{"id":2059,"date":"2025-04-22T02:54:20","date_gmt":"2025-04-22T02:54:20","guid":{"rendered":"https:\/\/www.pharmacopoeiatest.com\/?p=2059"},"modified":"2025-04-22T03:29:50","modified_gmt":"2025-04-22T03:29:50","slug":"flange-breakage-resistance-iso-11040-4","status":"publish","type":"post","link":"https:\/\/www.pharmacopoeiatest.com\/cs\/flange-breakage-resistance-iso-11040-4\/","title":{"rendered":"Odolnost p\u0159\u00edruby proti zlomen\u00ed - ISO 11040-4, p\u0159\u00edloha C1"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"2059\" class=\"elementor elementor-2059\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-99d088f e-flex e-con-boxed e-con e-parent\" data-id=\"99d088f\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-43cc8ff elementor-widget elementor-widget-heading\" data-id=\"43cc8ff\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Odolnost p\u0159\u00edruby proti zlomen\u00ed<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f9d7284 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"f9d7284\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1129df5 elementor-widget elementor-widget-heading\" data-id=\"1129df5\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">ISO 11040-4 P\u0159\u00edloha C1<\/h2>\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<div class=\"elementor-element elementor-element-b7ccfb2 e-flex e-con-boxed e-con e-parent\" data-id=\"b7ccfb2\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-254e154 elementor-widget elementor-widget-text-editor\" data-id=\"254e154\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"477\" data-end=\"932\"><em data-start=\"477\" data-end=\"505\">Odolnost proti zlomen\u00ed p\u0159\u00edruby<\/em> je kritick\u00fdm atributem kvality p\u0159i v\u00fdrob\u011b p\u0159edpln\u011bn\u00fdch injek\u010dn\u00edch st\u0159\u00edka\u010dek. Tato zkou\u0161ka ur\u010duje mechanickou pevnost p\u0159\u00edruby hlavn\u011b injek\u010dn\u00ed st\u0159\u00edka\u010dky - \u010d\u00e1sti, kter\u00e1 mus\u00ed odol\u00e1vat p\u016fsob\u00edc\u00edm sil\u00e1m p\u0159i klinick\u00e9m pou\u017eit\u00ed. Vzhledem k tomu, \u017ee se celosv\u011btov\u011b zp\u0159\u00eds\u0148uj\u00ed p\u0159edpisy v oblasti zdravotn\u00ed p\u00e9\u010de, je nutn\u00e9 splnit mechanick\u00e9 normy uveden\u00e9 v dokumentu <a href=\"https:\/\/www.pharmacopoeiatest.com\/cs\/flange-breakage-resistance-iso-11040-4\/\"><strong data-start=\"819\" data-end=\"843\">ISO 11040-4 P\u0159\u00edloha C1<\/strong><\/a> je z\u00e1sadn\u00ed pro v\u00fdrobce sklen\u011bn\u00fdch injek\u010dn\u00edch st\u0159\u00edka\u010dek a sterilizovan\u00fdch d\u00edl\u010d\u00edch st\u0159\u00edka\u010dek.<\/p><p class=\"\" data-start=\"934\" data-end=\"1146\">Spole\u010dnost Cell Instruments, l\u00eddr v oblasti p\u0159esn\u00fdch testovac\u00edch za\u0159\u00edzen\u00ed, nab\u00edz\u00ed robustn\u00ed \u0159e\u0161en\u00ed, kter\u00e1 zajist\u00ed, \u017ee va\u0161e <em data-start=\"1037\" data-end=\"1054\">testov\u00e1n\u00ed st\u0159\u00edka\u010dkou<\/em> spl\u0148uje mezin\u00e1rodn\u00ed normy a z\u00e1rove\u0148 maximalizuje p\u0159esnost a efektivitu provozu.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ededb4f elementor-widget elementor-widget-heading\" data-id=\"ededb4f\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">ISO 11040-4 a jej\u00ed pou\u017eit\u00ed p\u0159i zkou\u0161en\u00ed st\u0159\u00edka\u010dek<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a1f63cd elementor-widget elementor-widget-text-editor\" data-id=\"a1f63cd\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"1223\" data-end=\"1586\"><a href=\"https:\/\/www.pharmacopoeiatest.com\/cs\/iso-11040-4\/\"><strong data-start=\"1223\" data-end=\"1238\">ISO 11040-4<\/strong><\/a> upravuje sklen\u011bn\u00e9 barely pro injek\u010dn\u00ed p\u0159\u00edpravky, zejm\u00e9na se zam\u011b\u0159en\u00edm na struktur\u00e1ln\u00ed integritu a funk\u010dnost. Na adrese <em data-start=\"1346\" data-end=\"1368\">ISO 11040-4 P\u0159\u00edloha C1<\/em>, jsou stanoveny konkr\u00e9tn\u00ed pokyny pro hodnocen\u00ed <em data-start=\"1418\" data-end=\"1446\">odolnost proti zlomen\u00ed p\u0159\u00edruby<\/em>. C\u00edlem t\u00e9to zkou\u0161ky je simulovat podm\u00ednky, za kter\u00fdch by se p\u0159\u00edruba st\u0159\u00edka\u010dky mohla zlomit p\u0159i manipulaci nebo p\u0159i automatizovan\u00e9m pln\u011bn\u00ed.<\/p><p class=\"\" data-start=\"1588\" data-end=\"1752\">Norma se vztahuje nejen na kone\u010dn\u00e9 sudy st\u0159\u00edka\u010dek, ale tak\u00e9 na sterilizovan\u00e9 d\u00edl\u010d\u00ed sestaven\u00e9 st\u0159\u00edka\u010dky p\u0159ipraven\u00e9 k pln\u011bn\u00ed, \u010d\u00edm\u017e je zaji\u0161t\u011bna konzistence v cel\u00e9m dodavatelsk\u00e9m \u0159et\u011bzci.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d261813 elementor-widget elementor-widget-heading\" data-id=\"d261813\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Pro\u010d je d\u016fle\u017eit\u00e9 testov\u00e1n\u00ed odolnosti p\u0159\u00edruby proti zlomen\u00ed<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3f45136 elementor-widget elementor-widget-text-editor\" data-id=\"3f45136\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"1811\" data-end=\"2112\">Injek\u010dn\u00ed st\u0159\u00edka\u010dky jsou b\u011bhem p\u0159epravy, skladov\u00e1n\u00ed, pln\u011bn\u00ed a pod\u00e1v\u00e1n\u00ed vystaveny \u010detn\u00fdm mechanick\u00fdm nam\u00e1h\u00e1n\u00edm. P\u0159\u00edruba, konstruk\u010dn\u00ed prvek na konci v\u00e1lce st\u0159\u00edka\u010dky, je zn\u00e1m\u00fdm slab\u00fdm m\u00edstem. Pokud p\u0159\u00edruba sel\u017ee, m\u016f\u017ee to ohrozit sterilitu, p\u0159esnost d\u00e1vkov\u00e1n\u00ed a v kone\u010dn\u00e9m d\u016fsledku i bezpe\u010dnost pacienta.<\/p><p class=\"\" data-start=\"2114\" data-end=\"2168\">P\u0159esn\u00e9 <em data-start=\"2123\" data-end=\"2151\">odolnost proti zlomen\u00ed p\u0159\u00edruby<\/em> testov\u00e1n\u00ed pom\u00e1h\u00e1:<\/p><ul><li data-start=\"2171\" data-end=\"2216\">Ov\u011b\u0159en\u00ed konstruk\u010dn\u00edch a v\u00fdrobn\u00edch proces\u016f<\/li><li data-start=\"2171\" data-end=\"2216\">Spln\u011bn\u00ed po\u017eadavk\u016f p\u0159edpis\u016f<\/li><li data-start=\"2171\" data-end=\"2216\">Sn\u00ed\u017een\u00ed rizika selh\u00e1n\u00ed v\u00fdrobku v ter\u00e9nu<\/li><li data-start=\"2171\" data-end=\"2216\">Budov\u00e1n\u00ed d\u016fv\u011bry u regula\u010dn\u00edch org\u00e1n\u016f a klient\u016f<\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3fd48bf elementor-widget elementor-widget-heading\" data-id=\"3fd48bf\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">ISO 11040-4 P\u0159\u00edloha C1 Zku\u0161ebn\u00ed metoda odolnosti p\u0159\u00edruby proti zlomen\u00ed<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-ef26935 e-con-full e-flex e-con e-child\" data-id=\"ef26935\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-25fc654 e-con-full e-flex e-con e-child\" data-id=\"25fc654\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1372d22 elementor-widget elementor-widget-heading\" data-id=\"1372d22\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Po\u017eadovan\u00fd tester odolnosti proti zlomen\u00ed p\u0159\u00edruby<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c3c025e elementor-widget elementor-widget-text-editor\" data-id=\"c3c025e\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"2399\" data-end=\"2565\">Metoda popsan\u00e1 v <strong data-start=\"2422\" data-end=\"2446\">ISO 11040-4 P\u0159\u00edloha C1<\/strong> spo\u010d\u00edv\u00e1 v p\u016fsoben\u00ed \u0159\u00edzen\u00e9 tlakov\u00e9 s\u00edly na p\u0159\u00edrubu v\u00e1lce st\u0159\u00edka\u010dky, dokud nedojde k jej\u00edmu po\u0161kozen\u00ed. Postup je n\u00e1sleduj\u00edc\u00ed:<\/p><ul data-start=\"2590\" data-end=\"2834\"><li class=\"\" data-start=\"2590\" data-end=\"2707\"><p class=\"\" data-start=\"2592\" data-end=\"2707\"><strong data-start=\"2592\" data-end=\"2645\">Univerz\u00e1ln\u00ed tahov\u00fd a tlakov\u00fd zku\u0161ebn\u00ed stroj<\/strong> (nap\u0159. spole\u010dnost Cell Instruments' <em>Injek\u010dn\u00ed tester<\/em>)<\/p><\/li><li class=\"\" data-start=\"2708\" data-end=\"2766\"><p class=\"\" data-start=\"2710\" data-end=\"2766\"><strong data-start=\"2710\" data-end=\"2728\">Dr\u017e\u00e1k injek\u010dn\u00ed st\u0159\u00edka\u010dky<\/strong> z vhodn\u00e9ho materi\u00e1lu, jako je PEEK<\/p><\/li><li class=\"\" data-start=\"2767\" data-end=\"2834\"><p class=\"\" data-start=\"2769\" data-end=\"2834\"><strong data-start=\"2769\" data-end=\"2784\">Nakl\u00e1dac\u00ed kol\u00edk<\/strong>, nejl\u00e9pe polyacetal s j\u00e1drem z nerezov\u00e9 oceli.<\/p><\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a1e99e9 elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"a1e99e9\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"488\" height=\"1024\" src=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Syringe-Leakage-Testing-488x1024.webp\" class=\"attachment-large size-large wp-image-2048\" alt=\"ISO 11040-4 testov\u00e1n\u00ed t\u011bsnosti injek\u010dn\u00edch st\u0159\u00edka\u010dek\" srcset=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Syringe-Leakage-Testing-488x1024.webp 488w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Syringe-Leakage-Testing-143x300.webp 143w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Syringe-Leakage-Testing-768x1613.webp 768w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Syringe-Leakage-Testing-731x1536.webp 731w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Syringe-Leakage-Testing-975x2048.webp 975w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Syringe-Leakage-Testing-scaled.webp 1219w\" sizes=\"(max-width: 488px) 100vw, 488px\" \/>\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<\/div>\n\t\t<div class=\"elementor-element elementor-element-d45498c e-con-full e-flex e-con e-child\" data-id=\"d45498c\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-91d25ab elementor-widget elementor-widget-heading\" data-id=\"91d25ab\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">ISO 11040-4 P\u0159\u00edloha C1 Zku\u0161ebn\u00ed postup<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-922228a elementor-widget elementor-widget-text-editor\" data-id=\"922228a\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"2858\" data-end=\"2884\"><strong data-start=\"2858\" data-end=\"2882\">1. P\u0159\u00edprava zku\u0161ebn\u00edch vzork\u016f<br \/><\/strong><span style=\"font-size: 16px;\">Vyhn\u011bte se \u0161ok\u016fm p\u0159ed testov\u00e1n\u00edm. Vizu\u00e1ln\u011b zkontrolujte ka\u017edou st\u0159\u00edka\u010dku a dr\u017e\u00e1k, zda nejsou po\u0161kozeny.<\/span><\/p><p class=\"\" data-start=\"2975\" data-end=\"2986\"><strong data-start=\"2975\" data-end=\"2984\">2. Nastaven\u00ed zku\u0161ebn\u00edho stroje<br \/><\/strong><span style=\"font-size: 16px;\">Vlo\u017ete hlave\u0148 st\u0159\u00edka\u010dky do dr\u017e\u00e1ku. Vyrovnejte plnic\u00ed kol\u00edk v bl\u00edzkosti ramene st\u0159\u00edka\u010dky podle pokyn\u016f <\/span><strong style=\"font-size: 16px;\" data-start=\"3091\" data-end=\"3105\">Obr\u00e1zek C.2<\/strong><span style=\"font-size: 16px;\"> normy ISO.<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1c20220 elementor-widget__width-inherit elementor-widget elementor-widget-image\" data-id=\"1c20220\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"451\" height=\"297\" src=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Annex-C1.png\" class=\"attachment-large size-large wp-image-2064\" alt=\"ISO 11040-4, p\u0159\u00edloha C1, odolnost proti zlomen\u00ed p\u0159\u00edruby\" srcset=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Annex-C1.png 451w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Annex-C1-300x198.png 300w\" sizes=\"(max-width: 451px) 100vw, 451px\" \/>\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<div class=\"elementor-element elementor-element-0bc0e73 elementor-widget elementor-widget-text-editor\" data-id=\"0bc0e73\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"3131\" data-end=\"3151\"><strong data-start=\"3131\" data-end=\"3149\">3. Prov\u00e1d\u011bn\u00ed test\u016f<\/strong><\/p><ul><li data-start=\"3131\" data-end=\"3151\">Nastavte rychlost stroje na <strong data-start=\"3182\" data-end=\"3196\">100 mm\/min<\/strong> (nebo podle dohody).<\/li><li data-start=\"3131\" data-end=\"3151\">Zahajte zkou\u0161ku a p\u016fsobte silou, dokud nedojde k poru\u0161en\u00ed p\u0159\u00edruby.<\/li><li data-start=\"3131\" data-end=\"3151\">Z\u00e1znam <strong style=\"font-size: 16px;\" data-start=\"3302\" data-end=\"3328\">s\u00edla vs. posun<\/strong><span style=\"font-size: 16px;\"> vytvo\u0159it k\u0159ivku.<\/span><\/li><\/ul><p class=\"\" data-start=\"3131\" data-end=\"3151\"><strong data-start=\"3352\" data-end=\"3369\">4. Anal\u00fdza dat<br \/><\/strong>Ur\u010dete vrcholovou s\u00edlu z k\u0159ivky - tato hodnota p\u0159edstavuje hodnotu <em data-start=\"3442\" data-end=\"3470\">odolnost proti zlomen\u00ed p\u0159\u00edruby<\/em>.<\/p><p class=\"\" data-start=\"3478\" data-end=\"3493\"><strong data-start=\"3478\" data-end=\"3491\">5. Hl\u00e1\u0161en\u00ed<br \/><\/strong><span style=\"font-size: 16px;\">Uve\u010fte rychlost testu, po\u010det vzork\u016f, \u0161pi\u010dkov\u00e9 hodnoty a p\u0159\u00edpadn\u00e9 anom\u00e1lie. Zajist\u011bte, aby dokumentace spl\u0148ovala po\u017eadavky ISO na sledovatelnost.<\/span><\/p>\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\t\t<div class=\"elementor-element elementor-element-a9006f3 elementor-widget elementor-widget-heading\" data-id=\"a9006f3\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">St\u0159\u00edka\u010dkov\u00fd tester od spole\u010dnosti Cell Instruments<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e501b92 e-con-full e-flex e-con e-child\" data-id=\"e501b92\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-7a2147d e-con-full e-flex e-con e-child\" data-id=\"7a2147d\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-67dcd66 elementor-widget elementor-widget-heading\" data-id=\"67dcd66\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Kl\u00ed\u010dov\u00e9 v\u00fdhody st\u0159\u00edka\u010dkov\u00e9ho testovac\u00edho stroje<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fb2553c elementor-widget elementor-widget-text-editor\" data-id=\"fb2553c\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul><li data-start=\"4049\" data-end=\"4092\">Kompatibiln\u00ed s p\u0159\u00edpravky pro injek\u010dn\u00ed st\u0159\u00edka\u010dky<\/li><li data-start=\"4049\" data-end=\"4092\">Grafick\u00e9 vykreslov\u00e1n\u00ed s\u00edly a posunut\u00ed v re\u00e1ln\u00e9m \u010dase<\/li><li data-start=\"4049\" data-end=\"4092\">Nastaviteln\u00e9 rychlosti a rozsahy zat\u00ed\u017een\u00ed<\/li><li data-start=\"4049\" data-end=\"4092\">Vestav\u011bn\u00e1 mikrotisk\u00e1rna a voliteln\u00fd port RS232 pro bezprobl\u00e9mov\u00fd export dat<\/li><\/ul><p class=\"\" data-start=\"4258\" data-end=\"4427\">Modularita syst\u00e9mu je ide\u00e1ln\u00ed pro spole\u010dnosti, kter\u00e9 se zab\u00fdvaj\u00ed komplexn\u00ed \u010dinnost\u00ed. <em data-start=\"4336\" data-end=\"4353\">testov\u00e1n\u00ed st\u0159\u00edka\u010dkou<\/em>, v\u010detn\u011b <em data-start=\"4365\" data-end=\"4393\">odolnost proti zlomen\u00ed p\u0159\u00edruby<\/em> a dal\u0161\u00ed mechanick\u00e1 hodnocen\u00ed.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-9b6dbd6 e-con-full e-flex e-con e-child\" data-id=\"9b6dbd6\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2c4684f elementor-widget elementor-widget-heading\" data-id=\"2c4684f\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Nejlep\u0161\u00ed postupy pro testov\u00e1n\u00ed st\u0159\u00edka\u010dek<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f42b687 elementor-widget elementor-widget-text-editor\" data-id=\"f42b687\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul><li data-start=\"4495\" data-end=\"4556\"><strong data-start=\"4495\" data-end=\"4526\">Pou\u017eit\u00ed vysokofrekven\u010dn\u00edho vzorkov\u00e1n\u00ed<\/strong> (\u2265500 Hz) pro \u0161pi\u010dkovou p\u0159esnost<\/li><li data-start=\"4495\" data-end=\"4556\"><strong style=\"font-size: 16px;\" data-start=\"4559\" data-end=\"4584\">Ov\u011b\u0159en\u00ed zarovn\u00e1n\u00ed testu<\/strong><span style=\"font-size: 16px;\"> p\u0159ed ka\u017ed\u00fdm spu\u0161t\u011bn\u00edm, aby se zabr\u00e1nilo fale\u0161n\u00fdm \u00fadaj\u016fm<\/span><\/li><li data-start=\"4495\" data-end=\"4556\"><strong style=\"font-size: 16px;\" data-start=\"4629\" data-end=\"4655\">V\u00fdm\u011bna opot\u0159ebovan\u00fdch sou\u010d\u00e1st\u00ed<\/strong><span style=\"font-size: 16px;\"> (nakl\u00e1dac\u00ed kol\u00edk, dr\u017e\u00e1k) pravideln\u011b udr\u017eovat konzistenci.<\/span><\/li><li data-start=\"4495\" data-end=\"4556\"><strong style=\"font-size: 16px;\" data-start=\"4716\" data-end=\"4739\">V\u0161e zdokumentujte<\/strong><span style=\"font-size: 16px;\">, a to i v p\u0159\u00edpad\u011b drobn\u00fdch odchylek, aby se zlep\u0161ila sledovatelnost.<\/span><\/li><li data-start=\"4495\" data-end=\"4556\"><strong style=\"font-size: 16px;\" data-start=\"4792\" data-end=\"4822\">Spolupr\u00e1ce se z\u00e1kazn\u00edky<\/strong><span style=\"font-size: 16px;\"> dohodnout se na rychlosti test\u016f a kalibraci za\u0159\u00edzen\u00ed.<\/span><\/li><\/ul>\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\t\t<div class=\"elementor-element elementor-element-20579e3 elementor-widget elementor-widget-text-editor\" data-id=\"20579e3\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"4897\" data-end=\"5170\">Testov\u00e1n\u00ed odolnosti proti zlomen\u00ed p\u0159\u00edruby nen\u00ed jen za\u0161krt\u00e1vac\u00edm pol\u00ed\u010dkem - pro v\u00fdrobce st\u0159\u00edka\u010dek je to d\u016fle\u017eit\u00e1 sou\u010d\u00e1st zaji\u0161t\u011bn\u00ed kvality v\u00fdrobk\u016f. Slad\u011bn\u00edm testovac\u00edch postup\u016f s <strong data-start=\"5075\" data-end=\"5099\"><a href=\"https:\/\/www.iso.org\/standard\/82222.html\" target=\"_blank\" rel=\"noopener\">ISO 11040-4<\/a> P\u0159\u00edloha C1<\/strong>, m\u016f\u017eete zajistit trvanlivost, bezpe\u010dnost a p\u0159ijatelnost v\u00fdrobku pro regula\u010dn\u00ed org\u00e1ny.<\/p><p class=\"\" data-start=\"5172\" data-end=\"5418\"><a href=\"https:\/\/www.pharmacopoeiatest.com\/cs\/\" target=\"_blank\" rel=\"noopener\"><strong data-start=\"5172\" data-end=\"5192\">Cell Instruments<\/strong><\/a> je va\u0161\u00edm d\u016fv\u011bryhodn\u00fdm partnerem p\u0159i dosahov\u00e1n\u00ed dokonal\u00e9ho testov\u00e1n\u00ed. Na\u0161e str\u00e1nky <strong>Injek\u010dn\u00ed tester<\/strong>\u00a0pom\u00e1h\u00e1 zefektivnit pracovn\u00ed postupy testov\u00e1n\u00ed injek\u010dn\u00edch st\u0159\u00edka\u010dek a z\u00e1rove\u0148 zaji\u0161\u0165uje p\u0159esnost a shodu s po\u017eadavky modern\u00edch zdravotnick\u00fdch standard\u016f.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b3e233b elementor-widget elementor-widget-text-editor\" data-id=\"b3e233b\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"5420\" data-end=\"5503\">Dovolte n\u00e1m, abychom v\u00e1s podpo\u0159ili na cest\u011b k vysoce v\u00fdkonn\u00fdm v\u00fdrobk\u016fm, kter\u00e9 jsou v souladu s p\u0159edpisy.<\/p>\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\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Flange Breakage Resistance ISO 11040-4 Annex C1 Flange breakage resistance is a critical quality attribute in prefilled syringe manufacturing. This test determines the mechanical strength of the syringe barrel\u2019s flange\u2014the portion that must withstand applied forces during clinical use. As healthcare regulations tighten globally, meeting the mechanical performance standards outlined in ISO 11040-4 Annex C1 [&hellip;]<\/p>","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_uag_custom_page_level_css":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"footnotes":""},"categories":[26],"tags":[],"class_list":["post-2059","post","type-post","status-publish","format-standard","hentry","category-blog"],"acf":[],"uagb_featured_image_src":{"full":false,"thumbnail":false,"medium":false,"medium_large":false,"large":false,"1536x1536":false,"2048x2048":false,"trp-custom-language-flag":false},"uagb_author_info":{"display_name":"pharmacopoeiatest","author_link":"https:\/\/www.pharmacopoeiatest.com\/cs\/author\/pharmacopoeiatest\/"},"uagb_comment_info":0,"uagb_excerpt":"Flange Breakage Resistance ISO 11040-4 Annex C1 Flange breakage resistance is a critical quality attribute in prefilled syringe manufacturing. This test determines the mechanical strength of the syringe barrel\u2019s flange\u2014the portion that must withstand applied forces during clinical use. As healthcare regulations tighten globally, meeting the mechanical performance standards outlined in ISO 11040-4 Annex C1&hellip;","_links":{"self":[{"href":"https:\/\/www.pharmacopoeiatest.com\/cs\/wp-json\/wp\/v2\/posts\/2059","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharmacopoeiatest.com\/cs\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pharmacopoeiatest.com\/cs\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/cs\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/cs\/wp-json\/wp\/v2\/comments?post=2059"}],"version-history":[{"count":5,"href":"https:\/\/www.pharmacopoeiatest.com\/cs\/wp-json\/wp\/v2\/posts\/2059\/revisions"}],"predecessor-version":[{"id":2072,"href":"https:\/\/www.pharmacopoeiatest.com\/cs\/wp-json\/wp\/v2\/posts\/2059\/revisions\/2072"}],"wp:attachment":[{"href":"https:\/\/www.pharmacopoeiatest.com\/cs\/wp-json\/wp\/v2\/media?parent=2059"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/cs\/wp-json\/wp\/v2\/categories?post=2059"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/cs\/wp-json\/wp\/v2\/tags?post=2059"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}