{"id":2022,"date":"2025-04-09T05:01:05","date_gmt":"2025-04-09T05:01:05","guid":{"rendered":"https:\/\/www.pharmacopoeiatest.com\/?p=2022"},"modified":"2025-04-11T06:36:55","modified_gmt":"2025-04-11T06:36:55","slug":"needle-bonding-strength-test-iso-11040-4","status":"publish","type":"post","link":"https:\/\/www.pharmacopoeiatest.com\/sl\/needle-bonding-strength-test-iso-11040-4\/","title":{"rendered":"Preskus trdnosti lepljenja z iglo ISO 11040-4, Priloga G1"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"2022\" class=\"elementor elementor-2022\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-88e81b0 e-flex e-con-boxed e-con e-parent\" data-id=\"88e81b0\" 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-15151de elementor-widget elementor-widget-heading\" data-id=\"15151de\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Preskus trdnosti lepljenja z iglo<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3dc2194 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"3dc2194\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d585eff elementor-widget elementor-widget-heading\" data-id=\"d585eff\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">ISO 11040-4 Priloga G1<\/h2>\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-10ec79b e-flex e-con-boxed e-con e-parent\" data-id=\"10ec79b\" 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-7045eb5 elementor-widget elementor-widget-text-editor\" data-id=\"7045eb5\" 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<p class=\"\" data-start=\"372\" data-end=\"916\">V industriji medicinskih pripomo\u010dkov, zlasti za prednapolnjene injekcijske brizge z zataknjenimi iglami, je <em data-start=\"482\" data-end=\"505\">sila izvleka igle<\/em> Test je bistvenega pomena za preverjanje celovitosti povezave med iglo in brizgalko. V skladu z <strong data-start=\"609\" data-end=\"633\">ISO 11040-4 Priloga G1<\/strong>ta mehanski preskus je klju\u010dnega pomena za oceno varnosti, zanesljivosti in skladnosti brizgalnih sistemov s predpisi. Pravilna izvedba tega preskusa zagotavlja, da se igle ne odtrgajo v normalnih razmerah ali v razmerah stresne uporabe, kar je klju\u010dnega pomena za klini\u010dno uporabo in varnost bolnikov.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-53f39ac elementor-widget elementor-widget-heading\" data-id=\"53f39ac\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Pomen sile izvleka igle<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-232a548 elementor-widget elementor-widget-text-editor\" data-id=\"232a548\" 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<p class=\"\" data-start=\"982\" data-end=\"1259\"><em data-start=\"982\" data-end=\"1005\">Sila izvleka igle<\/em> se nana\u0161a na najve\u010djo aksialno silo, ki je potrebna, da se igla odtrga od brizge. Zaradi slabe povezave med iglo in pesto lahko pride do odcepitve med vbrizgavanjem, kar lahko povzro\u010di po\u0161kodbe, napake pri odmerjanju ali kontaminacijo. Ta preskus ima pomembno vlogo pri potrjevanju <strong data-start=\"1139\" data-end=\"1166\">trdnost vezave igel<\/strong> med proizvodnjo, s \u010dimer se zagotovi, da izpolnjuje vnaprej dolo\u010dene standarde u\u010dinkovitosti v okviru <strong data-start=\"1243\" data-end=\"1258\">ISO 11040-4<\/strong>.<\/p>\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-8452827 e-flex e-con-boxed e-con e-parent\" data-id=\"8452827\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-570817b e-con-full e-flex e-con e-child\" data-id=\"570817b\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-413bd47 elementor-widget elementor-widget-heading\" data-id=\"413bd47\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Preskusne metode iz Priloge G1 k standardu ISO 11040-4<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fcd29af elementor-widget elementor-widget-text-editor\" data-id=\"fcd29af\" 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<p class=\"\" data-start=\"1587\" data-end=\"1757\">Izvajanje <em data-start=\"1604\" data-end=\"1627\">sila izvleka igle<\/em> pravilno testirati, morajo proizvajalci upo\u0161tevati <strong data-start=\"1673\" data-end=\"1697\">ISO 11040-4 Priloga G1<\/strong> postopek. V nadaljevanju je raz\u010dlenjena standardizirana metoda.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-a860fa6 e-con-full e-flex e-con e-child\" data-id=\"a860fa6\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-996cc40 e-con-full e-flex e-con e-child\" data-id=\"996cc40\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2456c08 elementor-widget elementor-widget-heading\" data-id=\"2456c08\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Zahteve za nastavitev preskusa in opremo<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b295a09 elementor-widget elementor-widget-text-editor\" data-id=\"b295a09\" 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<p class=\"\" data-start=\"1807\" data-end=\"1924\">Osnovna oprema vklju\u010duje <strong data-start=\"1837\" data-end=\"1890\">univerzalni stroj za natezno in tla\u010dno testiranje<\/strong> ki izpolnjujejo naslednje pogoje:<\/p><ul data-start=\"1926\" data-end=\"2220\"><li class=\"\" data-start=\"1926\" data-end=\"1996\"><p class=\"\" data-start=\"1928\" data-end=\"1996\"><strong data-start=\"1928\" data-end=\"1942\">Obremenitvena celica:<\/strong> Najve\u010d 500 N (ali ustrezno glede na trdnost vzorca)<\/p><\/li><li class=\"\" data-start=\"1997\" data-end=\"2048\"><p class=\"\" data-start=\"1999\" data-end=\"2048\"><strong data-start=\"1999\" data-end=\"2014\">Hitrost testiranja:<\/strong> 50 mm\/min (priporo\u010dena privzeta vrednost)<\/p><\/li><li class=\"\" data-start=\"2049\" data-end=\"2097\"><p class=\"\" data-start=\"2051\" data-end=\"2097\"><strong data-start=\"2051\" data-end=\"2069\">Hitrost vzor\u010denja:<\/strong> \u2265500 Hz za najvi\u0161jo natan\u010dnost<\/p><\/li><li class=\"\" data-start=\"2098\" data-end=\"2157\"><p class=\"\" data-start=\"2100\" data-end=\"2157\"><strong data-start=\"2100\" data-end=\"2126\">Naprava za vpenjanje igle:<\/strong> Varen oprijem brez zdrsa<\/p><\/li><li class=\"\" data-start=\"2158\" data-end=\"2220\"><p class=\"\" data-start=\"2160\" data-end=\"2220\"><strong data-start=\"2160\" data-end=\"2179\">Dr\u017ealo za brizgo:<\/strong> Podpira brizgo s prirobnico ali ramo<\/p><\/li><\/ul><p class=\"\" data-start=\"2222\" data-end=\"2499\">Celi\u010dni instrumenti' <strong data-start=\"2240\" data-end=\"2275\">MPT-01 Tester medicinske embala\u017ee<\/strong> je odli\u010dna re\u0161itev za ta namen. Zasnovan je za testiranje medicinske embala\u017ee in pripomo\u010dkov ter zagotavlja nastavljivo hitrost testiranja, natan\u010dnost, ki jo nadzoruje PLC, in nastavljive sponke, prilagojene za ocenjevanje brizg in igel.<\/p>\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 class=\"elementor-element elementor-element-d9546da elementor-widget elementor-widget-image\" data-id=\"d9546da\" 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<a href=\"https:\/\/www.pharmacopoeiatest.com\/sl\/category\/product\/syringe-test\/\">\n\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"442\" height=\"1024\" src=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/Needle-Bonding-Strength-Testing-ISO-11040-4-Annex-G1-442x1024.webp\" class=\"attachment-large size-large wp-image-2024\" alt=\"Preizku\u0161anje trdnosti igelnega lepljenja ISO 11040-4, Priloga G1\" srcset=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/Needle-Bonding-Strength-Testing-ISO-11040-4-Annex-G1-442x1024.webp 442w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/Needle-Bonding-Strength-Testing-ISO-11040-4-Annex-G1-130x300.webp 130w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/Needle-Bonding-Strength-Testing-ISO-11040-4-Annex-G1-768x1779.webp 768w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/Needle-Bonding-Strength-Testing-ISO-11040-4-Annex-G1-663x1536.webp 663w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/Needle-Bonding-Strength-Testing-ISO-11040-4-Annex-G1-884x2048.webp 884w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/Needle-Bonding-Strength-Testing-ISO-11040-4-Annex-G1-scaled.webp 1105w\" sizes=\"(max-width: 442px) 100vw, 442px\" \/>\t\t\t\t\t\t\t\t<\/a>\n\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<div class=\"elementor-element elementor-element-27af015 elementor-widget elementor-widget-heading\" data-id=\"27af015\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Priprava vzorcev in ravnanje z njimi<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f39f978 elementor-widget elementor-widget-text-editor\" data-id=\"f39f978\" 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<ul><li class=\"\" data-start=\"2543\" data-end=\"2625\"><p class=\"\" data-start=\"2545\" data-end=\"2625\">Uporabite <strong data-start=\"2549\" data-end=\"2585\">sterilizirane sestavljene brizge<\/strong> pripravljen za polnjenje z iglo s kolkom.<\/p><\/li><li class=\"\" data-start=\"2626\" data-end=\"2718\"><p class=\"\" data-start=\"2628\" data-end=\"2718\">Zagotovite, da preskusni vzorci odra\u017eajo dejanske proizvodne pogoje, da se ohrani ustreznost rezultatov.<\/p><\/li><li class=\"\" data-start=\"2719\" data-end=\"2827\"><p class=\"\" data-start=\"2721\" data-end=\"2827\">Pred za\u010detkom merjenja se izogibajte predhodnim obremenitvam - nastavite merilno celico na <em data-start=\"2792\" data-end=\"2798\">ni\u010d<\/em> brez dodatnega pritiska.<\/p><\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-c6fdd34 e-con-full e-flex e-con e-child\" data-id=\"c6fdd34\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-793e953 e-con-full e-flex e-con e-child\" data-id=\"793e953\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b7b4771 elementor-widget elementor-widget-heading\" data-id=\"b7b4771\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Postopek presku\u0161anja trdnosti igelnega lepljenja<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6e44f24 elementor-widget elementor-widget-text-editor\" data-id=\"6e44f24\" 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<ol><li class=\"\" data-start=\"2870\" data-end=\"2924\"><p class=\"\" data-start=\"2873\" data-end=\"2924\">Brizgo namestite navpi\u010dno v presku\u0161evalno ogrodje.<\/p><\/li><li class=\"\" data-start=\"2925\" data-end=\"2975\"><p class=\"\" data-start=\"2928\" data-end=\"2975\">Iglo varno dr\u017eite, da ne zdrsne.<\/p><\/li><li class=\"\" data-start=\"2976\" data-end=\"3028\"><p class=\"\" data-start=\"2979\" data-end=\"3028\">Pred obremenitvijo nastavite merilno celico na ni\u010dlo.<\/p><\/li><li class=\"\" data-start=\"3029\" data-end=\"3071\"><p class=\"\" data-start=\"3032\" data-end=\"3071\">Test izvleka za\u010dnite izvajati pri hitrosti 50 mm\/min.<\/p><\/li><li class=\"\" data-start=\"3072\" data-end=\"3122\"><p class=\"\" data-start=\"3075\" data-end=\"3122\">Nadaljujte, dokler se igla ne odlepi ali zlomi.<\/p><\/li><li class=\"\" data-start=\"3123\" data-end=\"3172\"><p class=\"\" data-start=\"3126\" data-end=\"3172\">Zapi\u0161ite <strong data-start=\"3137\" data-end=\"3169\">krivulja sile v odvisnosti od premika<\/strong>.<\/p><\/li><li class=\"\" data-start=\"3173\" data-end=\"3256\"><p class=\"\" data-start=\"3176\" data-end=\"3256\">Upo\u0161tevajte <strong data-start=\"3185\" data-end=\"3207\">najve\u010dja najve\u010dja sila<\/strong>, ki predstavlja <em data-start=\"3230\" data-end=\"3253\">sila izvleka igle<\/em>.<\/p><\/li><\/ol>\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-9c468e4 e-con-full e-flex e-con e-child\" data-id=\"9c468e4\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4f65822 elementor-widget elementor-widget-heading\" data-id=\"4f65822\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Poro\u010danje o rezultatih<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d2e072e elementor-widget elementor-widget-text-editor\" data-id=\"d2e072e\" 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<p class=\"\" data-start=\"3290\" data-end=\"3357\">V skladu s Prilogo G1 k standardu ISO 11040-4 mora poro\u010dilo o preskusu vsebovati:<\/p><ul data-start=\"3359\" data-end=\"3509\"><li class=\"\" data-start=\"3359\" data-end=\"3385\"><p class=\"\" data-start=\"3361\" data-end=\"3385\">Najve\u010dja najve\u010dja sila (N)<\/p><\/li><li class=\"\" data-start=\"3386\" data-end=\"3418\"><p class=\"\" data-start=\"3388\" data-end=\"3418\">Graf sile v odvisnosti od premika<\/p><\/li><li class=\"\" data-start=\"3419\" data-end=\"3442\"><p class=\"\" data-start=\"3421\" data-end=\"3442\">Hitrost presku\u0161anja (mm\/min)<\/p><\/li><li class=\"\" data-start=\"3443\" data-end=\"3462\"><p class=\"\" data-start=\"3445\" data-end=\"3462\">Koli\u010dina vzorca<\/p><\/li><li class=\"\" data-start=\"3463\" data-end=\"3509\"><p class=\"\" data-start=\"3465\" data-end=\"3509\">vsa odstopanja, opa\u017eanja ali nepravilnosti<\/p><\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-753fbcc elementor-widget elementor-widget-text-editor\" data-id=\"753fbcc\" 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<p>Za napredno obdelavo podatkov je <strong data-start=\"3545\" data-end=\"3555\">MPT-01<\/strong> podpira vizualizacijo rezultatov, prikaz v realnem \u010dasu in izbirni izhod RS232 ali integracijo mikrotiskalnika.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-61b109f e-flex e-con-boxed e-con e-parent\" data-id=\"61b109f\" 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-1ddd053 elementor-widget elementor-widget-heading\" data-id=\"1ddd053\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Na\u0161 tester trdnosti lepljenja igel?<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-17dbcca elementor-widget elementor-widget-text-editor\" data-id=\"17dbcca\" 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<p class=\"\" data-start=\"4323\" data-end=\"4503\">S strokovnim znanjem na podro\u010dju presku\u0161anja medicinskih pripomo\u010dkov in embala\u017ee, <strong data-start=\"4379\" data-end=\"4409\">Cell Instruments Co., Ltd.<\/strong> ponuja prilagojene re\u0161itve za <em data-start=\"4440\" data-end=\"4463\">sila izvleka igle<\/em> ocenjevanja. Na\u0161 tester MPT-01 omogo\u010da:<\/p><ul data-start=\"4505\" data-end=\"4762\"><li class=\"\" data-start=\"4505\" data-end=\"4534\"><p class=\"\" data-start=\"4507\" data-end=\"4534\">Visoka natan\u010dnost (0,5% F.S.)<\/p><\/li><li class=\"\" data-start=\"4535\" data-end=\"4592\"><p class=\"\" data-start=\"4537\" data-end=\"4592\">Ve\u010dnamenskost za teste vle\u010denja in stiskanja<\/p><\/li><li class=\"\" data-start=\"4593\" data-end=\"4657\"><p class=\"\" data-start=\"4595\" data-end=\"4657\">Prilagojene zasnove pritrdilnih elementov za konfiguracije brizgalk in igel<\/p><\/li><li class=\"\" data-start=\"4658\" data-end=\"4701\"><p class=\"\" data-start=\"4660\" data-end=\"4701\">Programirljivi in ponovljivi testni protokoli<\/p><\/li><li class=\"\" data-start=\"4702\" data-end=\"4762\"><p class=\"\" data-start=\"4704\" data-end=\"4762\">Skladnost z <a href=\"https:\/\/www.iso.org\/standard\/82222.html\" target=\"_blank\" rel=\"noopener\">ISO 11040-4<\/a> in druge ustrezne standarde.<\/p><\/li><\/ul><p class=\"\" data-start=\"4764\" data-end=\"4917\">Ne glede na to, ali ste proizvajalec brizg ali strokovnjak za nadzor kakovosti, vam z zanesljivimi re\u0161itvami pomagamo pri izpolnjevanju zakonskih zahtev in izzivov pri presku\u0161anju.<\/p>\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-de82dd4 e-flex e-con-boxed e-con e-parent\" data-id=\"de82dd4\" 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-cd205c0 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"cd205c0\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a40b489 elementor-widget elementor-widget-heading\" data-id=\"a40b489\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Pogosta vpra\u0161anja<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c0c3e38 elementor-widget elementor-widget-toggle\" data-id=\"c0c3e38\" data-element_type=\"widget\" data-widget_type=\"toggle.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-toggle\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2021\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-2021\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewbox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewbox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">1. Kak\u0161en je pomen testiranja sile izvleka igle?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2021\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-2021\"><p>S tem preskusom se oceni mehanska pritrditev igle na brizgo, da se zagotovi, da se med uporabo ne bo odtrgala, s \u010dimer se ohranijo varnostni in zmogljivostni standardi.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2022\" class=\"elementor-tab-title\" data-tab=\"2\" role=\"button\" aria-controls=\"elementor-tab-content-2022\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewbox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewbox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">2. Kateri standard opisuje preskus trdnosti igelnega spoja?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2022\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"region\" aria-labelledby=\"elementor-tab-title-2022\"><p>Standard ISO 11040-4, zlasti Priloga G1, opredeljuje metodologijo za izvajanje preskusov sile izvleka igle na injekcijskih brizgah s pritrjeno iglo.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2023\" class=\"elementor-tab-title\" data-tab=\"3\" role=\"button\" aria-controls=\"elementor-tab-content-2023\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewbox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewbox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">3. Koliko vzorcev je potrebnih za testiranje sile izvleka igle?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2023\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"region\" aria-labelledby=\"elementor-tab-title-2023\"><p>\u0160tevilo je odvisno od va\u0161ih notranjih validacijskih protokolov in dogovorov s strankami, vendar je zaradi statisti\u010dne zanesljivosti priporo\u010dljivo uporabiti ve\u010d vzorcev.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2024\" class=\"elementor-tab-title\" data-tab=\"4\" role=\"button\" aria-controls=\"elementor-tab-content-2024\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewbox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewbox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">4. Kak\u0161ne so zahteve glede opreme za ta preskus?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2024\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"4\" role=\"region\" aria-labelledby=\"elementor-tab-title-2024\"><p>Potreben je univerzalni preskusni stroj z zmogljivostjo 500 N, preskusno hitrostjo 50 mm\/min, ustreznimi prijemali in visoko frekvenco vzor\u010denja (\u2265 500 Hz).<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2025\" class=\"elementor-tab-title\" data-tab=\"5\" role=\"button\" aria-controls=\"elementor-tab-content-2025\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewbox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewbox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">5. Ali je mogo\u010de za ta test prilagoditi MPT-01 Cell Instruments?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2025\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"5\" role=\"region\" aria-labelledby=\"elementor-tab-title-2025\"><p>Da, naprava MPT-01 ponuja prilagodljive nastavke, programabilne nastavitve in funkcije avtomatizacije, prilagojene za trdnost lepljenja igel in druge preskuse medicinskih pripomo\u010dkov.<\/p><\/div>\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\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Preskus trdnosti vezave igle ISO 11040-4, Priloga G1 V industriji medicinskih pripomo\u010dkov, zlasti pri prednapolnjenih brizgah z zataknjenimi iglami, je preskus sile izvleka igle bistven za preverjanje celovitosti vezave med iglo in brizgo. V skladu s Prilogo G1 k standardu ISO 11040-4 je ta mehanski preskus klju\u010dnega pomena za oceno varnosti, zanesljivosti in zanesljivosti injekcijske igle.<\/p>","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_uag_custom_page_level_css":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"footnotes":""},"categories":[26],"tags":[],"class_list":["post-2022","post","type-post","status-publish","format-standard","hentry","category-blog"],"acf":[],"uagb_featured_image_src":{"full":false,"thumbnail":false,"medium":false,"medium_large":false,"large":false,"1536x1536":false,"2048x2048":false,"trp-custom-language-flag":false},"uagb_author_info":{"display_name":"pharmacopoeiatest","author_link":"https:\/\/www.pharmacopoeiatest.com\/sl\/author\/pharmacopoeiatest\/"},"uagb_comment_info":0,"uagb_excerpt":"Needle Bonding Strength Test ISO 11040-4 Annex G1 In the medical device industry, especially for prefilled syringes with staked needles, the needle pull-out force test is essential for verifying the bonding integrity between the needle and the syringe. According to ISO 11040-4 Annex G1, this mechanical test is critical to assess the safety, reliability, and&hellip;","_links":{"self":[{"href":"https:\/\/www.pharmacopoeiatest.com\/sl\/wp-json\/wp\/v2\/posts\/2022","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharmacopoeiatest.com\/sl\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pharmacopoeiatest.com\/sl\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/sl\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/sl\/wp-json\/wp\/v2\/comments?post=2022"}],"version-history":[{"count":5,"href":"https:\/\/www.pharmacopoeiatest.com\/sl\/wp-json\/wp\/v2\/posts\/2022\/revisions"}],"predecessor-version":[{"id":2034,"href":"https:\/\/www.pharmacopoeiatest.com\/sl\/wp-json\/wp\/v2\/posts\/2022\/revisions\/2034"}],"wp:attachment":[{"href":"https:\/\/www.pharmacopoeiatest.com\/sl\/wp-json\/wp\/v2\/media?parent=2022"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/sl\/wp-json\/wp\/v2\/categories?post=2022"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/sl\/wp-json\/wp\/v2\/tags?post=2022"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}