{"id":1228,"date":"2025-06-24T11:24:43","date_gmt":"2025-06-24T03:24:43","guid":{"rendered":"https:\/\/www.puncturetest.com\/?page_id=1228"},"modified":"2025-07-03T15:43:22","modified_gmt":"2025-07-03T07:43:22","slug":"iso-11040-4","status":"publish","type":"page","link":"https:\/\/www.puncturetest.com\/de\/standards\/iso-11040-4\/","title":{"rendered":"ISO 11040-4"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"1228\" class=\"elementor elementor-1228\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c60fdbb e-flex e-con-boxed e-con e-parent\" data-id=\"c60fdbb\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-db6fcba e-con-full e-flex e-con e-child\" data-id=\"db6fcba\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-9d1f798 e-con-full e-flex e-con e-child\" data-id=\"9d1f798\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-8cc5a79 e-con-full e-flex e-con e-child\" data-id=\"8cc5a79\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b6b67d4 elementor-widget elementor-widget-heading\" data-id=\"b6b67d4\" 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<h1 class=\"elementor-heading-title elementor-size-default\">ISO 11040-4<br><small>Nadelpenetrationstest<\/small><\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-69f526a elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"69f526a\" 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 class=\"\" data-start=\"0\" data-end=\"201\">Die Gew\u00e4hrleistung der Leistung und Sicherheit von vorgef\u00fcllten Spritzen ist bei medizinischen und pharmazeutischen Anwendungen von entscheidender Bedeutung. <strong data-start=\"521\" data-end=\"536\">ISO 11040-4<\/strong> skizziert die wesentlichen Spezifikationen f\u00fcr <strong data-start=\"579\" data-end=\"667\">Glaskolben f\u00fcr Injektionsmittel und sterilisierte, abf\u00fcllfertige Fertigspritzen<\/strong>. Eine der entscheidenden Qualit\u00e4tsbewertungen im Rahmen dieser Norm ist die <strong data-start=\"736\" data-end=\"770\">Nadelpenetrationstestverfahren<\/strong>die bewertet, wie leicht eine Spritzennadel in ein Standardmaterial eindringt.<\/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-eff30d4 elementor-button-align-stretch elementor-widget elementor-widget-form\" data-id=\"eff30d4\" data-element_type=\"widget\" data-settings=\"{&quot;button_width&quot;:&quot;25&quot;,&quot;step_next_label&quot;:&quot;Next&quot;,&quot;step_previous_label&quot;:&quot;Previous&quot;,&quot;step_type&quot;:&quot;number_text&quot;,&quot;step_icon_shape&quot;:&quot;circle&quot;}\" data-widget_type=\"form.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<form class=\"elementor-form\" method=\"post\" name=\"New Form\" action=\"\">\n\t\t\t<input type=\"hidden\" name=\"post_id\" value=\"1228\"\/>\n\t\t\t<input type=\"hidden\" name=\"form_id\" value=\"eff30d4\"\/>\n\t\t\t<input type=\"hidden\" name=\"referer_title\" value=\"Puncture Test\" \/>\n\n\t\t\t\n\t\t\t<div class=\"elementor-form-fields-wrapper elementor-labels-\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-name elementor-col-100 elementor-field-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-name\" class=\"elementor-field-label elementor-screen-only\">\n\t\t\t\t\t\t\t\tName\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[name]\" id=\"form-field-name\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"Name\" required=\"required\" aria-required=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-field_26b0101 elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-field_26b0101\" class=\"elementor-field-label elementor-screen-only\">\n\t\t\t\t\t\t\t\tUnternehmen\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[field_26b0101]\" id=\"form-field-field_26b0101\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"Unternehmen\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-email elementor-field-group elementor-column elementor-field-group-email elementor-col-100 elementor-field-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-email\" class=\"elementor-field-label elementor-screen-only\">\n\t\t\t\t\t\t\t\tE-Mail\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"email\" name=\"form_fields[email]\" id=\"form-field-email\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"E-Mail\" required=\"required\" aria-required=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-textarea elementor-field-group elementor-column elementor-field-group-message elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-message\" class=\"elementor-field-label elementor-screen-only\">\n\t\t\t\t\t\t\t\tNachricht\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t<textarea class=\"elementor-field-textual elementor-field  elementor-size-sm\" name=\"form_fields[message]\" id=\"form-field-message\" rows=\"4\" placeholder=\"Nachricht\"><\/textarea>\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-recaptcha elementor-field-group elementor-column elementor-field-group-field_50f0fd6 elementor-col-100\">\n\t\t\t\t\t<div class=\"elementor-field\" id=\"form-field-field_50f0fd6\"><div class=\"elementor-g-recaptcha\" data-sitekey=\"6LcO3HUrAAAAAKhAi3KjswdM4-_7i5zKd1s5FO2N\" data-type=\"v2_checkbox\" data-theme=\"light\" data-size=\"normal\"><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-group elementor-column elementor-field-type-submit elementor-col-25 e-form__buttons\">\n\t\t\t\t\t<button class=\"elementor-button elementor-size-sm\" type=\"submit\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Senden Sie<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/button>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<input type=\"hidden\" name=\"trp-form-language\" value=\"de\"\/><\/form>\n\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-163fe1b e-con-full e-flex e-con e-child\" data-id=\"163fe1b\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\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-3f2b60d e-flex e-con-boxed e-con e-parent\" data-id=\"3f2b60d\" 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-7c5f6d2 elementor-widget elementor-widget-heading\" data-id=\"7c5f6d2\" 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\">Was ist ISO 11040-4 und warum ist sie so wichtig?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6126588 elementor-widget elementor-widget-text-editor\" data-id=\"6126588\" 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=\"1111\" data-end=\"1465\"><strong data-start=\"1111\" data-end=\"1126\">ISO 11040-4<\/strong> ist eine weltweit anerkannte Norm der Reihe ISO 11040, die sich speziell mit <strong data-start=\"1213\" data-end=\"1246\">Glasf\u00e4sser f\u00fcr Injektionsmittel<\/strong> und <strong data-start=\"1251\" data-end=\"1288\">vormontierte sterilisierte Spritzen<\/strong> die f\u00fcr die aseptische Abf\u00fcllung bestimmt sind. Sie stellt sicher, dass diese Komponenten strenge Ma\u00df- und Funktionskriterien erf\u00fcllen, um Produktsterilit\u00e4t, Kompatibilit\u00e4t und Patientensicherheit zu gew\u00e4hrleisten.<\/p><p data-start=\"1467\" data-end=\"1763\">Ein wesentlicher Bestandteil dieser Norm ist die <strong data-start=\"1510\" data-end=\"1537\">Nadelpenetrationstest<\/strong>die die <strong data-start=\"1558\" data-end=\"1584\">mechanische Leistung<\/strong> der Nadel w\u00e4hrend des Gebrauchs. Die Leichtigkeit, mit der eine Nadel ein Substrat durchstechen kann, spiegelt sich in ihrer <strong data-start=\"1681\" data-end=\"1731\">Sch\u00e4rfe, Materialqualit\u00e4t, Oberfl\u00e4chenbehandlung<\/strong>und die Konsistenz der Herstellung.<\/p><p data-start=\"1765\" data-end=\"1794\">Diese Pr\u00fcfung ist entscheidend f\u00fcr:<\/p><ul><li data-start=\"1798\" data-end=\"1858\">Sicherstellung reibungsloser Injektionen mit minimalem Unbehagen f\u00fcr den Patienten<\/li><li data-start=\"1861\" data-end=\"1900\">Verhinderung von Nadelbruch oder -verbiegung<\/li><li data-start=\"1903\" data-end=\"1956\">Gew\u00e4hrleistung der Kompatibilit\u00e4t mit Verpackungsmaterialien<\/li><li data-start=\"1959\" data-end=\"2008\">Best\u00e4tigung der Konformit\u00e4t f\u00fcr die Einreichung bei den Beh\u00f6rden<\/li><\/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-580df19 e-flex e-con-boxed e-con e-parent\" data-id=\"580df19\" 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-8262e73 elementor-widget elementor-widget-heading\" data-id=\"8262e73\" 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\">Erl\u00e4uterung der Methode des Nadeldurchdringungstests<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7c71437 elementor-widget elementor-widget-text-editor\" data-id=\"7c71437\" 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=\"2061\" data-end=\"2365\">Die <strong data-start=\"2065\" data-end=\"2099\">Nadelpenetrationstestverfahren<\/strong>wie in Anhang F der ISO 11040-4 beschrieben, bewertet die <strong data-start=\"2153\" data-end=\"2222\">Kraft, die eine Spritzennadel ben\u00f6tigt, um eine definierte Testfolie zu durchstechen<\/strong>. Dieses Verfahren ist von der DIN 13097-4 abgeleitet und wird referenziert in <a href=\"https:\/\/www.puncturetest.com\/de\/standards\/iso-7864-needle-penetration-drag-force-test\/\"><strong data-start=\"2288\" data-end=\"2300\">ISO 7864<\/strong><\/a>eine weitere wichtige Norm f\u00fcr sterile Injektionsnadeln.<\/p><p data-start=\"2367\" data-end=\"2404\">Zu den wichtigsten Komponenten der Methode geh\u00f6ren:<\/p><ul><li data-start=\"2408\" data-end=\"2534\"><strong data-start=\"2408\" data-end=\"2426\">Pr\u00fcfger\u00e4t<\/strong>: A <strong data-start=\"2430\" data-end=\"2474\">Universal-Zug- und Druckpr\u00fcfger\u00e4t<\/strong> mit einem Kraftbereich bis zu 10 N und einer Geschwindigkeit von 20-200 mm\/min.<\/li><li data-start=\"2537\" data-end=\"2612\"><strong data-start=\"2537\" data-end=\"2554\">Abtastrate<\/strong>: 500 Hz wird f\u00fcr eine genaue Spitzenkrafterfassung empfohlen.<\/li><li data-start=\"2615\" data-end=\"2685\"><strong data-start=\"2615\" data-end=\"2632\">Nadelhalter<\/strong>: Gew\u00e4hrleistet die vertikale Ausrichtung f\u00fcr ein pr\u00e4zises Eindringen.<\/li><li data-start=\"2688\" data-end=\"2779\"><strong data-start=\"2688\" data-end=\"2701\">Testfolie<\/strong>: Material und Dicke sind zwischen dem Hersteller und dem Kunden zu vereinbaren.<\/li><li data-start=\"2782\" data-end=\"2861\"><strong data-start=\"2782\" data-end=\"2800\">Nadelmuster<\/strong>: Kann je nach Verwendungszweck silikonisiert oder unbehandelt sein.<\/li><li data-start=\"2864\" data-end=\"2992\"><strong data-start=\"2864\" data-end=\"2883\">Datenerhebung<\/strong>: A <strong data-start=\"2887\" data-end=\"2919\">Kraft-Weg-Kurve<\/strong> wird f\u00fcr jeden Test generiert und misst <strong data-start=\"2958\" data-end=\"2972\">Spitzenkraft<\/strong> und <strong data-start=\"2977\" data-end=\"2991\">Schleppkraft<\/strong>.<\/li><\/ul><p data-start=\"2994\" data-end=\"3141\">Die Methode garantiert, dass die <strong data-start=\"3025\" data-end=\"3068\">Nadelsch\u00e4rfe und Gleichm\u00e4\u00dfigkeit der Beschichtung<\/strong> liegen innerhalb akzeptabler Parameter und gew\u00e4hrleisten eine zuverl\u00e4ssige Leistung der Spritze.<\/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-a9693b2 e-flex e-con-boxed e-con e-parent\" data-id=\"a9693b2\" 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-b44c843 elementor-widget elementor-widget-heading\" data-id=\"b44c843\" 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\">Bew\u00e4hrte Praktiken f\u00fcr den Spritzennadeltest<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3e38b53 elementor-widget elementor-widget-text-editor\" data-id=\"3e38b53\" 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=\"3188\" data-end=\"3329\">Bei der Durchf\u00fchrung einer <strong data-start=\"3206\" data-end=\"3229\">Spritzen-Nadel-Test<\/strong>ist es wichtig, die ISO-Richtlinien zu befolgen und gleichzeitig den Prozess f\u00fcr Konsistenz und Genauigkeit zu optimieren:<\/p><ol><li><strong data-start=\"3334\" data-end=\"3362\">Verwendung validierter Substrate<\/strong>: Wie zum Beispiel <strong data-start=\"3372\" data-end=\"3388\">Latexgummi<\/strong>, <strong data-start=\"3390\" data-end=\"3406\">Polyurethan<\/strong>, oder <strong data-start=\"3411\" data-end=\"3427\">Polyethylen<\/strong> die den Zustand der Haut oder der Verpackung nachahmen.<\/li><li><strong data-start=\"3472\" data-end=\"3507\">Kontrolle der Umweltvariablen<\/strong>: Konsistent bleiben <strong data-start=\"3529\" data-end=\"3557\">Temperatur und Feuchtigkeit<\/strong> w\u00e4hrend der Pr\u00fcfung.<\/li><li><strong data-start=\"3577\" data-end=\"3599\">Wiederverwendung von Proben vermeiden<\/strong>: F\u00fcr jeden Test muss ein neuer Abschnitt der Folie oder des Substrats verwendet werden.<\/li><li><strong data-start=\"3661\" data-end=\"3683\">Sicherstellen der Kalibrierung<\/strong>: Die Pr\u00fcfmaschine sollte regelm\u00e4\u00dfig mit r\u00fcckf\u00fchrbaren Standards kalibriert werden.<\/li><li><strong data-start=\"3765\" data-end=\"3788\">Gr\u00fcndlich dokumentieren<\/strong>: Geben Sie im Pr\u00fcfbericht die Folienspezifikationen, die Pr\u00fcfgeschwindigkeit, die Anzahl der Proben und alle Kraftkurven an.<\/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-a6df764 e-flex e-con-boxed e-con e-parent\" data-id=\"a6df764\" 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-15bd215 elementor-widget elementor-widget-heading\" data-id=\"15bd215\" 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\"><a href=\"https:\/\/www.puncturetest.com\/de\/tissue-paper-ball-burst-strength-test\/\">Nadelpenetrationstestger\u00e4te f\u00fcr die Einhaltung der ISO 11040-4<\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e5f91e3 e-con-full e-flex e-con e-child\" data-id=\"e5f91e3\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-44c6d75 elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"44c6d75\" 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=\"3963\" data-end=\"4156\">F\u00fcr Labors und Hersteller, die Nadelpenetrationstests gem\u00e4\u00df ISO 11040-4 durchf\u00fchren m\u00fcssen, <strong data-start=\"4060\" data-end=\"4114\">Cell Instruments' NPT-01 Nadelpenetrationstester<\/strong> ist eine zuverl\u00e4ssige und leistungsstarke L\u00f6sung.<\/p><p data-start=\"4158\" data-end=\"4197\">Die wichtigsten Merkmale des <strong data-start=\"4178\" data-end=\"4188\">NPT-01<\/strong> umfassen:<\/p><ul><li>Hochpr\u00e4zise Kraftsensoren mit \u00b10,5% Genauigkeit<\/li><li>Einstellbare Pr\u00fcfgeschwindigkeiten von 20 mm\/min bis 200 mm\/min<\/li><li>Echtzeit <strong data-start=\"4320\" data-end=\"4349\">Kraft-Weg-Kurven<\/strong> mit exportierbaren Daten<\/li><li>Anpassbare Nadelhalter und Folienklammern<\/li><li>Kompatibel mit verschiedenen Spritzengr\u00f6\u00dfen und Nadeldurchmessern<\/li><\/ul><p data-start=\"4482\" data-end=\"4726\">Die Verwendung des <strong data-start=\"4492\" data-end=\"4502\">NPT-01<\/strong> vereinfacht die Einhaltung der Normen ISO 11040-4 und ISO 7864 und verringert gleichzeitig die Variabilit\u00e4t und verbessert die Datenintegrit\u00e4t. Es ist besonders gut geeignet f\u00fcr <strong data-start=\"4648\" data-end=\"4684\">F&amp;E-Laboratorien, QC-Abteilungen<\/strong>und <strong data-start=\"4690\" data-end=\"4725\">regulatorische Validierungsprozesse<\/strong>.<\/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-e5f0632 elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"e5f0632\" 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.puncturetest.com\/de\/penetrability-tester-needle-penetration-test-method\/\">\n\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"500\" height=\"400\" src=\"https:\/\/www.puncturetest.com\/wp-content\/uploads\/2025\/06\/ISO-11040-4-Needle-Penetration-Test-Method.webp\" class=\"attachment-full size-full wp-image-1230\" alt=\"ISO 11040-4 Methode zur Pr\u00fcfung der Nadeldurchdringung\" srcset=\"https:\/\/www.puncturetest.com\/wp-content\/uploads\/2025\/06\/ISO-11040-4-Needle-Penetration-Test-Method.webp 500w, https:\/\/www.puncturetest.com\/wp-content\/uploads\/2025\/06\/ISO-11040-4-Needle-Penetration-Test-Method-300x240.webp 300w, https:\/\/www.puncturetest.com\/wp-content\/uploads\/2025\/06\/ISO-11040-4-Needle-Penetration-Test-Method-15x12.webp 15w\" sizes=\"(max-width: 500px) 100vw, 500px\" \/>\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>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6821011 e-con-full e-flex e-con e-parent\" data-id=\"6821011\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-665057d elementor-cta--skin-classic elementor-animated-content elementor-bg-transform elementor-bg-transform-zoom-in elementor-widget elementor-widget-call-to-action\" data-id=\"665057d\" data-element_type=\"widget\" data-widget_type=\"call-to-action.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-cta\">\n\t\t\t\t\t<div class=\"elementor-cta__bg-wrapper\">\n\t\t\t\t<div class=\"elementor-cta__bg elementor-bg\" style=\"background-image: url(https:\/\/www.puncturetest.com\/wp-content\/uploads\/2025\/02\/Elastomeric-Closures-Penetrability-Test-1024x256.webp);\" role=\"img\" aria-label=\"Pr\u00fcfung der Durchl\u00e4ssigkeit von Elastomerverschl\u00fcssen\"><\/div>\n\t\t\t\t<div class=\"elementor-cta__bg-overlay\"><\/div>\n\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-cta__content\">\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t<h2 class=\"elementor-cta__title elementor-cta__content-item elementor-content-item\">\n\t\t\t\t\t\tStellen Sie noch heute sicher, dass Ihre Spritzennadeln den Vorschriften entsprechen\t\t\t\t\t<\/h2>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-cta__description elementor-cta__content-item elementor-content-item\">\n\t\t\t\t\t\tVerstehen und Anwenden der <b>ISO 11040-4 Nadelpenetrationstestverfahren<\/b> ist entscheidend f\u00fcr jeden Hersteller, der <b>vorgef\u00fcllte Spritzen oder Injektionsnadeln<\/b>. Die Norm enth\u00e4lt klare Richtlinien f\u00fcr Ausr\u00fcstung, Testverfahren und Berichterstattung, um die Integrit\u00e4t der Nadel und die Sicherheit der Patienten zu gew\u00e4hrleisten. Durch die Integration von <b>zuverl\u00e4ssige Spritzen-Nadel-Testger\u00e4te<\/b> wie die <b>Puncturetest.com NPT-01<\/b>k\u00f6nnen Unternehmen die Einhaltung von Vorschriften optimieren, Risiken verringern und die Produktqualit\u00e4t verbessern.\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-cta__button-wrapper elementor-cta__content-item elementor-content-item\">\n\t\t\t\t\t<a class=\"elementor-cta__button elementor-button elementor-size-\" href=\"https:\/\/www.puncturetest.com\/de\/contact\/\">\n\t\t\t\t\t\tHier klicken\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\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>","protected":false},"excerpt":{"rendered":"<p>ISO 11040-4Needle Penetration Test Ensuring the performance and safety of prefilled syringes is vital in medical and pharmaceutical applications. ISO 11040-4 outlines the essential specifications for glass barrels for injectables and sterilized subassembled syringes ready for filling. One of the critical quality assessments under this standard is the needle penetration test method, which evaluates how [&hellip;]<\/p>","protected":false},"author":3,"featured_media":0,"parent":974,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-1228","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>ISO 11040-4 Needle Penetration Test Method - Syringe Needle Test<\/title>\n<meta name=\"description\" content=\"ISO 11040-4 Annex F needle penetration test method, syringe needle testing, and reliable test equipment like the NPT-01.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.puncturetest.com\/de\/standards\/iso-11040-4\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ISO 11040-4 Needle Penetration Test Method - Syringe Needle Test\" \/>\n<meta property=\"og:description\" content=\"ISO 11040-4 Annex F needle penetration test method, syringe needle testing, and reliable test equipment like the NPT-01.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.puncturetest.com\/de\/standards\/iso-11040-4\/\" \/>\n<meta property=\"og:site_name\" content=\"Puncture Test\" \/>\n<meta property=\"article:modified_time\" content=\"2025-07-03T07:43:22+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.puncturetest.com\/wp-content\/uploads\/2025\/06\/ISO-11040-4-Needle-Penetration-Test-Method.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"500\" \/>\n\t<meta property=\"og:image:height\" content=\"400\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/webp\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Gesch\u00e4tzte Lesezeit\" \/>\n\t<meta name=\"twitter:data1\" content=\"3\u00a0Minuten\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.puncturetest.com\/standards\/iso-11040-4\/\",\"url\":\"https:\/\/www.puncturetest.com\/standards\/iso-11040-4\/\",\"name\":\"ISO 11040-4 Needle Penetration Test Method - 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