{"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\/bs\/applications\/needle-penetration-test\/","title":{"rendered":"Test penetracije igle za ispitivanje medicinskih ure\u0111aja i ambala\u017ee"},"content":{"rendered":"<p>Test penetracije igle igra klju\u010dnu ulogu u procjeni mehani\u010dkih performansi hipodermijskih igala, prednapunjenih \u0161prica i gumenih \u010depova. Ovaj test osigurava da igle imaju dovoljnu o\u0161trinu i da \u010depovi omogu\u0107avaju pravilnu prohodnost uz odr\u017eavanje hermeti\u010dke cjelovitosti. Za proizvo\u0111a\u010de i stru\u010dnjake za kontrolu kvaliteta, razumijevanje ovog testa je neophodno 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\/bs\/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 testa proboja i ispitivanja 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\">Test probojnosti gumene \u010depa<\/strong> su klju\u010dne procjene u farmaceutskoj industriji i industriji medicinskih ure\u0111aja. Ove procjene osiguravaju jednostavnost injektiranja, minimiziraju nelagodu pacijenta i provjeravaju funkcionalnost sistema zatvaranja.<\/p>\n\n\n\n<p>Prema ISO 8871-5, <strong data-start=\"1256\" data-end=\"1273\">prohodnost<\/strong> Definira se kao sila potrebna za probijanje elastomerne zaporne membrane iglom. Istovremeno, ISO 7864 i ISO 11040-4 definiraju silu penetracije i silu trenja potrebne za provla\u010denje 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 prodora<\/strong> (ili probadna sila) kada vrh igle do\u0111e u kontakt sa podlogom.<\/li>\n\n\n\n<li>The <strong data-start=\"1697\" data-end=\"1724\">sile rezanja i trenja<\/strong> kako se pomjera osovina igle.<\/li>\n\n\n\n<li>Dosljednost performansi 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\">Standardi testiranja i primjenjivost<\/h2>\n\n\n\n<p>Test se primarno 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 obuhvataju kompletne sisteme, uklju\u010duju\u0107i staklene ili plasti\u010dne klipove.<\/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>: Hipodermijske igle \u2014 pru\u017ea smjernice za analizu vr\u0161ne sile i trenja tokom 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>Elastomerne \u010depove 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\u0107ima ili pri\u010dvr\u0161\u0107ene igle<\/li>\n\n\n\n<li>Gumene \u010depove<\/li>\n\n\n\n<li>Unaprijed napunjene \u0161price i sterilni podsklopovi<\/li>\n\n\n\n<li>Osiguranje kvaliteta 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 senzorske \u0107elije<\/strong>: do 10 N (ili prikladno 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>Dizajnirano da osigura <strong data-start=\"2993\" data-end=\"3015\">vertikalno 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 film u skladu sa smjernicama ISO 7864<\/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 silu stezanja i izlo\u017eiti a <strong data-start=\"3401\" data-end=\"3436\">10 mm kru\u017eno podru\u010dje 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 podloge 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 ma\u0161inu<\/strong>Primijenite pomicanje 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>Zapis <strong data-start=\"3870\" data-end=\"3892\">rezna sila (F1)<\/strong> i <strong data-start=\"3897\" data-end=\"3916\">snaga 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>: Izraditi krivu sile u odnosu na pomak, izra\u010dunati srednju vrijednost 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 na Hub kanuli | Tester \u010dvrsto\u0107e veze igle na \u0161prici\" 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\u0161taj o testiranju i dokumentacija o kvalitetu<\/h2>\n\n\n\n<p>Potpuni izvje\u0161taj za <strong data-start=\"4254\" data-end=\"4281\">test probijanja iglom<\/strong> treba uklju\u010divati:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Specifikacija i stanje podloge<\/li>\n\n\n\n<li>Specifikacije igle (pre\u010dnik, tip, tretman)<\/li>\n\n\n\n<li>Brzina i metoda ispitivanja<\/li>\n\n\n\n<li>Rezultati penetracije i sile otpora<\/li>\n\n\n\n<li>Veli\u010dina uzorka i statisti\u010dka evaluacija<\/li>\n\n\n\n<li>Uo\u010denja ili odstupanja<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Primjena i prednosti u kontroli kvaliteta<\/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> kod parenteralne primjene<\/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 ta\u010dnost i reproduktivnost <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 rje\u0161enje za testiranje\t\t\t\t<\/h2>\n\n\n\n<p>The <strong data-start=\"5527\" data-end=\"5554\"><a href=\"https:\/\/www.packqc.com\/bs\/product\/needle-penetration-test-equipment-iso-7864\/\">probojanje iglom<\/a> test<\/strong> je od vitalnog zna\u010daja za validaciju funkcionalnosti i sigurnosti sistema za injektiranje i gumenih \u010depova. Izravno utje\u010de na udobnost korisnika, integritet proizvoda i regulatorno odobrenje. Primjenom standardiziranih procedura i kori\u0161tenjem naprednih sistema za testiranje poput onih koje nudi <strong data-start=\"5821\" data-end=\"5841\">Cell Instruments<\/strong>, proizvo\u0111a\u010di mogu pouzdano osigurati pouzdanost i uskla\u0111enost 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\/bs\/wp-json\/wp\/v2\/applications\/9298","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/bs\/wp-json\/wp\/v2\/applications"}],"about":[{"href":"https:\/\/www.packqc.com\/bs\/wp-json\/wp\/v2\/types\/applications"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/bs\/wp-json\/wp\/v2\/media\/6744"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/bs\/wp-json\/wp\/v2\/media?parent=9298"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}