{"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\/sk\/flange-breakage-resistance-iso-11040-4\/","title":{"rendered":"Odolnos\u0165 pr\u00edruby proti pretrhnutiu - ISO 11040-4 pr\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\">Odolnos\u0165 pr\u00edruby proti zlomeniu<\/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 Pr\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\">Odolnos\u0165 pr\u00edruby proti zlomeniu<\/em> je kritick\u00fdm atrib\u00fatom kvality pri v\u00fdrobe predplnen\u00fdch injek\u010dn\u00fdch strieka\u010diek. Tento test ur\u010duje mechanick\u00fa pevnos\u0165 pr\u00edruby hlavne injek\u010dnej strieka\u010dky - \u010dasti, ktor\u00e1 mus\u00ed odol\u00e1va\u0165 p\u00f4sobiacim sil\u00e1m po\u010das klinick\u00e9ho pou\u017e\u00edvania. Vzh\u013eadom na celosvetov\u00e9 spr\u00eds\u0148ovanie predpisov v oblasti zdravotnej starostlivosti je splnenie noriem mechanick\u00e9ho v\u00fdkonu uveden\u00fdch v <a href=\"https:\/\/www.pharmacopoeiatest.com\/sk\/flange-breakage-resistance-iso-11040-4\/\"><strong data-start=\"819\" data-end=\"843\">ISO 11040-4 Pr\u00edloha C1<\/strong><\/a> je nevyhnutn\u00fd pre v\u00fdrobcov sklenen\u00fdch injek\u010dn\u00fdch strieka\u010diek a sterilizovan\u00fdch submontovan\u00fdch injek\u010dn\u00fdch strieka\u010diek.<\/p><p class=\"\" data-start=\"934\" data-end=\"1146\">Spolo\u010dnos\u0165 Cell Instruments, l\u00edder v oblasti presn\u00fdch testovac\u00edch zariaden\u00ed, pon\u00faka robustn\u00e9 rie\u0161enia, ktor\u00e9 zabezpe\u010dia, \u017ee va\u0161e <em data-start=\"1037\" data-end=\"1054\">testovanie injek\u010dnou strieka\u010dkou<\/em> sp\u013a\u0148a medzin\u00e1rodn\u00e9 normy a z\u00e1rove\u0148 maximalizuje presnos\u0165 a prev\u00e1dzkov\u00fa efekt\u00edvnos\u0165.<\/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 pou\u017eitie pri testovan\u00ed injek\u010dn\u00fdch strieka\u010diek<\/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\/sk\/iso-11040-4\/\"><strong data-start=\"1223\" data-end=\"1238\">ISO 11040-4<\/strong><\/a> upravuje sklenen\u00e9 sudy na injek\u010dn\u00e9 materi\u00e1ly, pri\u010dom sa zameriava najm\u00e4 na \u0161truktur\u00e1lnu integritu a funk\u010dnos\u0165. Na str\u00e1nke <em data-start=\"1346\" data-end=\"1368\">ISO 11040-4 Pr\u00edloha C1<\/em>, s\u00fa stanoven\u00e9 osobitn\u00e9 usmernenia pre hodnotenie <em data-start=\"1418\" data-end=\"1446\">odolnos\u0165 pr\u00edruby proti zlomeniu<\/em>. Cie\u013eom tohto testu je simulova\u0165 podmienky, za ktor\u00fdch by sa pr\u00edruba injek\u010dnej strieka\u010dky mohla zlomi\u0165 po\u010das manipul\u00e1cie alebo automatizovan\u00fdch plniacich procesov.<\/p><p class=\"\" data-start=\"1588\" data-end=\"1752\">Norma sa vz\u0165ahuje nielen na kone\u010dn\u00e9 sudy injek\u010dn\u00fdch strieka\u010diek, ale aj na sterilizovan\u00e9 zmontovan\u00e9 injek\u010dn\u00e9 strieka\u010dky pripraven\u00e9 na plnenie, \u010d\u00edm sa zabezpe\u010d\u00ed konzistentnos\u0165 v celom dod\u00e1vate\u013eskom re\u0165azci.<\/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\">Pre\u010do je d\u00f4le\u017eit\u00e9 testovanie odolnosti pr\u00edruby proti zlomeniu<\/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\u00e9 strieka\u010dky s\u00fa po\u010das prepravy, skladovania, plnenia a pod\u00e1vania vystaven\u00e9 mnoh\u00fdm mechanick\u00fdm za\u0165a\u017eeniam. Pr\u00edruba, kon\u0161truk\u010dn\u00fd prvok na konci tubusu injek\u010dnej strieka\u010dky, je zn\u00e1mym slab\u00fdm miestom. Ak pr\u00edruba zlyh\u00e1, m\u00f4\u017ee to ohrozi\u0165 sterilitu, presnos\u0165 d\u00e1vkovania a v kone\u010dnom d\u00f4sledku aj bezpe\u010dnos\u0165 pacienta.<\/p><p class=\"\" data-start=\"2114\" data-end=\"2168\">Presn\u00e9 <em data-start=\"2123\" data-end=\"2151\">odolnos\u0165 pr\u00edruby proti zlomeniu<\/em> testovanie pom\u00e1ha:<\/p><ul><li data-start=\"2171\" data-end=\"2216\">Overenie dizajnu a v\u00fdrobn\u00fdch procesov<\/li><li data-start=\"2171\" data-end=\"2216\">Dodr\u017eiavanie regula\u010dn\u00fdch predpisov<\/li><li data-start=\"2171\" data-end=\"2216\">Zn\u00ed\u017eenie rizika zlyhania v\u00fdrobku v ter\u00e9ne<\/li><li data-start=\"2171\" data-end=\"2216\">Budovanie d\u00f4very u regula\u010dn\u00fdch org\u00e1nov a klientov<\/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 Pr\u00edloha C1 Sk\u00fa\u0161obn\u00e1 met\u00f3da odolnosti pr\u00edruby proti pretrhnutiu<\/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\u017eaduje sa tester odolnosti proti pretrhnutiu pr\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\">Met\u00f3da uveden\u00e1 v <strong data-start=\"2422\" data-end=\"2446\">ISO 11040-4 Pr\u00edloha C1<\/strong> spo\u010d\u00edva v kontrolovanom p\u00f4soben\u00ed tlakovej sily na pr\u00edrubu valca injek\u010dnej strieka\u010dky, a\u017e k\u00fdm ned\u00f4jde k jej po\u0161kodeniu. Postup je nasledovn\u00fd:<\/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\u00e1lny stroj na sk\u00fa\u0161anie v \u0165ahu a tlaku<\/strong> (napr. Cell Instruments' <em>Injek\u010dn\u00fd 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\u017eiak injek\u010dnej strieka\u010dky<\/strong> z vhodn\u00e9ho materi\u00e1lu, ako 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\">Na\u010d\u00edtac\u00ed kol\u00edk<\/strong>, najlep\u0161ie polyacet\u00e1l s jadrom z nehrdzavej\u00facej ocele<\/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 testovanie tesnosti injek\u010dn\u00fdch strieka\u010diek\" 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 Pr\u00edloha C1 Sk\u00fa\u0161obn\u00fd 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. Pr\u00edprava sk\u00fa\u0161obn\u00fdch vzoriek<br \/><\/strong><span style=\"font-size: 16px;\">Vyhnite sa \u0161okom pred testovan\u00edm. Vizu\u00e1lne skontrolujte ka\u017ed\u00fa strieka\u010dku a dr\u017eiak, \u010di nie s\u00fa po\u0161koden\u00e9.<\/span><\/p><p class=\"\" data-start=\"2975\" data-end=\"2986\"><strong data-start=\"2975\" data-end=\"2984\">2. Nastavenie testovacieho stroja<br \/><\/strong><span style=\"font-size: 16px;\">Umiestnite hlave\u0148 injek\u010dnej strieka\u010dky do dr\u017eiaka. Zarovnajte nab\u00edjac\u00ed kol\u00edk v bl\u00edzkosti ramena injek\u010dnej strieka\u010dky pod\u013ea <\/span><strong style=\"font-size: 16px;\" data-start=\"3091\" data-end=\"3105\">Obr\u00e1zok 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 pr\u00edloha C1 odolnos\u0165 pr\u00edruby proti zlomeniu\" 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. Vykon\u00e1vanie testovania<\/strong><\/p><ul><li data-start=\"3131\" data-end=\"3151\">Nastavte r\u00fdchlos\u0165 stroja na <strong data-start=\"3182\" data-end=\"3196\">100 mm\/min<\/strong> (alebo pod\u013ea dohody).<\/li><li data-start=\"3131\" data-end=\"3151\">Spustite sk\u00fa\u0161ku a p\u00f4sobte silou, k\u00fdm ned\u00f4jde k poru\u0161eniu pr\u00edruby.<\/li><li data-start=\"3131\" data-end=\"3151\">Z\u00e1znam <strong style=\"font-size: 16px;\" data-start=\"3302\" data-end=\"3328\">sila vs. posun<\/strong><span style=\"font-size: 16px;\"> na vytvorenie krivky.<\/span><\/li><\/ul><p class=\"\" data-start=\"3131\" data-end=\"3151\"><strong data-start=\"3352\" data-end=\"3369\">4. Anal\u00fdza \u00fadajov<br \/><\/strong>Ur\u010dite maxim\u00e1lnu silu z krivky - t\u00e1to hodnota predstavuje <em data-start=\"3442\" data-end=\"3470\">odolnos\u0165 pr\u00edruby proti zlomeniu<\/em>.<\/p><p class=\"\" data-start=\"3478\" data-end=\"3493\"><strong data-start=\"3478\" data-end=\"3491\">5. Nahlasovanie<br \/><\/strong><span style=\"font-size: 16px;\">Uve\u010fte r\u00fdchlos\u0165 testu, po\u010det vzoriek, \u0161pi\u010dkov\u00e9 hodnoty a pr\u00edpadn\u00e9 anom\u00e1lie. Zabezpe\u010dte, aby dokument\u00e1cia sp\u013a\u0148ala po\u017eiadavky na sledovate\u013enos\u0165 ISO.<\/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\">Injek\u010dn\u00fd tester od spolo\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\">K\u013e\u00fa\u010dov\u00e9 v\u00fdhody strieka\u010dkov\u00e9ho testovacieho stroja<\/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\">Kompatibilita s pr\u00edslu\u0161enstvom \u0161pecifick\u00fdm pre injek\u010dn\u00e9 strieka\u010dky<\/li><li data-start=\"4049\" data-end=\"4092\">Grafick\u00e9 vykres\u013eovanie sily a posunutia v re\u00e1lnom \u010dase<\/li><li data-start=\"4049\" data-end=\"4092\">Nastavite\u013en\u00e9 r\u00fdchlosti a rozsahy za\u0165a\u017eenia<\/li><li data-start=\"4049\" data-end=\"4092\">Zabudovan\u00e1 mikrotla\u010diare\u0148 a volite\u013en\u00fd port RS232 na bezprobl\u00e9mov\u00fd export \u00fadajov<\/li><\/ul><p class=\"\" data-start=\"4258\" data-end=\"4427\">Modularita syst\u00e9mu je ide\u00e1lna pre spolo\u010dnosti, ktor\u00e9 sa zaoberaj\u00fa komplexnou <em data-start=\"4336\" data-end=\"4353\">testovanie injek\u010dnou strieka\u010dkou<\/em>, vr\u00e1tane <em data-start=\"4365\" data-end=\"4393\">odolnos\u0165 pr\u00edruby proti zlomeniu<\/em> a in\u00e9 mechanick\u00e9 hodnotenia.<\/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\">Najlep\u0161ie postupy pri testovan\u00ed strieka\u010diek<\/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\u017e\u00edvanie vysokofrekven\u010dn\u00e9ho vzorkovania<\/strong> (\u2265500 Hz) pre \u0161pi\u010dkov\u00fa presnos\u0165<\/li><li data-start=\"4495\" data-end=\"4556\"><strong style=\"font-size: 16px;\" data-start=\"4559\" data-end=\"4584\">Overenie zarovnania testu<\/strong><span style=\"font-size: 16px;\"> pred ka\u017ed\u00fdm spusten\u00edm, aby sa zabr\u00e1nilo falo\u0161n\u00fdm \u00fadajom<\/span><\/li><li data-start=\"4495\" data-end=\"4556\"><strong style=\"font-size: 16px;\" data-start=\"4629\" data-end=\"4655\">V\u00fdmena opotrebovan\u00fdch komponentov<\/strong><span style=\"font-size: 16px;\"> (nakladac\u00ed kol\u00edk, dr\u017eiak) pravidelne udr\u017eiava\u0165 konzistenciu<\/span><\/li><li data-start=\"4495\" data-end=\"4556\"><strong style=\"font-size: 16px;\" data-start=\"4716\" data-end=\"4739\">V\u0161etko zdokumentujte<\/strong><span style=\"font-size: 16px;\">, dokonca aj drobn\u00e9 odch\u00fdlky, aby sa zlep\u0161ila vysledovate\u013enos\u0165<\/span><\/li><li data-start=\"4495\" data-end=\"4556\"><strong style=\"font-size: 16px;\" data-start=\"4792\" data-end=\"4822\">Spolupr\u00e1ca so z\u00e1kazn\u00edkmi<\/strong><span style=\"font-size: 16px;\"> dohodn\u00fa\u0165 sa na testovac\u00edch r\u00fdchlostiach a kalibr\u00e1cii zariaden\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\">Testovanie odolnosti pr\u00edruby proti zlomeniu nie je len kontroln\u00e9 pol\u00ed\u010dko - je to d\u00f4le\u017eit\u00e1 s\u00fa\u010das\u0165 zabezpe\u010denia kvality v\u00fdrobkov pre v\u00fdrobcov injek\u010dn\u00fdch strieka\u010diek. Zos\u00faladen\u00edm testovac\u00edch postupov 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> Pr\u00edloha C1<\/strong>, m\u00f4\u017eete zaisti\u0165 trvanlivos\u0165, bezpe\u010dnos\u0165 a akceptovanie predpisov.<\/p><p class=\"\" data-start=\"5172\" data-end=\"5418\"><a href=\"https:\/\/www.pharmacopoeiatest.com\/sk\/\" target=\"_blank\" rel=\"noopener\"><strong data-start=\"5172\" data-end=\"5192\">Mobiln\u00e9 n\u00e1stroje<\/strong><\/a> je va\u0161\u00edm d\u00f4veryhodn\u00fdm partnerom pri dosahovan\u00ed dokonalosti testovania. Na\u0161e str\u00e1nky <strong>Injek\u010dn\u00fd tester<\/strong>\u00a0pom\u00e1ha zefekt\u00edvni\u0165 pracovn\u00e9 postupy pri testovan\u00ed injek\u010dn\u00fdch strieka\u010diek a z\u00e1rove\u0148 zabezpe\u010duje presnos\u0165 a zhodu s po\u017eiadavkami modern\u00fdch zdravotn\u00edckych noriem.<\/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\">Dovo\u013ete n\u00e1m, aby sme v\u00e1s podporili na ceste k vysoko v\u00fdkonn\u00fdm produktom, ktor\u00e9 s\u00fa v s\u00falade s predpismi.<\/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\/sk\/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\/sk\/wp-json\/wp\/v2\/posts\/2059","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/comments?post=2059"}],"version-history":[{"count":5,"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/posts\/2059\/revisions"}],"predecessor-version":[{"id":2072,"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/posts\/2059\/revisions\/2072"}],"wp:attachment":[{"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/media?parent=2059"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/categories?post=2059"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/tags?post=2059"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}