{"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\/sl\/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>Preskus prodiranja z iglo<\/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\">Zagotavljanje u\u010dinkovitosti in varnosti vnaprej napolnjenih injekcijskih brizgalk je klju\u010dnega pomena v medicinskih in farmacevtskih aplikacijah. <strong data-start=\"521\" data-end=\"536\">ISO 11040-4<\/strong> opredeljuje bistvene specifikacije za <strong data-start=\"579\" data-end=\"667\">steklene posode za injekcijska zdravila in sterilizirane, delno sestavljene brizge, pripravljene za polnjenje<\/strong>. Ena od klju\u010dnih ocen kakovosti v okviru tega standarda je <strong data-start=\"736\" data-end=\"770\">preskusna metoda penetracije z iglo<\/strong>, ki meri, kako zlahka igla brizge prodre skozi standardni material.<\/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\tIme\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=\"Ime\" 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\tPodjetje\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=\"Podjetje\">\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-po\u0161ta\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-po\u0161ta\" 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\tSporo\u010dilo\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=\"Sporo\u010dilo\"><\/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\">Po\u0161lji<\/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=\"sl\"\/><\/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\">Kaj je standard ISO 11040-4 in zakaj je pomemben<\/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 svetovno priznan standard iz serije ISO 11040, ki se posebej nana\u0161a na <strong data-start=\"1213\" data-end=\"1246\">steklene steklenice za injekcijska zdravila<\/strong> in . <strong data-start=\"1251\" data-end=\"1288\">vnaprej sestavljene sterilizirane brizge<\/strong> namenjen asepti\u010dnemu polnjenju. Zagotavlja, da ti sestavni deli izpolnjujejo stroga merilna in funkcionalna merila za ohranjanje sterilnosti izdelka, zdru\u017eljivosti in varnosti pacientov.<\/p><p data-start=\"1467\" data-end=\"1763\">Pomemben del tega standarda je <strong data-start=\"1510\" data-end=\"1537\">preskus prodora z iglo<\/strong>, ki preverja <strong data-start=\"1558\" data-end=\"1584\">mehanske lastnosti<\/strong> igle med uporabo. Enostavnost, s katero igla prebode podlago, vpliva na njeno <strong data-start=\"1681\" data-end=\"1731\">ostrina, kakovost materiala, povr\u0161inska obdelava<\/strong>, ter doslednost proizvodnje.<\/p><p data-start=\"1765\" data-end=\"1794\">To testiranje je klju\u010dnega pomena za:<\/p><ul><li data-start=\"1798\" data-end=\"1858\">Zagotavljanje nemotenega dajanja injekcij z minimalnim nelagodjem za pacienta<\/li><li data-start=\"1861\" data-end=\"1900\">Prepre\u010devanje zloma ali upogibanja igle<\/li><li data-start=\"1903\" data-end=\"1956\">Zagotavljanje zdru\u017eljivosti z embala\u017enimi materiali<\/li><li data-start=\"1959\" data-end=\"2008\">Potrditev skladnosti za predlo\u017eitev regulativnim organom<\/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\">Razlaga metode preskusa penetracije z iglo<\/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\">Spletna stran <strong data-start=\"2065\" data-end=\"2099\">preskusna metoda penetracije z iglo<\/strong>, kot je podrobno opisano v Prilogi F standarda ISO 11040-4, ocenjuje <strong data-start=\"2153\" data-end=\"2222\">sila, potrebna, da igla injekcijske brizge prebode dolo\u010deno preskusno folijo<\/strong>. Ta postopek izhaja iz standarda DIN 13097-4 in je naveden v <a href=\"https:\/\/www.puncturetest.com\/sl\/standards\/iso-7864-needle-penetration-drag-force-test\/\"><strong data-start=\"2288\" data-end=\"2300\">ISO 7864<\/strong><\/a>, \u0161e en pomemben standard, ki ureja sterilne injekcijske igle.<\/p><p data-start=\"2367\" data-end=\"2404\">Klju\u010dni elementi te metode so:<\/p><ul><li data-start=\"2408\" data-end=\"2534\"><strong data-start=\"2408\" data-end=\"2426\">Preskusna naprava<\/strong>: A <strong data-start=\"2430\" data-end=\"2474\">univerzalni preskusnik za natezne in tla\u010dne preskuse<\/strong> z obmo\u010djem sile do 10 N in hitrostjo 20\u2013200 mm\/min.<\/li><li data-start=\"2537\" data-end=\"2612\"><strong data-start=\"2537\" data-end=\"2554\">Frekvenca vzor\u010denja<\/strong>: Za natan\u010dno zaznavanje najve\u010dje sile se priporo\u010da frekvenca 500 Hz.<\/li><li data-start=\"2615\" data-end=\"2685\"><strong data-start=\"2615\" data-end=\"2632\">Dr\u017ealo za iglo<\/strong>: Zagotavlja navpi\u010dno poravnavo za natan\u010dno prodiranje.<\/li><li data-start=\"2688\" data-end=\"2779\"><strong data-start=\"2688\" data-end=\"2701\">Preskusna folija<\/strong>: O materialu in debelini se morata dogovoriti proizvajalec in naro\u010dnik.<\/li><li data-start=\"2782\" data-end=\"2861\"><strong data-start=\"2782\" data-end=\"2800\">Vzorci igel<\/strong>: Lahko je silikoniziran ali neobdelan, odvisno od namena uporabe.<\/li><li data-start=\"2864\" data-end=\"2992\"><strong data-start=\"2864\" data-end=\"2883\">Zbiranje podatkov<\/strong>: A <strong data-start=\"2887\" data-end=\"2919\">krivulja sile proti premiku<\/strong> se za vsak preskus generira, pri \u010demer se meri <strong data-start=\"2958\" data-end=\"2972\">najve\u010dja sila<\/strong> in . <strong data-start=\"2977\" data-end=\"2991\">sila upora<\/strong>.<\/li><\/ul><p data-start=\"2994\" data-end=\"3141\">Ta metoda zagotavlja, da <strong data-start=\"3025\" data-end=\"3068\">ostrina igle in enakomernost prevleke<\/strong> so v okviru sprejemljivih parametrov, kar zagotavlja zanesljivo delovanje brizge.<\/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\">Najbolj\u0161e prakse pri testiranju igel za injekcijske brizge<\/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\">Pri izvajanju <strong data-start=\"3206\" data-end=\"3229\">preskus z iglo injekcijske brizge<\/strong>, pri optimizaciji procesa za zagotavljanje doslednosti in natan\u010dnosti je nujno upo\u0161tevati smernice ISO:<\/p><ol><li><strong data-start=\"3334\" data-end=\"3362\">Uporabljajte validirane substrate<\/strong>: Na primer <strong data-start=\"3372\" data-end=\"3388\">lateks<\/strong>, <strong data-start=\"3390\" data-end=\"3406\">poliuretan<\/strong>, ali <strong data-start=\"3411\" data-end=\"3427\">polietilen<\/strong> ki posnemajo razmere na ko\u017ei ali na embala\u017ei.<\/li><li><strong data-start=\"3472\" data-end=\"3507\">Nadzor okoljskih spremenljivk<\/strong>: Ohranite doslednost <strong data-start=\"3529\" data-end=\"3557\">temperatura in vla\u017enost<\/strong> med testiranjem.<\/li><li><strong data-start=\"3577\" data-end=\"3599\">Izogibajte se ponovni uporabi vzorcev<\/strong>: Pri vsakem preskusu je treba uporabiti nov kos folije ali podlage.<\/li><li><strong data-start=\"3661\" data-end=\"3683\">Zagotovite kalibracijo<\/strong>: Preskusni stroj je treba redno kalibrirati z merilnimi vzorci, katerih vrednosti so sledljive.<\/li><li><strong data-start=\"3765\" data-end=\"3788\">Dokument temeljito dokumentirajte<\/strong>: V poro\u010dilo o preskusu vklju\u010dite specifikacije folije, preskusno hitrost, \u0161tevilo vzorcev in vse krivulje sile.<\/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\/sl\/tissue-paper-ball-burst-strength-test\/\">Oprema za preskus penetracije z iglo v skladu z 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\">Za laboratorije in proizvajalce, ki morajo izvajati preskuse prodora igle v skladu s standardom ISO 11040-4, <strong data-start=\"4060\" data-end=\"4114\">Cell Instruments\u2019 NPT-01 \u2013 naprava za presku\u0161anje penetracije z iglo<\/strong> je zanesljiva in visoko zmogljiva re\u0161itev.<\/p><p data-start=\"4158\" data-end=\"4197\">Glavne zna\u010dilnosti <strong data-start=\"4178\" data-end=\"4188\">NPT-01<\/strong> vklju\u010dujejo:<\/p><ul><li>Visoko natan\u010dni senzorji sile z natan\u010dnostjo \u00b10,51 TP4T<\/li><li>Nastavljive hitrosti preskusa od 20 mm\/min do 200 mm\/min<\/li><li>V realnem \u010dasu <strong data-start=\"4320\" data-end=\"4349\">krivulje sile in premika<\/strong> z izvozljivimi podatki<\/li><li>Prilagodljivi dr\u017eali za igle in sponke za folijo<\/li><li>Zdru\u017eljivo z brizgalkami razli\u010dnih velikosti in iglami razli\u010dnih premerov<\/li><\/ul><p data-start=\"4482\" data-end=\"4726\">Z uporabo <strong data-start=\"4492\" data-end=\"4502\">NPT-01<\/strong> poenostavlja skladnost s standardoma ISO 11040-4 in ISO 7864, hkrati pa zmanj\u0161uje odstopanja in izbolj\u0161uje celovitost podatkov. Zlasti je primeren za <strong data-start=\"4648\" data-end=\"4684\">Raziskovalno-razvojni laboratoriji, oddelki za nadzor kakovosti<\/strong>in <strong data-start=\"4690\" data-end=\"4725\">regulativni postopki potrjevanja<\/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\/sl\/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=\"Metoda preskusa penetracije z iglo po standardu ISO 11040-4\" 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=\"Preskus penetrabilnosti elastomernih zapiral\"><\/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\t\u0160e danes poskrbite za skladnost va\u0161ih igel za injekcijske brizge\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\tRazumevanje in uporaba <b>Metoda preskusa penetracije z iglo po standardu ISO 11040-4<\/b> je klju\u010dnega pomena za vsakega proizvajalca, ki izdeluje <b>vnaprej napolnjene injekcijske brizge ali injekcijske igle<\/b>. Standard vsebuje jasna navodila glede opreme, postopka presku\u0161anja in poro\u010danja, da se zagotovita neopore\u010dnost igle in varnost pacientov. Z vklju\u010ditvijo <b>zanesljiva oprema za testiranje igel za injekcijske brizge<\/b> kot je <b>Puncturetest.com NPT-01<\/b>, lahko podjetja poenostavijo izpolnjevanje predpisov, zmanj\u0161ajo tveganje in izbolj\u0161ajo kakovost izdelkov.\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\/sl\/contact\/\">\n\t\t\t\t\t\tKliknite tukaj\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\/sl\/standards\/iso-11040-4\/\" \/>\n<meta property=\"og:locale\" content=\"sl_SI\" \/>\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\/sl\/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=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"3 minute\" \/>\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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