{"id":4091,"date":"2025-05-07T16:12:42","date_gmt":"2025-05-07T08:12:42","guid":{"rendered":"https:\/\/www.leakagetester.com\/?p=4091"},"modified":"2025-05-07T16:30:00","modified_gmt":"2025-05-07T08:30:00","slug":"syringe-leak-test-method-liquid-leakage-test","status":"publish","type":"post","link":"https:\/\/www.leakagetester.com\/cs\/syringe-leak-test-method-liquid-leakage-test\/","title":{"rendered":"Metoda zkou\u0161ky t\u011bsnosti injek\u010dn\u00ed st\u0159\u00edka\u010dky - zkou\u0161ka t\u011bsnosti kapaliny"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Zaji\u0161t\u011bn\u00ed integrity injek\u010dn\u00edch st\u0159\u00edka\u010dek je z\u00e1sadn\u00ed pro bezpe\u010dnost pacient\u016f a kvalitu v\u00fdrobk\u016f ve zdravotnictv\u00ed a farmaceutick\u00e9m pr\u016fmyslu. Jedn\u00edm z nejkriti\u010dt\u011bj\u0161\u00edch postup\u016f kontroly kvality je <strong>metoda zkou\u0161ky t\u011bsnosti injek\u010dn\u00ed st\u0159\u00edka\u010dky<\/strong>, kter\u00fd ur\u010duje, zda st\u0159\u00edka\u010dka dok\u00e1\u017ee za ur\u010dit\u00fdch podm\u00ednek zabr\u00e1nit \u00faniku kapaliny. Tato zkou\u0161ka je obzvl\u00e1\u0161t\u011b d\u016fle\u017eit\u00e1 jak pro ru\u010dn\u011b ovl\u00e1dan\u00e9 jednor\u00e1zov\u00e9 st\u0159\u00edka\u010dky, tak pro p\u0159edpln\u011bn\u00e9 st\u0159\u00edka\u010dky pou\u017e\u00edvan\u00e9 v automatizovan\u00fdch pod\u00e1vac\u00edch syst\u00e9mech.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">P\u0159ehled metody zkou\u0161en\u00ed t\u011bsnosti injek\u010dn\u00ed st\u0159\u00edka\u010dky<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The <strong>metoda zkou\u0161ky t\u011bsnosti injek\u010dn\u00ed st\u0159\u00edka\u010dky<\/strong> ozna\u010duje proces ov\u011b\u0159ov\u00e1n\u00ed, zda p\u0159i mechanick\u00e9m nam\u00e1h\u00e1n\u00ed nebo vnit\u0159n\u00edm tlaku nedoch\u00e1z\u00ed k \u00faniku kapaliny z t\u011bla injek\u010dn\u00ed st\u0159\u00edka\u010dky nebo syst\u00e9mu uz\u00e1v\u011bru. \u00danik m\u016f\u017ee ohrozit sterilitu a p\u0159esnost d\u00e1vkov\u00e1n\u00ed, co\u017e p\u0159edstavuje v\u00e1\u017en\u00e9 riziko pro u\u017eivatele.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Testov\u00e1n\u00ed t\u011bsnosti st\u0159\u00edka\u010dek se \u0159\u00edd\u00ed dv\u011bma z\u00e1kladn\u00edmi normami:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong><a href=\"https:\/\/www.leakagetester.com\/cs\/standards\/iso-7886-1\/\" target=\"_blank\" rel=\"noreferrer noopener\">ISO 7886-1<\/a><\/strong>: Zam\u011b\u0159uje se na <strong>st\u0159\u00edka\u010dky pro ru\u010dn\u00ed pou\u017eit\u00ed<\/strong>, b\u011b\u017en\u011b zn\u00e1m\u00e9 jako jednor\u00e1zov\u00e9 injek\u010dn\u00ed st\u0159\u00edka\u010dky.<\/li>\n\n\n\n<li><strong>ISO 11040-4<\/strong>: Plat\u00ed pro <strong>sklen\u011bn\u00e9 barely pro p\u0159edpln\u011bn\u00e9 injek\u010dn\u00ed st\u0159\u00edka\u010dky<\/strong>, zejm\u00e9na ty, kter\u00e9 se pou\u017e\u00edvaj\u00ed v automatizovan\u00fdch procesech pln\u011bn\u00ed a dokon\u010dov\u00e1n\u00ed.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Ka\u017ed\u00e1 norma definuje specifick\u00e9 p\u0159\u00edstroje, podm\u00ednky a zku\u0161ebn\u00ed parametry pro hodnocen\u00ed odolnosti r\u016fzn\u00fdch typ\u016f injek\u010dn\u00edch st\u0159\u00edka\u010dek proti net\u011bsnosti.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<div class=\"wp-block-uagb-advanced-heading uagb-block-218a8fd5\"><h2 class=\"uagb-heading-text\">Zkou\u0161ka t\u011bsnosti ru\u010dn\u00edch st\u0159\u00edka\u010dek (ISO 7886-1)<\/h2><\/div>\n\n\n\n<h3 class=\"wp-block-heading\">Zkou\u0161ka \u00faniku kapaliny z injek\u010dn\u00ed st\u0159\u00edka\u010dky p\u0159i stla\u010den\u00ed<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Podle p\u0159\u00edlohy D <strong>ISO 7886-1<\/strong>, c\u00edlem je posoudit \u00fanik p\u0159es <strong>t\u011bsn\u011bn\u00ed z\u00e1tky p\u00edstu<\/strong> p\u0159i p\u016fsoben\u00ed s\u00edly. Tyto kroky zahrnuj\u00ed:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>N\u00e1pl\u0148<\/strong> st\u0159\u00edka\u010dku s <strong>destilovan\u00e1 voda<\/strong> nad jeho jmenovitou kapacitu.<\/li>\n\n\n\n<li><strong>Vyh\u00e1n\u011bn\u00ed vzduchu<\/strong>, pot\u00e9 upravte vodu na jmenovit\u00fd objem.<\/li>\n\n\n\n<li><strong>T\u011bsn\u011bn\u00ed<\/strong> st\u0159\u00edka\u010dkov\u00e9 trysky pomoc\u00ed referen\u010dn\u00edho ocelov\u00e9ho ku\u017eelov\u00e9ho \u0161rouben\u00ed podle normy ISO 80369-7.<\/li>\n\n\n\n<li>Pou\u017eit\u00ed <strong>bo\u010dn\u00ed s\u00edla<\/strong> 0,25-3 N pro vyvol\u00e1n\u00ed radi\u00e1ln\u00edho pohybu p\u00edstu.<\/li>\n\n\n\n<li>Pou\u017eit\u00ed <strong>axi\u00e1ln\u00ed tlak<\/strong> (200 nebo 300 kPa) na p\u00edst pro <strong>30-35 sekund<\/strong>.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Krit\u00e9ria vyhov\u011bn\u00ed\/ne\u00fasp\u011bchu<\/strong>: P\u0159es t\u011bsn\u011bn\u00ed z\u00e1tky p\u00edstu by nem\u011bla unikat voda. V\u00fdsledky mus\u00ed b\u00fdt zdokumentov\u00e1ny s uveden\u00edm objemu st\u0159\u00edka\u010dky, pozorov\u00e1n\u00ed \u00faniku a data zkou\u0161ky.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Doporu\u010den\u00fd n\u00e1stroj:<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Cell Instruments\u2019 <strong>SPPT-01 Tester t\u011bsnosti injek\u010dn\u00ed st\u0159\u00edka\u010dky<\/strong> automatizuje tento proces a zaji\u0161\u0165uje <strong>p\u0159esn\u00e9 \u0159\u00edzen\u00ed s\u00edly a tlaku<\/strong>, a z\u00e1rove\u0148 nab\u00edz\u00ed snadn\u00e9 vykazov\u00e1n\u00ed test\u016f.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Zkou\u0161ka t\u011bsnosti p\u0159edpln\u011bn\u00fdch injek\u010dn\u00edch st\u0159\u00edka\u010dek (ISO 11040-4, p\u0159\u00edloha G3)<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Test t\u011bsnosti syst\u00e9mu uzav\u00edr\u00e1n\u00ed st\u0159\u00edka\u010dek<\/h3>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<p class=\"wp-block-paragraph\">Pro <strong>p\u0159edpln\u011bn\u00e9 injek\u010dn\u00ed st\u0159\u00edka\u010dky<\/strong>, p\u0159\u00edloha G <strong>ISO 11040-4<\/strong> popisuje metodu pro hodnocen\u00ed integrity t\u011bsn\u011bn\u00ed <strong>\u0161t\u00edty jehel nebo krytky hrot\u016f<\/strong>. Tato zkou\u0161ka simuluje tlakov\u00e9 r\u00e1zy p\u0159i p\u0159eprav\u011b nebo pln\u011bn\u00ed.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Postup<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Nechte <strong>uzav\u00edrac\u00ed syst\u00e9m v klidu po dobu 12 hodin<\/strong> p\u0159ed testov\u00e1n\u00edm stabilizovat.<\/li>\n\n\n\n<li>Napl\u0148te st\u0159\u00edka\u010dku na <strong>1\/3-2\/3 sv\u00e9 kapacity<\/strong> s destilovanou vodou.<\/li>\n\n\n\n<li>Vlo\u017ete st\u0159\u00edka\u010dku do <strong>zku\u0161ebn\u00ed dr\u017e\u00e1k<\/strong> a vyv\u00edjejte tlak <strong>110 kPa<\/strong> pro <strong>5 sekund<\/strong> pomoc\u00ed stla\u010den\u00e9ho vzduchu nebo tahov\u00e9ho\/stla\u010den\u00e9ho testeru.<\/li>\n\n\n\n<li><strong>Vizu\u00e1ln\u00ed kontrola<\/strong> pro tvorbu kapek nebo odd\u011blov\u00e1n\u00ed slo\u017eek.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Krit\u00e9ria p\u0159ijatelnosti<\/strong>: St\u0159\u00edka\u010dka projde, pokud nejsou pozorov\u00e1ny \u017e\u00e1dn\u00e9 kapky a uzav\u00edrac\u00ed syst\u00e9m z\u016fstane neporu\u0161en\u00fd.<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\">\n<div class=\"wp-block-uagb-image aligncenter uagb-block-c7693e0f wp-block-uagb-image--layout-default wp-block-uagb-image--effect-static wp-block-uagb-image--align-center\"><figure class=\"wp-block-uagb-image__figure\"><img loading=\"lazy\" decoding=\"async\" srcset=\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2025\/05\/Syringe-Leak-Test-Method-Liquid-Leakage-Test-ISO-11040-4-nnex-G3.webp ,https:\/\/www.leakagetester.com\/wp-content\/uploads\/2025\/05\/Syringe-Leak-Test-Method-Liquid-Leakage-Test-ISO-11040-4-nnex-G3.webp 780w, https:\/\/www.leakagetester.com\/wp-content\/uploads\/2025\/05\/Syringe-Leak-Test-Method-Liquid-Leakage-Test-ISO-11040-4-nnex-G3.webp 360w\" sizes=\"auto, (max-width: 480px) 150px\" src=\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2025\/05\/Syringe-Leak-Test-Method-Liquid-Leakage-Test-ISO-11040-4-nnex-G3.webp\" alt=\"Metoda zkou\u0161ky t\u011bsnosti st\u0159\u00edka\u010dky - zkou\u0161ka t\u011bsnosti kapalin ISO 11040-4 nnex G3\" class=\"uag-image-4099\" width=\"255\" height=\"279\" title=\"Metoda zkou\u0161ky t\u011bsnosti st\u0159\u00edka\u010dky - zkou\u0161ka t\u011bsnosti kapalin ISO 11040-4 nnex G3\" role=\"img\"\/><\/figure><\/div>\n<\/div>\n<\/div>\n\n\n\n<h3 class=\"wp-block-heading\">Doporu\u010den\u00fd n\u00e1stroj:<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Cell Instruments\u2019 <strong>MST-01 Tester zdravotnick\u00fdch prost\u0159edk\u016f<\/strong> nab\u00edz\u00ed mo\u017enost stla\u010dov\u00e1n\u00ed vzduchu i mechanick\u00e9 komprese. Podporuje vysokofrekven\u010dn\u00ed vzorkov\u00e1n\u00ed (\u2265100 Hz), \u010d\u00edm\u017e zvy\u0161uje frekvenci vzorkov\u00e1n\u00ed. <strong>p\u0159esnost a opakovatelnost<\/strong> v\u00fdsledk\u016f.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Pro\u010d je testov\u00e1n\u00ed t\u011bsnosti st\u0159\u00edka\u010dek d\u016fle\u017eit\u00e9<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Net\u011bsnost injek\u010dn\u00edch st\u0159\u00edka\u010dek vede nejen ke ztr\u00e1t\u00e1m d\u00e1vek a kontaminaci, ale tak\u00e9 k nedodr\u017een\u00ed p\u0159edpis\u016f. Dodr\u017eov\u00e1n\u00ed <strong>ISO 7886-1<\/strong> a <strong>ISO 11040-4<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Zlep\u0161uje <strong>bezpe\u010dnost pacient\u016f<\/strong> a spolehlivost v\u00fdrobk\u016f.<\/li>\n\n\n\n<li>Podporuje <strong>zaji\u0161t\u011bn\u00ed kvality<\/strong> b\u011bhem v\u00fdroby.<\/li>\n\n\n\n<li>Zaji\u0161\u0165uje <strong>schv\u00e1len\u00ed regula\u010dn\u00edmi org\u00e1ny<\/strong> pro dom\u00e1c\u00ed i mezin\u00e1rodn\u00ed trhy.<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>V\u00fdb\u011br spr\u00e1vn\u00e9ho testeru t\u011bsnosti zdravotnick\u00fdch prost\u0159edk\u016f<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">V\u00fdb\u011br spr\u00e1vn\u00e9ho <strong>tester t\u011bsnosti l\u00e9ka\u0159sk\u00fdch p\u0159\u00edstroj\u016f<\/strong> z\u00e1vis\u00ed na typu st\u0159\u00edka\u010dky, objemu testov\u00e1n\u00ed a pot\u0159eb\u00e1ch automatizace. Pro v\u00fdrobce, kte\u0159\u00ed se zab\u00fdvaj\u00ed \u0161irokou \u0161k\u00e1lou st\u0159\u00edka\u010dek - v\u010detn\u011b jednor\u00e1zov\u00fdch i p\u0159edpln\u011bn\u00fdch - je nezbytn\u00e9 pou\u017e\u00edvat univerz\u00e1ln\u00ed p\u0159\u00edstroje, kter\u00e9 dok\u00e1\u017e\u00ed simulovat v\u0161echny po\u017eadovan\u00e9 s\u00edly a tlaky definovan\u00e9 normami.<\/p>\n\n\n\n<div class=\"wp-block-uagb-container uagb-block-8ea3bd21 alignfull uagb-is-root-container\"><div class=\"uagb-container-inner-blocks-wrap\"><\/div><\/div>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Bun\u011b\u010dn\u00e9 n\u00e1stroje<\/strong> nab\u00edz\u00ed p\u0159izp\u016fsobiteln\u00e1, automatizovan\u00e1 \u0159e\u0161en\u00ed, jako je nap\u0159. <strong>SPPT-01<\/strong> a <strong>SLT-01<\/strong>, ide\u00e1ln\u00ed pro prost\u0159ed\u00ed v\u00fdzkumu a v\u00fdvoje i v\u00fdrobn\u00ed linky.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p class=\"wp-block-paragraph\">Porozum\u011bn\u00ed <strong>metoda zkou\u0161ky t\u011bsnosti injek\u010dn\u00ed st\u0159\u00edka\u010dky<\/strong> m\u00e1 z\u00e1sadn\u00ed v\u00fdznam pro zachov\u00e1n\u00ed kvality a bezpe\u010dnosti zdravotnick\u00fdch prost\u0159edk\u016f. A\u0165 u\u017e pracujete s injek\u010dn\u00edmi st\u0159\u00edka\u010dkami pro ru\u010dn\u00ed pou\u017eit\u00ed nebo s p\u0159edpln\u011bn\u00fdmi sklen\u011bn\u00fdmi barely, je nutn\u00e9 dodr\u017eovat po\u017eadavky na <strong>ISO 7886-1<\/strong> a <strong>ISO 11040-4<\/strong> zaji\u0161\u0165uje spolehlivou funk\u010dnost ka\u017ed\u00e9 jednotky v re\u00e1ln\u00fdch podm\u00ednk\u00e1ch. Vyu\u017eit\u00edm p\u0159esn\u00fdch a vyhovuj\u00edc\u00edch p\u0159\u00edstroj\u016f pro testov\u00e1n\u00ed t\u011bsnosti od spole\u010dnosti <strong>Bun\u011b\u010dn\u00e9 n\u00e1stroje<\/strong>, mohou v\u00fdrobci pos\u00edlit sv\u00e9 syst\u00e9my kontroly kvality a s jistotou splnit glob\u00e1ln\u00ed normy.<\/p>","protected":false},"excerpt":{"rendered":"<p>Zaji\u0161t\u011bn\u00ed integrity injek\u010dn\u00edch st\u0159\u00edka\u010dek je z\u00e1sadn\u00ed pro bezpe\u010dnost pacient\u016f a kvalitu v\u00fdrobk\u016f ve zdravotnictv\u00ed a farmaceutick\u00e9m pr\u016fmyslu. Jedn\u00edm z nejd\u016fle\u017eit\u011bj\u0161\u00edch postup\u016f kontroly kvality je metoda zkou\u0161ky t\u011bsnosti st\u0159\u00edka\u010dky, kter\u00e1 ur\u010duje, zda st\u0159\u00edka\u010dka dok\u00e1\u017ee za ur\u010dit\u00fdch podm\u00ednek zabr\u00e1nit \u00faniku kapaliny. Tato zkou\u0161ka je zvl\u00e1\u0161t\u011b d\u016fle\u017eit\u00e1 pro ru\u010dn\u011b ovl\u00e1dan\u00e9 st\u0159\u00edka\u010dky, kter\u00e9 jsou [...]","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_uag_custom_page_level_css":"","footnotes":""},"categories":[1],"tags":[],"class_list":["post-4091","post","type-post","status-publish","format-standard","hentry","category-test-method"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Syringe Leak Test Method - Liquid Leakage Test - Leakage Tester<\/title>\n<meta name=\"description\" content=\"Syringe leak test method with insights from ISO 7886-1 and ISO 11040-4, including liquid leakage test procedures.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.leakagetester.com\/cs\/syringe-leak-test-method-liquid-leakage-test\/\" \/>\n<meta property=\"og:locale\" content=\"cs_CZ\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Syringe Leak Test Method - Liquid Leakage Test - Leakage Tester\" \/>\n<meta property=\"og:description\" content=\"Syringe leak test method with insights from ISO 7886-1 and ISO 11040-4, including liquid leakage test procedures.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.leakagetester.com\/cs\/syringe-leak-test-method-liquid-leakage-test\/\" \/>\n<meta property=\"og:site_name\" content=\"Leakage Tester\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/cellinstruments\/\" \/>\n<meta property=\"article:published_time\" content=\"2025-05-07T08:12:42+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-05-07T08:30:00+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2025\/05\/Syringe-Leak-Test-Method-Liquid-Leakage-Test-ISO-11040-4-nnex-G3.webp\" \/>\n<meta name=\"author\" content=\"leakagetester\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Napsal(a)\" \/>\n\t<meta name=\"twitter:data1\" content=\"leakagetester\" \/>\n\t<meta name=\"twitter:label2\" content=\"Odhadovan\u00e1 doba \u010dten\u00ed\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minuty\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.leakagetester.com\/syringe-leak-test-method-liquid-leakage-test\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.leakagetester.com\/syringe-leak-test-method-liquid-leakage-test\/\"},\"author\":{\"name\":\"leakagetester\",\"@id\":\"https:\/\/www.leakagetester.com\/#\/schema\/person\/96aac8c7a484e71f92e270fcd275b658\"},\"headline\":\"Syringe Leak Test Method &#8211; 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