{"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\/cs\/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>Test penetrace jehlou<\/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\">Zaji\u0161t\u011bn\u00ed v\u00fdkonu a bezpe\u010dnosti p\u0159edpln\u011bn\u00fdch injek\u010dn\u00edch st\u0159\u00edka\u010dek m\u00e1 z\u00e1sadn\u00ed v\u00fdznam pro l\u00e9ka\u0159sk\u00e9 a farmaceutick\u00e9 aplikace. <strong data-start=\"521\" data-end=\"536\">ISO 11040-4<\/strong> popisuje z\u00e1kladn\u00ed specifikace pro <strong data-start=\"579\" data-end=\"667\">sklen\u011bn\u00e9 sudy na injek\u010dn\u00ed materi\u00e1l a sterilizovan\u00e9 smontovan\u00e9 injek\u010dn\u00ed st\u0159\u00edka\u010dky p\u0159ipraven\u00e9 k pln\u011bn\u00ed.<\/strong>. Jedn\u00edm z kritick\u00fdch hodnocen\u00ed kvality podle t\u00e9to normy je <strong data-start=\"736\" data-end=\"770\">metoda penetra\u010dn\u00ed zkou\u0161ky jehlou<\/strong>, kter\u00fd hodnot\u00ed, jak snadno pronikne jehla injek\u010dn\u00ed st\u0159\u00edka\u010dky standardn\u00edm materi\u00e1lem.<\/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\tN\u00e1zev\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=\"N\u00e1zev\" 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\tSpole\u010dnost\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=\"Spole\u010dnost\">\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\tZpr\u00e1va\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=\"Zpr\u00e1va\"><\/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\">Odeslat<\/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=\"cs\"\/><\/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\">Co je ISO 11040-4 a pro\u010d je d\u016fle\u017eit\u00e1<\/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> je celosv\u011btov\u011b uzn\u00e1vanou normou \u0159ady ISO 11040, kter\u00e1 se konkr\u00e9tn\u011b zab\u00fdv\u00e1 <strong data-start=\"1213\" data-end=\"1246\">sklen\u011bn\u00e9 sudy na injek\u010dn\u00ed p\u0159\u00edpravky<\/strong> a <strong data-start=\"1251\" data-end=\"1288\">p\u0159edem sestaven\u00e9 sterilizovan\u00e9 injek\u010dn\u00ed st\u0159\u00edka\u010dky<\/strong> ur\u010den\u00e9 k aseptick\u00e9mu pln\u011bn\u00ed. Zaji\u0161\u0165uje, aby tyto komponenty spl\u0148ovaly p\u0159\u00edsn\u00e1 rozm\u011brov\u00e1 a funk\u010dn\u00ed krit\u00e9ria pro zachov\u00e1n\u00ed sterility, kompatibility a bezpe\u010dnosti pacient\u016f.<\/p><p data-start=\"1467\" data-end=\"1763\">V\u00fdznamnou sou\u010d\u00e1st\u00ed t\u00e9to normy je <strong data-start=\"1510\" data-end=\"1537\">penetra\u010dn\u00ed test jehlou<\/strong>, kter\u00fd ov\u011b\u0159uje <strong data-start=\"1558\" data-end=\"1584\">mechanick\u00fd v\u00fdkon<\/strong> jehly b\u011bhem pou\u017e\u00edv\u00e1n\u00ed. Snadnost, s jakou jehla prop\u00edchne podklad, se odr\u00e1\u017e\u00ed na jej\u00ed kvalit\u011b. <strong data-start=\"1681\" data-end=\"1731\">ostrost, kvalita materi\u00e1lu, povrchov\u00e1 \u00faprava<\/strong>a konzistenci v\u00fdroby.<\/p><p data-start=\"1765\" data-end=\"1794\">Toto testov\u00e1n\u00ed je d\u016fle\u017eit\u00e9 pro:<\/p><ul><li data-start=\"1798\" data-end=\"1858\">Zaji\u0161t\u011bn\u00ed hladk\u00e9ho pr\u016fb\u011bhu injekc\u00ed s minim\u00e1ln\u00edm nepohodl\u00edm pacienta<\/li><li data-start=\"1861\" data-end=\"1900\">Prevence zlomen\u00ed nebo ohnut\u00ed jehly<\/li><li data-start=\"1903\" data-end=\"1956\">Zaji\u0161t\u011bn\u00ed kompatibility s obalov\u00fdmi materi\u00e1ly<\/li><li data-start=\"1959\" data-end=\"2008\">Potvrzen\u00ed shody pro p\u0159edlo\u017een\u00ed regula\u010dn\u00edm org\u00e1n\u016fm<\/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\">Vysv\u011btlen\u00ed metody penetra\u010dn\u00ed zkou\u0161ky jehlou<\/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\">Na str\u00e1nk\u00e1ch <strong data-start=\"2065\" data-end=\"2099\">metoda penetra\u010dn\u00ed zkou\u0161ky jehlou<\/strong>, jak je podrobn\u011b pops\u00e1no v p\u0159\u00edloze F normy ISO 11040-4, posuzuje <strong data-start=\"2153\" data-end=\"2222\">s\u00edla pot\u0159ebn\u00e1 k tomu, aby jehla injek\u010dn\u00ed st\u0159\u00edka\u010dky prop\u00edchla definovanou zku\u0161ebn\u00ed f\u00f3lii.<\/strong>. Tento postup je odvozen z normy DIN 13097-4 a je na n\u011bj odkazov\u00e1no v dokumentu <a href=\"https:\/\/www.puncturetest.com\/cs\/standards\/iso-7864-needle-penetration-drag-force-test\/\"><strong data-start=\"2288\" data-end=\"2300\">ISO 7864<\/strong><\/a>, dal\u0161\u00ed d\u016fle\u017eit\u00e1 norma vztahuj\u00edc\u00ed se na steriln\u00ed injek\u010dn\u00ed jehly.<\/p><p data-start=\"2367\" data-end=\"2404\">Mezi hlavn\u00ed sou\u010d\u00e1sti metody pat\u0159\u00ed:<\/p><ul><li data-start=\"2408\" data-end=\"2534\"><strong data-start=\"2408\" data-end=\"2426\">Zku\u0161ebn\u00ed p\u0159\u00edstroj<\/strong>: A <strong data-start=\"2430\" data-end=\"2474\">univerz\u00e1ln\u00ed tahov\u00fd a tlakov\u00fd tester<\/strong> s rozsahem s\u00edly a\u017e 10 N a rychlost\u00ed 20-200 mm\/min.<\/li><li data-start=\"2537\" data-end=\"2612\"><strong data-start=\"2537\" data-end=\"2554\">Rychlost odb\u011bru vzork\u016f<\/strong>: Pro p\u0159esnou detekci \u0161pi\u010dkov\u00e9 s\u00edly se doporu\u010duje frekvence 500 Hz.<\/li><li data-start=\"2615\" data-end=\"2685\"><strong data-start=\"2615\" data-end=\"2632\">Dr\u017e\u00e1k jehly<\/strong>: Zaji\u0161\u0165uje vertik\u00e1ln\u00ed vyrovn\u00e1n\u00ed pro p\u0159esn\u00e9 pronik\u00e1n\u00ed.<\/li><li data-start=\"2688\" data-end=\"2779\"><strong data-start=\"2688\" data-end=\"2701\">Testovac\u00ed f\u00f3lie<\/strong>: Materi\u00e1l a tlou\u0161\u0165ku dohodne v\u00fdrobce se z\u00e1kazn\u00edkem.<\/li><li data-start=\"2782\" data-end=\"2861\"><strong data-start=\"2782\" data-end=\"2800\">Vzorky jehel<\/strong>: V z\u00e1vislosti na zam\u00fd\u0161len\u00e9m pou\u017eit\u00ed m\u016f\u017ee b\u00fdt silikonizovan\u00fd nebo neo\u0161et\u0159en\u00fd.<\/li><li data-start=\"2864\" data-end=\"2992\"><strong data-start=\"2864\" data-end=\"2883\">Sb\u011br dat<\/strong>: A <strong data-start=\"2887\" data-end=\"2919\">k\u0159ivka z\u00e1vislosti s\u00edly na posunu<\/strong> se generuje pro ka\u017ed\u00fd test, p\u0159i\u010dem\u017e se m\u011b\u0159\u00ed <strong data-start=\"2958\" data-end=\"2972\">\u0161pi\u010dkov\u00e1 s\u00edla<\/strong> a <strong data-start=\"2977\" data-end=\"2991\">ta\u017en\u00e1 s\u00edla<\/strong>.<\/li><\/ul><p data-start=\"2994\" data-end=\"3141\">Metoda zaru\u010duje, \u017ee <strong data-start=\"3025\" data-end=\"3068\">ostrost jehel a rovnom\u011brnost povlaku<\/strong> jsou v r\u00e1mci p\u0159ijateln\u00fdch parametr\u016f, co\u017e zaji\u0161\u0165uje spolehliv\u00fd v\u00fdkon st\u0159\u00edka\u010dky.<\/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\">Osv\u011bd\u010den\u00e9 postupy pro testov\u00e1n\u00ed injek\u010dn\u00ed jehlou<\/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\">P\u0159i prov\u00e1d\u011bn\u00ed <strong data-start=\"3206\" data-end=\"3229\">zkou\u0161ka jehlou injek\u010dn\u00ed st\u0159\u00edka\u010dky<\/strong>, je nezbytn\u00e9 dodr\u017eovat pokyny ISO a z\u00e1rove\u0148 optimalizovat proces pro zaji\u0161t\u011bn\u00ed konzistence a p\u0159esnosti:<\/p><ol><li><strong data-start=\"3334\" data-end=\"3362\">Pou\u017eit\u00ed ov\u011b\u0159en\u00fdch substr\u00e1t\u016f<\/strong>: Jako nap\u0159. <strong data-start=\"3372\" data-end=\"3388\">latexov\u00e1 pry\u017e<\/strong>, <strong data-start=\"3390\" data-end=\"3406\">polyuretan<\/strong>, nebo <strong data-start=\"3411\" data-end=\"3427\">polyethylen<\/strong> kter\u00e9 napodobuj\u00ed stav k\u016f\u017ee nebo obalu.<\/li><li><strong data-start=\"3472\" data-end=\"3507\">\u0158\u00edzen\u00ed prom\u011bnn\u00fdch prost\u0159ed\u00ed<\/strong>: Udr\u017eujte konzistentn\u00ed <strong data-start=\"3529\" data-end=\"3557\">teplota a vlhkost<\/strong> b\u011bhem testov\u00e1n\u00ed.<\/li><li><strong data-start=\"3577\" data-end=\"3599\">Zamezte opakovan\u00e9mu pou\u017eit\u00ed vzorku<\/strong>: P\u0159i ka\u017ed\u00e9 zkou\u0161ce se mus\u00ed pou\u017e\u00edt nov\u00e1 \u010d\u00e1st f\u00f3lie nebo podkladu.<\/li><li><strong data-start=\"3661\" data-end=\"3683\">Zaji\u0161t\u011bn\u00ed kalibrace<\/strong>: Zku\u0161ebn\u00ed stroj by m\u011bl b\u00fdt pravideln\u011b kalibrov\u00e1n pomoc\u00ed sledovateln\u00fdch etalon\u016f.<\/li><li><strong data-start=\"3765\" data-end=\"3788\">D\u016fkladn\u011b zdokumentujte<\/strong>: Do protokolu o zkou\u0161ce uve\u010fte specifikace f\u00f3lie, rychlost zkou\u0161ky, po\u010det vzork\u016f a v\u0161echny silok\u0159ivky.<\/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\/cs\/tissue-paper-ball-burst-strength-test\/\">Za\u0159\u00edzen\u00ed pro testov\u00e1n\u00ed penetrace jehlou pro spln\u011bn\u00ed po\u017eadavk\u016f normy 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\">Pro laborato\u0159e a v\u00fdrobce, kte\u0159\u00ed pot\u0159ebuj\u00ed prov\u00e1d\u011bt penetra\u010dn\u00ed testy jehlou v souladu s normou ISO 11040-4, <strong data-start=\"4060\" data-end=\"4114\">Cell Instruments' NPT-01 jehlov\u00fd penetra\u010dn\u00ed tester<\/strong> je spolehliv\u00e9 a vysoce v\u00fdkonn\u00e9 \u0159e\u0161en\u00ed.<\/p><p data-start=\"4158\" data-end=\"4197\">Kl\u00ed\u010dov\u00e9 vlastnosti <strong data-start=\"4178\" data-end=\"4188\">NPT-01<\/strong> zahrnuj\u00ed:<\/p><ul><li>Vysoce p\u0159esn\u00e9 sn\u00edma\u010de s\u00edly s p\u0159esnost\u00ed \u00b10,5%<\/li><li>Nastaviteln\u00e9 zku\u0161ebn\u00ed rychlosti od 20 mm\/min do 200 mm\/min<\/li><li>V re\u00e1ln\u00e9m \u010dase <strong data-start=\"4320\" data-end=\"4349\">k\u0159ivky s\u00edla-posun<\/strong> s mo\u017enost\u00ed exportu dat<\/li><li>P\u0159izp\u016fsobiteln\u00e9 dr\u017e\u00e1ky jehel a svorky na f\u00f3lie<\/li><li>Kompatibiln\u00ed s r\u016fzn\u00fdmi velikostmi injek\u010dn\u00edch st\u0159\u00edka\u010dek a jehel.<\/li><\/ul><p data-start=\"4482\" data-end=\"4726\">Pou\u017eit\u00ed <strong data-start=\"4492\" data-end=\"4502\">NPT-01<\/strong> zefektiv\u0148uje shodu s normami ISO 11040-4 a ISO 7864 a z\u00e1rove\u0148 sni\u017euje variabilitu a zvy\u0161uje integritu dat. Je obzvl\u00e1\u0161t\u011b vhodn\u00fd pro <strong data-start=\"4648\" data-end=\"4684\">Laborato\u0159e v\u00fdzkumu a v\u00fdvoje, odd\u011blen\u00ed kontroly kvality<\/strong>a <strong data-start=\"4690\" data-end=\"4725\">regula\u010dn\u00ed valida\u010dn\u00ed procesy<\/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\/cs\/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 Zku\u0161ebn\u00ed metoda penetrace jehlou\" 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=\"Elastomerov\u00e9 uz\u00e1v\u011bry Zkou\u0161ka prody\u0161nosti\"><\/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\tZajist\u011bte si shodu s po\u017eadavky na injek\u010dn\u00ed jehly je\u0161t\u011b dnes\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\tPochopen\u00ed a pou\u017eit\u00ed <b>ISO 11040-4 metoda zkou\u0161ky pr\u016fniku jehly<\/b> je pro ka\u017ed\u00e9ho v\u00fdrobce, kter\u00fd vyr\u00e1b\u00ed <b>p\u0159edpln\u011bn\u00e9 injek\u010dn\u00ed st\u0159\u00edka\u010dky nebo podko\u017en\u00ed jehly.<\/b>. Norma poskytuje jasn\u00e9 pokyny pro vybaven\u00ed, zku\u0161ebn\u00ed postupy a hl\u00e1\u0161en\u00ed, aby byla zaji\u0161t\u011bna integrita jehel a bezpe\u010dnost pacient\u016f. Integrac\u00ed <b>spolehliv\u00e9 za\u0159\u00edzen\u00ed pro testov\u00e1n\u00ed injek\u010dn\u00edch jehel<\/b> jako je <b>Puncturetest.com NPT-01<\/b>, mohou spole\u010dnosti zefektivnit dodr\u017eov\u00e1n\u00ed p\u0159edpis\u016f, sn\u00ed\u017eit rizika a zv\u00fd\u0161it kvalitu v\u00fdrobk\u016f.\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\/cs\/contact\/\">\n\t\t\t\t\t\tKlikn\u011bte zde\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\/cs\/standards\/iso-11040-4\/\" \/>\n<meta property=\"og:locale\" content=\"cs_CZ\" \/>\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\/cs\/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=\"Odhadovan\u00e1 doba \u010dten\u00ed\" \/>\n\t<meta name=\"twitter:data1\" content=\"3 minuty\" \/>\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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