{"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\/de\/standards\/iso-11040-4\/","title":{"rendered":"ISO 11040-4"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"4110\" class=\"elementor elementor-4110\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4987d4e6 e-flex e-con-boxed e-con e-parent\" data-id=\"4987d4e6\" 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-7b47303e elementor-widget elementor-widget-text-editor\" data-id=\"7b47303e\" 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\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-b290316 e-con-full e-flex e-con e-parent\" data-id=\"b290316\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-5c5c9cd e-con-full e-flex e-con e-child\" data-id=\"5c5c9cd\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0192e7d elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"0192e7d\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeIn&quot;}\" 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\">ISO 11040-4<\/h1>\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-dad80d0 e-con-full e-flex e-con e-child\" data-id=\"dad80d0\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3d5573c elementor-widget elementor-widget-heading\" data-id=\"3d5573c\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">Fertigspritzen<br>Teil 4: Glaskolben f\u00fcr Injektionsmittel und sterilisierte, f\u00fcllfertige Fertigspritzen<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-14bfcde elementor-tablet-align-center elementor-mobile-align-center elementor-widget__width-inherit elementor-invisible elementor-widget elementor-widget-button\" data-id=\"14bfcde\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeIn&quot;,&quot;_animation_delay&quot;:200}\" 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=\"\/de\/contact\/\">\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\">Angebot anfordern<\/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<div class=\"elementor-element elementor-element-7db034b e-flex e-con-boxed e-con e-parent\" data-id=\"7db034b\" data-element_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<div class=\"elementor-element elementor-element-0b99b3c e-con-full e-flex e-con e-child\" data-id=\"0b99b3c\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-dee3d55 elementor-widget elementor-widget-heading\" data-id=\"dee3d55\" data-element_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\">Standardzusammenfassung<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-070771a elementor-widget elementor-widget-text-editor\" data-id=\"070771a\" 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\t\t<p data-start=\"1249\" data-end=\"1545\">Die Dichtheitspr\u00fcfung der Spritze dient der \u00dcberpr\u00fcfung der <strong data-start=\"1290\" data-end=\"1346\">Widerstandsf\u00e4higkeit von Spritzenverschlusssystemen gegen Fl\u00fcssigkeitsaustritt<\/strong> unter definierten Druckbedingungen. Nach <em data-start=\"1395\" data-end=\"1420\">Anhang G2 der ISO 11040-4<\/em>, Der Test simuliert den inneren \u00dcberdruck (typischerweise 110 kPa), dem Spritzen beim Bef\u00fcllen oder Transport ausgesetzt sein k\u00f6nnen.<\/p>\n<p data-start=\"1249\" data-end=\"1545\">Dieser Test bewertet sowohl <strong data-start=\"1572\" data-end=\"1590\">Nadelschutzvorrichtungen<\/strong> Und <strong data-start=\"1595\" data-end=\"1607\">Abdeckkappen<\/strong>, Dadurch wird sichergestellt, dass diese Verschl\u00fcsse sicher bleiben und unter Belastung nicht auslaufen.<\/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<div class=\"elementor-element elementor-element-5e86730 e-con-full e-flex e-con e-child\" data-id=\"5e86730\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ae0f79e elementor-widget elementor-widget-image\" data-id=\"ae0f79e\" 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\t\t\t<a href=\"https:\/\/www.iso.org\/standard\/82222.html\" target=\"_blank\">\n\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"600\" height=\"200\" src=\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2025\/05\/ISO-11040-4.webp\" class=\"attachment-medium size-medium wp-image-4116\" alt=\"ISO 11040-4\" srcset=\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2025\/05\/ISO-11040-4.webp 600w, https:\/\/www.leakagetester.com\/wp-content\/uploads\/2025\/05\/ISO-11040-4-18x6.webp 18w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/>\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<div class=\"elementor-element elementor-element-b86c929 elementor-widget elementor-widget-text-editor\" data-id=\"b86c929\" 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\t\t<p>Eine solche Bewertung ist f\u00fcr die pharmazeutische Qualit\u00e4tskontrolle, die Vermeidung von Verunreinigungen und die Sicherstellung der Dosierungsgenauigkeit unerl\u00e4sslich.<\/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<div class=\"elementor-element elementor-element-5a6238d e-flex e-con-boxed e-con e-parent\" data-id=\"5a6238d\" data-element_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-84ad92e elementor-widget elementor-widget-heading\" data-id=\"84ad92e\" data-element_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\">Spritzenverschlusssystem Fl\u00fcssigkeitsleckage Testmethode<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b15d017 elementor-widget elementor-widget-text-editor\" data-id=\"b15d017\" 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\t\t<p data-start=\"1859\" data-end=\"1908\"><strong data-start=\"1859\" data-end=\"1908\">Wichtige Pr\u00fcfschritte (gem\u00e4\u00df ISO 11040-4 Anhang G2):<\/strong><\/p>\n<ul>\n<li data-start=\"1912\" data-end=\"2038\"><strong data-start=\"1912\" data-end=\"1935\">Probenvorbereitung:<\/strong> Verwenden Sie sterilisierte, vormontierte und f\u00fcllfertige Spritzen. Vermeiden Sie es, den Verschluss vor dem Test zu \u00f6ffnen.<\/li>\n<li data-start=\"2041\" data-end=\"2125\"><strong data-start=\"2041\" data-end=\"2060\">Wartezeit:<\/strong> Zwischen dem Abbinden des Verschlusses und der Pr\u00fcfung m\u00fcssen mindestens 12 Stunden vergehen.<\/li>\n<li data-start=\"2128\" data-end=\"2245\"><strong data-start=\"2128\" data-end=\"2140\">F\u00fcllen:<\/strong> F\u00fcllen Sie die Spritze zu 1\/3 bis 2\/3 ihres Nennvolumens mit destilliertem Wasser oder Wasser gleicher Reinheit.<\/li>\n<li data-start=\"2248\" data-end=\"2399\"><strong data-start=\"2248\" data-end=\"2267\">Druckbeaufschlagung:<\/strong> Bewerbung <strong data-start=\"2274\" data-end=\"2285\">110 kPa<\/strong> Druck mit Druckluft oder einem <strong data-start=\"2321\" data-end=\"2374\">Universal-Zug- und Druckpr\u00fcfmaschine<\/strong>. Halten f\u00fcr <strong data-start=\"2385\" data-end=\"2398\">5 Sekunden<\/strong>.<\/li>\n<li data-start=\"2402\" data-end=\"2537\"><strong data-start=\"2402\" data-end=\"2417\">\u00dcberwachung:<\/strong> Achten Sie w\u00e4hrend und nach der Pr\u00fcfung auf Fl\u00fcssigkeitsaustritt. Leckagen erscheinen als sichtbare Tr\u00f6pfchen auf der \u00e4u\u00dferen Oberfl\u00e4che des Verschlusses.<\/li>\n<li data-start=\"2540\" data-end=\"2654\"><strong data-start=\"2540\" data-end=\"2558\">Kriterien f\u00fcr das Bestehen:<\/strong> Es d\u00fcrfen keine Tr\u00f6pfchen sichtbar sein, und der Verschluss (Spitzenkappe oder Nadelschutz) muss aufgesetzt bleiben.<\/li>\n<\/ul>\n<blockquote data-start=\"2656\" data-end=\"2793\">\n<p data-start=\"2658\" data-end=\"2793\">Die Pr\u00fcfung gilt sowohl f\u00fcr Spritzenzylinder als auch f\u00fcr sterile Unterbaugruppen. Die visuelle Inspektion ist unerl\u00e4sslich, um zu bestimmen, ob die Pr\u00fcfung bestanden oder nicht bestanden wurde.<\/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<div class=\"elementor-element elementor-element-e2cd145 e-flex e-con-boxed e-con e-parent\" data-id=\"e2cd145\" data-element_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-384e6ec elementor-widget elementor-widget-heading\" data-id=\"384e6ec\" data-element_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\">Unverzichtbare Ausr\u00fcstung f\u00fcr die Dichtheitspr\u00fcfung von Spritzen<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4cd2af2 elementor-widget elementor-widget-text-editor\" data-id=\"4cd2af2\" 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\t\t<p data-start=\"2850\" data-end=\"2893\">Die Ausr\u00fcstung f\u00fcr diesen Test umfasst:<\/p>\n<ul>\n<li data-start=\"2897\" data-end=\"2985\"><strong data-start=\"2897\" data-end=\"2941\">Universal-Zug- und Druckpr\u00fcfger\u00e4t<\/strong> oder <strong data-start=\"2945\" data-end=\"2985\">Druckluftzufuhrsystem<\/strong><\/li>\n<li data-start=\"2988\" data-end=\"3038\"><strong data-start=\"2988\" data-end=\"3006\">Spritzenhalter<\/strong> mit einem sicheren Verschlussmechanismus<\/li>\n<li data-start=\"3041\" data-end=\"3116\"><strong data-start=\"3041\" data-end=\"3071\">Druckmesser oder Software<\/strong> die in der Lage sind, 110 kPa zu erreichen und zu halten<\/li>\n<li data-start=\"3119\" data-end=\"3208\"><strong data-start=\"3119\" data-end=\"3165\">Datenerfassungssystem mit hoher Abtastrate<\/strong> (empfohlen 500 Hz f\u00fcr Spitzenmessungen)<\/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<div class=\"elementor-element elementor-element-4bdb15f e-flex e-con-boxed e-con e-parent\" data-id=\"4bdb15f\" data-element_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-f031e68 elementor-widget elementor-widget-heading\" data-id=\"f031e68\" data-element_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\">Cell Instruments' L\u00f6sungen:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9831b44 elementor-widget elementor-widget-text-editor\" data-id=\"9831b44\" 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\t\t<p data-start=\"3210\" data-end=\"3472\">Durchf\u00fchrung von Dichtheitspr\u00fcfungen f\u00fcr Spritzen gem\u00e4\u00df ISO 11040-4, <strong data-start=\"3307\" data-end=\"3373\">Cell Instruments bietet anpassbare Plattformen f\u00fcr Spritzentests<\/strong>, Unsere Systeme sind sowohl mit Druckluft als auch mit mechanischer Kraftanwendung kompatibel. Unsere Systeme gew\u00e4hrleisten:<\/p>\n<ul>\n<li data-start=\"3476\" data-end=\"3517\"><strong data-start=\"3476\" data-end=\"3517\">Genaue Kontrolle des Innendrucks<\/strong><\/li>\n<li data-start=\"3520\" data-end=\"3560\"><strong data-start=\"3520\" data-end=\"3560\">Hochfrequenzabtastung bis zu 500 Hz<\/strong><\/li>\n<li data-start=\"3563\" data-end=\"3610\"><strong data-start=\"3563\" data-end=\"3610\">Volle \u00dcbereinstimmung mit den ISO-Pr\u00fcfverfahren<\/strong><\/li>\n<li data-start=\"3613\" data-end=\"3675\"><strong data-start=\"3613\" data-end=\"3649\">Automatisierte Dokumentationsfunktionen<\/strong> f\u00fcr eine pr\u00fcfungsreife Berichterstattung<\/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<div class=\"elementor-element elementor-element-d0f3e8d e-flex e-con-boxed e-con e-parent\" data-id=\"d0f3e8d\" data-element_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<div class=\"elementor-element elementor-element-bdde50c e-con-full e-flex e-con e-child\" data-id=\"bdde50c\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4b4c297 elementor-widget elementor-widget-heading\" data-id=\"4b4c297\" data-element_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\">Cell Instruments' L\u00f6sungen:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f28aead elementor-widget elementor-widget-text-editor\" data-id=\"f28aead\" 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\t\t<p data-start=\"3210\" data-end=\"3472\">Durchf\u00fchrung von Dichtheitspr\u00fcfungen f\u00fcr Spritzen gem\u00e4\u00df ISO 11040-4, <strong data-start=\"3307\" data-end=\"3373\">Cell Instruments bietet anpassbare Plattformen f\u00fcr Spritzentests<\/strong>, Unsere Systeme sind sowohl mit Druckluft als auch mit mechanischer Kraftanwendung kompatibel. Unsere Systeme gew\u00e4hrleisten:<\/p>\n<ul>\n<li data-start=\"3476\" data-end=\"3517\"><strong data-start=\"3476\" data-end=\"3517\">Genaue Kontrolle des Innendrucks<\/strong><\/li>\n<li data-start=\"3520\" data-end=\"3560\"><strong data-start=\"3520\" data-end=\"3560\">Hochfrequenzabtastung bis zu 500 Hz<\/strong><\/li>\n<li data-start=\"3563\" data-end=\"3610\"><strong data-start=\"3563\" data-end=\"3610\">Volle \u00dcbereinstimmung mit den ISO-Pr\u00fcfverfahren<\/strong><\/li>\n<li data-start=\"3613\" data-end=\"3675\"><strong data-start=\"3613\" data-end=\"3649\">Automatisierte Dokumentationsfunktionen<\/strong> f\u00fcr eine pr\u00fcfungsreife Berichterstattung<\/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<div class=\"elementor-element elementor-element-513146a e-flex e-con-boxed e-con e-parent\" data-id=\"513146a\" data-element_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<div class=\"elementor-element elementor-element-f93229d e-con-full e-flex e-con e-child\" data-id=\"f93229d\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ad6986d elementor-widget elementor-widget-heading\" data-id=\"ad6986d\" data-element_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\">Datenerfassung und Dokumentation<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b242490 elementor-widget elementor-widget-text-editor\" data-id=\"b242490\" 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\t\t<p data-start=\"3720\" data-end=\"3781\">Nach Angaben von <em data-start=\"3733\" data-end=\"3743\">Anhang G2<\/em>, muss ein vollst\u00e4ndiger Pr\u00fcfbericht enthalten:<\/p>\n<ul>\n<li data-start=\"3785\" data-end=\"3835\"><strong data-start=\"3785\" data-end=\"3805\">Angewandter Druck<\/strong> (kPa) oder \u00e4quivalente Kraft (N)<\/li>\n<li data-start=\"3838\" data-end=\"3867\"><strong data-start=\"3838\" data-end=\"3867\">Anzahl der gepr\u00fcften Spritzen<\/strong><\/li>\n<li data-start=\"3870\" data-end=\"3905\"><strong data-start=\"3870\" data-end=\"3905\">Anzahl der bestandenen\/nicht bestandenen Proben<\/strong><\/li>\n<li data-start=\"3908\" data-end=\"3945\"><strong data-start=\"3908\" data-end=\"3945\">Visuelle Beobachtungen oder Abweichungen<\/strong><\/li>\n<li data-start=\"3946\" data-end=\"4011\">\n<p data-start=\"3948\" data-end=\"4011\"><strong data-start=\"3948\" data-end=\"3984\">R\u00fcckverfolgbarkeit der Einrichtungsparameter<\/strong> (manuell oder \u00fcber Software)<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"4013\" data-end=\"4193\">Durch die Dokumentation der Testbedingungen und -ergebnisse weisen die Hersteller die Einhaltung der ISO 11040-4 nach und gew\u00e4hrleisten <strong data-start=\"4123\" data-end=\"4150\">regulatorische R\u00fcckverfolgbarkeit<\/strong>-ein Muss f\u00fcr pharmazeutische Qualit\u00e4tssysteme.<\/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<div class=\"elementor-element elementor-element-c13f4f1 e-con-full e-flex e-con e-child\" data-id=\"c13f4f1\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-fa7bb58 elementor-widget elementor-widget-heading\" data-id=\"fa7bb58\" data-element_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\">Berechnung der inneren Kraft<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e89f57a elementor-widget elementor-widget-text-editor\" data-id=\"e89f57a\" 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\t\t<p data-start=\"4232\" data-end=\"4417\">Bei Einrichtungen, die mechanische Kraft anstelle von Luftdruck anwenden, ist die erforderliche <strong data-start=\"4311\" data-end=\"4324\">Kraft (F)<\/strong> um 110 kPa Innendruck zu simulieren, kann mit den Formeln aus ISO 11040-4 berechnet werden:<\/p>\n<blockquote data-start=\"4419\" data-end=\"4459\">\n<p data-start=\"4421\" data-end=\"4459\"><strong data-start=\"4421\" data-end=\"4448\">F = p \u00d7 \u03c0\/4 \u00d7 d\u00b2 \u00d7 10-\u00b3<\/strong><br data-start=\"4448\" data-end=\"4451\" \/>Wo:<\/p>\n<\/blockquote>\n<ul>\n<li data-start=\"4462\" data-end=\"4488\"><strong data-start=\"4462\" data-end=\"4467\">F<\/strong> = Kraft in Newton<\/li>\n<li data-start=\"4491\" data-end=\"4519\"><strong data-start=\"4491\" data-end=\"4496\">p<\/strong> = Druck (110 kPa)<\/li>\n<li data-start=\"4522\" data-end=\"4562\"><strong data-start=\"4522\" data-end=\"4527\">d<\/strong> = Innendurchmesser der Spritze (mm)<\/li>\n<\/ul>\n<p data-start=\"4564\" data-end=\"4647\">Diese Berechnung tr\u00e4gt dazu bei, dass <strong data-start=\"4594\" data-end=\"4623\">genaue Testwiederholung<\/strong> und Ger\u00e4tekalibrierung.<\/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":"<p>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) [&#8230;]","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":"<!-- This site is optimized with the Yoast SEO plugin v25.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>ISO 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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