{"id":173,"date":"2025-04-30T03:56:30","date_gmt":"2025-04-30T03:56:30","guid":{"rendered":"https:\/\/www.syringetest.com\/?page_id=173"},"modified":"2026-05-19T08:03:46","modified_gmt":"2026-05-19T08:03:46","slug":"front-end-breakage-resistance-iso-11040-4-annex-c2","status":"publish","type":"page","link":"https:\/\/www.syringetest.com\/sl\/front-end-breakage-resistance-iso-11040-4-annex-c2","title":{"rendered":"Preizku\u0161anje odpornosti proti zlomu sprednjega dela brizge"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"173\" class=\"elementor elementor-173\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0877670 e-flex e-con-boxed e-con e-parent\" data-id=\"0877670\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b2fa34d elementor-widget elementor-widget-heading\" data-id=\"b2fa34d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Preizku\u0161anje odpornosti proti zlomu sprednjega dela brizge<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9e27540 elementor-widget elementor-widget-text-editor\" data-id=\"9e27540\" data-element_type=\"widget\" data-e-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\t\t<p>Spletna stran <strong>odpornost proti zlomu sprednjega dela<\/strong> brizge je kriti\u010dni parameter kakovosti v farmacevtski embala\u017ei. Ta lastnost zagotavlja, da lahko brizga brez okvare prenese stranske obremenitve med rokovanjem, prevozom ali dajanjem. Za proizvajalce in strokovnjake za nadzor kakovosti je razumevanje in pravilno presku\u0161anje te odpornosti bistvenega pomena za varnost pacientov in skladnost izdelka.<\/p>\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<div class=\"elementor-element elementor-element-f441832 e-flex e-con-boxed e-con e-parent\" data-id=\"f441832\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5c84ac0 elementor-widget elementor-widget-heading\" data-id=\"5c84ac0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Pomen testiranja sile odriva in sile drsenja<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-88abe9f elementor-widget elementor-widget-text-editor\" data-id=\"88abe9f\" data-element_type=\"widget\" data-e-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\t\t<p>Odpornost na lomljenje sprednjega dela ni le zakonska zahteva - je varovalo za zdravje bolnikov in u\u010dinkovitost brizgalke. \u0160ibke steklene konice lahko med klini\u010dno uporabo odpovejo, kar predstavlja tveganje za po\u0161kodbe, kontaminacijo ali napake pri odmerjanju. Zlasti, <a href=\"https:\/\/www.syringetest.com\/sl\/standards\/iso-11040-4\/\"><strong>ISO 11040-4<\/strong><\/a> in njegov normativni <strong>Priloga C2<\/strong> opredeliti standardne metode in zahteve za izvajanje tega klju\u010dnega preskusa na <strong>stekleni sodi za injiciranje<\/strong>. Z izvajanjem <strong>Testiranje po standardu ISO 11040-4<\/strong>, lahko proizvajalci:<\/p><ul><li>Zgodnje odkrivanje napak v zasnovi ali materialu<\/li><li>Izbolj\u0161anje strukturne celovitosti<\/li><li>Zagotavljanje skladnosti in zaupanja strank<\/li><\/ul><p><strong>Sistemi testiranja Syringetest.com<\/strong> omogo\u010dajo laboratorijem, da spo\u0161tujejo globalne standarde in hkrati dosegajo u\u010dinkovite in ponovljive rezultate.<\/p>\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<div class=\"elementor-element elementor-element-316973d e-flex e-con-boxed e-con e-parent\" data-id=\"316973d\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3e8b6ba elementor-widget elementor-widget-heading\" data-id=\"3e8b6ba\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">ISO 11040-4 Testiranje in Priloga C2<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8b275e4 elementor-widget elementor-widget-text-editor\" data-id=\"8b275e4\" data-element_type=\"widget\" data-e-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\t\t<p>ISO 11040-4 opisuje specifikacije za <strong>predhodno sterilizirane steklene brizge<\/strong> in . <strong>sodi za brizge<\/strong>, pri \u010demer je treba zagotoviti, da vsak sestavni del izpolnjuje farmacevtske varnostne zahteve. <strong>Priloga C2<\/strong> se osredoto\u010da zlasti na <strong>preskus odpornosti proti zlomu sprednjega dela<\/strong>, mehanski preskus, ki simulira dejansko obremenitev najbolj ranljivega dela brizgalke - sprednjega dela.<\/p><p>V skladu s standardom:<\/p><ul><li>Test ocenjuje <em>najve\u010dja sila<\/em> ki jo sprednji del brizge lahko vzdr\u017ei, preden se zlomi.<\/li><li>Sodi brizge (s podsklopom ali brez njega) se preskusijo z uporabo <strong>univerzalni stroj za natezno in tla\u010dno testiranje<\/strong>.<\/li><li>A <strong>palica in dr\u017ealo iz nerjave\u010dega jekla<\/strong> nastavitev simulira stransko obremenitev, pri \u010demer pritisne 2 mm od konice brizge.<\/li><\/ul><p>Ta preskus je obvezen za oblike steklenih brizg, prikazane na slikah 2, 3 in 5 standarda ISO 11040-4, ki predstavljajo obi\u010dajne oblike sodov.<\/p>\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-a250905 elementor-widget elementor-widget-image\" data-id=\"a250905\" data-element_type=\"widget\" data-e-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\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"1190\" height=\"300\" src=\"https:\/\/www.syringetest.com\/wp-content\/uploads\/2025\/04\/Syringe-Front-End-Breakage-Resistance-ISO-11040-4-Annex-C2.webp\" class=\"attachment-full size-full wp-image-192\" alt=\"Odpornost prednjega dela brizge proti zlomu - ISO 11040-4, Priloga C2\" srcset=\"https:\/\/www.syringetest.com\/wp-content\/uploads\/2025\/04\/Syringe-Front-End-Breakage-Resistance-ISO-11040-4-Annex-C2.webp 1190w, https:\/\/www.syringetest.com\/wp-content\/uploads\/2025\/04\/Syringe-Front-End-Breakage-Resistance-ISO-11040-4-Annex-C2-300x76.webp 300w, https:\/\/www.syringetest.com\/wp-content\/uploads\/2025\/04\/Syringe-Front-End-Breakage-Resistance-ISO-11040-4-Annex-C2-1024x258.webp 1024w, https:\/\/www.syringetest.com\/wp-content\/uploads\/2025\/04\/Syringe-Front-End-Breakage-Resistance-ISO-11040-4-Annex-C2-768x194.webp 768w\" sizes=\"(max-width: 1190px) 100vw, 1190px\" \/>\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<div class=\"elementor-element elementor-element-c56e688 e-flex e-con-boxed e-con e-parent\" data-id=\"c56e688\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-37e25ec elementor-widget elementor-widget-heading\" data-id=\"37e25ec\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Zahteve glede opreme in nastavitev za testiranje brizge<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-dee37ee elementor-widget elementor-widget-text-editor\" data-id=\"dee37ee\" data-element_type=\"widget\" data-e-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\t\t<p>Za izvedbo <strong>preskus odpornosti proti zlomu sprednjega dela<\/strong>, mora biti laboratorij, ki izpolnjuje zahteve, opremljen z naslednjim:<\/p><ul><li><strong>Univerzalni stroj za natezno in tla\u010dno testiranje<\/strong>, ki lahko vzdr\u017euje <strong>25 mm\/min<\/strong> hitrost nalaganja.<\/li><li>Obremenitvena celica, prilagojena za merjenje sil preloma, obi\u010dajno v <strong>njuton (N)<\/strong>.<\/li><li><strong>Mo\u017enost vzor\u010denja pri visoki hitrosti<\/strong> (za meritve najve\u010dje sile je priporo\u010dljivo 500 Hz).<\/li><li><strong>Komplet adapterjev in pribor<\/strong> ki ustreza geometriji brizge.<\/li><li><strong>Dr\u017ealo in za\u0161\u010ditno ohi\u0161je, varno za steklo<\/strong> da bi prepre\u010dili po\u0161kodbe zaradi razbitih delov.<\/li><\/ul><p>Nastavitev stroja, hitrost presku\u0161anja in natan\u010dnost to\u010dke obremenitve (2 mm od konice) bistveno vplivajo na zanesljivost rezultatov.<\/p><p><strong>Re\u0161itve za testiranje brizg dru\u017ebe Syringetest.com<\/strong> vklju\u010dujejo pametne programske vmesnike, nastavljive napeljave in natan\u010dne senzorje, ki so v celoti skladni z zahtevami standarda ISO 11040-4.<\/p>\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<div class=\"elementor-element elementor-element-f793b7c e-flex e-con-boxed e-con e-parent\" data-id=\"f793b7c\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e082694 elementor-widget elementor-widget-heading\" data-id=\"e082694\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Kako opraviti preskus odpornosti proti zlomu sprednjega dela<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d2248d3 elementor-widget elementor-widget-text-editor\" data-id=\"d2248d3\" data-element_type=\"widget\" data-e-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\t\t<p>Sledite tem korakom za natan\u010dno <strong>ISO 11040-4, Priloga C2, presku\u0161anje brizge<\/strong>:<\/p><h3>1. Pripravite napravo:<\/h3><ul><li>Preverite zdru\u017eljivost in celovitost adapterja.<\/li><li>Preverite konfiguracijo programske opreme in varnostna ohi\u0161ja.<\/li><\/ul><h3>2. Namestite vzorec:<\/h3><ul><li>Vstavite valj brizge v dr\u017ealo za pritrditev.<\/li><li>Prepri\u010dajte se, da je sprednja stran natan\u010dno poravnana z nakladalnim zati\u010dem.<\/li><\/ul><h3>3. Izvedite test:<\/h3><ul><li>Hitrost nastavite na 25 mm\/min.<\/li><li>Za\u010dni stiskati, dokler se sprednji del sod\u010dka ne zlomi.<\/li><li>Zapi\u0161ite <em>najve\u010dja sila pri zlomu<\/em>.<\/li><\/ul><h3>4. Posttestni koraki:<\/h3><ul><li>varno odstranite in zavrzite razbito steklo.<\/li><li>Pred naslednjim preskusom o\u010distite in ponastavite napeljave.<\/li><\/ul><h3>5. Interpretacija rezultatov in dokumentacija<\/h3><p>Preskus se \u0161teje za veljavnega, \u010de pride do zloma na sprednjem delu pod dolo\u010denimi pogoji. Poro\u010dilo o preskusu mora vsebovati:<\/p><ol><li>Uporabljena preskusna hitrost (mm\/min)<\/li><li>Razdalja delovanja sile (\u22482 mm od konice)<\/li><li>Najve\u010dja sila pri lomljenju (N)<\/li><li>\u0160tevilo preskusnih vzorcev<\/li><li>morebitne nepravilnosti ali odstopanja<\/li><\/ol>\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<div class=\"elementor-element elementor-element-e3da57f e-grid e-con-full e-con e-parent\" data-id=\"e3da57f\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-389299e elementor-widget elementor-widget-image\" data-id=\"389299e\" data-element_type=\"widget\" data-e-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\t\t<img decoding=\"async\" width=\"800\" height=\"643\" src=\"https:\/\/www.syringetest.com\/wp-content\/uploads\/2025\/04\/06a8c2a0-image-3.png\" class=\"attachment-large size-large wp-image-65\" alt=\"\" srcset=\"https:\/\/www.syringetest.com\/wp-content\/uploads\/2025\/04\/06a8c2a0-image-3.png 875w, https:\/\/www.syringetest.com\/wp-content\/uploads\/2025\/04\/06a8c2a0-image-3-300x241.png 300w, https:\/\/www.syringetest.com\/wp-content\/uploads\/2025\/04\/06a8c2a0-image-3-768x617.png 768w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\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<div class=\"elementor-element elementor-element-18dd657 e-con-full e-flex e-con e-child\" data-id=\"18dd657\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-555d851 elementor-widget elementor-widget-heading\" data-id=\"555d851\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Zakaj izbrati <b>Syringetest.com?<\/b><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-88e1f19 elementor-widget elementor-widget-text-editor\" data-id=\"88e1f19\" data-element_type=\"widget\" data-e-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\t\t<p>Razumevanje in uporaba <strong>odpornost proti zlomu sprednjega dela<\/strong> testiranje, kot je opredeljeno v <strong><a href=\"https:\/\/www.iso.org\/standard\/82222.html\" target=\"_blank\" rel=\"noopener\">ISO 11040-4<\/a> Priloga C2<\/strong> zagotavlja, da brizgalke izpolnjujejo stroga varnostna pri\u010dakovanja. Ne glede na to, ali ste proizvajalec, nadzorni uradnik ali in\u017eenir za nadzor kakovosti, je natan\u010dno in skladno testiranje bistvenega pomena.<\/p><p><strong>Syringetest.com<\/strong> zagotavlja <strong>zanesljive, s standardi skladne re\u0161itve za testiranje brizgalk<\/strong> ki racionalizirajo delovne postopke in izbolj\u0161ujejo u\u010dinkovitost izdelkov. Razi\u0161\u010dite na\u0161o celotno paleto instrumentov za testiranje medicinske embala\u017ee in \u0161e danes izbolj\u0161ajte zmogljivosti svojega laboratorija.<\/p>\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-a51db32 elementor-widget__width-auto elementor-align-left elementor-widget elementor-widget-button\" data-id=\"a51db32\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/www.syringetest.com\/sl\/contact-us\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Pi\u0161ite nam<\/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\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Syringe Front End Breakage Resistance Testing The front end breakage resistance of a syringe is a critical quality parameter in pharmaceutical packaging. This attribute ensures that the syringe can withstand side loads during handling, transportation, or administration without failure. For manufacturers and quality control professionals, understanding and properly testing this resistance is essential to patient [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-173","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.syringetest.com\/sl\/wp-json\/wp\/v2\/pages\/173","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.syringetest.com\/sl\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.syringetest.com\/sl\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.syringetest.com\/sl\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.syringetest.com\/sl\/wp-json\/wp\/v2\/comments?post=173"}],"version-history":[{"count":0,"href":"https:\/\/www.syringetest.com\/sl\/wp-json\/wp\/v2\/pages\/173\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.syringetest.com\/sl\/wp-json\/wp\/v2\/media?parent=173"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}