{"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\/sk\/syringe-leak-test-method-liquid-leakage-test\/","title":{"rendered":"Met\u00f3da sk\u00fa\u0161ky tesnosti injek\u010dnou strieka\u010dkou - sk\u00fa\u0161ka \u00faniku kvapaliny"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Zabezpe\u010denie integrity injek\u010dn\u00fdch strieka\u010diek je nevyhnutn\u00e9 pre bezpe\u010dnos\u0165 pacientov a kvalitu v\u00fdrobkov v lek\u00e1rskom a farmaceutickom priemysle. Jedn\u00fdm z najd\u00f4le\u017eitej\u0161\u00edch postupov kontroly kvality je <strong>met\u00f3da sk\u00fa\u0161ky tesnosti injek\u010dnej strieka\u010dky<\/strong>, ktor\u00e1 ur\u010duje, \u010di injek\u010dn\u00e1 strieka\u010dka dok\u00e1\u017ee zabr\u00e1ni\u0165 \u00faniku kvapaliny za ur\u010dit\u00fdch podmienok. Tento test je mimoriadne d\u00f4le\u017eit\u00fd pre ru\u010dne ovl\u00e1dan\u00e9 jednorazov\u00e9 injek\u010dn\u00e9 strieka\u010dky aj pre predplnen\u00e9 injek\u010dn\u00e9 strieka\u010dky pou\u017e\u00edvan\u00e9 v automatizovan\u00fdch d\u00e1vkovac\u00edch syst\u00e9moch.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Preh\u013ead met\u00f3dy sk\u00fa\u0161ky tesnosti injek\u010dnej strieka\u010dky<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The <strong>met\u00f3da sk\u00fa\u0161ky tesnosti injek\u010dnej strieka\u010dky<\/strong> sa vz\u0165ahuje na proces overovania, \u010di pri mechanickom nam\u00e1han\u00ed alebo vn\u00fatornom tlaku nedoch\u00e1dza k \u00faniku kvapaliny z tela injek\u010dnej strieka\u010dky alebo uzatv\u00e1racieho syst\u00e9mu. \u00danik m\u00f4\u017ee ohrozi\u0165 sterilitu a presnos\u0165 d\u00e1vkovania, \u010do predstavuje v\u00e1\u017ene riziko pre pou\u017e\u00edvate\u013eov.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Testovanie tesnosti injek\u010dn\u00fdch strieka\u010diek sa riadi dvoma z\u00e1kladn\u00fdmi normami:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong><a href=\"https:\/\/www.leakagetester.com\/sk\/standards\/iso-7886-1\/\" target=\"_blank\" rel=\"noreferrer noopener\">ISO 7886-1<\/a><\/strong>: Zameriava sa na <strong>strieka\u010dky na ru\u010dn\u00e9 pou\u017eitie<\/strong>, be\u017ene zn\u00e1me ako jednorazov\u00e9 injek\u010dn\u00e9 strieka\u010dky.<\/li>\n\n\n\n<li><strong>ISO 11040-4<\/strong>: Vz\u0165ahuje sa na <strong>sklenen\u00e9 sudy pre predplnen\u00e9 injek\u010dn\u00e9 strieka\u010dky<\/strong>, najm\u00e4 tie, ktor\u00e9 sa pou\u017e\u00edvaj\u00fa v automatizovan\u00fdch procesoch plnenia a dokon\u010dovania.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Ka\u017ed\u00e1 norma definuje \u0161pecifick\u00e9 pr\u00edstroje, podmienky a sk\u00fa\u0161obn\u00e9 parametre na hodnotenie odolnosti r\u00f4znych typov injek\u010dn\u00fdch strieka\u010diek vo\u010di netesnosti.<\/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\">Sk\u00fa\u0161ka tesnosti ru\u010dn\u00fdch injek\u010dn\u00fdch strieka\u010diek (ISO 7886-1)<\/h2><\/div>\n\n\n\n<h3 class=\"wp-block-heading\">Sk\u00fa\u0161ka \u00faniku kvapaliny zo strieka\u010dky pri stla\u010den\u00ed<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Pod\u013ea pr\u00edlohy D <strong>ISO 7886-1<\/strong>, cie\u013eom je pos\u00fadi\u0165 \u00fanik za <strong>tesnenie piestovej z\u00e1tky<\/strong> pri p\u00f4soben\u00ed sily. Tieto kroky zah\u0155\u0148aj\u00fa:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Plnenie<\/strong> strieka\u010dku s <strong>destilovan\u00e1 voda<\/strong> nad jeho nomin\u00e1lnu kapacitu.<\/li>\n\n\n\n<li><strong>Vyh\u00e1\u0148anie vzduchu<\/strong>, potom upravte vodu na menovit\u00fd objem.<\/li>\n\n\n\n<li><strong>Tesnenie<\/strong> strieka\u010dkovej trysky pomocou referen\u010dn\u00e9ho oce\u013eov\u00e9ho ku\u017ee\u013eov\u00e9ho spojenia v s\u00falade s normou ISO 80369-7.<\/li>\n\n\n\n<li>Pou\u017eitie <strong>bo\u010dn\u00e1 sila<\/strong> 0,25-3 N, aby sa v pieste vyvolal radi\u00e1lny pohyb.<\/li>\n\n\n\n<li>Aplik\u00e1cia <strong>axi\u00e1lny tlak<\/strong> (200 alebo 300 kPa) na piest pre <strong>30-35 sek\u00fand<\/strong>.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Krit\u00e9ri\u00e1 \u00faspe\u0161nosti\/ne\u00faspe\u0161nosti<\/strong>: Voda by nemala presakova\u0165 cez tesnenie z\u00e1tky piestu. V\u00fdsledky sa musia zdokumentova\u0165 s uveden\u00edm objemu strieka\u010dky, pozorovania \u00faniku a d\u00e1tumu testu.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Odpor\u00fa\u010dan\u00fd n\u00e1stroj:<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Cell Instruments\u2019 <strong>SPPT-01 Tester tesnosti injek\u010dnej strieka\u010dky<\/strong> automatizuje tento proces a zabezpe\u010duje <strong>presn\u00e9 ovl\u00e1danie sily a tlaku<\/strong>, a z\u00e1rove\u0148 pon\u00faka jednoduch\u00e9 nahlasovanie testov.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Sk\u00fa\u0161ka tesnosti predplnen\u00fdch injek\u010dn\u00fdch strieka\u010diek (ISO 11040-4 pr\u00edloha G3)<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Test tesnosti syst\u00e9mu uzatv\u00e1rania injek\u010dn\u00fdch strieka\u010diek<\/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\">Pre <strong>predplnen\u00e9 injek\u010dn\u00e9 strieka\u010dky<\/strong>, pr\u00edloha G <strong>ISO 11040-4<\/strong> opisuje met\u00f3du hodnotenia integrity tesnenia <strong>\u0161t\u00edty ihiel alebo krytky hrotov<\/strong>. T\u00e1to sk\u00fa\u0161ka simuluje tlakov\u00e9 r\u00e1zy po\u010das prepravy alebo plnenia.<\/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>Nechajte <strong>uzatv\u00e1rac\u00ed syst\u00e9m na 12 hod\u00edn<\/strong> pred testovan\u00edm stabilizova\u0165.<\/li>\n\n\n\n<li>Napl\u0148te injek\u010dn\u00fa strieka\u010dku po <strong>1\/3 a\u017e 2\/3 jeho kapacity<\/strong> s destilovanou vodou.<\/li>\n\n\n\n<li>Vlo\u017ete injek\u010dn\u00fa strieka\u010dku do <strong>testovac\u00ed dr\u017eiak<\/strong> a vyvin\u00fa\u0165 tlak <strong>110 kPa<\/strong> pre <strong>5 sek\u00fand<\/strong> bu\u010f pomocou stla\u010den\u00e9ho vzduchu, alebo \u0165ahov\u00e9ho\/stla\u010den\u00e9ho testera.<\/li>\n\n\n\n<li><strong>Vizu\u00e1lna kontrola<\/strong> pre tvorbu kvapiek alebo odde\u013eovanie komponentov.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Krit\u00e9ri\u00e1 prijatia<\/strong>: Injek\u010dn\u00e1 strieka\u010dka prejde, ak nie s\u00fa pozorovan\u00e9 \u017eiadne kvap\u00f4\u010dky a syst\u00e9m uz\u00e1veru zostane 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=\"Met\u00f3da sk\u00fa\u0161ky tesnosti injek\u010dnej strieka\u010dky - Sk\u00fa\u0161ka tesnosti kvapaliny ISO 11040-4 nnex G3\" class=\"uag-image-4099\" width=\"255\" height=\"279\" title=\"Met\u00f3da sk\u00fa\u0161ky tesnosti injek\u010dnej strieka\u010dky - Sk\u00fa\u0161ka tesnosti kvapaliny ISO 11040-4 nnex G3\" role=\"img\"\/><\/figure><\/div>\n<\/div>\n<\/div>\n\n\n\n<h3 class=\"wp-block-heading\">Odpor\u00fa\u010dan\u00fd n\u00e1stroj:<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Cell Instruments\u2019 <strong>MST-01 Tester zdravotn\u00edckych pom\u00f4cok<\/strong> pon\u00faka mo\u017enosti stla\u010denia vzduchu aj mechanickej kompresie. Podporuje vysokofrekven\u010dn\u00e9 vzorkovanie (\u2265 100 Hz), \u010d\u00edm zvy\u0161uje <strong>presnos\u0165 a opakovate\u013enos\u0165<\/strong> v\u00fdsledkov.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Pre\u010do je d\u00f4le\u017eit\u00e9 testovanie tesnosti injek\u010dn\u00fdch strieka\u010diek<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Netesnosti v injek\u010dn\u00fdch strieka\u010dk\u00e1ch ved\u00fa nielen k strate d\u00e1vky a kontamin\u00e1cii, ale aj k nedodr\u017eiavaniu predpisov. Dodr\u017eiavanie <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\u010dnos\u0165 pacientov<\/strong> a spo\u013eahlivos\u0165 v\u00fdrobku.<\/li>\n\n\n\n<li>Podporuje <strong>zabezpe\u010denie kvality<\/strong> po\u010das v\u00fdroby.<\/li>\n\n\n\n<li>Zabezpe\u010duje <strong>regula\u010dn\u00e9 schv\u00e1lenie<\/strong> pre dom\u00e1ce a medzin\u00e1rodn\u00e9 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\u00fdber spr\u00e1vneho testera netesnost\u00ed zdravotn\u00edckych pom\u00f4cok<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">V\u00fdber spr\u00e1vneho <strong>tester tesnosti zdravotn\u00edckych pom\u00f4cok<\/strong> z\u00e1vis\u00ed od typu strieka\u010dky, objemu testovania a potrieb automatiz\u00e1cie. Pre v\u00fdrobcov, ktor\u00ed pracuj\u00fa so \u0161irokou \u0161k\u00e1lou injek\u010dn\u00fdch strieka\u010diek - vr\u00e1tane jednorazov\u00fdch aj predplnen\u00fdch - je nevyhnutn\u00e9 pou\u017e\u00edva\u0165 univerz\u00e1lne pr\u00edstroje, ktor\u00e9 dok\u00e1\u017eu simulova\u0165 v\u0161etky po\u017eadovan\u00e9 sily 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>Cell Instruments<\/strong> pon\u00faka prisp\u00f4sobite\u013en\u00e9, automatizovan\u00e9 rie\u0161enia, ako je <strong>SPPT-01<\/strong> a <strong>SLT-01<\/strong>, ide\u00e1lne pre prostredie v\u00fdskumu a v\u00fdvoja aj v\u00fdrobnej linky.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p class=\"wp-block-paragraph\">Pochopenie <strong>met\u00f3da sk\u00fa\u0161ky tesnosti injek\u010dnej strieka\u010dky<\/strong> m\u00e1 z\u00e1sadn\u00fd v\u00fdznam pre zachovanie kvality a bezpe\u010dnosti zdravotn\u00edckych pom\u00f4cok. \u010ci u\u017e pracujete s injek\u010dn\u00fdmi strieka\u010dkami na ru\u010dn\u00e9 pou\u017eitie alebo s predplnen\u00fdmi sklenen\u00fdmi sudmi, dodr\u017eiavanie <strong>ISO 7886-1<\/strong> a <strong>ISO 11040-4<\/strong> zaru\u010duje spo\u013eahliv\u00e9 fungovanie ka\u017edej jednotky v re\u00e1lnych podmienkach. Vyu\u017eit\u00edm presn\u00fdch a vyhovuj\u00facich pr\u00edstrojov na testovanie tesnosti od <strong>Cell Instruments<\/strong>, m\u00f4\u017eu v\u00fdrobcovia posilni\u0165 svoje syst\u00e9my kontroly kvality a s istotou sp\u013a\u0148a\u0165 glob\u00e1lne normy.<\/p>","protected":false},"excerpt":{"rendered":"<p>Zabezpe\u010denie integrity injek\u010dn\u00fdch strieka\u010diek je nevyhnutn\u00e9 pre bezpe\u010dnos\u0165 pacientov a kvalitu v\u00fdrobkov v lek\u00e1rskom a farmaceutickom priemysle. Jedn\u00fdm z najd\u00f4le\u017eitej\u0161\u00edch postupov kontroly kvality je met\u00f3da sk\u00fa\u0161ky tesnosti injek\u010dn\u00fdch strieka\u010diek, ktorou sa ur\u010duje, \u010di injek\u010dn\u00e1 strieka\u010dka dok\u00e1\u017ee za ur\u010dit\u00fdch podmienok zabr\u00e1ni\u0165 \u00faniku kvapaliny. T\u00e1to sk\u00fa\u0161ka je mimoriadne d\u00f4le\u017eit\u00e1 v pr\u00edpade ru\u010dne ovl\u00e1dan\u00fdch injek\u010dn\u00fdch strieka\u010diek, ako aj v pr\u00edpade [...]","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\/sk\/syringe-leak-test-method-liquid-leakage-test\/\" \/>\n<meta property=\"og:locale\" content=\"sk_SK\" \/>\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\/sk\/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=\"Autor\" \/>\n\t<meta name=\"twitter:data1\" content=\"leakagetester\" \/>\n\t<meta name=\"twitter:label2\" content=\"Predpokladan\u00fd \u010das \u010d\u00edtania\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 min\u00faty\" \/>\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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