{"id":1994,"date":"2025-04-02T06:13:33","date_gmt":"2025-04-02T06:13:33","guid":{"rendered":"https:\/\/www.pharmacopoeiatest.com\/?p=1994"},"modified":"2025-04-02T06:30:46","modified_gmt":"2025-04-02T06:30:46","slug":"syringes-needle-penetration-test-iso-11040-4","status":"publish","type":"post","link":"https:\/\/www.pharmacopoeiatest.com\/nl\/syringes-needle-penetration-test-iso-11040-4\/","title":{"rendered":"Naaldpenetratietest voor injectiespuiten ISO 11040-4 Bijlage F"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"1994\" class=\"elementor elementor-1994\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d8f0949 e-flex e-con-boxed e-con e-parent\" data-id=\"d8f0949\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-af89456 elementor-widget elementor-widget-heading\" data-id=\"af89456\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Penetratietesten met naalden<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-75ecf40 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"75ecf40\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-20ce2df elementor-widget elementor-widget-heading\" data-id=\"20ce2df\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">ISO 11040-4 Bijlage F<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-c9ca423 e-flex e-con-boxed e-con e-parent\" data-id=\"c9ca423\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-41f75ef e-con-full e-flex e-con e-child\" data-id=\"41f75ef\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5114c7b elementor-widget elementor-widget-text-editor\" data-id=\"5114c7b\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>De <strong>penetratietest met naalden<\/strong> is een cruciale procedure in de industrie voor medische hulpmiddelen, die de scherpte en effectiviteit van naalden voor medische toepassingen garandeert. Deze test evalueert de <strong>penetratiekracht van de naald<\/strong> nodig om een testfolie te doorboren, wat het gemak weerspiegelt waarmee een naald de menselijke huid of andere materialen kan penetreren.<\/p><p>Om de veiligheid van de pati\u00ebnt en de betrouwbaarheid van het product te garanderen, zijn internationale normen zoals <strong>ISO 11040-4<\/strong> beschrijven precieze testmethoden voor injectienaalden. Deze normen helpen fabrikanten bij het handhaven van kwaliteitscontrole en naleving van de regelgeving.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1c4a1c1 elementor-widget elementor-widget-heading\" data-id=\"1c4a1c1\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Benodigde naaldpenetratietestapparatuur<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-405b6c1 elementor-widget elementor-widget-text-editor\" data-id=\"405b6c1\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-pm-slice=\"1 3 []\">Volgens <strong>ISO 11040-4<\/strong>is het volgende apparaat essentieel voor het uitvoeren van een <a href=\"https:\/\/www.pharmacopoeiatest.com\/nl\/syringe-needle-penetration-test\/\" target=\"_blank\" rel=\"noopener\"><strong>naaldpenetratietest<\/strong><\/a>:<\/p><ul><li data-pm-slice=\"1 3 []\"><strong>Universele trek- en compressietestmachine<\/strong> met een meetbereik tot 10 N (of naar behoefte) en een testsnelheid tussen 20 mm\/min en 200 mm\/min.<\/li><li data-pm-slice=\"1 3 []\"><strong>Naaldhouder<\/strong> om de naald vast te zetten tijdens het testen.<\/li><li data-pm-slice=\"1 3 []\"><strong>Testfolie<\/strong>met specificaties die zijn overeengekomen door fabrikanten en klanten.<\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3315f97 elementor-widget elementor-widget-image\" data-id=\"3315f97\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.pharmacopoeiatest.com\/nl\/syringe-needle-penetration-test\/\">\n\t\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/elementor\/thumbs\/ISO-11040-4-syringes-needle-penetration-test-equipment-r3r52op9pahd5s2kzyk3xzbhif0hy69cozbct55ytk.webp\" title=\"ISO 11040-4 apparatuur voor het testen van naaldpenetratie\" alt=\"ISO 11040-4 apparatuur voor het testen van naaldpenetratie\" loading=\"lazy\" \/>\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ff15e94 elementor-widget elementor-widget-heading\" data-id=\"ff15e94\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Methode voor naaldpenetratietest met spuiten<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fe76308 elementor-widget elementor-widget-text-editor\" data-id=\"fe76308\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ol><li>Zet de testfolie vast in een spanningsvrije houder.<\/li><li>Zet de naald loodrecht in de houder en lijn de punt uit met het geometrische middelpunt van de testfolie.<\/li><li>Start de test en laat de naald met een gecontroleerde snelheid door de folie gaan.<\/li><li>Registreer de kracht-verplaatsingscurve om de penetratiekenmerken te analyseren.<\/li><li>Herhaal de test met een nieuw stuk folie voor elke meting.<\/li><\/ol><p>Hogere samplesnelheden, zoals 500 Hz, verbeteren de meetnauwkeurigheid bij het registreren van piekkrachtwaarden.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-60ebd0c elementor-widget elementor-widget-heading\" data-id=\"60ebd0c\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Belangrijkste parameters voor naaldpenetratiekracht bij testen<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0f1cf32 elementor-widget elementor-widget-text-editor\" data-id=\"0f1cf32\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-pm-slice=\"1 1 []\">De kracht die wordt uitgeoefend tijdens de penetratie wordt ingedeeld in verschillende stadia:<\/p><ul data-spread=\"false\"><li><strong>Doordringende kracht (F<sub>0<\/sub>):<\/strong> De kracht die nodig is om de naaldpunt door de folie te krijgen.<\/li><li><strong>Snijkracht (F<sub>1<\/sub>):<\/strong> De kracht die door de snijkanten wordt gebruikt.<\/li><li><strong>Hielkracht (F<sub>2<\/sub>):<\/strong> De kracht die wordt uitgeoefend wanneer de hiel van de naald er doorheen gaat.<\/li><li><strong>Indringingskracht van de sleep (F<sub>3<\/sub>):<\/strong> De weerstandskracht na volledige penetratie.<\/li><\/ul><p>Door deze parameters te evalueren kunnen fabrikanten ervoor zorgen dat naalden voldoen aan de vereiste normen voor scherpte en bruikbaarheid.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-84d059d elementor-widget elementor-widget-heading\" data-id=\"84d059d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Voldoet aan ISO 11040-4 voor kwaliteitsborging<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7a670d9 elementor-widget elementor-widget-text-editor\" data-id=\"7a670d9\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-pm-slice=\"1 3 []\">ISO 11040-4 geeft uitgebreide richtlijnen voor het testen van voorgevulde spuiten en zorgt ervoor dat:<\/p><ul><li data-pm-slice=\"1 3 []\">Gestandaardiseerd <strong>penetratiekracht van de naald<\/strong> meting.<\/li><li data-pm-slice=\"1 3 []\">Consistentie tussen verschillende typen naalden en spuiten.<\/li><li data-pm-slice=\"1 3 []\">Voldoen aan wereldwijde medische veiligheidsvereisten.<\/li><li data-pm-slice=\"1 3 []\">Vermindering van risico's in verband met onjuiste naaldpenetratie.<\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5e1f022 elementor-widget elementor-widget-heading\" data-id=\"5e1f022\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">NPT-01 Testapparatuur voor naaldpenetratie<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-53d8fee elementor-widget elementor-widget-text-editor\" data-id=\"53d8fee\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-pm-slice=\"1 3 []\">De <strong>NPT-01 apparatuur voor naaldpenetratietest<\/strong> is ontworpen om te voldoen aan <strong>ISO 11040-4<\/strong> en biedt tegelijkertijd nauwkeurige testoplossingen. Kenmerken:<\/p><ul><li data-pm-slice=\"1 3 []\"><strong>PLC-besturing en 7-inch HMI-touchscreen<\/strong> voor eenvoudige bediening.<\/li><li data-pm-slice=\"1 3 []\"><strong>Stappenmotor en precisiekogelomloopspil<\/strong> voor consistente resultaten.<\/li><li data-pm-slice=\"1 3 []\"><strong>Variabele testsnelheden (1-500 mm\/min)<\/strong> voor flexibele testomstandigheden.<\/li><li data-pm-slice=\"1 3 []\"><strong>Mallen met meerdere monsters<\/strong> voor verschillende soorten naalden en spuiten.<\/li><li data-pm-slice=\"1 3 []\"><strong>Ge\u00efntegreerde microprinter en RS232-uitgang<\/strong> voor effici\u00ebnte gegevensregistratie.<\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f7e5035 elementor-widget elementor-widget-text-editor\" data-id=\"f7e5035\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-pm-slice=\"1 1 []\">De <strong>penetratietest met naalden<\/strong> is van vitaal belang voor de scherpte van de naald, de veiligheid van de pati\u00ebnt en naleving van de regelgeving. Door <strong>ISO 11040-4<\/strong> richtlijnen en het gebruik van geavanceerde testapparatuur zoals de <strong>NPT-01<\/strong>Fabrikanten kunnen de productkwaliteit verbeteren en tegelijkertijd voldoen aan de industrienormen.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Needle Penetration Testing ISO 11040-4 Annex F The syringes needle penetration test is a crucial procedure in the medical device industry, ensuring the sharpness and effectiveness of needles used in medical applications. This test evaluates the needle penetration force required to pierce a test foil, reflecting the ease with which a needle can penetrate human [&hellip;]<\/p>","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_uag_custom_page_level_css":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"footnotes":""},"categories":[26],"tags":[],"class_list":["post-1994","post","type-post","status-publish","format-standard","hentry","category-blog"],"acf":[],"uagb_featured_image_src":{"full":false,"thumbnail":false,"medium":false,"medium_large":false,"large":false,"1536x1536":false,"2048x2048":false,"trp-custom-language-flag":false},"uagb_author_info":{"display_name":"pharmacopoeiatest","author_link":"https:\/\/www.pharmacopoeiatest.com\/nl\/author\/pharmacopoeiatest\/"},"uagb_comment_info":0,"uagb_excerpt":"Needle Penetration Testing ISO 11040-4 Annex F The syringes needle penetration test is a crucial procedure in the medical device industry, ensuring the sharpness and effectiveness of needles used in medical applications. This test evaluates the needle penetration force required to pierce a test foil, reflecting the ease with which a needle can penetrate human&hellip;","_links":{"self":[{"href":"https:\/\/www.pharmacopoeiatest.com\/nl\/wp-json\/wp\/v2\/posts\/1994","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharmacopoeiatest.com\/nl\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pharmacopoeiatest.com\/nl\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/nl\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/nl\/wp-json\/wp\/v2\/comments?post=1994"}],"version-history":[{"count":5,"href":"https:\/\/www.pharmacopoeiatest.com\/nl\/wp-json\/wp\/v2\/posts\/1994\/revisions"}],"predecessor-version":[{"id":2009,"href":"https:\/\/www.pharmacopoeiatest.com\/nl\/wp-json\/wp\/v2\/posts\/1994\/revisions\/2009"}],"wp:attachment":[{"href":"https:\/\/www.pharmacopoeiatest.com\/nl\/wp-json\/wp\/v2\/media?parent=1994"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/nl\/wp-json\/wp\/v2\/categories?post=1994"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/nl\/wp-json\/wp\/v2\/tags?post=1994"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}