{"id":9298,"date":"2026-02-02T11:23:36","date_gmt":"2026-02-02T03:23:36","guid":{"rendered":"https:\/\/www.packqc.com\/applications\/needle-penetration-test\/"},"modified":"2026-03-16T11:37:31","modified_gmt":"2026-03-16T03:37:31","slug":"needle-penetration-test","status":"publish","type":"applications","link":"https:\/\/www.packqc.com\/hr\/applications\/needle-penetration-test\/","title":{"rendered":"Test penetracije iglom za ispitivanje medicinskih ure\u0111aja i ambala\u017ee"},"content":{"rendered":"<p>Test prodiranja igle ima klju\u010dnu ulogu u procjeni mehani\u010dkih svojstava hipodermijskih igala, prednapunjenih \u0161trcaljki i gumenih \u010depova. Ovaj test osigurava da igle imaju dovoljnu o\u0161trinu i da \u010depovi omogu\u0107uju pravilno prodiranje uz odr\u017eavanje hermeti\u010dke nepropusnosti. Za proizvo\u0111a\u010de i stru\u010dnjake za kontrolu kvalitete razumijevanje ovog testa je klju\u010dno za uskla\u0111enost s me\u0111unarodnim standardima kao \u0161to su <strong data-start=\"808\" data-end=\"823\">ISO 11040-4<\/strong>, <strong data-start=\"825\" data-end=\"837\">ISO 7864<\/strong>, i <a href=\"https:\/\/www.packqc.com\/hr\/product-category\/iso\/iso-8871-5\/\"><strong data-start=\"843\" data-end=\"857\">ISO 8871-5<\/strong><\/a>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregled ispitivanja proboja i o\u0161trine igle<\/h2>\n\n\n\n<p><strong data-start=\"926\" data-end=\"948\">Test proboja<\/strong>, <strong data-start=\"950\" data-end=\"978\">test o\u0161trine igle<\/strong>, i <strong data-start=\"984\" data-end=\"1026\">Ispitivanje proboja gumenih \u010depova<\/strong> Klju\u010dne su procjene u farmaceutskoj industriji i industriji medicinskih proizvoda. Ove procjene osiguravaju jednostavnost injektiranja, smanjuju nelagodu pacijenta i provjeravaju funkcionalnost sustava zatvaranja.<\/p>\n\n\n\n<p>Prema ISO 8871-5, <strong data-start=\"1256\" data-end=\"1273\">probojanost<\/strong> Definira se kao sila potrebna za probijanje elastomerne zaporne membrane iglom. Istovremeno, ISO 7864 i ISO 11040-4 definiraju silu prodiranja i silu trenja potrebnu za prolazak igle kroz standardni podlogu ili foliju.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Principi i ciljevi testa<\/h2>\n\n\n\n<p>The <strong data-start=\"1546\" data-end=\"1573\">test probijanja iglom<\/strong> cilja na mjerenje:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The <strong data-start=\"1597\" data-end=\"1626\">po\u010detna sila prodiranja<\/strong> (ili probadna sila) kada vrh igle do\u0111e u kontakt sa supstratom.<\/li>\n\n\n\n<li>The <strong data-start=\"1697\" data-end=\"1724\">sile rezanja i trenja<\/strong> kako se napreduje osovina igle.<\/li>\n\n\n\n<li>Dosljednost izvedbe u vi\u0161e uzoraka.<\/li>\n<\/ul>\n\n\n\n<p>Ovaj test nije samo klju\u010dan za <strong data-start=\"1848\" data-end=\"1876\">test o\u0161trine igle<\/strong>, ali tako\u0111er provjerava <strong data-start=\"1900\" data-end=\"1936\">Propusnost gumenih \u010depova<\/strong> koristi se u sterilnim posudama.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Standardni testovi i primjenjivost<\/h2>\n\n\n\n<p>Test se prvenstveno provodi u skladu sa sljede\u0107im me\u0111unarodnim standardima:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.iso.org\/standard\/82222.html\" target=\"_blank\" rel=\"noopener nofollow\"><strong data-start=\"2095\" data-end=\"2110\">ISO 11040-4<\/strong><\/a>: Prednapunjene \u0161price \u2014 obuhva\u0107aju potpune sustave, uklju\u010duju\u0107i staklena ili plasti\u010dna tijela.<\/li>\n\n\n\n<li><a href=\"https:\/\/www.iso.org\/standard\/60481.html\" target=\"_blank\" rel=\"noopener nofollow\"><strong data-start=\"2195\" data-end=\"2207\">ISO 7864<\/strong><\/a>: Inzultne igle \u2014 pru\u017ea smjernice za analizu vr\u0161ne sile i trenja tijekom umetanja igle.<\/li>\n\n\n\n<li><a href=\"https:\/\/www.iso.org\/standard\/68560.html\" target=\"_blank\" rel=\"noopener nofollow\"><strong data-start=\"2307\" data-end=\"2321\">ISO 8871-5<\/strong><\/a>Elastomerna zatvara\u010da za bo\u010dice \u2014 procjenjuje propusnost, fragmentaciju i sposobnost samoljepljenja.<\/li>\n<\/ul>\n\n\n\n<p>Test se primjenjuje na:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Igle na \u0161tapi\u0107u ili pri\u010dvr\u0161\u0107ene igle<\/li>\n\n\n\n<li>Gumene \u010depove<\/li>\n\n\n\n<li>Prednapunjene \u0161price i sterilni podsklopovi<\/li>\n\n\n\n<li>Osiguranje kvalitete sirovina i gotovih proizvoda<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Oprema i zahtjevi za postavljanje<\/h2>\n\n\n\n<p>Prigovor <strong data-start=\"2664\" data-end=\"2691\">test probijanja iglom<\/strong> zahtijeva:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">1. Univerzalni ispitni stroj<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"2742\" data-end=\"2764\">Kapacitet optere\u0107ne \u0107elije<\/strong>: do 10 N (ili primjereno za raspon ispitivanja)<\/li>\n\n\n\n<li><strong data-start=\"2811\" data-end=\"2828\">Kontrola brzine<\/strong>: obi\u010dno izme\u0111u 20 mm\/min i 200 mm\/min, naj\u010de\u0161\u0107e 100 mm\/min<\/li>\n\n\n\n<li><strong data-start=\"2896\" data-end=\"2913\">Brzina uzorkovanja<\/strong>: 500 Hz za preciznost vr\u0161ne sile<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">2. Dr\u017ea\u010d igala<\/h3>\n\n\n\n<p>Osmi\u0161ljeno da osigura <strong data-start=\"2993\" data-end=\"3015\">okomito poravnanje<\/strong> i precizna kontrola puta umetanja.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">3. Testni supstrat<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"3084\" data-end=\"3093\">Folije<\/strong> za metodu ISO 11040-4<\/li>\n\n\n\n<li><strong data-start=\"3119\" data-end=\"3143\">Sinteti\u010dki elastomeri<\/strong> kao \u0161to su:\n<ul class=\"wp-block-list\">\n<li>Lateks guma (40\u00b15 Shore A, debljina 1,0 mm)<\/li>\n\n\n\n<li>Poliuretan (85\u00b110 Shore A, debljina 0,40 mm)<\/li>\n\n\n\n<li>Silikonska guma ili LDPE folija u skladu s ISO 7864 smjernicama<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">4. Dr\u017ea\u010d supstrata<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Trebalo bi odr\u017eavati dosljednu steznu silu i izlo\u017eiti a <strong data-start=\"3401\" data-end=\"3436\">10 mm kru\u017eni promjer prodora<\/strong><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Detaljan postupak testiranja<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"3474\" data-end=\"3503\">Pripremite ispitni uzorak.<\/strong>: Pri\u010dvrstite svje\u017ei komad folije ili elastomera u dr\u017ea\u010d uzorka bez napetosti.<\/li>\n\n\n\n<li><strong data-start=\"3590\" data-end=\"3610\">Postavite iglu<\/strong>Osigurajte testnu iglu okomitu na povr\u0161inu za test pomo\u0107u kalibriranog dr\u017ea\u010da.<\/li>\n\n\n\n<li><strong data-start=\"3699\" data-end=\"3718\">Postavite stroj<\/strong>Primijenite pomak pri konstantnoj brzini (obi\u010dno 100 mm\/min).<\/li>\n\n\n\n<li><strong data-start=\"3779\" data-end=\"3803\">Prodrijeti i zabilje\u017eiti<\/strong>:\n<ul class=\"wp-block-list\">\n<li>Izmjeri <strong data-start=\"3822\" data-end=\"3841\">vr\u0161na sila (F0)<\/strong> za vrh igle<\/li>\n\n\n\n<li>Zapisnik <strong data-start=\"3870\" data-end=\"3892\">rezna sila (F1)<\/strong> i <strong data-start=\"3897\" data-end=\"3916\">sila pete (F2)<\/strong><\/li>\n\n\n\n<li>Mjeri <strong data-start=\"3930\" data-end=\"3949\">sila otpora (F3)<\/strong> za potpunu penetraciju osovine<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong data-start=\"3980\" data-end=\"3998\">Povuci iglu<\/strong>Zavr\u0161ite ciklus i za svaki uzorak koristite novo mjesto.<\/li>\n\n\n\n<li><strong data-start=\"4058\" data-end=\"4075\">Analiza podataka<\/strong>Izradite krivulju sile u odnosu na pomak, izra\u010dunajte prosjek i standardnu devijaciju za vr\u0161ne i vu\u010dne sile.<\/li>\n<\/ul>\n\n\n\n<figure class=\"wp-block-embed is-type-video is-provider-youtube wp-block-embed-youtube wp-embed-aspect-16-9 wp-has-aspect-ratio\"><div class=\"wp-block-embed__wrapper\">\n<div class=\"ast-oembed-container\" style=\"height: 100%;\"><iframe title=\"Test \u010dvrsto\u0107e veze igle kanile na hubu | Tester \u010dvrsto\u0107e veze igle \u0161trcaljke\" width=\"500\" height=\"281\" src=\"https:\/\/www.youtube.com\/embed\/FgYmfLnK5Vg?feature=oembed\" frameborder=\"0\" allow=\"accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share\" referrerpolicy=\"strict-origin-when-cross-origin\" allowfullscreen><\/iframe><\/div>\n<\/div><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">Izvje\u0161\u0107e o testiranju i dokumentacija o kvaliteti<\/h2>\n\n\n\n<p>Potpuno izvje\u0161\u0107e za <strong data-start=\"4254\" data-end=\"4281\">test probijanja iglom<\/strong> treba uklju\u010diti:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Specifikacija i stanje supstrata<\/li>\n\n\n\n<li>Specifikacije igle (promjer, vrsta, obrada)<\/li>\n\n\n\n<li>Brzina i metoda ispitivanja<\/li>\n\n\n\n<li>Rezultati penetracije i sile vu\u010denja<\/li>\n\n\n\n<li>Veli\u010dina uzorka i statisti\u010dka procjena<\/li>\n\n\n\n<li>Uo\u010davanja ili odstupanja<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Primjena i prednosti u kontroli kvalitete<\/h2>\n\n\n\n<p>Za farmaceutske proizvo\u0111a\u010de, uskla\u0111enost s ovim testovima podr\u017eava:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"4650\" data-end=\"4676\">Regulatorne prijave<\/strong> (npr. FDA, EMA)<\/li>\n\n\n\n<li><strong data-start=\"4696\" data-end=\"4730\">Sigurnost i dosljednost proizvoda<\/strong><\/li>\n\n\n\n<li><strong data-start=\"4733\" data-end=\"4761\">Pobolj\u0161ano korisni\u010dko iskustvo<\/strong> u parenteralnoj primjeni<\/li>\n\n\n\n<li><strong data-start=\"4787\" data-end=\"4813\">Smanjena bol pri injekciji<\/strong> i nelagoda pacijenta<\/li>\n<\/ul>\n\n\n\n<p>Kako bi se pobolj\u0161ala to\u010dnost i reproducibilnost <strong data-start=\"4889\" data-end=\"4911\">test penetrabilnosti<\/strong>, napredna instrumentacija je neophodna.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\n\t\t\t\tKontaktirajte nas Nabavite Bloom Testing Solution\t\t\t\t<\/h2>\n\n\n\n<p>The <strong data-start=\"5527\" data-end=\"5554\"><a href=\"https:\/\/www.packqc.com\/hr\/product\/needle-penetration-test-equipment-iso-7864\/\">probojanje iglom<\/a> test<\/strong> je klju\u010dno za provjeru funkcionalnosti i sigurnosti sustava za injektiranje i gumenih \u010depova. Izravno utje\u010de na udobnost korisnika, integritet proizvoda i regulatorno odobrenje. Primjenom standardiziranih postupaka i kori\u0161tenjem naprednih sustava za testiranje poput onih koje nudi <strong data-start=\"5821\" data-end=\"5841\">Stani\u010dni instrumenti<\/strong>, proizvo\u0111a\u010di mogu pouzdano osigurati pouzdanost i sukladnost proizvoda.<\/p>","protected":false},"excerpt":{"rendered":"<p>Needle penetration test plays a critical role in evaluating the mechanical performance of hypodermic needles, prefilled syringes, and rubber closures. This test ensures that needles possess sufficient sharpness and that closures offer proper penetrability while maintaining sealing integrity. For manufacturers and quality control professionals, understanding this test is essential for compliance with international standards such [&hellip;]<\/p>","protected":false},"featured_media":6744,"parent":0,"template":"","meta":{"_acf_changed":true,"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":""}}},"class_list":["post-9298","applications","type-applications","status-publish","has-post-thumbnail","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.packqc.com\/hr\/wp-json\/wp\/v2\/applications\/9298","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/hr\/wp-json\/wp\/v2\/applications"}],"about":[{"href":"https:\/\/www.packqc.com\/hr\/wp-json\/wp\/v2\/types\/applications"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/hr\/wp-json\/wp\/v2\/media\/6744"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/hr\/wp-json\/wp\/v2\/media?parent=9298"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}