{"id":9833,"date":"2026-02-24T15:11:44","date_gmt":"2026-02-24T07:11:44","guid":{"rendered":"https:\/\/www.packqc.com\/standard\/iso-7864\/"},"modified":"2026-04-16T09:54:22","modified_gmt":"2026-04-16T01:54:22","slug":"iso-7864","status":"publish","type":"standard","link":"https:\/\/www.packqc.com\/cs\/standard\/iso-7864\/","title":{"rendered":"ISO 7864"},"content":{"rendered":"<h2 class=\"wp-block-heading\">ISO 7864 pro test steriln\u00ed injek\u010dn\u00ed jehly<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong data-start=\"1102\" data-end=\"1114\">ISO 7864<\/strong>, s n\u00e1zvem <em data-start=\"1123\" data-end=\"1200\">\"Steriln\u00ed injek\u010dn\u00ed jehly pro jednor\u00e1zov\u00e9 pou\u017eit\u00ed - Po\u017eadavky a zku\u0161ebn\u00ed metody\"<\/em>, definuje kl\u00ed\u010dov\u00e1 mechanick\u00e1 a v\u00fdkonnostn\u00ed krit\u00e9ria pro injek\u010dn\u00ed jehly. Norma zaji\u0161\u0165uje, aby ka\u017ed\u00e1 jehla vykazovala dostate\u010dnou ostrost, struktur\u00e1ln\u00ed integritu a spolehliv\u00e9 spojen\u00ed mezi jehlou a jehlou. <strong data-start=\"1402\" data-end=\"1425\">trubka jehly a n\u00e1boj<\/strong>. P\u0159edepisuje tak\u00e9 podrobn\u00e9 postupy jak pro <strong data-start=\"1475\" data-end=\"1504\">testov\u00e1n\u00ed penetra\u010dn\u00ed s\u00edly<\/strong> a <strong data-start=\"1509\" data-end=\"1534\">zkou\u0161ka pevnosti spoje<\/strong>, kter\u00e9 jsou z\u00e1kladn\u00edmi ukazateli kvality p\u0159i v\u00fdrob\u011b steriln\u00edch jehel.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Test penetra\u010dn\u00ed s\u00edly jehly<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The <strong data-start=\"1671\" data-end=\"1698\">penetra\u010dn\u00ed test jehlou<\/strong> m\u011b\u0159\u00ed, jak\u00e1 s\u00edla je zapot\u0159eb\u00ed k zaveden\u00ed jehly do ur\u010dit\u00e9ho substr\u00e1tu konstantn\u00ed rychlost\u00ed. Podle <strong>ISO 7864 p\u0159\u00edloha D<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>A <strong data-start=\"1839\" data-end=\"1870\">p\u0159\u00edstroj pro m\u011b\u0159en\u00ed s\u00edly<\/strong> (nap\u0159. tester zalo\u017een\u00fd na sn\u00edma\u010di zat\u00ed\u017een\u00ed).<\/li>\n\n\n\n<li>Rychlost testu je obvykle <strong data-start=\"1943\" data-end=\"1957\">100 mm\/min<\/strong>.<\/li>\n\n\n\n<li>Jehly mus\u00ed proniknout a\u017e do <strong data-start=\"1990\" data-end=\"2021\">80% jejich jmenovit\u00e9 d\u00e9lky<\/strong>.<\/li>\n\n\n\n<li>Podklady jako p\u0159\u00edrodn\u00ed latexov\u00e1 pry\u017e nebo polyuretan simuluj\u00ed lidskou k\u016f\u017ei.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Jsou zachyceny dva kritick\u00e9 parametry:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"2140\" data-end=\"2166\">\u0160pi\u010dkov\u00e1 penetra\u010dn\u00ed s\u00edla<\/strong>: Maxim\u00e1ln\u00ed s\u00edla pot\u0159ebn\u00e1 k tomu, aby jehla pronikla podkladem.<\/li>\n\n\n\n<li><strong data-start=\"2237\" data-end=\"2251\">S\u00edla odporu<\/strong>: Pr\u016fm\u011brn\u00fd t\u0159ec\u00ed odpor p\u0159i zav\u00e1d\u011bn\u00ed.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Cell Instruments nab\u00edz\u00ed a <strong data-start=\"2513\" data-end=\"2551\">p\u0159esn\u00fd tester penetra\u010dn\u00ed s\u00edly<\/strong>, ide\u00e1ln\u00ed pro prov\u00e1d\u011bn\u00ed <strong data-start=\"2578\" data-end=\"2605\">penetra\u010dn\u00ed test jehlou<\/strong>. Jeho senzory s vysok\u00fdm rozli\u0161en\u00edm a programovateln\u00e1 regulace ot\u00e1\u010dek zaji\u0161\u0165uj\u00ed plnou shodu s normou ISO 7864.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Zkou\u0161ka pevnosti jehlov\u00e9ho spoje<br>-<small>Mezi jehlovou trubkou a n\u00e1bojem<\/small><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>P\u0159\u00edloha E<\/strong> normy ISO 7864 se zam\u011b\u0159uje na <strong data-start=\"2807\" data-end=\"2839\">zkou\u0161ka pevnosti jehlov\u00e9ho spoje<\/strong>, kter\u00fd zaji\u0161\u0165uje, \u017ee vazba mezi <strong data-start=\"2881\" data-end=\"2904\">trubka jehly a n\u00e1boj<\/strong> vydr\u017e\u00ed mechanick\u00e9 nam\u00e1h\u00e1n\u00ed, ani\u017e by se odd\u011blily.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Postup zahrnuje:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Svisl\u00e1 mont\u00e1\u017e jehly do <strong data-start=\"3019\" data-end=\"3047\">univerz\u00e1ln\u00ed tahov\u00fd tester<\/strong>.<\/li>\n\n\n\n<li>Pou\u017e\u00edv\u00e1n\u00ed specializovan\u00fdch \u00fachyt\u016f, aby se zabr\u00e1nilo prokluzov\u00e1n\u00ed nebo deformaci.<\/li>\n\n\n\n<li>P\u016fsoben\u00ed tahov\u00e9 s\u00edly na <strong data-start=\"3137\" data-end=\"3150\">50 mm\/min<\/strong> dokud vazba nesel\u017ee.<\/li>\n\n\n\n<li>Zaznamen\u00e1v\u00e1n\u00ed <strong data-start=\"3189\" data-end=\"3214\">maxim\u00e1ln\u00ed tahov\u00e1 s\u00edla<\/strong> p\u0159i kter\u00e9m dojde k poru\u0161e.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Tato zkou\u0161ka ov\u011b\u0159uje mechanickou integritu <strong data-start=\"3293\" data-end=\"3318\">syst\u00e9m lepen\u00ed jehel<\/strong>, co\u017e je kl\u00ed\u010dov\u00fd po\u017eadavek, aby se p\u0159ede\u0161lo l\u00e9ka\u0159sk\u00fdm nehod\u00e1m b\u011bhem injekc\u00ed nebo p\u0159enosu tekutin.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The <strong data-start=\"3436\" data-end=\"3477\">Cell Instruments Tester pevnosti spoje<\/strong> podporuje tahov\u00e9 zkou\u0161ky podle normy ISO 7864 s p\u0159izp\u016fsobiteln\u00fdmi p\u0159\u00edpravky pro r\u016fzn\u00e9 typy jehel.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Aplikace nap\u0159\u00ed\u010d odv\u011btv\u00edmi<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Zku\u0161ebn\u00ed metody ISO 7864 nejsou omezeny pouze na v\u00fdrobce l\u00e9ka\u0159sk\u00fdch st\u0159\u00edka\u010dek. Vztahuj\u00ed se tak\u00e9 na:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"4658\" data-end=\"4686\">Farmaceutick\u00e9 spole\u010dnosti<\/strong> v\u00fdvoj injek\u010dn\u00edch syst\u00e9m\u016f pro pod\u00e1v\u00e1n\u00ed l\u00e9\u010div.<\/li>\n\n\n\n<li><strong data-start=\"4739\" data-end=\"4766\">V\u00fdrobci obal\u016f<\/strong> v\u00fdroba sad p\u0159edpln\u011bn\u00fdch injek\u010dn\u00edch st\u0159\u00edka\u010dek.<\/li>\n\n\n\n<li><strong data-start=\"4803\" data-end=\"4834\">Agentury pro kontrolu kvality<\/strong> prov\u00e1d\u011bn\u00ed regula\u010dn\u00edch test\u016f.<\/li>\n\n\n\n<li><strong data-start=\"4868\" data-end=\"4880\">V\u00fdzkumn\u00e9 a v\u00fdvojov\u00e9 laborato\u0159e<\/strong> zkoum\u00e1n\u00ed kompatibility a v\u00fdkonnosti materi\u00e1l\u016f.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Za\u0159\u00edzen\u00ed spole\u010dnosti Cell Instruments se celosv\u011btov\u011b pou\u017e\u00edv\u00e1 ve <strong data-start=\"4981\" data-end=\"5030\">zdravotnictv\u00ed, farmacie, lepidla, obaly<\/strong>a <strong data-start=\"5036\" data-end=\"5063\">odv\u011btv\u00ed kontroly kvality<\/strong>, co\u017e posiluje na\u0161i pov\u011bst technick\u00e9 dokonalosti.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">V\u00fdb\u011br spr\u00e1vn\u00e9ho zku\u0161ebn\u00edho za\u0159\u00edzen\u00ed pro ISO 7864<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">P\u0159esnost testov\u00e1n\u00ed z\u00e1vis\u00ed na pou\u017eit\u00ed spr\u00e1vn\u00fdch n\u00e1stroj\u016f. P\u0159i v\u00fdb\u011bru <a href=\"https:\/\/www.packqc.com\/cs\/product\/needle-penetration-test-equipment-iso-7864\/\"><strong data-start=\"3777\" data-end=\"3814\">za\u0159\u00edzen\u00ed pro testov\u00e1n\u00ed penetrace jehly<\/strong><\/a> nebo <strong data-start=\"3820\" data-end=\"3844\">tester pevnosti spoje<\/strong>, zva\u017ete n\u00e1sleduj\u00edc\u00ed:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"3873\" data-end=\"3895\">P\u0159esnost zat\u011b\u017eovac\u00ed bu\u0148ky<\/strong>: Ujist\u011bte se, \u017ee je v souladu s po\u017eadovan\u00fdm rozsahem s\u00edly (a\u017e 500 N pro zkou\u0161ky lepen\u00ed).<\/li>\n\n\n\n<li><strong data-start=\"3979\" data-end=\"3996\">\u0158\u00edzen\u00ed rychlosti<\/strong>: Norma ISO 7864 p\u0159edepisuje p\u0159esn\u00e9 rychlosti (nap\u0159. 50 mm\/min, 100 mm\/min).<\/li>\n\n\n\n<li><strong data-start=\"4062\" data-end=\"4084\">Manipulace se substr\u00e1tem<\/strong>: Dr\u017e\u00e1k substr\u00e1tu by m\u011bl poskytovat konzistentn\u00ed up\u00ednac\u00ed a penetra\u010dn\u00ed plochu.<\/li>\n\n\n\n<li><strong data-start=\"4166\" data-end=\"4190\">Softwarov\u00e1 integrace<\/strong>: Funkce sb\u011bru a anal\u00fdzy dat zvy\u0161uj\u00ed transparentnost a reprodukovatelnost testov\u00e1n\u00ed.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong data-start=\"4281\" data-end=\"4301\">Bun\u011b\u010dn\u00e9 n\u00e1stroje<\/strong> se specializuje na testovac\u00ed syst\u00e9my na m\u00edru pro zdravotnick\u00e9 prost\u0159edky, v\u010detn\u011b steriln\u00edch injek\u010dn\u00edch jehel. Na\u0161e slu\u017eby automatizace a p\u0159izp\u016fsoben\u00ed v\u00e1m umo\u017en\u00ed p\u0159esn\u011b a efektivn\u011b splnit po\u017eadavky normy ISO 7864.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u010casto kladen\u00e9 ot\u00e1zky<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">1. K \u010demu slou\u017e\u00ed penetra\u010dn\u00ed test jehlou?<br>Test proniknut\u00ed jehly m\u011b\u0159\u00ed s\u00edlu pot\u0159ebnou k proniknut\u00ed podko\u017en\u00ed jehly standardn\u00edm podkladem, simuluje proniknut\u00ed k\u016f\u017e\u00ed a hodnot\u00ed ostrost a snadnost pou\u017eit\u00ed.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">2. Jak definuje norma ISO 7864 p\u0159ijatelnou pevnost spoje?<br>Norma ISO 7864 stanovuje po\u017eadavky na minim\u00e1ln\u00ed s\u00edlu spojen\u00ed mezi trubi\u010dkou jehly a n\u00e1bojem v z\u00e1vislosti na velikosti jehly. Zkou\u0161ka zaji\u0161\u0165uje, \u017ee spojen\u00ed b\u011bhem pou\u017e\u00edv\u00e1n\u00ed nesel\u017ee.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3. Jak\u00fd substr\u00e1t se pou\u017e\u00edv\u00e1 p\u0159i penetra\u010dn\u00edch testech jehlou?<br>Mezi b\u011b\u017en\u00e9 substr\u00e1ty pat\u0159\u00ed p\u0159\u00edrodn\u00ed latexov\u00e1 pry\u017e, polyuretan, silikonov\u00e1 pry\u017e nebo polyethylenov\u00e9 f\u00f3lie, kter\u00e9 jsou validov\u00e1ny pro konzistenci testu.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">4. Pro\u010d by m\u011bl ka\u017ed\u00fd penetra\u010dn\u00ed test vyu\u017e\u00edvat nov\u00fd podkladov\u00fd web?<br>Opakovan\u00e9 pou\u017eit\u00ed m\u00edst na substr\u00e1tu m\u016f\u017ee ovlivnit p\u0159esnost zkou\u0161ky v d\u016fsledku deformace nebo opot\u0159eben\u00ed, co\u017e vede k nespolehliv\u00fdm m\u011b\u0159en\u00edm s\u00edly.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Kontaktujte n\u00e1s Z\u00edskejte \u0159e\u0161en\u00ed pro testov\u00e1n\u00ed ISO 7864 <\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Soulad s <strong data-start=\"5156\" data-end=\"5168\"><a href=\"https:\/\/www.iso.org\/standard\/60481.html\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">ISO 7864<\/a><\/strong> je pro ka\u017ed\u00e9ho v\u00fdrobce steriln\u00edch injek\u010dn\u00edch jehel nepominuteln\u00e1. Pochopen\u00ed <strong data-start=\"5257\" data-end=\"5284\">penetra\u010dn\u00ed test jehlou<\/strong>, <strong data-start=\"5286\" data-end=\"5312\">zkou\u0161ka penetra\u010dn\u00ed s\u00edly<\/strong>a <strong data-start=\"5318\" data-end=\"5350\">zkou\u0161ka pevnosti jehlov\u00e9ho spoje<\/strong> zaji\u0161\u0165uje, \u017ee jehly spl\u0148uj\u00ed po\u017eadovan\u00e9 bezpe\u010dnostn\u00ed a v\u00fdkonnostn\u00ed normy. D\u00edky modern\u00edmu vybaven\u00ed odpov\u00eddaj\u00edc\u00edmu norm\u00e1m od <strong data-start=\"5468\" data-end=\"5488\">Bun\u011b\u010dn\u00e9 n\u00e1stroje<\/strong>, je testov\u00e1n\u00ed p\u0159esn\u011bj\u0161\u00ed, spolehliv\u011bj\u0161\u00ed a efektivn\u011bj\u0161\u00ed - co\u017e v\u00e1m pom\u016f\u017ee dod\u00e1vat produkty, kter\u00e9 spl\u0148uj\u00ed o\u010dek\u00e1v\u00e1n\u00ed regula\u010dn\u00edch org\u00e1n\u016f i pacient\u016f.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>","protected":false},"excerpt":{"rendered":"<p>ISO 7864 pro zkou\u0161en\u00ed steriln\u00edch podko\u017en\u00edch jehel Norma ISO 7864 s n\u00e1zvem \u201cSteriln\u00ed podko\u017en\u00ed jehly pro jednor\u00e1zov\u00e9 pou\u017eit\u00ed - Po\u017eadavky a zku\u0161ebn\u00ed metody\u201d definuje kl\u00ed\u010dov\u00e1 mechanick\u00e1 a v\u00fdkonnostn\u00ed krit\u00e9ria pro podko\u017en\u00ed jehly. Norma zaji\u0161\u0165uje, aby ka\u017ed\u00e1 jehla vykazovala dostate\u010dnou ostrost, struktur\u00e1ln\u00ed integritu a spolehliv\u00e9 spojen\u00ed mezi trubi\u010dkou jehly a n\u00e1bojem. P\u0159edepisuje tak\u00e9 podrobn\u00e9 postupy pro [...]<\/p>","protected":false},"featured_media":5505,"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":""}}},"standard-category":[612],"class_list":["post-9833","standard","type-standard","status-publish","has-post-thumbnail","hentry","standard-category-iso"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.packqc.com\/cs\/wp-json\/wp\/v2\/standard\/9833","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/cs\/wp-json\/wp\/v2\/standard"}],"about":[{"href":"https:\/\/www.packqc.com\/cs\/wp-json\/wp\/v2\/types\/standard"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/cs\/wp-json\/wp\/v2\/media\/5505"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/cs\/wp-json\/wp\/v2\/media?parent=9833"}],"wp:term":[{"taxonomy":"standard-category","embeddable":true,"href":"https:\/\/www.packqc.com\/cs\/wp-json\/wp\/v2\/standard-category?post=9833"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}