{"id":4110,"date":"2025-05-26T17:13:43","date_gmt":"2025-05-26T09:13:43","guid":{"rendered":"https:\/\/www.leakagetester.com\/?page_id=4110"},"modified":"2025-05-27T08:28:34","modified_gmt":"2025-05-27T00:28:34","slug":"iso-11040-4","status":"publish","type":"page","link":"https:\/\/www.leakagetester.com\/vi\/standards\/iso-11040-4\/","title":{"rendered":"ISO 11040-4"},"content":{"rendered":"
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ISO 11040-4<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\u1ed0ng ti\u00eam \u0111\u00e3 n\u1ea1p s\u1eb5n
Ph\u1ea7n 4: L\u1ecd th\u1ee7y tinh d\u00f9ng cho thu\u1ed1c ti\u00eam v\u00e0 \u1ed1ng ti\u00eam \u0111\u00e3 \u0111\u01b0\u1ee3c ti\u1ec7t tr\u00f9ng v\u00e0 l\u1eafp r\u00e1p s\u1eb5n, s\u1eb5n s\u00e0ng \u0111\u1ec3 chi\u1ebft r\u00f3t<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tY\u00eau c\u1ea7u b\u00e1o gi\u00e1<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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T\u00f3m t\u1eaft chu\u1ea9n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Th\u1eed nghi\u1ec7m r\u00f2 r\u1ec9 \u1ed1ng ti\u00eam nh\u1eb1m m\u1ee5c \u0111\u00edch ki\u1ec3m tra kh\u1ea3 n\u0103ng ch\u1ed1ng r\u00f2 r\u1ec9 ch\u1ea5t l\u1ecfng c\u1ee7a c\u00e1c h\u1ec7 th\u1ed1ng n\u1eafp \u0111\u1eady \u1ed1ng ti\u00eam<\/strong> trong \u0111i\u1ec1u ki\u1ec7n \u00e1p su\u1ea5t \u0111\u00e3 \u0111\u1ecbnh. Theo Ph\u1ee5 l\u1ee5c G2 c\u1ee7a ti\u00eau chu\u1ea9n ISO 11040-4<\/em>, th\u1eed nghi\u1ec7m n\u00e0y m\u00f4 ph\u1ecfng \u00e1p su\u1ea5t d\u01b0 b\u00ean trong (th\u01b0\u1eddng l\u00e0 110 kPa) m\u00e0 \u1ed1ng ti\u00eam c\u00f3 th\u1ec3 ph\u1ea3i ch\u1ecbu trong qu\u00e1 tr\u00ecnh chi\u1ebft r\u00f3t ho\u1eb7c v\u1eadn chuy\u1ec3n.<\/p>\n

B\u00e0i ki\u1ec3m tra n\u00e0y \u0111\u00e1nh gi\u00e1 c\u1ea3 hai n\u1eafp b\u1ea3o v\u1ec7 kim<\/strong> V\u00e0 n\u1eafp \u0111\u1eady<\/strong>, \u0111\u1ea3m b\u1ea3o c\u00e1c m\u1ed1i n\u1ed1i n\u00e0y v\u1eabn k\u00edn kh\u00edt v\u00e0 kh\u00f4ng b\u1ecb r\u00f2 r\u1ec9 khi ch\u1ecbu l\u1ef1c.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\"ISO\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Vi\u1ec7c \u0111\u00e1nh gi\u00e1 n\u00e0y c\u00f3 vai tr\u00f2 quan tr\u1ecdng trong vi\u1ec7c ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng d\u01b0\u1ee3c ph\u1ea9m, ng\u0103n ng\u1eeba \u00f4 nhi\u1ec5m v\u00e0 \u0111\u1ea3m b\u1ea3o \u0111\u1ed9 ch\u00ednh x\u00e1c c\u1ee7a li\u1ec1u l\u01b0\u1ee3ng.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Ph\u01b0\u01a1ng ph\u00e1p th\u1eed nghi\u1ec7m r\u00f2 r\u1ec9 ch\u1ea5t l\u1ecfng c\u1ee7a h\u1ec7 th\u1ed1ng n\u1eafp \u0111\u1eady \u1ed1ng ti\u00eam<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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C\u00e1c b\u01b0\u1edbc th\u1eed nghi\u1ec7m ch\u00ednh (theo Ph\u1ee5 l\u1ee5c G2 c\u1ee7a ti\u00eau chu\u1ea9n ISO 11040-4):<\/strong><\/p>\n

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  • Chu\u1ea9n b\u1ecb m\u1eabu:<\/strong> S\u1eed d\u1ee5ng c\u00e1c \u1ed1ng ti\u00eam \u0111\u00e3 \u0111\u01b0\u1ee3c ti\u1ec7t tr\u00f9ng v\u00e0 l\u1eafp r\u00e1p s\u1eb5n, ch\u1ec9 c\u1ea7n b\u01a1m thu\u1ed1c v\u00e0o. Tr\u00e1nh l\u00e0m x\u00e1o tr\u1ed9n n\u1eafp \u0111\u1eady tr\u01b0\u1edbc khi ti\u1ebfn h\u00e0nh x\u00e9t nghi\u1ec7m.<\/li>\n
  • Th\u1eddi gian ch\u1edd:<\/strong> H\u00e3y \u0111\u1ec3 \u00edt nh\u1ea5t 12 gi\u1edd k\u1ec3 t\u1eeb khi \u0111\u00f3ng n\u1eafp cho \u0111\u1ebfn khi ti\u1ebfn h\u00e0nh ki\u1ec3m tra.<\/li>\n
  • Nh\u00e2n:<\/strong> \u0110\u1ed5 n\u01b0\u1edbc c\u1ea5t ho\u1eb7c n\u01b0\u1edbc c\u00f3 \u0111\u1ed9 tinh khi\u1ebft t\u01b0\u01a1ng \u0111\u01b0\u01a1ng v\u00e0o \u1ed1ng ti\u00eam cho \u0111\u1ebfn khi \u0111\u1ea1t m\u1ee9c t\u1eeb 1\/3 \u0111\u1ebfn 2\/3 th\u1ec3 t\u00edch danh \u0111\u1ecbnh c\u1ee7a \u1ed1ng ti\u00eam.<\/li>\n
  • \u00c1p su\u1ea5t:<\/strong> \u0110\u0103ng k\u00fd 110 kPa<\/strong> \u00e1p su\u1ea5t b\u1eb1ng kh\u00ed n\u00e9n ho\u1eb7c m\u1ed9t m\u00e1y th\u1eed k\u00e9o v\u00e0 n\u00e9n \u0111a n\u0103ng<\/strong>. Vui l\u00f2ng ch\u1edd 5 gi\u00e2y<\/strong>.<\/li>\n
  • Gi\u00e1m s\u00e1t:<\/strong> Theo d\u00f5i xem c\u00f3 r\u00f2 r\u1ec9 ch\u1ea5t l\u1ecfng trong v\u00e0 sau khi th\u1eed nghi\u1ec7m hay kh\u00f4ng. Hi\u1ec7n t\u01b0\u1ee3ng r\u00f2 r\u1ec9 th\u1ec3 hi\u1ec7n d\u01b0\u1edbi d\u1ea1ng c\u00e1c gi\u1ecdt n\u01b0\u1edbc c\u00f3 th\u1ec3 nh\u00ecn th\u1ea5y tr\u00ean b\u1ec1 m\u1eb7t b\u00ean ngo\u00e0i c\u1ee7a n\u1eafp \u0111\u1eady.<\/li>\n
  • Ti\u00eau ch\u00ed \u0111\u1ed7:<\/strong> Kh\u00f4ng \u0111\u01b0\u1ee3c th\u1ea5y b\u1ea5t k\u1ef3 gi\u1ecdt ch\u1ea5t l\u1ecfng n\u00e0o, v\u00e0 n\u1eafp \u0111\u1eady (n\u1eafp \u0111\u1ea7u \u1ed1ng ti\u00eam ho\u1eb7c n\u1eafp b\u1ea3o v\u1ec7 kim ti\u00eam) ph\u1ea3i \u0111\u01b0\u1ee3c gi\u1eef nguy\u00ean v\u1ecb tr\u00ed.<\/li>\n<\/ul>\n
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    Vi\u1ec7c ki\u1ec3m tra n\u00e0y \u00e1p d\u1ee5ng cho c\u1ea3 th\u00e2n \u1ed1ng ti\u00eam v\u00e0 c\u00e1c b\u1ed9 ph\u1eadn l\u1eafp r\u00e1p v\u00f4 tr\u00f9ng. Ki\u1ec3m tra b\u1eb1ng m\u1eaft th\u01b0\u1eddng l\u00e0 b\u01b0\u1edbc kh\u00f4ng th\u1ec3 thi\u1ebfu \u0111\u1ec3 x\u00e1c \u0111\u1ecbnh k\u1ebft qu\u1ea3 \u0111\u1ea1t hay kh\u00f4ng \u0111\u1ea1t.<\/p>\n<\/blockquote>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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    Thi\u1ebft b\u1ecb c\u1ea7n thi\u1ebft \u0111\u1ec3 ki\u1ec3m tra r\u00f2 r\u1ec9 \u1ed1ng ti\u00eam<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    C\u00e1c thi\u1ebft b\u1ecb \u0111\u01b0\u1ee3c chu\u1ea9n b\u1ecb cho th\u1eed nghi\u1ec7m n\u00e0y bao g\u1ed3m:<\/p>\n

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    • M\u00e1y th\u1eed k\u00e9o v\u00e0 n\u00e9n \u0111a n\u0103ng<\/strong> ho\u1eb7c h\u1ec7 th\u1ed1ng n\u00e9n kh\u00ed<\/strong><\/li>\n
    • Gi\u00e1 \u0111\u1ee1 \u1ed1ng ti\u00eam<\/strong> v\u1edbi c\u01a1 ch\u1ebf \u0111\u00f3ng k\u00edn an to\u00e0n<\/li>\n
    • \u0110\u1ed3ng h\u1ed3 \u0111o \u00e1p su\u1ea5t ho\u1eb7c ph\u1ea7n m\u1ec1m<\/strong> c\u00f3 kh\u1ea3 n\u0103ng \u0111\u1ea1t v\u00e0 duy tr\u00ec \u00e1p su\u1ea5t 110 kPa<\/li>\n
    • H\u1ec7 th\u1ed1ng thu th\u1eadp d\u1eef li\u1ec7u c\u00f3 t\u1ed1c \u0111\u1ed9 l\u1ea5y m\u1eabu cao<\/strong> (khuy\u1ebfn ngh\u1ecb 500 Hz \u0111\u1ec3 \u0111o gi\u00e1 tr\u1ecb \u0111\u1ec9nh)<\/li>\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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      C\u00e1c gi\u1ea3i ph\u00e1p c\u1ee7a Cell Instruments:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      \u0110\u1ec3 th\u1ef1c hi\u1ec7n c\u00e1c th\u1eed nghi\u1ec7m r\u00f2 r\u1ec9 \u1ed1ng ti\u00eam theo ti\u00eau chu\u1ea9n ISO 11040-4, Cell Instruments cung c\u1ea5p c\u00e1c n\u1ec1n t\u1ea3ng ki\u1ec3m tra \u1ed1ng ti\u00eam c\u00f3 th\u1ec3 t\u00f9y ch\u1ec9nh<\/strong>, t\u01b0\u01a1ng th\u00edch v\u1edbi c\u1ea3 ph\u01b0\u01a1ng ph\u00e1p s\u1eed d\u1ee5ng kh\u00ed n\u00e9n v\u00e0 l\u1ef1c c\u01a1 h\u1ecdc. H\u1ec7 th\u1ed1ng c\u1ee7a ch\u00fang t\u00f4i \u0111\u1ea3m b\u1ea3o:<\/p>\n

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      • Ki\u1ec3m so\u00e1t ch\u00ednh x\u00e1c \u00e1p su\u1ea5t b\u00ean trong<\/strong><\/li>\n
      • L\u1ea5y m\u1eabu t\u1ea7n s\u1ed1 cao l\u00ean \u0111\u1ebfn 500 Hz<\/strong><\/li>\n
      • Tu\u00e2n th\u1ee7 \u0111\u1ea7y \u0111\u1ee7 c\u00e1c quy tr\u00ecnh th\u1eed nghi\u1ec7m theo ti\u00eau chu\u1ea9n ISO<\/strong><\/li>\n
      • C\u00e1c t\u00ednh n\u0103ng t\u1ef1 \u0111\u1ed9ng h\u00f3a vi\u1ec7c l\u1eadp t\u00e0i li\u1ec7u<\/strong> \u0111\u1ec3 l\u1eadp b\u00e1o c\u00e1o s\u1eb5n s\u00e0ng cho vi\u1ec7c ki\u1ec3m to\u00e1n<\/li>\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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        C\u00e1c gi\u1ea3i ph\u00e1p c\u1ee7a Cell Instruments:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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        \u0110\u1ec3 th\u1ef1c hi\u1ec7n c\u00e1c th\u1eed nghi\u1ec7m r\u00f2 r\u1ec9 \u1ed1ng ti\u00eam theo ti\u00eau chu\u1ea9n ISO 11040-4, Cell Instruments cung c\u1ea5p c\u00e1c n\u1ec1n t\u1ea3ng ki\u1ec3m tra \u1ed1ng ti\u00eam c\u00f3 th\u1ec3 t\u00f9y ch\u1ec9nh<\/strong>, t\u01b0\u01a1ng th\u00edch v\u1edbi c\u1ea3 ph\u01b0\u01a1ng ph\u00e1p s\u1eed d\u1ee5ng kh\u00ed n\u00e9n v\u00e0 l\u1ef1c c\u01a1 h\u1ecdc. H\u1ec7 th\u1ed1ng c\u1ee7a ch\u00fang t\u00f4i \u0111\u1ea3m b\u1ea3o:<\/p>\n

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        • Ki\u1ec3m so\u00e1t ch\u00ednh x\u00e1c \u00e1p su\u1ea5t b\u00ean trong<\/strong><\/li>\n
        • L\u1ea5y m\u1eabu t\u1ea7n s\u1ed1 cao l\u00ean \u0111\u1ebfn 500 Hz<\/strong><\/li>\n
        • Tu\u00e2n th\u1ee7 \u0111\u1ea7y \u0111\u1ee7 c\u00e1c quy tr\u00ecnh th\u1eed nghi\u1ec7m theo ti\u00eau chu\u1ea9n ISO<\/strong><\/li>\n
        • C\u00e1c t\u00ednh n\u0103ng t\u1ef1 \u0111\u1ed9ng h\u00f3a vi\u1ec7c l\u1eadp t\u00e0i li\u1ec7u<\/strong> \u0111\u1ec3 l\u1eadp b\u00e1o c\u00e1o s\u1eb5n s\u00e0ng cho vi\u1ec7c ki\u1ec3m to\u00e1n<\/li>\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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          Ghi ch\u00e9p v\u00e0 l\u1eadp h\u1ed3 s\u01a1 d\u1eef li\u1ec7u<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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          Theo Ph\u1ee5 l\u1ee5c G2<\/em>, m\u1ed9t b\u00e1o c\u00e1o th\u1eed nghi\u1ec7m \u0111\u1ea7y \u0111\u1ee7 ph\u1ea3i bao g\u1ed3m:<\/p>\n

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          • \u00c1p l\u1ef1c t\u00e1c d\u1ee5ng<\/strong> (kPa) ho\u1eb7c l\u1ef1c t\u01b0\u01a1ng \u0111\u01b0\u01a1ng (N)<\/li>\n
          • S\u1ed1 l\u01b0\u1ee3ng \u1ed1ng ti\u00eam \u0111\u00e3 \u0111\u01b0\u1ee3c ki\u1ec3m tra<\/strong><\/li>\n
          • S\u1ed1 m\u1eabu \u0111\u1ea1t\/kh\u00f4ng \u0111\u1ea1t<\/strong><\/li>\n
          • Quan s\u00e1t b\u1eb1ng m\u1eaft th\u01b0\u1eddng ho\u1eb7c c\u00e1c sai l\u1ec7ch<\/strong><\/li>\n
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            Kh\u1ea3 n\u0103ng truy xu\u1ea5t ngu\u1ed3n g\u1ed1c c\u1ee7a c\u00e1c th\u00f4ng s\u1ed1 c\u00e0i \u0111\u1eb7t<\/strong> (b\u1eb1ng tay ho\u1eb7c th\u00f4ng qua ph\u1ea7n m\u1ec1m)<\/p>\n<\/li>\n<\/ul>\n

            B\u1eb1ng c\u00e1ch ghi ch\u00e9p c\u00e1c \u0111i\u1ec1u ki\u1ec7n v\u00e0 k\u1ebft qu\u1ea3 th\u1eed nghi\u1ec7m, c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t ch\u1ee9ng minh s\u1ef1 tu\u00e2n th\u1ee7 ti\u00eau chu\u1ea9n ISO 11040-4 v\u00e0 \u0111\u1ea3m b\u1ea3o kh\u1ea3 n\u0103ng truy xu\u1ea5t ngu\u1ed3n g\u1ed1c theo quy \u0111\u1ecbnh<\/strong>\u2014m\u1ed9t y\u1ebfu t\u1ed1 kh\u00f4ng th\u1ec3 thi\u1ebfu \u0111\u1ed1i v\u1edbi c\u00e1c h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng d\u01b0\u1ee3c ph\u1ea9m.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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            T\u00ednh to\u00e1n l\u1ef1c n\u1ed9i<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
            \n\t\t\t\t
            \n\t\t\t\t\t\t\t\t\t

            \u0110\u1ed1i v\u1edbi c\u00e1c thi\u1ebft b\u1ecb s\u1eed d\u1ee5ng l\u1ef1c c\u01a1 h\u1ecdc thay v\u00ec \u00e1p su\u1ea5t kh\u00f4ng kh\u00ed, y\u00eau c\u1ea7u l\u1ef1c (F)<\/strong> \u0110\u1ec3 m\u00f4 ph\u1ecfng \u00e1p su\u1ea5t b\u00ean trong 110 kPa, c\u00f3 th\u1ec3 t\u00ednh to\u00e1n b\u1eb1ng c\u00e1ch s\u1eed d\u1ee5ng c\u00e1c c\u00f4ng th\u1ee9c trong ti\u00eau chu\u1ea9n ISO 11040-4:<\/p>\n

            \n

            F = p \u00d7 \u03c0\/4 \u00d7 d\u00b2 \u00d7 10\u207b\u00b3<\/strong>
            \u0110\u1ecba \u0111i\u1ec3m:<\/p>\n<\/blockquote>\n

              \n
            • F<\/strong> = L\u1ef1c t\u00ednh b\u1eb1ng Newton<\/li>\n
            • p<\/strong> = \u00c1p su\u1ea5t (110 kPa)<\/li>\n
            • d<\/strong> = \u0110\u01b0\u1eddng k\u00ednh trong c\u1ee7a \u1ed1ng ti\u00eam (mm)<\/li>\n<\/ul>\n

              C\u00e1ch t\u00ednh n\u00e0y gi\u00fap \u0111\u1ea3m b\u1ea3o t\u00e1i t\u1ea1o th\u1eed nghi\u1ec7m ch\u00ednh x\u00e1c<\/strong> v\u00e0 hi\u1ec7u chu\u1ea9n thi\u1ebft b\u1ecb.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

              ISO 11040-4 Prefilled syringesPart 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling Request a Quote Standard Summary The syringe leak test aims to verify the liquid leakage resistance of syringe closure systems under defined pressure conditions. According to Annex G2 of ISO 11040-4, the test simulates internal overpressure (typically 110 kPa) […]","protected":false},"author":2,"featured_media":0,"parent":2112,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"_uag_custom_page_level_css":"","footnotes":""},"class_list":["post-4110","page","type-page","status-publish","hentry"],"yoast_head":"\nISO 11040-4 Syringe Leak Test - Closure System Liquid Leakage<\/title>\n<meta name=\"description\" content=\"Syringe leak test per ISO 11040-4 Annex G2 to ensure closure integrity. 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