{"id":1994,"date":"2025-04-02T06:13:33","date_gmt":"2025-04-02T06:13:33","guid":{"rendered":"https:\/\/www.pharmacopoeiatest.com\/?p=1994"},"modified":"2025-04-02T06:30:46","modified_gmt":"2025-04-02T06:30:46","slug":"syringes-needle-penetration-test-iso-11040-4","status":"publish","type":"post","link":"https:\/\/www.pharmacopoeiatest.com\/sk\/syringes-needle-penetration-test-iso-11040-4\/","title":{"rendered":"Sk\u00fa\u0161ka penetr\u00e1cie injek\u010dn\u00fdch strieka\u010diek ISO 11040-4 pr\u00edloha F"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"1994\" class=\"elementor elementor-1994\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d8f0949 e-flex e-con-boxed e-con e-parent\" data-id=\"d8f0949\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-af89456 elementor-widget elementor-widget-heading\" data-id=\"af89456\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Penetra\u010dn\u00e9 testovanie ihlou<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-75ecf40 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"75ecf40\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-20ce2df elementor-widget elementor-widget-heading\" data-id=\"20ce2df\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">ISO 11040-4 Pr\u00edloha F<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-c9ca423 e-flex e-con-boxed e-con e-parent\" data-id=\"c9ca423\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-41f75ef e-con-full e-flex e-con e-child\" data-id=\"41f75ef\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5114c7b elementor-widget elementor-widget-text-editor\" data-id=\"5114c7b\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>Str\u00e1nka <strong>test penetr\u00e1cie injek\u010dn\u00fdch strieka\u010diek<\/strong> je k\u013e\u00fa\u010dov\u00fdm postupom v odvetv\u00ed zdravotn\u00edckych pom\u00f4cok, ktor\u00fd zabezpe\u010duje ostros\u0165 a \u00fa\u010dinnos\u0165 ihiel pou\u017e\u00edvan\u00fdch v medic\u00edne. T\u00fdmto testom sa hodnot\u00ed <strong>sila prieniku ihly<\/strong> potrebn\u00e9 na prepichnutie testovacej f\u00f3lie, \u010do odr\u00e1\u017ea \u013eahkos\u0165, s akou m\u00f4\u017ee ihla prenikn\u00fa\u0165 \u013eudskou ko\u017eou alebo in\u00fdmi materi\u00e1lmi.<\/p><p>Na zaru\u010denie bezpe\u010dnosti pacientov a spo\u013eahlivosti v\u00fdrobkov sa pou\u017e\u00edvaj\u00fa medzin\u00e1rodn\u00e9 normy, ako napr. <strong>ISO 11040-4<\/strong> na\u010drtn\u00fa\u0165 presn\u00e9 metodiky testovania injek\u010dn\u00fdch ihiel. Tieto normy pom\u00e1haj\u00fa v\u00fdrobcom udr\u017eiava\u0165 kontrolu kvality a dodr\u017eiavanie predpisov.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1c4a1c1 elementor-widget elementor-widget-heading\" data-id=\"1c4a1c1\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Potrebn\u00e9 vybavenie na testovanie penetr\u00e1cie ihlou<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-405b6c1 elementor-widget elementor-widget-text-editor\" data-id=\"405b6c1\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-pm-slice=\"1 3 []\">Pod\u013ea <strong>ISO 11040-4<\/strong>, na vykonanie sk\u00fa\u0161ky je nevyhnutn\u00fd tento pr\u00edstroj <a href=\"https:\/\/www.pharmacopoeiatest.com\/sk\/syringe-needle-penetration-test\/\" target=\"_blank\" rel=\"noopener\"><strong>penetra\u010dn\u00fd test ihlou<\/strong><\/a>:<\/p><ul><li data-pm-slice=\"1 3 []\"><strong>Univerz\u00e1lny stroj na sk\u00fa\u0161anie v \u0165ahu a tlaku<\/strong> s rozsahom merania do 10 N (alebo pod\u013ea potreby) a sk\u00fa\u0161obnou r\u00fdchlos\u0165ou od 20 mm\/min do 200 mm\/min.<\/li><li data-pm-slice=\"1 3 []\"><strong>Dr\u017eiak ihly<\/strong> na zabezpe\u010denie ihly po\u010das testovania.<\/li><li data-pm-slice=\"1 3 []\"><strong>Testovacia f\u00f3lia<\/strong>, so \u0161pecifik\u00e1ciami dohodnut\u00fdmi v\u00fdrobcami a z\u00e1kazn\u00edkmi.<\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3315f97 elementor-widget elementor-widget-image\" data-id=\"3315f97\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.pharmacopoeiatest.com\/sk\/syringe-needle-penetration-test\/\">\n\t\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/elementor\/thumbs\/ISO-11040-4-syringes-needle-penetration-test-equipment-r3r52op9pahd5s2kzyk3xzbhif0hy69cozbct55ytk.webp\" title=\"ISO 11040-4 Injek\u010dn\u00e9 strieka\u010dky Zariadenie na testovanie penetr\u00e1cie ihiel\" alt=\"ISO 11040-4 Injek\u010dn\u00e9 strieka\u010dky Zariadenie na testovanie penetr\u00e1cie ihiel\" loading=\"lazy\" \/>\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ff15e94 elementor-widget elementor-widget-heading\" data-id=\"ff15e94\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Met\u00f3da sk\u00fa\u0161ky penetr\u00e1cie injek\u010dn\u00fdch strieka\u010diek<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fe76308 elementor-widget elementor-widget-text-editor\" data-id=\"fe76308\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ol><li>Upevnite testovaciu f\u00f3liu do beznap\u00e4\u0165ov\u00e9ho dr\u017eiaka.<\/li><li>Upevnite ihlu kolmo do dr\u017eiaka a zarovnajte jej hrot do geometrick\u00e9ho stredu sk\u00fa\u0161obnej f\u00f3lie.<\/li><li>Spustite test a nechajte ihlu prenikn\u00fa\u0165 do f\u00f3lie kontrolovanou r\u00fdchlos\u0165ou.<\/li><li>Zaznamenajte krivku sily a posunutia na anal\u00fdzu charakterist\u00edk prieniku.<\/li><li>Pri ka\u017edom meran\u00ed zopakujte test s novou \u010das\u0165ou f\u00f3lie.<\/li><\/ol><p>Vy\u0161\u0161ia vzorkovacia frekvencia, napr\u00edklad 500 Hz, zvy\u0161uje presnos\u0165 merania pri zaznamen\u00e1van\u00ed \u0161pi\u010dkov\u00fdch hodn\u00f4t sily.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-60ebd0c elementor-widget elementor-widget-heading\" data-id=\"60ebd0c\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">K\u013e\u00fa\u010dov\u00e9 parametre penetra\u010dnej sily ihly pri testovan\u00ed<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0f1cf32 elementor-widget elementor-widget-text-editor\" data-id=\"0f1cf32\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-pm-slice=\"1 1 []\">Sila p\u00f4sobiaca po\u010das penetr\u00e1cie sa rozde\u013euje do r\u00f4znych f\u00e1z:<\/p><ul data-spread=\"false\"><li><strong>Prierazn\u00e1 sila (F<sub>0<\/sub>):<\/strong> Sila potrebn\u00e1 na prechod hrotu ihly cez f\u00f3liu.<\/li><li><strong>Rezn\u00e1 sila (F<sub>1<\/sub>):<\/strong> Sila, ktor\u00fa pou\u017e\u00edvaj\u00fa rezn\u00e9 hrany.<\/li><li><strong>Sila na p\u00e4tu (F<sub>2<\/sub>):<\/strong> Sila, ktor\u00e1 p\u00f4sob\u00ed pri prechode p\u00e4ty ihly.<\/li><li><strong>Vle\u010dn\u00e1 penetra\u010dn\u00e1 sila (F<sub>3<\/sub>):<\/strong> Sila odporu po \u00faplnom prieniku.<\/li><\/ul><p>Vyhodnoten\u00edm t\u00fdchto parametrov m\u00f4\u017eu v\u00fdrobcovia zabezpe\u010di\u0165, aby ihly sp\u013a\u0148ali po\u017eadovan\u00e9 normy ostrosti a pou\u017eite\u013enosti.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-84d059d elementor-widget elementor-widget-heading\" data-id=\"84d059d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">S\u00falad s normou ISO 11040-4 pre zabezpe\u010denie kvality<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7a670d9 elementor-widget elementor-widget-text-editor\" data-id=\"7a670d9\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-pm-slice=\"1 3 []\">Norma ISO 11040-4 stanovuje komplexn\u00e9 usmernenia na testovanie predplnen\u00fdch injek\u010dn\u00fdch strieka\u010diek, ktor\u00e9 zabezpe\u010duj\u00fa:<\/p><ul><li data-pm-slice=\"1 3 []\">\u0160tandardizovan\u00e9 <strong>sila prieniku ihly<\/strong> meranie.<\/li><li data-pm-slice=\"1 3 []\">Konzistentnos\u0165 pri r\u00f4znych typoch ihiel a strieka\u010diek.<\/li><li data-pm-slice=\"1 3 []\">S\u00falad s glob\u00e1lnymi po\u017eiadavkami na bezpe\u010dnos\u0165 v zdravotn\u00edctve.<\/li><li data-pm-slice=\"1 3 []\">Zn\u00ed\u017eenie riz\u00edk spojen\u00fdch s nespr\u00e1vnym prienikom ihly.<\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5e1f022 elementor-widget elementor-widget-heading\" data-id=\"5e1f022\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">NPT-01 Zariadenie na testovanie penetr\u00e1cie ihlou<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-53d8fee elementor-widget elementor-widget-text-editor\" data-id=\"53d8fee\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-pm-slice=\"1 3 []\">Str\u00e1nka <strong>Zariadenie na testovanie prieniku ihly NPT-01<\/strong> je navrhnut\u00fd tak, aby sp\u013a\u0148al <strong>ISO 11040-4<\/strong> dodr\u017eiavanie predpisov a z\u00e1rove\u0148 pon\u00faka presn\u00e9 testovacie rie\u0161enia. M\u00e1 tieto vlastnosti:<\/p><ul><li data-pm-slice=\"1 3 []\"><strong>Ovl\u00e1danie PLC a 7-palcov\u00e1 dotykov\u00e1 obrazovka HMI<\/strong> pre jednoduch\u00fa obsluhu.<\/li><li data-pm-slice=\"1 3 []\"><strong>Krokov\u00fd motor a presn\u00e1 gu\u013e\u00f4\u010dkov\u00e1 skrutka<\/strong> zabezpe\u010denie konzistentn\u00fdch v\u00fdsledkov.<\/li><li data-pm-slice=\"1 3 []\"><strong>Variabiln\u00e9 testovacie r\u00fdchlosti (1-500 mm\/min)<\/strong> pre flexibiln\u00e9 podmienky testovania.<\/li><li data-pm-slice=\"1 3 []\"><strong>Viacn\u00e1sobn\u00e9 dr\u017eiaky na vzorky<\/strong> pre r\u00f4zne typy ihiel a strieka\u010diek.<\/li><li data-pm-slice=\"1 3 []\"><strong>Zabudovan\u00e1 mikrotla\u010diare\u0148 a v\u00fdstup RS232<\/strong> na efekt\u00edvne zaznamen\u00e1vanie \u00fadajov.<\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f7e5035 elementor-widget elementor-widget-text-editor\" data-id=\"f7e5035\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-pm-slice=\"1 1 []\">Str\u00e1nka <strong>test penetr\u00e1cie injek\u010dn\u00fdch strieka\u010diek<\/strong> je nevyhnutn\u00fd na zabezpe\u010denie ostrosti ihiel, bezpe\u010dnosti pacientov a dodr\u017eiavania predpisov. Dodr\u017eiavan\u00edm <strong>ISO 11040-4<\/strong> usmernenia a pou\u017e\u00edvanie modern\u00fdch testovac\u00edch zariaden\u00ed, ako je napr. <strong>NPT-01<\/strong>, m\u00f4\u017eu v\u00fdrobcovia zv\u00fd\u0161i\u0165 kvalitu v\u00fdrobkov a z\u00e1rove\u0148 dodr\u017eiava\u0165 priemyseln\u00e9 normy.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Sk\u00fa\u0161ka penetr\u00e1cie ihly ISO 11040-4 Pr\u00edloha F Sk\u00fa\u0161ka penetr\u00e1cie ihly injek\u010dnej strieka\u010dky je k\u013e\u00fa\u010dov\u00fdm postupom v odvetv\u00ed zdravotn\u00edckych pom\u00f4cok, ktor\u00fd zabezpe\u010duje ostros\u0165 a \u00fa\u010dinnos\u0165 ihiel pou\u017e\u00edvan\u00fdch v lek\u00e1rskych aplik\u00e1ci\u00e1ch. Touto sk\u00fa\u0161kou sa hodnot\u00ed sila prieniku ihly potrebn\u00e1 na prepichnutie sk\u00fa\u0161obnej f\u00f3lie, ktor\u00e1 odr\u00e1\u017ea \u013eahkos\u0165, s akou m\u00f4\u017ee ihla prenikn\u00fa\u0165 do \u013eudsk\u00e9ho tela.<\/p>","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_uag_custom_page_level_css":"","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":"disabled","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":""}},"footnotes":""},"categories":[26],"tags":[],"class_list":["post-1994","post","type-post","status-publish","format-standard","hentry","category-blog"],"acf":[],"uagb_featured_image_src":{"full":false,"thumbnail":false,"medium":false,"medium_large":false,"large":false,"1536x1536":false,"2048x2048":false,"trp-custom-language-flag":false},"uagb_author_info":{"display_name":"pharmacopoeiatest","author_link":"https:\/\/www.pharmacopoeiatest.com\/sk\/author\/pharmacopoeiatest\/"},"uagb_comment_info":0,"uagb_excerpt":"Needle Penetration Testing ISO 11040-4 Annex F The syringes needle penetration test is a crucial procedure in the medical device industry, ensuring the sharpness and effectiveness of needles used in medical applications. This test evaluates the needle penetration force required to pierce a test foil, reflecting the ease with which a needle can penetrate human&hellip;","_links":{"self":[{"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/posts\/1994","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/comments?post=1994"}],"version-history":[{"count":5,"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/posts\/1994\/revisions"}],"predecessor-version":[{"id":2009,"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/posts\/1994\/revisions\/2009"}],"wp:attachment":[{"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/media?parent=1994"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/categories?post=1994"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/tags?post=1994"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}