{"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\/fr\/syringe-leak-test-method-liquid-leakage-test\/","title":{"rendered":"M\u00e9thode de test d'\u00e9tanch\u00e9it\u00e9 \u00e0 la seringue - Test de fuite de liquide"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Garantir l'int\u00e9grit\u00e9 des seringues est essentiel pour la s\u00e9curit\u00e9 des patients et la qualit\u00e9 des produits dans les industries m\u00e9dicales et pharmaceutiques. L'une des proc\u00e9dures les plus critiques pour le contr\u00f4le de la qualit\u00e9 est l'analyse des seringues. <strong>m\u00e9thode d'essai d'\u00e9tanch\u00e9it\u00e9 des seringues<\/strong>, Ce test d\u00e9termine si une seringue peut emp\u00eacher les fuites de liquide dans des conditions sp\u00e9cifiques. Ce test est particuli\u00e8rement important pour les seringues jetables manuelles et les seringues pr\u00e9remplies utilis\u00e9es dans les syst\u00e8mes d'administration automatis\u00e9s.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Aper\u00e7u de la m\u00e9thode de test d'\u00e9tanch\u00e9it\u00e9 des seringues<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Le <strong>m\u00e9thode d'essai d'\u00e9tanch\u00e9it\u00e9 des seringues<\/strong> se r\u00e9f\u00e8re au processus consistant \u00e0 v\u00e9rifier si le liquide s'\u00e9chappe du corps de la seringue ou du syst\u00e8me de fermeture lorsqu'il est soumis \u00e0 une contrainte m\u00e9canique ou \u00e0 une pression interne. Les fuites peuvent compromettre la st\u00e9rilit\u00e9 et la pr\u00e9cision du dosage, ce qui pr\u00e9sente des risques graves pour les utilisateurs.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Deux normes principales r\u00e9gissent les tests d'\u00e9tanch\u00e9it\u00e9 des seringues :<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong><a href=\"https:\/\/www.leakagetester.com\/fr\/standards\/iso-7886-1\/\" target=\"_blank\" rel=\"noreferrer noopener\">ISO 7886-1<\/a><\/strong>: Se concentre sur <strong>seringues \u00e0 usage manuel<\/strong>, commun\u00e9ment appel\u00e9es seringues jetables.<\/li>\n\n\n\n<li><strong>ISO 11040-4<\/strong>: S'applique \u00e0 <strong>barils en verre pour seringues pr\u00e9-remplies<\/strong>, en particulier ceux utilis\u00e9s dans les processus automatis\u00e9s de remplissage et de finition.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Chaque norme d\u00e9finit un appareil, des conditions et des param\u00e8tres de test sp\u00e9cifiques pour \u00e9valuer la r\u00e9sistance \u00e0 l'\u00e9tanch\u00e9it\u00e9 de diff\u00e9rents types de seringues.<\/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 d'\u00e9tanch\u00e9it\u00e9 pour seringues manuelles (ISO 7886-1)<\/h2><\/div>\n\n\n\n<h3 class=\"wp-block-heading\">Test de fuite de liquide \u00e0 la seringue sous compression<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Conform\u00e9ment \u00e0 l'annexe D de la <strong>ISO 7886-1<\/strong>, L'objectif est d'\u00e9valuer les fuites au-del\u00e0 du <strong>piston bouchon joint<\/strong> lorsqu'une force est appliqu\u00e9e. Les \u00e9tapes sont les suivantes :<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Remplissage<\/strong> la seringue avec <strong>eau distill\u00e9e<\/strong> au-dessus de sa capacit\u00e9 nominale.<\/li>\n\n\n\n<li><strong>Expulsion de l'air<\/strong>, puis en ajustant l'eau au volume nominal.<\/li>\n\n\n\n<li><strong>Scellement<\/strong> l'embout de la seringue \u00e0 l'aide d'un raccord conique en acier de r\u00e9f\u00e9rence conforme \u00e0 la norme ISO 80369-7.<\/li>\n\n\n\n<li>Application d'un <strong>force lat\u00e9rale<\/strong> de 0,25 \u00e0 3 N pour induire un mouvement radial dans le plongeur.<\/li>\n\n\n\n<li>Application <strong>pression axiale<\/strong> (200 ou 300 kPa) sur le plongeur pour la <strong>30-35 secondes<\/strong>.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Crit\u00e8res de r\u00e9ussite\/\u00e9chec<\/strong>: Aucune eau ne doit s'\u00e9couler au-del\u00e0 du joint d'\u00e9tanch\u00e9it\u00e9 du piston. Les r\u00e9sultats doivent \u00eatre document\u00e9s avec la capacit\u00e9 de la seringue, les observations de fuite et la date du test.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Instrument recommand\u00e9 :<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Instruments cellulaires\u2019 <strong>SPPT-01 Testeur d'\u00e9tanch\u00e9it\u00e9 de seringue et de piston<\/strong> automatise ce processus, garantissant ainsi <strong>contr\u00f4le pr\u00e9cis de la force et de la pression<\/strong>, tout en facilitant l'\u00e9tablissement de rapports sur les tests.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Test d'\u00e9tanch\u00e9it\u00e9 pour seringues pr\u00e9-remplies (ISO 11040-4 Annexe G3)<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Test d'\u00e9tanch\u00e9it\u00e9 du syst\u00e8me de fermeture des seringues<\/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\">Pour <strong>seringues pr\u00e9remplies<\/strong>, l'annexe G de la <strong>ISO 11040-4<\/strong> d\u00e9crit une m\u00e9thode permettant d'\u00e9valuer l'int\u00e9grit\u00e9 du joint d'\u00e9tanch\u00e9it\u00e9 des <strong>des protections d'aiguille ou des capuchons d'embout<\/strong>. Ce test simule les coups de b\u00e9lier lors du transport ou du remplissage.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Proc\u00e9dure<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Laissez le <strong>le syst\u00e8me de fermeture doit rester en place pendant 12 heures<\/strong> avant d'\u00eatre test\u00e9 pour se stabiliser.<\/li>\n\n\n\n<li>Remplir la seringue jusqu'\u00e0 <strong>1\/3-2\/3 de sa capacit\u00e9<\/strong> avec de l'eau distill\u00e9e.<\/li>\n\n\n\n<li>Placer la seringue dans un <strong>support de test<\/strong> et appliquer une pression de <strong>110 kPa<\/strong> pour <strong>5 secondes<\/strong> \u00e0 l'aide d'air comprim\u00e9 ou d'un testeur de traction\/compression.<\/li>\n\n\n\n<li><strong>Inspecter visuellement<\/strong> pour la formation de gouttelettes ou le d\u00e9tachement de composants.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Crit\u00e8res d'acceptation<\/strong>: La seringue passe si aucune goutte n'est observ\u00e9e et si le syst\u00e8me de fermeture reste intact.<\/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=\"M\u00e9thode d&#039;essai d&#039;\u00e9tanch\u00e9it\u00e9 de seringue - Essai d&#039;\u00e9tanch\u00e9it\u00e9 de liquide ISO 11040-4 nnex G3\" class=\"uag-image-4099\" width=\"255\" height=\"279\" title=\"M\u00e9thode d&#039;essai d&#039;\u00e9tanch\u00e9it\u00e9 de seringue - Essai d&#039;\u00e9tanch\u00e9it\u00e9 de liquide ISO 11040-4 nnex G3\" role=\"img\"\/><\/figure><\/div>\n<\/div>\n<\/div>\n\n\n\n<h3 class=\"wp-block-heading\">Instrument recommand\u00e9 :<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Instruments cellulaires\u2019 <strong>MST-01 Testeur de dispositifs m\u00e9dicaux<\/strong> offre des options de pressurisation d'air et de compression m\u00e9canique. Il prend en charge l'\u00e9chantillonnage \u00e0 haute fr\u00e9quence (\u2265100 Hz), ce qui accro\u00eet l'efficacit\u00e9 de l'\u00e9chantillonnage. <strong>la pr\u00e9cision et la r\u00e9p\u00e9tabilit\u00e9<\/strong> des r\u00e9sultats.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">L'importance du test d'\u00e9tanch\u00e9it\u00e9 des seringues<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Les fuites dans les seringues n'entra\u00eenent pas seulement une perte de dosage et une contamination, mais aussi un non-respect de la r\u00e9glementation. Le respect des <strong>ISO 7886-1<\/strong> et <strong>ISO 11040-4<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Am\u00e9liore <strong>la s\u00e9curit\u00e9 des patients<\/strong> et la fiabilit\u00e9 des produits.<\/li>\n\n\n\n<li>Soutien <strong>l'assurance qualit\u00e9<\/strong> pendant la production.<\/li>\n\n\n\n<li>Garantit <strong>approbation r\u00e9glementaire<\/strong> pour les march\u00e9s nationaux et internationaux.<\/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>Choisir le bon testeur d'\u00e9tanch\u00e9it\u00e9 pour les dispositifs m\u00e9dicaux<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Choisir la bonne <strong>testeur d'\u00e9tanch\u00e9it\u00e9 pour dispositifs m\u00e9dicaux<\/strong> d\u00e9pend du type de seringue, du volume de test et des besoins d'automatisation. Pour les fabricants qui utilisent une grande vari\u00e9t\u00e9 de seringues - y compris des options jetables et pr\u00e9-remplies - il est essentiel d'utiliser des instruments polyvalents capables de simuler toutes les forces et pressions requises, telles que d\u00e9finies par les normes.<\/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>Instruments cellulaires<\/strong> offre des solutions automatis\u00e9es et personnalisables telles que le <strong>SPPT-01<\/strong> et <strong>SLT-01<\/strong>, Le syst\u00e8me est id\u00e9al pour les environnements de R&amp;D et les cha\u00eenes de production.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p class=\"wp-block-paragraph\">Comprendre la <strong>m\u00e9thode d'essai d'\u00e9tanch\u00e9it\u00e9 des seringues<\/strong> est essentielle au maintien de la qualit\u00e9 et de la s\u00e9curit\u00e9 des dispositifs m\u00e9dicaux. Que vous travailliez avec des seringues \u00e0 usage manuel ou des cylindres en verre pr\u00e9-remplis, la conformit\u00e9 avec les normes de l'UE est essentielle. <strong>ISO 7886-1<\/strong> et <strong>ISO 11040-4<\/strong> garantit que chaque unit\u00e9 fonctionne de mani\u00e8re fiable dans des conditions r\u00e9elles. En s'appuyant sur les instruments d'essai d'\u00e9tanch\u00e9it\u00e9 pr\u00e9cis et conformes de <strong>Instruments cellulaires<\/strong>, Les fabricants peuvent ainsi renforcer leurs syst\u00e8mes de contr\u00f4le de la qualit\u00e9 et r\u00e9pondre aux normes mondiales en toute confiance.<\/p>","protected":false},"excerpt":{"rendered":"<p>Garantir l'int\u00e9grit\u00e9 des seringues est essentiel pour la s\u00e9curit\u00e9 des patients et la qualit\u00e9 des produits dans les industries m\u00e9dicales et pharmaceutiques. L'une des proc\u00e9dures les plus critiques pour le contr\u00f4le de la qualit\u00e9 est la m\u00e9thode de test d'\u00e9tanch\u00e9it\u00e9 des seringues, qui d\u00e9termine si une seringue peut emp\u00eacher les fuites de liquide dans des conditions sp\u00e9cifiques. Ce test est particuli\u00e8rement important pour les seringues manuelles [...]","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\/fr\/syringe-leak-test-method-liquid-leakage-test\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\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\/fr\/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=\"\u00c9crit par\" \/>\n\t<meta name=\"twitter:data1\" content=\"leakagetester\" \/>\n\t<meta name=\"twitter:label2\" content=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\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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