{"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\/cs\/standards\/iso-11040-4\/","title":{"rendered":"ISO 11040-4"},"content":{"rendered":"
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\n\t\t\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\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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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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P\u0159edpln\u011bn\u00e9 injek\u010dn\u00ed st\u0159\u00edka\u010dky
\u010c\u00e1st 4: Sklen\u011bn\u00e9 sudy na injek\u010dn\u00ed materi\u00e1l a sterilizovan\u00e9 smontovan\u00e9 injek\u010dn\u00ed st\u0159\u00edka\u010dky p\u0159ipraven\u00e9 k pln\u011bn\u00ed<\/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\tVy\u017e\u00e1dejte si cenovou nab\u00eddku<\/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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Standardn\u00ed shrnut\u00ed<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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C\u00edlem zkou\u0161ky t\u011bsnosti injek\u010dn\u00ed st\u0159\u00edka\u010dky je ov\u011b\u0159it, zda je odolnost uz\u00e1v\u011br\u016f injek\u010dn\u00edch st\u0159\u00edka\u010dek proti \u00faniku kapaliny<\/strong> za definovan\u00fdch tlakov\u00fdch podm\u00ednek. Podle P\u0159\u00edloha G2 normy ISO 11040-4<\/em>, zkou\u0161ka simuluje vnit\u0159n\u00ed p\u0159etlak (obvykle 110 kPa), kter\u00fd m\u016f\u017ee vzniknout p\u0159i pln\u011bn\u00ed nebo p\u0159eprav\u011b injek\u010dn\u00edch st\u0159\u00edka\u010dek.<\/p>\n

Tento test hodnot\u00ed jak \u0161t\u00edty jehel<\/strong> a uz\u00e1v\u011bry \u0161pi\u010dek<\/strong>, co\u017e zaji\u0161\u0165uje, \u017ee tyto uz\u00e1v\u011bry z\u016fstanou bezpe\u010dn\u00e9 a p\u0159i z\u00e1t\u011b\u017ei neprot\u00e9kaj\u00ed.<\/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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Toto hodnocen\u00ed je nezbytn\u00e9 pro kontrolu kvality l\u00e9\u010div, prevenci kontaminace a zaji\u0161t\u011bn\u00ed p\u0159esnosti d\u00e1vkov\u00e1n\u00ed.<\/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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Zku\u0161ebn\u00ed metoda \u00faniku kapaliny ze syst\u00e9mu uzav\u00edr\u00e1n\u00ed injek\u010dn\u00edch st\u0159\u00edka\u010dek<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Kl\u00ed\u010dov\u00e9 kroky zkou\u0161ky (podle p\u0159\u00edlohy G2 normy ISO 11040-4):<\/strong><\/p>\n

    \n
  • P\u0159\u00edprava vzorku:<\/strong> Pou\u017e\u00edvejte sterilizovan\u00e9, p\u0159edem sestaven\u00e9 injek\u010dn\u00ed st\u0159\u00edka\u010dky p\u0159ipraven\u00e9 k pln\u011bn\u00ed. P\u0159ed testem nenaru\u0161ujte uz\u00e1v\u011br.<\/li>\n
  • \u010cekac\u00ed doba:<\/strong> Mezi nastaven\u00edm uz\u00e1v\u011bru a testov\u00e1n\u00edm nechte uplynout minim\u00e1ln\u011b 12 hodin.<\/li>\n
  • N\u00e1pl\u0148:<\/strong> Napl\u0148te st\u0159\u00edka\u010dku destilovanou vodou nebo vodou stejn\u00e9 \u010distoty do 1\/3 a\u017e 2\/3 jej\u00edho jmenovit\u00e9ho objemu.<\/li>\n
  • Natlakov\u00e1n\u00ed:<\/strong> Pou\u017e\u00edt 110 kPa<\/strong> tlak pomoc\u00ed stla\u010den\u00e9ho vzduchu nebo univerz\u00e1ln\u00ed stroj pro zkou\u0161en\u00ed v tahu a tlaku<\/strong>. Podr\u017ete pro 5 sekund<\/strong>.<\/li>\n
  • Monitorov\u00e1n\u00ed:<\/strong> B\u011bhem zkou\u0161ky a po n\u00ed sledujte, zda nedoch\u00e1z\u00ed k \u00faniku kapaliny. \u00danik se projev\u00ed jako viditeln\u00e9 kapky na vn\u011bj\u0161\u00edm povrchu uz\u00e1v\u011bru.<\/li>\n
  • Krit\u00e9ria \u00fasp\u011b\u0161nosti:<\/strong> Nesm\u00ed b\u00fdt vid\u011bt \u017e\u00e1dn\u00e9 kapi\u010dky a uz\u00e1v\u011br (kryt hrotu nebo \u0161t\u00edt jehly) mus\u00ed z\u016fstat na m\u00edst\u011b.<\/li>\n<\/ul>\n
    \n

    Testov\u00e1n\u00ed je platn\u00e9 jak pro barely st\u0159\u00edka\u010dek, tak pro steriln\u00ed podsestavy. Vizu\u00e1ln\u00ed kontrola je nezbytn\u00e1 pro ur\u010den\u00ed vyhovuj\u00edc\u00edch\/nevyhovuj\u00edc\u00edch v\u00fdsledk\u016f.<\/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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    Z\u00e1kladn\u00ed vybaven\u00ed pro testov\u00e1n\u00ed t\u011bsnosti st\u0159\u00edka\u010dek<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    Za\u0159\u00edzen\u00ed pro tento test zahrnuje:<\/p>\n

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    • Univerz\u00e1ln\u00ed tahov\u00e1 a tlakov\u00e1 zkou\u0161e\u010dka<\/strong> nebo syst\u00e9m stla\u010dov\u00e1n\u00ed stla\u010den\u00e9ho vzduchu<\/strong><\/li>\n
    • Dr\u017e\u00e1k injek\u010dn\u00ed st\u0159\u00edka\u010dky<\/strong> s bezpe\u010dn\u00fdm t\u011bsn\u00edc\u00edm mechanismem<\/li>\n
    • Tlakom\u011br nebo software<\/strong> schopn\u00e9 dos\u00e1hnout a udr\u017eet tlak 110 kPa<\/li>\n
    • Syst\u00e9m sb\u011bru dat s vysokou vzorkovac\u00ed frekvenc\u00ed<\/strong> (doporu\u010den\u00e1 frekvence 500 Hz pro \u0161pi\u010dkov\u00e1 m\u011b\u0159en\u00ed)<\/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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      \u0158e\u0161en\u00ed Cell Instruments:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      Prov\u00e1d\u011bn\u00ed zkou\u0161ek t\u011bsnosti injek\u010dn\u00edch st\u0159\u00edka\u010dek podle normy ISO 11040-4, Spole\u010dnost Cell Instruments nab\u00edz\u00ed p\u0159izp\u016fsobiteln\u00e9 testovac\u00ed platformy pro injek\u010dn\u00ed st\u0159\u00edka\u010dky<\/strong>, kompatibiln\u00ed s metodami aplikace stla\u010den\u00e9ho vzduchu i mechanick\u00e9 s\u00edly. Na\u0161e syst\u00e9my zaji\u0161\u0165uj\u00ed:<\/p>\n

        \n
      • P\u0159esn\u00e1 kontrola vnit\u0159n\u00edho tlaku<\/strong><\/li>\n
      • Vysokofrekven\u010dn\u00ed vzorkov\u00e1n\u00ed a\u017e do 500 Hz<\/strong><\/li>\n
      • Pln\u00e9 dodr\u017eov\u00e1n\u00ed zku\u0161ebn\u00edch postup\u016f ISO<\/strong><\/li>\n
      • Funkce automatizovan\u00e9 dokumentace<\/strong> pro v\u00fdkaznictv\u00ed p\u0159ipraven\u00e9 na audit<\/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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        \u0158e\u0161en\u00ed Cell Instruments:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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        Prov\u00e1d\u011bn\u00ed zkou\u0161ek t\u011bsnosti injek\u010dn\u00edch st\u0159\u00edka\u010dek podle normy ISO 11040-4, Spole\u010dnost Cell Instruments nab\u00edz\u00ed p\u0159izp\u016fsobiteln\u00e9 testovac\u00ed platformy pro injek\u010dn\u00ed st\u0159\u00edka\u010dky<\/strong>, kompatibiln\u00ed s metodami aplikace stla\u010den\u00e9ho vzduchu i mechanick\u00e9 s\u00edly. Na\u0161e syst\u00e9my zaji\u0161\u0165uj\u00ed:<\/p>\n

          \n
        • P\u0159esn\u00e1 kontrola vnit\u0159n\u00edho tlaku<\/strong><\/li>\n
        • Vysokofrekven\u010dn\u00ed vzorkov\u00e1n\u00ed a\u017e do 500 Hz<\/strong><\/li>\n
        • Pln\u00e9 dodr\u017eov\u00e1n\u00ed zku\u0161ebn\u00edch postup\u016f ISO<\/strong><\/li>\n
        • Funkce automatizovan\u00e9 dokumentace<\/strong> pro v\u00fdkaznictv\u00ed p\u0159ipraven\u00e9 na audit<\/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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          Zaznamen\u00e1v\u00e1n\u00ed a dokumentace dat<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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          Podle P\u0159\u00edloha G2<\/em>, \u00fapln\u00fd protokol o zkou\u0161ce mus\u00ed obsahovat:<\/p>\n

            \n
          • Pou\u017eit\u00fd tlak<\/strong> (kPa) nebo ekvivalentn\u00ed s\u00edla (N)<\/li>\n
          • Po\u010det testovan\u00fdch st\u0159\u00edka\u010dek<\/strong><\/li>\n
          • Po\u010det vyhovuj\u00edc\u00edch\/nevyhovuj\u00edc\u00edch vzork\u016f<\/strong><\/li>\n
          • Vizu\u00e1ln\u00ed pozorov\u00e1n\u00ed nebo odchylky<\/strong><\/li>\n
          • \n

            Sledovatelnost parametr\u016f nastaven\u00ed<\/strong> (ru\u010dn\u011b nebo pomoc\u00ed softwaru)<\/p>\n<\/li>\n<\/ul>\n

            Zdokumentov\u00e1n\u00edm podm\u00ednek a v\u00fdsledk\u016f zkou\u0161ek v\u00fdrobci prokazuj\u00ed shodu s normou ISO 11040-4 a zaji\u0161\u0165uj\u00ed, \u017ee. regula\u010dn\u00ed sledovatelnost<\/strong>-nezbytnost pro farmaceutick\u00e9 syst\u00e9my kvality.<\/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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            V\u00fdpo\u010det vnit\u0159n\u00ed s\u00edly<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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            U za\u0159\u00edzen\u00ed, kde se m\u00edsto tlaku vzduchu pou\u017e\u00edv\u00e1 mechanick\u00e1 s\u00edla, je po\u017eadovan\u00e1 hodnota s\u00edla (F)<\/strong> pro simulaci vnit\u0159n\u00edho tlaku 110 kPa lze vypo\u010d\u00edtat pomoc\u00ed vzorc\u016f z normy ISO 11040-4:<\/p>\n

            \n

            F = p \u00d7 \u03c0\/4 \u00d7 d\u00b2 \u00d7 10-\u00b3<\/strong>
            Kde:<\/p>\n<\/blockquote>\n

              \n
            • F<\/strong> = S\u00edla v newtonech<\/li>\n
            • p<\/strong> = Tlak (110 kPa)<\/li>\n
            • d<\/strong> = Vnit\u0159n\u00ed pr\u016fm\u011br st\u0159\u00edka\u010dky (mm)<\/li>\n<\/ul>\n

              Tento v\u00fdpo\u010det pom\u00e1h\u00e1 zajistit p\u0159esn\u00e1 replikace test\u016f<\/strong> a kalibraci za\u0159\u00edzen\u00ed.<\/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 P\u0159edpln\u011bn\u00e9 injek\u010dn\u00ed st\u0159\u00edka\u010dky\u010c\u00e1st 4: Sklen\u011bn\u00e9 barely pro injek\u010dn\u00ed p\u0159\u00edpravky a sterilizovan\u00e9 smontovan\u00e9 injek\u010dn\u00ed st\u0159\u00edka\u010dky p\u0159ipraven\u00e9 k pln\u011bn\u00ed Vy\u017e\u00e1dat si cenovou nab\u00eddku Souhrn normy C\u00edlem zkou\u0161ky t\u011bsnosti injek\u010dn\u00edch st\u0159\u00edka\u010dek je ov\u011b\u0159it odolnost syst\u00e9m\u016f uz\u00e1v\u011br\u016f injek\u010dn\u00edch st\u0159\u00edka\u010dek proti \u00faniku kapaliny za definovan\u00fdch tlakov\u00fdch podm\u00ednek. Podle p\u0159\u00edlohy G2 normy ISO 11040-4 se p\u0159i zkou\u0161ce simuluje vnit\u0159n\u00ed p\u0159etlak (obvykle 110 kPa) a [...]","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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According to Annex G2 of ISO 11040-4, the test simulates internal overpressure (typically 110 kPa)…","_links":{"self":[{"href":"https:\/\/www.leakagetester.com\/cs\/wp-json\/wp\/v2\/pages\/4110","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.leakagetester.com\/cs\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.leakagetester.com\/cs\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/cs\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/cs\/wp-json\/wp\/v2\/comments?post=4110"}],"version-history":[{"count":0,"href":"https:\/\/www.leakagetester.com\/cs\/wp-json\/wp\/v2\/pages\/4110\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/cs\/wp-json\/wp\/v2\/pages\/2112"}],"wp:attachment":[{"href":"https:\/\/www.leakagetester.com\/cs\/wp-json\/wp\/v2\/media?parent=4110"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}