{"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\/cs\/applications\/needle-penetration-test\/","title":{"rendered":"Test penetrace jehlou pro testov\u00e1n\u00ed zdravotnick\u00fdch prost\u0159edk\u016f a obal\u016f"},"content":{"rendered":"<p>Zkou\u0161ka pr\u016fniku jehly hraje z\u00e1sadn\u00ed roli p\u0159i hodnocen\u00ed mechanick\u00fdch vlastnost\u00ed injek\u010dn\u00edch jehel, p\u0159edpln\u011bn\u00fdch injek\u010dn\u00edch st\u0159\u00edka\u010dek a pry\u017eov\u00fdch uz\u00e1v\u011br\u016f. Tato zkou\u0161ka zaji\u0161\u0165uje, \u017ee jehly jsou dostate\u010dn\u011b ostr\u00e9 a \u017ee uz\u00e1v\u011bry maj\u00ed spr\u00e1vnou penetra\u010dn\u00ed schopnost p\u0159i zachov\u00e1n\u00ed celistvosti t\u011bsn\u011bn\u00ed. Pro v\u00fdrobce a odborn\u00edky na kontrolu kvality je pochopen\u00ed t\u00e9to zkou\u0161ky nezbytn\u00e9 pro spln\u011bn\u00ed mezin\u00e1rodn\u00edch norem, jako jsou nap\u0159. <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\/cs\/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\">P\u0159ehled zkou\u0161ek pr\u016fchodnosti a ostrosti jehel<\/h2>\n\n\n\n<p><strong data-start=\"926\" data-end=\"948\">Zkou\u0161ka pr\u016fchodnosti<\/strong>, <strong data-start=\"950\" data-end=\"978\">testov\u00e1n\u00ed ostrosti jehel<\/strong>a <strong data-start=\"984\" data-end=\"1026\">zkou\u0161ka pr\u016fchodnosti pry\u017eov\u00fdch z\u00e1tek<\/strong> jsou z\u00e1sadn\u00ed hodnocen\u00ed ve farmaceutick\u00e9m pr\u016fmyslu a v oblasti zdravotnick\u00fdch prost\u0159edk\u016f. Tato hodnocen\u00ed zaji\u0161\u0165uj\u00ed snadn\u00e9 vst\u0159ikov\u00e1n\u00ed, minimalizuj\u00ed nepohodl\u00ed pacient\u016f a ov\u011b\u0159uj\u00ed funk\u010dnost uzav\u00edrac\u00edch syst\u00e9m\u016f.<\/p>\n\n\n\n<p>Podle normy ISO 8871-5 se <strong data-start=\"1256\" data-end=\"1273\">pr\u016fchodnost<\/strong> je definov\u00e1na jako s\u00edla pot\u0159ebn\u00e1 k prop\u00edchnut\u00ed elastomerov\u00e9ho uz\u00e1v\u011bru jehlou. Sou\u010dasn\u011b normy ISO 7864 a ISO 11040-4 definuj\u00ed s\u00edlu pr\u016fniku a s\u00edlu odporu pot\u0159ebnou k pr\u016fchodu jehly standardn\u00edm podkladem nebo f\u00f3li\u00ed.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Principy a c\u00edle test\u016f<\/h2>\n\n\n\n<p>The <strong data-start=\"1546\" data-end=\"1573\">penetra\u010dn\u00ed test jehlou<\/strong> se zam\u011b\u0159uje na m\u011b\u0159en\u00ed:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The <strong data-start=\"1597\" data-end=\"1626\">po\u010d\u00e1te\u010dn\u00ed penetra\u010dn\u00ed s\u00edla<\/strong> (nebo propichovac\u00ed s\u00edla), kdy\u017e se hrot jehly dotkne podkladu.<\/li>\n\n\n\n<li>The <strong data-start=\"1697\" data-end=\"1724\">\u0159ezn\u00e9 a vle\u010dn\u00e9 s\u00edly<\/strong> p\u0159i posunu jehlov\u00e9ho h\u0159\u00eddele.<\/li>\n\n\n\n<li>Konzistence v\u00fdkonnosti ve v\u00edce vzorc\u00edch.<\/li>\n<\/ul>\n\n\n\n<p>Tento test je kl\u00ed\u010dov\u00fd nejen pro <strong data-start=\"1848\" data-end=\"1876\">testov\u00e1n\u00ed ostrosti jehel<\/strong>, ale tak\u00e9 ov\u011b\u0159uje <strong data-start=\"1900\" data-end=\"1936\">pr\u016fchodnost pry\u017eov\u00fdch z\u00e1tek<\/strong> se pou\u017e\u00edvaj\u00ed ve steriln\u00edch n\u00e1dob\u00e1ch.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Zku\u0161ebn\u00ed normy a pou\u017eitelnost<\/h2>\n\n\n\n<p>Zkou\u0161ka se prov\u00e1d\u00ed p\u0159edev\u0161\u00edm podle n\u00e1sleduj\u00edc\u00edch mezin\u00e1rodn\u00edch norem:<\/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>: P\u0159edpln\u011bn\u00e9 injek\u010dn\u00ed st\u0159\u00edka\u010dky - zahrnuje kompletn\u00ed syst\u00e9my v\u010detn\u011b sklen\u011bn\u00fdch nebo plastov\u00fdch barel\u016f.<\/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>: Podko\u017en\u00ed jehly - poskytuje n\u00e1vod k anal\u00fdze maxim\u00e1ln\u00ed s\u00edly a odporu p\u0159i zav\u00e1d\u011bn\u00ed jehly.<\/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>: Elastomerov\u00e9 uz\u00e1v\u011bry pro lahvi\u010dky - hodnot\u00ed pr\u016fchodnost, fragmentaci a samouzav\u00edrac\u00ed schopnost.<\/li>\n<\/ul>\n\n\n\n<p>Test se vztahuje na:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Jehly s kol\u00edky nebo p\u0159ipevn\u011bn\u00e9 jehly<\/li>\n\n\n\n<li>Gumov\u00e9 z\u00e1tky<\/li>\n\n\n\n<li>P\u0159edpln\u011bn\u00e9 injek\u010dn\u00ed st\u0159\u00edka\u010dky a steriln\u00ed podsestavy<\/li>\n\n\n\n<li>Zaji\u0161t\u011bn\u00ed kvality surovin a hotov\u00fdch v\u00fdrobk\u016f<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Po\u017eadavky na vybaven\u00ed a nastaven\u00ed<\/h2>\n\n\n\n<p>A vyhovuj\u00edc\u00ed <strong data-start=\"2664\" data-end=\"2691\">penetra\u010dn\u00ed test jehlou<\/strong> vy\u017eaduje:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">1. Univerz\u00e1ln\u00ed zku\u0161ebn\u00ed stroj<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"2742\" data-end=\"2764\">Kapacita zat\u011b\u017eovac\u00ed bu\u0148ky<\/strong>: do 10 N (nebo odpov\u00eddaj\u00edc\u00ed zku\u0161ebn\u00edmu rozsahu)<\/li>\n\n\n\n<li><strong data-start=\"2811\" data-end=\"2828\">\u0158\u00edzen\u00ed rychlosti<\/strong>: obvykle mezi 20 mm\/min a 200 mm\/min, b\u011b\u017en\u011b 100 mm\/min<\/li>\n\n\n\n<li><strong data-start=\"2896\" data-end=\"2913\">Rychlost odb\u011bru vzork\u016f<\/strong>: 500 Hz pro p\u0159esnost \u0161pi\u010dkov\u00e9 s\u00edly<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">2. Dr\u017e\u00e1k jehly<\/h3>\n\n\n\n<p>Navr\u017eeno tak, aby zajistilo <strong data-start=\"2993\" data-end=\"3015\">vertik\u00e1ln\u00ed zarovn\u00e1n\u00ed<\/strong> a p\u0159esn\u00e9 \u0159\u00edzen\u00ed dr\u00e1hy zasunut\u00ed.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">3. Zku\u0161ebn\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> pro metodu ISO 11040-4<\/li>\n\n\n\n<li><strong data-start=\"3119\" data-end=\"3143\">Syntetick\u00e9 elastomery<\/strong> jako jsou:\n<ul class=\"wp-block-list\">\n<li>Latexov\u00e1 pry\u017e (40\u00b15 Shore A, tlou\u0161\u0165ka 1,0 mm)<\/li>\n\n\n\n<li>Polyuretan (85\u00b110 Shore A, tlou\u0161\u0165ka 0,40 mm)<\/li>\n\n\n\n<li>Silikonov\u00e1 pry\u017e nebo LDPE f\u00f3lie podle ISO 7864<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">4. Dr\u017e\u00e1k substr\u00e1tu<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>M\u011bla by udr\u017eovat st\u00e1lou up\u00ednac\u00ed s\u00edlu a vystavovat <strong data-start=\"3401\" data-end=\"3436\">10 mm kruhov\u00e1 plocha pr\u016fniku<\/strong><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Podrobn\u00fd zku\u0161ebn\u00ed postup<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"3474\" data-end=\"3503\">P\u0159\u00edprava zku\u0161ebn\u00edho vzorku<\/strong>: Do dr\u017e\u00e1ku substr\u00e1tu upevn\u011bte \u010derstv\u00fd \u00fasek f\u00f3lie nebo elastomeru bez nap\u011bt\u00ed.<\/li>\n\n\n\n<li><strong data-start=\"3590\" data-end=\"3610\">Mont\u00e1\u017e jehly<\/strong>: Zku\u0161ebn\u00ed jehlu upevn\u011bte kolmo ke zku\u0161ebn\u00edmu povrchu pomoc\u00ed kalibrovan\u00e9ho dr\u017e\u00e1ku.<\/li>\n\n\n\n<li><strong data-start=\"3699\" data-end=\"3718\">Nastaven\u00ed stroje<\/strong>: Pohybujte se konstantn\u00ed rychlost\u00ed (b\u011b\u017en\u011b 100 mm\/min).<\/li>\n\n\n\n<li><strong data-start=\"3779\" data-end=\"3803\">Proniknout a zaznamenat<\/strong>:\n<ul class=\"wp-block-list\">\n<li>Zm\u011b\u0159te <strong data-start=\"3822\" data-end=\"3841\">\u0161pi\u010dkov\u00e1 s\u00edla (F0)<\/strong> pro \u0161pi\u010dku jehly<\/li>\n\n\n\n<li>P\u0159ihl\u00e1sit se <strong data-start=\"3870\" data-end=\"3892\">\u0159ezn\u00e1 s\u00edla (F1)<\/strong> a <strong data-start=\"3897\" data-end=\"3916\">s\u00edla na pat\u011b (F2)<\/strong><\/li>\n\n\n\n<li>Opat\u0159en\u00ed <strong data-start=\"3930\" data-end=\"3949\">odporov\u00e1 s\u00edla (F3)<\/strong> pro pln\u00fd pr\u016fnik h\u0159\u00eddele<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong data-start=\"3980\" data-end=\"3998\">Zata\u017een\u00ed jehly<\/strong>: Dokon\u010dete cyklus a pro ka\u017ed\u00fd vzorek pou\u017eijte nov\u00e9 m\u00edsto.<\/li>\n\n\n\n<li><strong data-start=\"4058\" data-end=\"4075\">Anal\u00fdza dat<\/strong>: Vytvo\u0159te k\u0159ivku z\u00e1vislosti s\u00edly na posunut\u00ed, vypo\u010d\u00edtejte pr\u016fm\u011br a sm\u011brodatnou odchylku pro \u0161pi\u010dkovou a odporovou s\u00edlu.<\/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=\"Zkou\u0161ka pevnosti lepen\u00ed jehly n\u00e1boje|Tester pevnosti lepen\u00ed jehly st\u0159\u00edka\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\">Zpr\u00e1va o zkou\u0161ce a dokumentace kvality<\/h2>\n\n\n\n<p>\u00dapln\u00e1 zpr\u00e1va pro <strong data-start=\"4254\" data-end=\"4281\">penetra\u010dn\u00ed test jehlou<\/strong> by m\u011bl obsahovat:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Specifikace a stav substr\u00e1tu<\/li>\n\n\n\n<li>Specifikace jehly (pr\u016fm\u011br, typ, o\u0161et\u0159en\u00ed)<\/li>\n\n\n\n<li>Rychlost a zku\u0161ebn\u00ed metoda<\/li>\n\n\n\n<li>V\u00fdsledky penetra\u010dn\u00ed a odporov\u00e9 s\u00edly<\/li>\n\n\n\n<li>Velikost vzorku a statistick\u00e9 hodnocen\u00ed<\/li>\n\n\n\n<li>Pozorov\u00e1n\u00ed nebo odchylky<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Pou\u017eit\u00ed a v\u00fdhody p\u0159i kontrole kvality<\/h2>\n\n\n\n<p>Pro v\u00fdrobce l\u00e9\u010div je dodr\u017eov\u00e1n\u00ed t\u011bchto test\u016f podporou:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"4650\" data-end=\"4676\">P\u0159edlo\u017een\u00ed regula\u010dn\u00edch dokument\u016f<\/strong> (nap\u0159. FDA, EMA).<\/li>\n\n\n\n<li><strong data-start=\"4696\" data-end=\"4730\">Bezpe\u010dnost a konzistence v\u00fdrobk\u016f<\/strong><\/li>\n\n\n\n<li><strong data-start=\"4733\" data-end=\"4761\">Vylep\u0161en\u00e9 u\u017eivatelsk\u00e9 prost\u0159ed\u00ed<\/strong> p\u0159i parenter\u00e1ln\u00edm pod\u00e1n\u00ed<\/li>\n\n\n\n<li><strong data-start=\"4787\" data-end=\"4813\">Sn\u00ed\u017een\u00ed bolesti p\u0159i injekci<\/strong> a nepohodl\u00ed pacient\u016f<\/li>\n<\/ul>\n\n\n\n<p>Ke zv\u00fd\u0161en\u00ed p\u0159esnosti a reprodukovatelnosti <strong data-start=\"4889\" data-end=\"4911\">test penetrability<\/strong>, je nezbytn\u00e9 pokro\u010dil\u00e9 p\u0159\u00edstrojov\u00e9 vybaven\u00ed.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\n\t\t\t\tKontaktujte n\u00e1s Z\u00edskejte \u0159e\u0161en\u00ed pro testov\u00e1n\u00ed kv\u011btin\t\t\t\t<\/h2>\n\n\n\n<p>The <strong data-start=\"5527\" data-end=\"5554\"><a href=\"https:\/\/www.packqc.com\/cs\/product\/needle-penetration-test-equipment-iso-7864\/\">pr\u016fnik jehly<\/a> test<\/strong> m\u00e1 z\u00e1sadn\u00ed v\u00fdznam pro ov\u011b\u0159en\u00ed funk\u010dnosti a bezpe\u010dnosti vst\u0159ikovac\u00edch syst\u00e9m\u016f a pry\u017eov\u00fdch uz\u00e1v\u011br\u016f. M\u00e1 p\u0159\u00edm\u00fd vliv na u\u017eivatelsk\u00fd komfort, integritu v\u00fdrobku a schv\u00e1len\u00ed regula\u010dn\u00edmi org\u00e1ny. Uplat\u0148ov\u00e1n\u00edm standardizovan\u00fdch postup\u016f a pou\u017e\u00edv\u00e1n\u00edm pokro\u010dil\u00fdch testovac\u00edch syst\u00e9m\u016f, jako jsou ty, kter\u00e9 nab\u00edz\u00ed nap\u0159. <strong data-start=\"5821\" data-end=\"5841\">Bun\u011b\u010dn\u00e9 n\u00e1stroje<\/strong>, mohou v\u00fdrobci s jistotou zajistit spolehlivost a shodu v\u00fdrobk\u016f.<\/p>","protected":false},"excerpt":{"rendered":"<p>Zkou\u0161ka pr\u016fniku jehly hraje z\u00e1sadn\u00ed roli p\u0159i hodnocen\u00ed mechanick\u00fdch vlastnost\u00ed injek\u010dn\u00edch jehel, p\u0159edpln\u011bn\u00fdch injek\u010dn\u00edch st\u0159\u00edka\u010dek a pry\u017eov\u00fdch uz\u00e1v\u011br\u016f. Tato zkou\u0161ka zaji\u0161\u0165uje, \u017ee jehly jsou dostate\u010dn\u011b ostr\u00e9 a \u017ee uz\u00e1v\u011bry maj\u00ed spr\u00e1vnou penetra\u010dn\u00ed schopnost p\u0159i zachov\u00e1n\u00ed celistvosti t\u011bsn\u011bn\u00ed. Pro v\u00fdrobce a pracovn\u00edky v oblasti kontroly kvality je pochopen\u00ed t\u00e9to zkou\u0161ky nezbytn\u00e9 pro zaji\u0161t\u011bn\u00ed souladu s mezin\u00e1rodn\u00edmi normami, jako je nap\u0159\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\/cs\/wp-json\/wp\/v2\/applications\/9298","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/cs\/wp-json\/wp\/v2\/applications"}],"about":[{"href":"https:\/\/www.packqc.com\/cs\/wp-json\/wp\/v2\/types\/applications"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/cs\/wp-json\/wp\/v2\/media\/6744"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/cs\/wp-json\/wp\/v2\/media?parent=9298"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}