{"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\/sk\/applications\/needle-penetration-test\/","title":{"rendered":"Test penetr\u00e1cie ihlou na testovanie zdravotn\u00edckych pom\u00f4cok a obalov"},"content":{"rendered":"<p>Test penetr\u00e1cie ihly zohr\u00e1va k\u013e\u00fa\u010dov\u00fa \u00falohu pri hodnoten\u00ed mechanick\u00fdch vlastnost\u00ed injek\u010dn\u00fdch ihiel, predplnen\u00fdch injek\u010dn\u00fdch strieka\u010diek a gumov\u00fdch uz\u00e1verov. T\u00e1to sk\u00fa\u0161ka zabezpe\u010duje, aby ihly boli dostato\u010dne ostr\u00e9 a aby uz\u00e1very poskytovali spr\u00e1vnu priechodnos\u0165 pri zachovan\u00ed integrity tesnenia. Pre v\u00fdrobcov a odborn\u00edkov na kontrolu kvality je pochopenie tejto sk\u00fa\u0161ky nevyhnutn\u00e9 na dosiahnutie s\u00faladu s medzin\u00e1rodn\u00fdmi normami, ako napr. <strong data-start=\"808\" data-end=\"823\">ISO 11040-4<\/strong>, <strong data-start=\"825\" data-end=\"837\">ISO 7864<\/strong>, a <a href=\"https:\/\/www.packqc.com\/sk\/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\">Preh\u013ead testov priepustnosti a ostrosti ihiel<\/h2>\n\n\n\n<p><strong data-start=\"926\" data-end=\"948\">Sk\u00fa\u0161ka priepustnosti<\/strong>, <strong data-start=\"950\" data-end=\"978\">testovanie ostrosti ihiel<\/strong>, a <strong data-start=\"984\" data-end=\"1026\">sk\u00fa\u0161ka priepustnosti gumov\u00fdch z\u00e1tok<\/strong> s\u00fa z\u00e1kladn\u00fdmi hodnoteniami vo farmaceutickom priemysle a v oblasti zdravotn\u00edckych pom\u00f4cok. Tieto hodnotenia zabezpe\u010duj\u00fa jednoduchos\u0165 vstrekovania, minimalizuj\u00fa nepohodlie pacienta a overuj\u00fa funk\u010dnos\u0165 uzatv\u00e1rac\u00edch syst\u00e9mov.<\/p>\n\n\n\n<p>Pod\u013ea normy ISO 8871-5 <strong data-start=\"1256\" data-end=\"1273\">priepustnos\u0165<\/strong> je definovan\u00e1 ako sila potrebn\u00e1 na prepichnutie elastom\u00e9rov\u00e9ho uz\u00e1veru ihlou. S\u00fa\u010dasne normy ISO 7864 a ISO 11040-4 definuj\u00fa silu prieniku a silu odporu potrebn\u00fa na prechod ihly cez \u0161tandardn\u00fd substr\u00e1t alebo f\u00f3liu.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Z\u00e1sady a ciele testovania<\/h2>\n\n\n\n<p>The <strong data-start=\"1546\" data-end=\"1573\">penetra\u010dn\u00fd test ihlou<\/strong> sa zameriava na meranie:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The <strong data-start=\"1597\" data-end=\"1626\">po\u010diato\u010dn\u00e1 penetra\u010dn\u00e1 sila<\/strong> (alebo prepichovacia sila), ke\u010f sa hrot ihly dotkne podkladu.<\/li>\n\n\n\n<li>The <strong data-start=\"1697\" data-end=\"1724\">rezn\u00e9 a \u0165a\u017en\u00e9 sily<\/strong> ako sa pos\u00fava ihlov\u00fd hriade\u013e.<\/li>\n\n\n\n<li>Konzistentnos\u0165 v\u00fdkonu vo viacer\u00fdch vzork\u00e1ch.<\/li>\n<\/ul>\n\n\n\n<p>Tento test je d\u00f4le\u017eit\u00fd nielen pre <strong data-start=\"1848\" data-end=\"1876\">testovanie ostrosti ihiel<\/strong>, ale tie\u017e overuje <strong data-start=\"1900\" data-end=\"1936\">priepustnos\u0165 gumov\u00fdch z\u00e1tok<\/strong> pou\u017e\u00edva v steriln\u00fdch n\u00e1dob\u00e1ch.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Testovacie normy a uplatnite\u013enos\u0165<\/h2>\n\n\n\n<p>Test sa vykon\u00e1va predov\u0161etk\u00fdm pod\u013ea t\u00fdchto medzin\u00e1rodn\u00fdch noriem:<\/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>: Predplnen\u00e9 injek\u010dn\u00e9 strieka\u010dky - vz\u0165ahuje sa na kompletn\u00e9 syst\u00e9my vr\u00e1tane sklenen\u00fdch alebo plastov\u00fdch sudov.<\/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>: Hypodermick\u00e9 ihly - poskytuje n\u00e1vod na anal\u00fdzu maxim\u00e1lnej sily a odporu pri zav\u00e1dzan\u00ed ihly.<\/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>: Elastom\u00e9rov\u00e9 uz\u00e1very pre f\u013ea\u0161ti\u010dky - hodnot\u00ed priepustnos\u0165, fragment\u00e1ciu a samotesniace vlastnosti.<\/li>\n<\/ul>\n\n\n\n<p>Test sa vz\u0165ahuje na:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Ihly s kol\u00edkom alebo pripevnen\u00e9 ihly<\/li>\n\n\n\n<li>Gumov\u00e9 z\u00e1tky<\/li>\n\n\n\n<li>Predplnen\u00e9 injek\u010dn\u00e9 strieka\u010dky a steriln\u00e9 podskupiny<\/li>\n\n\n\n<li>Zabezpe\u010denie kvality surov\u00edn a hotov\u00fdch v\u00fdrobkov<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Po\u017eiadavky na vybavenie a nastavenie<\/h2>\n\n\n\n<p>A vyhovuj\u00face <strong data-start=\"2664\" data-end=\"2691\">penetra\u010dn\u00fd test ihlou<\/strong> vy\u017eaduje:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">1. Univerz\u00e1lny sk\u00fa\u0161obn\u00fd stroj<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"2742\" data-end=\"2764\">Kapacita za\u0165a\u017eovacej bunky<\/strong>: do 10 N (alebo primerane testovan\u00e9mu rozsahu)<\/li>\n\n\n\n<li><strong data-start=\"2811\" data-end=\"2828\">Regul\u00e1cia r\u00fdchlosti<\/strong>: zvy\u010dajne od 20 mm\/min do 200 mm\/min, be\u017ene 100 mm\/min<\/li>\n\n\n\n<li><strong data-start=\"2896\" data-end=\"2913\">Vzorkovacia frekvencia<\/strong>: 500 Hz pre presnos\u0165 maxim\u00e1lnej sily<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">2. Dr\u017eiak ihly<\/h3>\n\n\n\n<p>Navrhnut\u00e9 na zabezpe\u010denie <strong data-start=\"2993\" data-end=\"3015\">vertik\u00e1lne zarovnanie<\/strong> a presn\u00e9 riadenie dr\u00e1hy vkladania.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">3. Testovac\u00ed substr\u00e1t<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"3084\" data-end=\"3093\">F\u00f3lie<\/strong> pre met\u00f3du ISO 11040-4<\/li>\n\n\n\n<li><strong data-start=\"3119\" data-end=\"3143\">Syntetick\u00e9 elastom\u00e9ry<\/strong> ako napr\u00edklad:\n<ul class=\"wp-block-list\">\n<li>Latexov\u00e1 guma (40\u00b15 Shore A, hr\u00fabka 1,0 mm)<\/li>\n\n\n\n<li>Polyuret\u00e1n (85\u00b110 Shore A, hr\u00fabka 0,40 mm)<\/li>\n\n\n\n<li>Silik\u00f3nov\u00e1 guma alebo LDPE f\u00f3lia pod\u013ea smernice ISO 7864<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">4. Dr\u017eiak substr\u00e1tu<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Mali by udr\u017eiava\u0165 konzistentn\u00fa up\u00ednaciu silu a vystavi\u0165 <strong data-start=\"3401\" data-end=\"3436\">10 mm kruhov\u00e1 oblas\u0165 prieniku<\/strong><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Podrobn\u00fd postup testovania<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"3474\" data-end=\"3503\">Pr\u00edprava sk\u00fa\u0161obnej vzorky<\/strong>: Upevnite \u010derstv\u00fa \u010das\u0165 f\u00f3lie alebo elastom\u00e9ru do dr\u017eiaka substr\u00e1tu bez nap\u00e4tia.<\/li>\n\n\n\n<li><strong data-start=\"3590\" data-end=\"3610\">Mont\u00e1\u017e ihly<\/strong>: Pomocou kalibrovan\u00e9ho dr\u017eiaka zaistite sk\u00fa\u0161obn\u00fa ihlu kolmo na sk\u00fa\u0161obn\u00fd povrch.<\/li>\n\n\n\n<li><strong data-start=\"3699\" data-end=\"3718\">Nastavenie stroja<\/strong>: Pohybujte sa kon\u0161tantnou r\u00fdchlos\u0165ou (be\u017ene 100 mm\/min).<\/li>\n\n\n\n<li><strong data-start=\"3779\" data-end=\"3803\">Prenikn\u00fa\u0165 a zaznamena\u0165<\/strong>:\n<ul class=\"wp-block-list\">\n<li>Meranie <strong data-start=\"3822\" data-end=\"3841\">maxim\u00e1lna sila (F0)<\/strong> pre hrot ihly<\/li>\n\n\n\n<li>Prihl\u00e1si\u0165 sa <strong data-start=\"3870\" data-end=\"3892\">rezn\u00e1 sila (F1)<\/strong> a <strong data-start=\"3897\" data-end=\"3916\">sila na p\u00e4tu (F2)<\/strong><\/li>\n\n\n\n<li>Opatrenie <strong data-start=\"3930\" data-end=\"3949\">odporov\u00e1 sila (F3)<\/strong> pre \u00fapln\u00fd prienik do hriade\u013ea<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong data-start=\"3980\" data-end=\"3998\">Zasunutie ihly<\/strong>: Dokon\u010dite cyklus a pre ka\u017ed\u00fa vzorku pou\u017eite nov\u00e9 miesto.<\/li>\n\n\n\n<li><strong data-start=\"4058\" data-end=\"4075\">Anal\u00fdza \u00fadajov<\/strong>: Vytvorte krivku z\u00e1vislosti sily od posunu, vypo\u010d\u00edtajte priemern\u00fa hodnotu a \u0161tandardn\u00fa odch\u00fdlku pre \u0161pi\u010dkov\u00fa a odporov\u00fa silu.<\/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=\"Sk\u00fa\u0161ka pevnosti spojenia ihly n\u00e1bojovej kanyly|Tester pevnosti spojenia ihly injek\u010dnej strieka\u010dky\" 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\">Testovacia spr\u00e1va a dokument\u00e1cia kvality<\/h2>\n\n\n\n<p>\u00dapln\u00e1 spr\u00e1va pre <strong data-start=\"4254\" data-end=\"4281\">penetra\u010dn\u00fd test ihlou<\/strong> by mala obsahova\u0165:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u0160pecifik\u00e1cia a stav substr\u00e1tu<\/li>\n\n\n\n<li>\u0160pecifik\u00e1cie ihly (priemer, typ, o\u0161etrenie)<\/li>\n\n\n\n<li>R\u00fdchlos\u0165 a sk\u00fa\u0161obn\u00e1 met\u00f3da<\/li>\n\n\n\n<li>V\u00fdsledky penetra\u010dnej a odporovej sily<\/li>\n\n\n\n<li>Ve\u013ekos\u0165 vzorky a \u0161tatistick\u00e9 hodnotenie<\/li>\n\n\n\n<li>Pripomienky alebo odch\u00fdlky<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Pou\u017eitie a v\u00fdhody pri kontrole kvality<\/h2>\n\n\n\n<p>Pre v\u00fdrobcov liekov je s\u00falad s t\u00fdmito testami podporou:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"4650\" data-end=\"4676\">Predkladanie regula\u010dn\u00fdch dokumentov<\/strong> (napr. FDA, EMA)<\/li>\n\n\n\n<li><strong data-start=\"4696\" data-end=\"4730\">Bezpe\u010dnos\u0165 a konzistentnos\u0165 v\u00fdrobku<\/strong><\/li>\n\n\n\n<li><strong data-start=\"4733\" data-end=\"4761\">Zlep\u0161en\u00e1 pou\u017e\u00edvate\u013esk\u00e1 sk\u00fasenos\u0165<\/strong> pri parenter\u00e1lnom pod\u00e1van\u00ed<\/li>\n\n\n\n<li><strong data-start=\"4787\" data-end=\"4813\">Zn\u00ed\u017eenie bolesti pri injekcii<\/strong> a nepohodlie pacienta<\/li>\n<\/ul>\n\n\n\n<p>Na zv\u00fd\u0161enie presnosti a reprodukovate\u013enosti <strong data-start=\"4889\" data-end=\"4911\">test penetrability<\/strong>, je nevyhnutn\u00e9 modern\u00e9 pr\u00edstrojov\u00e9 vybavenie.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\n\t\t\t\tKontaktujte n\u00e1s Z\u00edskajte rie\u0161enie testovania Bloom\t\t\t\t<\/h2>\n\n\n\n<p>The <strong data-start=\"5527\" data-end=\"5554\"><a href=\"https:\/\/www.packqc.com\/sk\/product\/needle-penetration-test-equipment-iso-7864\/\">prienik ihly<\/a> test<\/strong> je ve\u013emi d\u00f4le\u017eit\u00e1 na overenie funk\u010dnosti a bezpe\u010dnosti vstrekovac\u00edch syst\u00e9mov a gumov\u00fdch uz\u00e1verov. Priamo ovplyv\u0148uje pohodlie pou\u017e\u00edvate\u013eov, integritu v\u00fdrobku a schva\u013eovanie regula\u010dn\u00fdmi org\u00e1nmi. Uplat\u0148ovan\u00edm \u0161tandardizovan\u00fdch postupov a pou\u017e\u00edvan\u00edm pokro\u010dil\u00fdch testovac\u00edch syst\u00e9mov, ak\u00e9 pon\u00faka napr. <strong data-start=\"5821\" data-end=\"5841\">Cell Instruments<\/strong>, m\u00f4\u017eu v\u00fdrobcovia s istotou zabezpe\u010di\u0165 spo\u013eahlivos\u0165 a zhodu v\u00fdrobku.<\/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\/sk\/wp-json\/wp\/v2\/applications\/9298","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/sk\/wp-json\/wp\/v2\/applications"}],"about":[{"href":"https:\/\/www.packqc.com\/sk\/wp-json\/wp\/v2\/types\/applications"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/sk\/wp-json\/wp\/v2\/media\/6744"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/sk\/wp-json\/wp\/v2\/media?parent=9298"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}