{"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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\"><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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">\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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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>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\u00edklad [...]<\/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}]}}