{"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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\"><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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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>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 [\u2026]<\/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}]}}