{"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\/eu\/syringe-leak-test-method-liquid-leakage-test\/","title":{"rendered":"Eskaliparen ihes-proba metodoa \u2013 Likidoen ihes-proba"},"content":{"rendered":"<p>Siringen osotasuna bermatzea funtsezkoa da pazienteen segurtasunerako eta produktuaren kalitaterako medikuntza- eta farmazia-industrietan. Kalitate-kontrolerako prozedura kritikoenetako bat da <strong>Eskuhotz-ihesaren proba-metodoa<\/strong>, zeinak baldintza zehatzetan injekzio-siringa batek likido-ihesak saihestu ditzakeen ala ez zehazten duen. Proba hau bereziki garrantzitsua da bai eskuz eragindako behin-behineko injekzio-siringetarako, bai banaketa-sistema automatikoetan erabiltzen diren aurrez betetako injekzio-siringetarako.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Eskuhotz-ihesaren proba-metodaren ikuspegi orokorra<\/h2>\n\n\n\n<p>The <strong>Eskuhotz-ihesaren proba-metodoa<\/strong> Hori injekzio-siringaren gorputzetik edo itxiera-sistematik likido-ihesak dauden egiaztatzeko prozesuari dagokio, mekanikoki estresatu edo barne-presioaren menpe jartzean. Ihesek esterilitatea eta dosi-zehaztasuna arriskuan jar dezakete, erabiltzaileentzat arrisku larriak sortuz.<\/p>\n\n\n\n<p>Bi estandar nagusi daude xiringen ihesak probatzeko:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong><a href=\"https:\/\/www.leakagetester.com\/eu\/standards\/iso-7886-1\/\" target=\"_blank\" rel=\"noreferrer noopener\">ISO 7886-1<\/a><\/strong>: Zuzentzen da <strong>eskuzko erabilerarako xiringak<\/strong>, ohiko izenez behin-erabilgarriak diren xiringak.<\/li>\n\n\n\n<li><strong>ISO 11040-4<\/strong>: aplikagarria da <strong>aurrez betetako xiringetarako beirazko barrilak<\/strong>, bereziki automatizatutako betetzeko eta bukatzeko prozesuetan erabiltzen direnak.<\/li>\n<\/ul>\n\n\n\n<p>Est\u00e1ndar bakoitzak aparatua, baldintzak eta proba-parametro zehatzak definitzen ditu, injekzio-siringa mota desberdinen ihes-erresistentzia ebaluatzeko.<\/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\">Eskuzko xiringetarako ihes-proba (ISO 7886-1)<\/h2><\/div>\n\n\n\n<h3 class=\"wp-block-heading\">Konpresioaren pean xiringako likido-ihesaren proba<\/h3>\n\n\n\n<p>D eranskina arabera <strong>ISO 7886-1<\/strong>, helburua da pasatze-ihesaren ebaluazioa egitea <strong>pistoi-tapoi-zigilua<\/strong> Indarra aplikatzen denean. Pausoak honako hauek dira:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Betetzea<\/strong> siringa <strong>ur distilatua<\/strong> Bere izendatutako gaitasunaren gainetik.<\/li>\n\n\n\n<li><strong>Airea kanporatzea<\/strong>, ondoren ura bolumen nominalera egokituz.<\/li>\n\n\n\n<li><strong>Zigilatzea<\/strong> siringa-tutu-ahoila, ISO 80369-7 estandarrarekin bat datorren altzairuzko kono-konektore erreferentzia bat erabiliz.<\/li>\n\n\n\n<li>Aplikatuz <strong>alboko indarra<\/strong> 0,25\u20133 N-eko indarra plunjeraren mugimendu erradiala eragiteko.<\/li>\n\n\n\n<li>Aplikatzea <strong>ardatz-presioa<\/strong> (200 edo 300 kPa) pistoiarentzat <strong>30\u201335 segundo<\/strong>.<\/li>\n<\/ul>\n\n\n\n<p><strong>Gaindi\/ez gainditzeko irizpideak<\/strong>Ez da ura iragazi behar pistoi-tapoiaren zigilutik harago. Emaitzak dokumentatu behar dira xiringaren edukiera, ihes-behaketak eta proba-data adierazita.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Gomendatutako instrumentua:<\/h3>\n\n\n\n<p>Cell Instrumentuen\u2019 <strong>SPPT-01 xiringa-pistoi ihes-probagailua<\/strong> prozesu hau automatizatzen du, bermatuz <strong>Indar eta presioaren kontrol zehatza<\/strong>, proba-txosten errazak eskaintzen dituen bitartean.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Aurrez betetako xiringetarako ihes-proba (ISO 11040-4 G3 eranskina)<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Eskirola itxiera-sistemaren ihes-proba<\/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>Gatazka armatuaren biktima izan ziren pertsonentzat <strong>aurrez betetako xiringak<\/strong>, G eranskina <strong>ISO 11040-4<\/strong> zigiluaren osotasuna ebaluatzeko metodo bat zehazten du <strong>orratz-babesleak edo punta-estalkiak<\/strong>. Proba honek garraioan edo betetzean sortzen diren presio-igoerak simulatzen ditu.<\/p>\n\n\n\n<p><strong>Prozedura<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Utzi <strong>Itxiera-sistema 12 orduz utzi<\/strong> Probak egin aurretik egonkortzeko.<\/li>\n\n\n\n<li>Bete xiringa <strong>Bere gaitasunaren 1\/3\u20132\/3<\/strong> ur destilatua erabiliz.<\/li>\n\n\n\n<li>Sartu xiringa batean <strong>proba-edalea<\/strong> eta presio bat aplikatu <strong>110 kPa<\/strong> gatik <strong>5 segundo<\/strong> aire konpresatua edo tentsio- eta konpresio-probatzaile bat erabiliz.<\/li>\n\n\n\n<li><strong>Begiz ikuskapena egin<\/strong> tanta-formaziorako edo osagai-separaziorako.<\/li>\n<\/ul>\n\n\n\n<p><strong>Onarpen irizpideak<\/strong>: Ezer tantarik ikusi ezean, xiringa pasatzen da eta itxiera-sistema osorik mantentzen da.<\/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=\"Eskalaparen ihes-proba metodoa - Likidoen ihes-proba ISO 11040-4 Annex G3\" class=\"uag-image-4099\" width=\"255\" height=\"279\" title=\"Eskalaparen ihes-proba metodoa - Likidoen ihes-proba ISO 11040-4 Annex G3\" role=\"img\"\/><\/figure><\/div>\n<\/div>\n<\/div>\n\n\n\n<h3 class=\"wp-block-heading\">Gomendatutako instrumentua:<\/h3>\n\n\n\n<p>Cell Instrumentuen\u2019 <strong>MST-01 Mediku Gailu Probatzailea<\/strong> airearen presurizazioa eta konpresio mekanikoaren aukerak eskaintzen ditu. Maiztasun handiko lagin-hartzea (\u2265100 Hz) onartzen du, handituz <strong>zehaztasuna eta errepikagarritasuna<\/strong> emaitzen.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Zergatik den garrantzitsua xiringen ihes-proba<\/h2>\n\n\n\n<p>Xiringetako ihesek ez dute soilik dosiaren galera eta kutsadura eragiten, baita araudiaren betetzean ere huts egiten dute. Atxikitzea <strong>ISO 7886-1<\/strong> eta <strong>ISO 11040-4<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Hobetzen du <strong>Pazientearen segurtasuna<\/strong> eta produktuen fidagarritasuna.<\/li>\n\n\n\n<li>Euskarriek <strong>kalitate ziurtapena<\/strong> Ekoizpenean zehar.<\/li>\n\n\n\n<li>Ziurtatzen du <strong>erregulazio-onarpen<\/strong> barne- eta nazioarteko merkatuetarako.<\/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>Mediku-gailuetarako ihes-probagailu egokia hautatzea<\/strong><\/h2>\n\n\n\n<p>Zuzena aukeratzea <strong>Mediku-gailuen ihes-probagailua<\/strong> Hori xiringa motaren, proba bolumenaren eta automatizazio beharraren araberakoa da. Xiringa aniztasun zabala kudeatzen duten fabrikatzaileentzat \u2014barne behin-behineko eta aurrez betetako aukerak\u2014 ezinbestekoa da estandarrek definitutako indar eta presio guztiak simulatzeko gai diren tresna anitzak erabiltzea.<\/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>Zelula-tresnak<\/strong> Pertsonalizagarri eta automatizatutako soluzioak eskaintzen ditu, hala nola <strong>SPPT-01<\/strong> eta <strong>SLT-01<\/strong>, Ikerketa eta garapenerako zein ekoizpen-lineako inguruneetarako egokia.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p>Ulertzea <strong>Eskuhotz-ihesaren proba-metodoa<\/strong> mediku-gailuen kalitatea eta segurtasuna mantentzeko funtsezkoa da. Eskuzko xiringekin edo aurrez betetako beirazko zilindroekin lan egiten ari zaren ala ez, betetzeak <strong>ISO 7886-1<\/strong> eta <strong>ISO 11040-4<\/strong> bermatzen du unitate bakoitzak mundu errealeko baldintzetan fidagarritasunez funtzionatzen duela. Zehatzak eta araudiekin bat datozen ihes-detekzio tresnak erabiliz <strong>Zelula-tresnak<\/strong>, fabrikatzaileek beren kalitate-kontrol sistemak indartu eta mundu-mailako estandarrak konfiantzaz bete ditzakete.<\/p>","protected":false},"excerpt":{"rendered":"<p>Eskerinen osotasuna bermatzea funtsezkoa da pazienteen segurtasunerako eta produktuen kalitaterako medikuntza eta farmazia industrietan. Kalitate-kontrolerako prozedura kritikoenetako bat eskeringa-ihes-proba metodoa da, zeinak baldintza zehatzetan likido-ihesak saihestu ditzakeen ala ez zehazten duen. Proba hau bereziki garrantzitsua da bai eskuz eragindako [\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\/eu\/syringe-leak-test-method-liquid-leakage-test\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\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\/eu\/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 minutua\" \/>\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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