 Y t\u1ebf, Lao \u0111\u1ed9ng v\u00e0 Ph\u00fac l\u1ee3i Nh\u1eadt B\u1ea3n (MHLW) \u0111\u1ec1u y\u00eau c\u1ea7u c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t th\u1ef1c hi\u1ec7n quy tr\u00ecnh qu\u1ea3n l\u00fd r\u1ee7i ro to\u00e0n di\u1ec7n v\u00e0 l\u01b0u gi\u1eef t\u00e0i li\u1ec7u chi ti\u1ebft v\u1ec1 c\u00e1c ho\u1ea1t \u0111\u1ed9ng qu\u1ea3n l\u00fd r\u1ee7i ro c\u1ee7a h\u1ecd. Vi\u1ec7c tu\u00e2n th\u1ee7 c\u00e1c ti\u00eau chu\u1ea9n qu\u1ea3n l\u00fd r\u1ee7i ro ISO 14971 kh\u00f4ng ch\u1ec9 gi\u00fap c\u00e1c c\u00f4ng ty ph\u00f9 h\u1ee3p v\u1edbi k\u1ef3 v\u1ecdng c\u1ee7a c\u01a1 quan qu\u1ea3n l\u00fd m\u00e0 c\u00f2n mang l\u1ea1i cho h\u1ecd l\u1ee3i th\u1ebf c\u1ea1nh tranh tr\u00ean th\u1ecb tr\u01b0\u1eddng.<\/p>\n

Ti\u1ebfn \u0110\u00f4ng<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"

Ti\u00eau chu\u1ea9n ISO 14971 l\u00e0 ch\u1ee9ng nh\u1eadn cho khung qu\u1ea3n l\u00fd r\u1ee7i ro d\u00e0nh cho thi\u1ebft b\u1ecb y t\u1ebf, \u0111\u00f3ng vai tr\u00f2 quan tr\u1ecdng trong vi\u1ec7c \u0111\u1ea3m b\u1ea3o an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 c\u1ee7a c\u00e1c s\u1ea3n ph\u1ea9m y t\u1ebf hi\u1ec7n \u0111\u1ea1i. ISO 14971 l\u00e0 ti\u00eau chu\u1ea9n qu\u1ed1c t\u1ebf v\u1ec1 \u1ee9ng d\u1ee5ng qu\u1ea3n l\u00fd r\u1ee7i ro […]<\/p>\n","protected":false},"author":10,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[11,59,22],"tags":[],"acf":{"linh-vuc":"\u0110o l\u01b0\u1eddng"},"_links":{"self":[{"href":"https:\/\/tcvn.gov.vn\/wp-json\/wp\/v2\/posts\/85902"}],"collection":[{"href":"https:\/\/tcvn.gov.vn\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/tcvn.gov.vn\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/tcvn.gov.vn\/wp-json\/wp\/v2\/users\/10"}],"replies":[{"embeddable":true,"href":"https:\/\/tcvn.gov.vn\/wp-json\/wp\/v2\/comments?post=85902"}],"version-history":[{"count":2,"href":"https:\/\/tcvn.gov.vn\/wp-json\/wp\/v2\/posts\/85902\/revisions"}],"predecessor-version":[{"id":90816,"href":"https:\/\/tcvn.gov.vn\/wp-json\/wp\/v2\/posts\/85902\/revisions\/90816"}],"wp:attachment":[{"href":"https:\/\/tcvn.gov.vn\/wp-json\/wp\/v2\/media?parent=85902"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/tcvn.gov.vn\/wp-json\/wp\/v2\/categories?post=85902"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/tcvn.gov.vn\/wp-json\/wp\/v2\/tags?post=85902"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}