{"id":2022,"date":"2025-04-09T05:01:05","date_gmt":"2025-04-09T05:01:05","guid":{"rendered":"https:\/\/www.pharmacopoeiatest.com\/?p=2022"},"modified":"2025-04-11T06:36:55","modified_gmt":"2025-04-11T06:36:55","slug":"needle-bonding-strength-test-iso-11040-4","status":"publish","type":"post","link":"https:\/\/www.pharmacopoeiatest.com\/sk\/needle-bonding-strength-test-iso-11040-4\/","title":{"rendered":"Sk\u00fa\u0161ka pevnosti ihlov\u00e9ho spoja ISO 11040-4 pr\u00edloha G1"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"2022\" class=\"elementor elementor-2022\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-88e81b0 e-flex e-con-boxed e-con e-parent\" data-id=\"88e81b0\" 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-15151de elementor-widget elementor-widget-heading\" data-id=\"15151de\" 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\">Sk\u00fa\u0161ka pevnosti lepenia ihlou<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3dc2194 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"3dc2194\" 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-d585eff elementor-widget elementor-widget-heading\" data-id=\"d585eff\" 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 G1<\/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-10ec79b e-flex e-con-boxed e-con e-parent\" data-id=\"10ec79b\" 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-7045eb5 elementor-widget elementor-widget-text-editor\" data-id=\"7045eb5\" 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 class=\"\" data-start=\"372\" data-end=\"916\">V odvetv\u00ed zdravotn\u00edckych pom\u00f4cok, najm\u00e4 v pr\u00edpade predplnen\u00fdch injek\u010dn\u00fdch strieka\u010diek s ihlami s kol\u00edkom, sa <em data-start=\"482\" data-end=\"505\">sila vytiahnutia ihly<\/em> Test je nevyhnutn\u00fd na overenie celistvosti spojenia medzi ihlou a injek\u010dnou strieka\u010dkou. Pod\u013ea <strong data-start=\"609\" data-end=\"633\">ISO 11040-4 Pr\u00edloha G1<\/strong>, t\u00e1to mechanick\u00e1 sk\u00fa\u0161ka je rozhoduj\u00faca na pos\u00fadenie bezpe\u010dnosti, spo\u013eahlivosti a s\u00faladu injek\u010dn\u00fdch syst\u00e9mov s predpismi. Spr\u00e1vne vykonanie tohto testu zabezpe\u010duje, \u017ee sa ihly neodde\u013euj\u00fa za norm\u00e1lnych podmienok ani pri z\u00e1\u0165a\u017eovom pou\u017e\u00edvan\u00ed, \u010do je rozhoduj\u00face pre klinick\u00e9 pou\u017eitie aj bezpe\u010dnos\u0165 pacienta.<\/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-53f39ac elementor-widget elementor-widget-heading\" data-id=\"53f39ac\" 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\">V\u00fdznam sily vytiahnutia ihly<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-232a548 elementor-widget elementor-widget-text-editor\" data-id=\"232a548\" 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 class=\"\" data-start=\"982\" data-end=\"1259\"><em data-start=\"982\" data-end=\"1005\">Sila vytiahnutia ihly<\/em> sa vz\u0165ahuje na maxim\u00e1lnu axi\u00e1lnu silu potrebn\u00fa na odpojenie ihly od injek\u010dnej strieka\u010dky. Nedostato\u010dn\u00e9 spojenie medzi ihlou a n\u00e1bojom m\u00f4\u017ee vies\u0165 k oddeleniu po\u010das injekcie, \u010do m\u00f4\u017ee sp\u00f4sobi\u0165 poranenia, chyby v d\u00e1vkovan\u00ed alebo kontamin\u00e1ciu. Tento test zohr\u00e1va v\u00fdznamn\u00fa \u00falohu pri overovan\u00ed <strong data-start=\"1139\" data-end=\"1166\">pevnos\u0165 spojenia ihly<\/strong> po\u010das v\u00fdroby, \u010d\u00edm sa zabezpe\u010d\u00ed, \u017ee sp\u013a\u0148a vopred stanoven\u00e9 v\u00fdkonnostn\u00e9 normy v r\u00e1mci <strong data-start=\"1243\" data-end=\"1258\">ISO 11040-4<\/strong>.<\/p>\t\t\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<div class=\"elementor-element elementor-element-8452827 e-flex e-con-boxed e-con e-parent\" data-id=\"8452827\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-570817b e-con-full e-flex e-con e-child\" data-id=\"570817b\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-413bd47 elementor-widget elementor-widget-heading\" data-id=\"413bd47\" 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\">Sk\u00fa\u0161obn\u00e9 met\u00f3dy v pr\u00edlohe G1 k norme ISO 11040-4<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fcd29af elementor-widget elementor-widget-text-editor\" data-id=\"fcd29af\" 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 class=\"\" data-start=\"1587\" data-end=\"1757\">Vykon\u00e1va\u0165 <em data-start=\"1604\" data-end=\"1627\">sila vytiahnutia ihly<\/em> testova\u0165 spr\u00e1vne, musia v\u00fdrobcovia dodr\u017eiava\u0165 <strong data-start=\"1673\" data-end=\"1697\">ISO 11040-4 Pr\u00edloha G1<\/strong> postup. Ni\u017e\u0161ie je uveden\u00fd rozpis \u0161tandardizovanej met\u00f3dy.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-a860fa6 e-con-full e-flex e-con e-child\" data-id=\"a860fa6\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-996cc40 e-con-full e-flex e-con e-child\" data-id=\"996cc40\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2456c08 elementor-widget elementor-widget-heading\" data-id=\"2456c08\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Po\u017eiadavky na testovacie nastavenie a vybavenie<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b295a09 elementor-widget elementor-widget-text-editor\" data-id=\"b295a09\" 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 class=\"\" data-start=\"1807\" data-end=\"1924\">Z\u00e1kladn\u00e9 vybavenie zah\u0155\u0148a <strong data-start=\"1837\" data-end=\"1890\">univerz\u00e1lny stroj na sk\u00fa\u0161anie v \u0165ahu a tlaku<\/strong> sp\u013a\u0148a tieto podmienky:<\/p><ul data-start=\"1926\" data-end=\"2220\"><li class=\"\" data-start=\"1926\" data-end=\"1996\"><p class=\"\" data-start=\"1928\" data-end=\"1996\"><strong data-start=\"1928\" data-end=\"1942\">Za\u0165a\u017eovacia bunka:<\/strong> Max. 500 N (alebo primerane pod\u013ea pevnosti vzorky)<\/p><\/li><li class=\"\" data-start=\"1997\" data-end=\"2048\"><p class=\"\" data-start=\"1999\" data-end=\"2048\"><strong data-start=\"1999\" data-end=\"2014\">Testovacia r\u00fdchlos\u0165:<\/strong> 50 mm\/min (odpor\u00fa\u010dan\u00e9 predvolen\u00e9 nastavenie)<\/p><\/li><li class=\"\" data-start=\"2049\" data-end=\"2097\"><p class=\"\" data-start=\"2051\" data-end=\"2097\"><strong data-start=\"2051\" data-end=\"2069\">Vzorkovacia frekvencia:<\/strong> \u2265 500 Hz pre \u0161pi\u010dkov\u00fa presnos\u0165<\/p><\/li><li class=\"\" data-start=\"2098\" data-end=\"2157\"><p class=\"\" data-start=\"2100\" data-end=\"2157\"><strong data-start=\"2100\" data-end=\"2126\">Zariadenie na uchopenie ihly:<\/strong> Bezpe\u010dn\u00e9 uchopenie bez po\u0161myknutia<\/p><\/li><li class=\"\" data-start=\"2158\" data-end=\"2220\"><p class=\"\" data-start=\"2160\" data-end=\"2220\"><strong data-start=\"2160\" data-end=\"2179\">Dr\u017eiak na injek\u010dn\u00fa strieka\u010dku:<\/strong> Podporuje strieka\u010dku pr\u00edrubou alebo ramenom<\/p><\/li><\/ul><p class=\"\" data-start=\"2222\" data-end=\"2499\">Cell Instruments' <strong data-start=\"2240\" data-end=\"2275\">MPT-01 Tester lek\u00e1rskych obalov<\/strong> je na tento \u00fa\u010del vynikaj\u00facim rie\u0161en\u00edm. Je navrhnut\u00fd na testovanie lek\u00e1rskych obalov a zariaden\u00ed a poskytuje nastavite\u013en\u00fa r\u00fdchlos\u0165 testovania, presnos\u0165 riaden\u00fa PLC a konfigurovate\u013en\u00e9 svorky prisp\u00f4soben\u00e9 na hodnotenie injek\u010dn\u00fdch strieka\u010diek a ihiel.<\/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<div class=\"elementor-element elementor-element-d9546da elementor-widget elementor-widget-image\" data-id=\"d9546da\" 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\/category\/product\/syringe-test\/\">\n\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"442\" height=\"1024\" src=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/Needle-Bonding-Strength-Testing-ISO-11040-4-Annex-G1-442x1024.webp\" class=\"attachment-large size-large wp-image-2024\" alt=\"Sk\u00fa\u0161ka pevnosti ihlov\u00e9ho spoja ISO 11040-4 pr\u00edloha G1\" srcset=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/Needle-Bonding-Strength-Testing-ISO-11040-4-Annex-G1-442x1024.webp 442w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/Needle-Bonding-Strength-Testing-ISO-11040-4-Annex-G1-130x300.webp 130w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/Needle-Bonding-Strength-Testing-ISO-11040-4-Annex-G1-768x1779.webp 768w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/Needle-Bonding-Strength-Testing-ISO-11040-4-Annex-G1-663x1536.webp 663w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/Needle-Bonding-Strength-Testing-ISO-11040-4-Annex-G1-884x2048.webp 884w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/Needle-Bonding-Strength-Testing-ISO-11040-4-Annex-G1-scaled.webp 1105w\" sizes=\"(max-width: 442px) 100vw, 442px\" \/>\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>\n\t\t\t\t<div class=\"elementor-element elementor-element-27af015 elementor-widget elementor-widget-heading\" data-id=\"27af015\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Pr\u00edprava vzoriek a manipul\u00e1cia s nimi<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f39f978 elementor-widget elementor-widget-text-editor\" data-id=\"f39f978\" 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<ul><li class=\"\" data-start=\"2543\" data-end=\"2625\"><p class=\"\" data-start=\"2545\" data-end=\"2625\">Pou\u017eite <strong data-start=\"2549\" data-end=\"2585\">sterilizovan\u00e9 submontovan\u00e9 injek\u010dn\u00e9 strieka\u010dky<\/strong> pripraven\u00e9 na plnenie pomocou ihly s kol\u00edkom.<\/p><\/li><li class=\"\" data-start=\"2626\" data-end=\"2718\"><p class=\"\" data-start=\"2628\" data-end=\"2718\">Zabezpe\u010dte, aby testovacie vzorky odr\u00e1\u017eali skuto\u010dn\u00e9 v\u00fdrobn\u00e9 podmienky, aby sa zachovala relevantnos\u0165 v\u00fdsledkov.<\/p><\/li><li class=\"\" data-start=\"2719\" data-end=\"2827\"><p class=\"\" data-start=\"2721\" data-end=\"2827\">Pred za\u010dat\u00edm merania sa vyhnite predbe\u017en\u00e9mu za\u0165a\u017eeniu - nastavte sn\u00edma\u010d za\u0165a\u017eenia na <em data-start=\"2792\" data-end=\"2798\">nula<\/em> bez \u010fal\u0161ieho tlaku.<\/p><\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-c6fdd34 e-con-full e-flex e-con e-child\" data-id=\"c6fdd34\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-793e953 e-con-full e-flex e-con e-child\" data-id=\"793e953\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b7b4771 elementor-widget elementor-widget-heading\" data-id=\"b7b4771\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Postup sk\u00fa\u0161ky pevnosti ihlov\u00e9ho spoja<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6e44f24 elementor-widget elementor-widget-text-editor\" data-id=\"6e44f24\" 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 class=\"\" data-start=\"2870\" data-end=\"2924\"><p class=\"\" data-start=\"2873\" data-end=\"2924\">Injek\u010dn\u00fa strieka\u010dku upevnite do sk\u00fa\u0161obn\u00e9ho pr\u00edpravku vo zvislej polohe.<\/p><\/li><li class=\"\" data-start=\"2925\" data-end=\"2975\"><p class=\"\" data-start=\"2928\" data-end=\"2975\">Ihlu pevne uchopte, aby sa zabr\u00e1nilo jej sk\u013aznutiu.<\/p><\/li><li class=\"\" data-start=\"2976\" data-end=\"3028\"><p class=\"\" data-start=\"2979\" data-end=\"3028\">Pred za\u0165a\u017een\u00edm nastavte sn\u00edma\u010d za\u0165a\u017eenia na nulu.<\/p><\/li><li class=\"\" data-start=\"3029\" data-end=\"3071\"><p class=\"\" data-start=\"3032\" data-end=\"3071\">Spustite sk\u00fa\u0161ku vytiahnutia pri r\u00fdchlosti 50 mm\/min.<\/p><\/li><li class=\"\" data-start=\"3072\" data-end=\"3122\"><p class=\"\" data-start=\"3075\" data-end=\"3122\">Pokra\u010dujte, k\u00fdm sa ihla neodpoj\u00ed alebo nezlom\u00ed.<\/p><\/li><li class=\"\" data-start=\"3123\" data-end=\"3172\"><p class=\"\" data-start=\"3126\" data-end=\"3172\">Zaznamenajte <strong data-start=\"3137\" data-end=\"3169\">krivka z\u00e1vislosti sily od posunu<\/strong>.<\/p><\/li><li class=\"\" data-start=\"3173\" data-end=\"3256\"><p class=\"\" data-start=\"3176\" data-end=\"3256\">V\u0161imnite si <strong data-start=\"3185\" data-end=\"3207\">maxim\u00e1lna maxim\u00e1lna sila<\/strong>, ktor\u00fd predstavuje <em data-start=\"3230\" data-end=\"3253\">sila vytiahnutia ihly<\/em>.<\/p><\/li><\/ol>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-9c468e4 e-con-full e-flex e-con e-child\" data-id=\"9c468e4\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4f65822 elementor-widget elementor-widget-heading\" data-id=\"4f65822\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Pod\u00e1vanie spr\u00e1v o v\u00fdsledkoch<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d2e072e elementor-widget elementor-widget-text-editor\" data-id=\"d2e072e\" 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 class=\"\" data-start=\"3290\" data-end=\"3357\">Pod\u013ea normy ISO 11040-4, pr\u00edloha G1, by mal protokol o sk\u00fa\u0161ke obsahova\u0165:<\/p><ul data-start=\"3359\" data-end=\"3509\"><li class=\"\" data-start=\"3359\" data-end=\"3385\"><p class=\"\" data-start=\"3361\" data-end=\"3385\">Maxim\u00e1lna \u0161pi\u010dkov\u00e1 sila (N)<\/p><\/li><li class=\"\" data-start=\"3386\" data-end=\"3418\"><p class=\"\" data-start=\"3388\" data-end=\"3418\">Graf z\u00e1vislosti sily od posunu<\/p><\/li><li class=\"\" data-start=\"3419\" data-end=\"3442\"><p class=\"\" data-start=\"3421\" data-end=\"3442\">Sk\u00fa\u0161obn\u00e1 r\u00fdchlos\u0165 (mm\/min)<\/p><\/li><li class=\"\" data-start=\"3443\" data-end=\"3462\"><p class=\"\" data-start=\"3445\" data-end=\"3462\">Mno\u017estvo vzorky<\/p><\/li><li class=\"\" data-start=\"3463\" data-end=\"3509\"><p class=\"\" data-start=\"3465\" data-end=\"3509\">Ak\u00e9ko\u013evek odch\u00fdlky, pozorovania alebo anom\u00e1lie<\/p><\/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-753fbcc elementor-widget elementor-widget-text-editor\" data-id=\"753fbcc\" 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>Na pokro\u010dil\u00e9 spracovanie \u00fadajov je k dispoz\u00edcii <strong data-start=\"3545\" data-end=\"3555\">MPT-01<\/strong> podporuje vizualiz\u00e1ciu v\u00fdsledkov, zobrazenie v re\u00e1lnom \u010dase a volite\u013en\u00fd v\u00fdstup RS232 alebo integr\u00e1ciu mikrotla\u010diarne.<\/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<\/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-61b109f e-flex e-con-boxed e-con e-parent\" data-id=\"61b109f\" 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-1ddd053 elementor-widget elementor-widget-heading\" data-id=\"1ddd053\" 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\">N\u00e1\u0161 tester pevnosti ihlov\u00e9ho spoja?<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-17dbcca elementor-widget elementor-widget-text-editor\" data-id=\"17dbcca\" 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 class=\"\" data-start=\"4323\" data-end=\"4503\">S odborn\u00fdmi znalos\u0165ami v oblasti testovania zdravotn\u00edckych pom\u00f4cok a obalov, <strong data-start=\"4379\" data-end=\"4409\">Cell Instruments Co., Ltd.<\/strong> pon\u00faka rie\u0161enia \u0161it\u00e9 na mieru pre <em data-start=\"4440\" data-end=\"4463\">sila vytiahnutia ihly<\/em> hodnotenia. N\u00e1\u0161 tester MPT-01 umo\u017e\u0148uje:<\/p><ul data-start=\"4505\" data-end=\"4762\"><li class=\"\" data-start=\"4505\" data-end=\"4534\"><p class=\"\" data-start=\"4507\" data-end=\"4534\">Vysok\u00e1 presnos\u0165 (0,5% F.S.)<\/p><\/li><li class=\"\" data-start=\"4535\" data-end=\"4592\"><p class=\"\" data-start=\"4537\" data-end=\"4592\">Multifunk\u010dnos\u0165 pre \u0165ahov\u00e9 a tlakov\u00e9 sk\u00fa\u0161ky<\/p><\/li><li class=\"\" data-start=\"4593\" data-end=\"4657\"><p class=\"\" data-start=\"4595\" data-end=\"4657\">Vlastn\u00e9 kon\u0161trukcie pr\u00edpravkov pre konfigur\u00e1cie injek\u010dn\u00fdch strieka\u010diek a ihiel<\/p><\/li><li class=\"\" data-start=\"4658\" data-end=\"4701\"><p class=\"\" data-start=\"4660\" data-end=\"4701\">Programovate\u013en\u00e9, opakovate\u013en\u00e9 testovacie protokoly<\/p><\/li><li class=\"\" data-start=\"4702\" data-end=\"4762\"><p class=\"\" data-start=\"4704\" data-end=\"4762\">S\u00falad s <a href=\"https:\/\/www.iso.org\/standard\/82222.html\" target=\"_blank\" rel=\"noopener\">ISO 11040-4<\/a> a \u010fal\u0161ie pr\u00edslu\u0161n\u00e9 normy<\/p><\/li><\/ul><p class=\"\" data-start=\"4764\" data-end=\"4917\">\u010ci u\u017e ste v\u00fdrobca injek\u010dn\u00fdch strieka\u010diek alebo \u0161pecialista na kontrolu kvality, podporujeme va\u0161e regula\u010dn\u00e9 potreby a testovacie v\u00fdzvy spo\u013eahliv\u00fdmi rie\u0161eniami.<\/p>\t\t\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<div class=\"elementor-element elementor-element-de82dd4 e-flex e-con-boxed e-con e-parent\" data-id=\"de82dd4\" 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-cd205c0 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"cd205c0\" 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-a40b489 elementor-widget elementor-widget-heading\" data-id=\"a40b489\" 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\">\u010casto kladen\u00e9 ot\u00e1zky<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c0c3e38 elementor-widget elementor-widget-toggle\" data-id=\"c0c3e38\" data-element_type=\"widget\" data-widget_type=\"toggle.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-toggle\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2021\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-2021\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewbox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewbox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">1. Ak\u00fd v\u00fdznam m\u00e1 testovanie sily vytiahnutia ihly?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2021\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-2021\"><p>Pri tomto teste sa hodnot\u00ed mechanick\u00e9 upevnenie ihly k injek\u010dnej strieka\u010dke, aby sa zabezpe\u010dilo, \u017ee sa po\u010das pou\u017e\u00edvania neodpoj\u00ed, \u010d\u00edm sa zachovaj\u00fa bezpe\u010dnostn\u00e9 a v\u00fdkonnostn\u00e9 normy.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2022\" class=\"elementor-tab-title\" data-tab=\"2\" role=\"button\" aria-controls=\"elementor-tab-content-2022\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewbox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewbox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">2. Ktor\u00e1 norma opisuje sk\u00fa\u0161ku pevnosti spojenia ihlou?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2022\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"region\" aria-labelledby=\"elementor-tab-title-2022\"><p>Norma ISO 11040-4, konkr\u00e9tne pr\u00edloha G1, definuje metodiku vykon\u00e1vania sk\u00fa\u0161ok sily vytrhnutia ihly na injek\u010dn\u00fdch strieka\u010dk\u00e1ch s kol\u00edkom.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2023\" class=\"elementor-tab-title\" data-tab=\"3\" role=\"button\" aria-controls=\"elementor-tab-content-2023\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewbox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewbox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">3. Ko\u013eko vzoriek je potrebn\u00fdch na testovanie sily vytiahnutia ihly?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2023\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"region\" aria-labelledby=\"elementor-tab-title-2023\"><p>Po\u010det z\u00e1vis\u00ed od va\u0161ich intern\u00fdch valida\u010dn\u00fdch protokolov a doh\u00f4d so z\u00e1kazn\u00edkmi, ale kv\u00f4li \u0161tatistickej spo\u013eahlivosti sa odpor\u00fa\u010da viacero vzoriek.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2024\" class=\"elementor-tab-title\" data-tab=\"4\" role=\"button\" aria-controls=\"elementor-tab-content-2024\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewbox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewbox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">4. Ak\u00e9 s\u00fa po\u017eiadavky na vybavenie pre tento test?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2024\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"4\" role=\"region\" aria-labelledby=\"elementor-tab-title-2024\"><p>Vy\u017eaduje sa univerz\u00e1lny sk\u00fa\u0161obn\u00fd stroj s kapacitou 500 N, sk\u00fa\u0161obnou r\u00fdchlos\u0165ou 50 mm\/min, vhodn\u00fdmi ch\u00e1padlami a vysokou frekvenciou vzorkovania (\u2265 500 Hz).<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2025\" class=\"elementor-tab-title\" data-tab=\"5\" role=\"button\" aria-controls=\"elementor-tab-content-2025\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewbox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewbox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">5. M\u00f4\u017ee by\u0165 MPT-01 od Cell Instruments prisp\u00f4soben\u00fd na tento test?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2025\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"5\" role=\"region\" aria-labelledby=\"elementor-tab-title-2025\"><p>\u00c1no, MPT-01 pon\u00faka prisp\u00f4sobite\u013en\u00e9 pr\u00edpravky, programovate\u013en\u00e9 nastavenia a automatiza\u010dn\u00e9 funkcie prisp\u00f4soben\u00e9 na testovanie pevnosti spojenia ihiel a in\u00fdch zdravotn\u00edckych pom\u00f4cok.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\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>Needle Bonding Strength Test ISO 11040-4 Annex G1 In the medical device industry, especially for prefilled syringes with staked needles, the needle pull-out force test is essential for verifying the bonding integrity between the needle and the syringe. According to ISO 11040-4 Annex G1, this mechanical test is critical to assess the safety, reliability, and [&hellip;]<\/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":"","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-2022","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 Bonding Strength Test ISO 11040-4 Annex G1 In the medical device industry, especially for prefilled syringes with staked needles, the needle pull-out force test is essential for verifying the bonding integrity between the needle and the syringe. According to ISO 11040-4 Annex G1, this mechanical test is critical to assess the safety, reliability, and&hellip;","_links":{"self":[{"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/posts\/2022","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=2022"}],"version-history":[{"count":5,"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/posts\/2022\/revisions"}],"predecessor-version":[{"id":2034,"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/posts\/2022\/revisions\/2034"}],"wp:attachment":[{"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/media?parent=2022"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/categories?post=2022"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/tags?post=2022"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}