{"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\/bs\/syringe-leak-test-method-liquid-leakage-test\/","title":{"rendered":"Metoda ispitivanja curenja \u0161price \u2013 Ispitivanje curenja te\u010dnosti"},"content":{"rendered":"<p>Osiguravanje integriteta \u0161prica je od su\u0161tinskog zna\u010daja za sigurnost pacijenata i kvalitet proizvoda u medicinskoj i farmaceutskoj industriji. Jedan od najkriti\u010dnijih postupaka kontrole kvaliteta je <strong>Metoda ispitivanja curenja \u0161price<\/strong>, koji odre\u0111uje mo\u017ee li \u0161prica sprije\u010diti curenje teku\u0107ine pod odre\u0111enim uvjetima. Ovaj test je posebno klju\u010dan i za ru\u010dno upravljane jednokratne \u0161price i za unaprijed napunjene \u0161price koje se koriste u automatiziranim sustavima za primjenu.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregled metode za test curenja \u0161price<\/h2>\n\n\n\n<p>The <strong>Metoda ispitivanja curenja \u0161price<\/strong> odnosi se na proces provjere curi li teku\u0107ina iz tijela \u0161price ili zatvara\u010dkog sistema kada je izlo\u017een mehani\u010dkom naprezanju ili unutra\u0161njem pritisku. curenje mo\u017ee ugroziti sterilnost i ta\u010dnost doziranja, predstavljaju\u0107i ozbiljne rizike za korisnike.<\/p>\n\n\n\n<p>Postoje dva glavna standarda koja reguli\u0161u ispitivanje curenja \u0161prica:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong><a href=\"https:\/\/www.leakagetester.com\/bs\/standards\/iso-7886-1\/\" target=\"_blank\" rel=\"noreferrer noopener\">ISO 7886-1<\/a><\/strong>: Fokusira se na <strong>\u0161price za ru\u010dnu upotrebu<\/strong>, op\u0107enito poznate kao jednokratne \u0161price.<\/li>\n\n\n\n<li><strong>ISO 11040-4<\/strong>: Primjenjuje se na <strong>stakleni spremnici za unaprijed napunjene \u0161price<\/strong>, posebno onih koji se koriste u automatiziranim procesima punjenja i zavr\u0161ne obrade.<\/li>\n<\/ul>\n\n\n\n<p>Svaki standard definira specifi\u010dne aparate, uvjete i parametre ispitivanja za procjenu otpornosti na curenje razli\u010ditih vrsta \u0161prica.<\/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\">Test nepropusnosti za ru\u010dne \u0161price (ISO 7886-1)<\/h2><\/div>\n\n\n\n<h3 class=\"wp-block-heading\">Test curenja teku\u0107ine iz \u0161price pod kompresijom<\/h3>\n\n\n\n<p>Prema Aneksu D od <strong>ISO 7886-1<\/strong>, cilj je procijeniti curenje pored <strong>zapor za kliza\u010d, brtva<\/strong> kada se primijeni sila. Koraci uklju\u010duju:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Punjenje<\/strong> \u0161prica sa <strong>destilirana voda<\/strong> iznad svoje nominalne snage.<\/li>\n\n\n\n<li><strong>Izbacivanje zraka<\/strong>, zatim prilago\u0111avanje vode na nominalni volumen.<\/li>\n\n\n\n<li><strong>Zaptivanje<\/strong> mlaznica \u0161price koriste\u0107i referentni \u010deli\u010dni konusni spoj u skladu sa standardom ISO 80369-7.<\/li>\n\n\n\n<li>Primjena a <strong>bo\u010dna sila<\/strong> od 0,25\u20133 N za induciranje radijalnog pomaka klipa.<\/li>\n\n\n\n<li>Prijava <strong>osni pritisak<\/strong> (200 ili 300 kPa) na kliza\u010d za <strong>30\u201335 sekundi<\/strong>.<\/li>\n<\/ul>\n\n\n\n<p><strong>Kriterijumi za prolaz\/neuspeh<\/strong>Ne smije pro\u0107i voda pored brtve klipa. Rezultati se moraju dokumentovati kapacitetom \u0161price, zapa\u017eanjima o curenju i datumom testa.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Preporu\u010deni instrument:<\/h3>\n\n\n\n<p>Cell Instruments\u2019 <strong>SPPT-01 Tester curenja klipa \u0161price<\/strong> automatizira ovaj proces, osiguravaju\u0107i <strong>precizna kontrola sile i pritiska<\/strong>, uz jednostavno izvje\u0161tavanje o testovima.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Test nepropusnosti za unaprijed napunjene \u0161price (ISO 11040-4 Aneks G3)<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Test curenja sistema zatvaranja \u0161price<\/h3>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 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>Za <strong>prednapunjene \u0161price<\/strong>, Prilog G od <strong>ISO 11040-4<\/strong> iznosi metodu za procjenu integriteta brtve <strong>\u0161titnici za igle ili \u010depi\u0107i za vrhove<\/strong>. Ovaj test simulira skokove pritiska tokom transporta ili punjenja.<\/p>\n\n\n\n<p><strong>Postupci<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Neka <strong>Sistem za zatvaranje ostaviti da stoji 12 sati.<\/strong> prije testiranja stabilizirati.<\/li>\n\n\n\n<li>Napunite \u0161pricu do <strong>1\/3\u20132\/3 svoje kapaciteta<\/strong> s destilovanom vodom.<\/li>\n\n\n\n<li>Stavite \u0161pricu u <strong>dr\u017ea\u010d testa<\/strong> i primijeniti pritisak od <strong>110 kPa<\/strong> za <strong>5 sekundi<\/strong> koriste\u0107i ili komprimirani zrak ili testeru za istezanje\/kompresiju.<\/li>\n\n\n\n<li><strong>Pregledajte vizuelno<\/strong> za formiranje kapljice ili odvajanje komponente.<\/li>\n<\/ul>\n\n\n\n<p><strong>Kriteriji prihvatanja<\/strong>\u0160prica prolazi ako se ne uo\u010de kapljice i sistem zatvaranja ostaje netaknut.<\/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 ispitivanja curenja \u0161price - Ispitivanje curenja te\u010dnosti ISO 11040-4 Aneks G3\" class=\"uag-image-4099\" width=\"255\" height=\"279\" title=\"Metoda ispitivanja curenja \u0161price - Ispitivanje curenja te\u010dnosti ISO 11040-4 Aneks G3\" role=\"img\"\/><\/figure><\/div>\n<\/div>\n<\/div>\n\n\n\n<h3 class=\"wp-block-heading\">Preporu\u010deni instrument:<\/h3>\n\n\n\n<p>Cell Instruments\u2019 <strong>MST-01 Tester medicinskih ure\u0111aja<\/strong> Nudi i opcije za zra\u010dno nadimanje i mehani\u010dko komprimiranje. Podr\u017eava uzorkovanje visoke frekvencije (\u2265100 Hz), pove\u0107avaju\u0107i <strong>ta\u010dnost i ponovljivost<\/strong> rezultata.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Za\u0161to je va\u017eno testiranje curenja \u0161prica<\/h2>\n\n\n\n<p>Procurivanje u \u0161pricama ne samo da dovodi do gubitka doze i kontaminacije, ve\u0107 i ne ispunjava regulatorne zahtjeve. Pridr\u017eavanje <strong>ISO 7886-1<\/strong> i <strong>ISO 11040-4<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Pobolj\u0161ava <strong>sigurnost pacijenata<\/strong> i pouzdanost proizvoda.<\/li>\n\n\n\n<li>Podr\u017eava <strong>osiguranje kvaliteta<\/strong> tokom proizvodnje.<\/li>\n\n\n\n<li>Osigurava <strong>regulatorno odobrenje<\/strong> za doma\u0107e i me\u0111unarodna tr\u017ei\u0161ta.<\/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>Odabir pravog testera curenja medicinskih ure\u0111aja<\/strong><\/h2>\n\n\n\n<p>Odabir ispravnog <strong>tester curenja medicinskih ure\u0111aja<\/strong> Ovisi o vrsti \u0161price, testnom volumenu i potrebama automatizacije. Za proizvo\u0111a\u010de koji se bave \u0161irokim spektrom \u0161prica \u2014 uklju\u010duju\u0107i jednokratne i unaprijed napunjene opcije \u2014 klju\u010dno je koristiti svestrane instrumente koji mogu simulirati sve potrebne sile i pritiske kako je definirano standardima.<\/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><strong>Cell Instruments<\/strong> nudi prilagodljiva, automatizirana rje\u0161enja poput <strong>SPPT-01<\/strong> i <strong>SLT-01<\/strong>, idealan za okru\u017eenja istra\u017eivanja i razvoja i proizvodnih linija.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p>Razumijevanje <strong>Metoda ispitivanja curenja \u0161price<\/strong> je klju\u010dno za odr\u017eavanje kvaliteta i sigurnosti medicinskih ure\u0111aja. Bilo da radite sa \u0161pricama za ru\u010dnu upotrebu ili prednapunjenim staklenim bo\u010dicama, uskla\u0111enost sa <strong>ISO 7886-1<\/strong> i <strong>ISO 11040-4<\/strong> osigurava da svaka jedinica pouzdano radi u stvarnim uvjetima. Kori\u0161tenjem preciznih i uskla\u0111enih instrumenata za testiranje curenja od <strong>Cell Instruments<\/strong>, proizvo\u0111a\u010di mogu oja\u010dati svoje sisteme kontrole kvaliteta i s povjerenjem zadovoljiti globalne standarde.<\/p>","protected":false},"excerpt":{"rendered":"<p>Osiguravanje integriteta \u0161prica je od su\u0161tinskog zna\u010daja za sigurnost pacijenata i kvalitet proizvoda u medicinskoj i farmaceutskoj industriji. Jedna od najkriti\u010dnijih procedura kontrole kvaliteta je metoda testa curenja \u0161price, koja utvr\u0111uje mo\u017ee li \u0161prica sprije\u010diti curenje teku\u0107ine pod odre\u0111enim uslovima. Ovaj test je posebno klju\u010dan i za ru\u010dno upravljane [\u2026]","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\/bs\/syringe-leak-test-method-liquid-leakage-test\/\" \/>\n<meta property=\"og:locale\" content=\"bs_BA\" \/>\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\/bs\/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=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"leakagetester\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minute\" \/>\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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