{"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\/da\/syringes-needle-penetration-test-iso-11040-4\/","title":{"rendered":"Test af n\u00e5lepenetration ISO 11040-4 Annex 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\">Penetrationstest med n\u00e5l<\/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 Bilag 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>Den <strong>spr\u00f8jter n\u00e5l penetrationstest<\/strong> er en vigtig procedure i industrien for medicinsk udstyr, der sikrer skarpheden og effektiviteten af n\u00e5le, der bruges i medicinske applikationer. Denne test evaluerer <strong>N\u00e5lens indtr\u00e6ngningskraft<\/strong> der skal til for at gennembore en testfolie, hvilket afspejler den lethed, hvormed en n\u00e5l kan tr\u00e6nge igennem menneskehud eller andre materialer.<\/p><p>For at garantere patientsikkerhed og produktp\u00e5lidelighed er internationale standarder som <strong>ISO 11040-4<\/strong> beskriver pr\u00e6cise testmetoder for spr\u00f8jten\u00e5le. Disse standarder hj\u00e6lper producenterne med at opretholde kvalitetskontrol og overholdelse af lovgivningen.<\/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\">N\u00f8dvendigt udstyr til n\u00e5lepenetrationstest<\/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 []\">If\u00f8lge <strong>ISO 11040-4<\/strong>er f\u00f8lgende apparat vigtigt for at gennemf\u00f8re en <a href=\"https:\/\/www.pharmacopoeiatest.com\/da\/syringe-needle-penetration-test\/\" target=\"_blank\" rel=\"noopener\"><strong>Penetrationstest med n\u00e5l<\/strong><\/a>:<\/p><ul><li data-pm-slice=\"1 3 []\"><strong>Universal tr\u00e6k- og trykpr\u00f8vemaskine<\/strong> med et m\u00e5leomr\u00e5de p\u00e5 op til 10 N (eller efter behov) og en testhastighed p\u00e5 mellem 20 mm\/min og 200 mm\/min.<\/li><li data-pm-slice=\"1 3 []\"><strong>Holder til n\u00e5le<\/strong> for at sikre n\u00e5len under testen.<\/li><li data-pm-slice=\"1 3 []\"><strong>Testfolie<\/strong>med specifikationer, der er aftalt mellem producenter og kunder.<\/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\/da\/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 spr\u00f8jter udstyr til penetrationstest af n\u00e5le\" alt=\"ISO 11040-4 spr\u00f8jter udstyr til penetrationstest af n\u00e5le\" 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\">Procedure for test af n\u00e5lepenetration i spr\u00f8jter<\/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>Fastg\u00f8r testfolien i en sp\u00e6ndingsfri holder.<\/li><li>Fastg\u00f8r n\u00e5len vinkelret i holderen, og juster spidsen til det geometriske centrum af testfolien.<\/li><li>Start testen, og lad n\u00e5len tr\u00e6nge ind i folien med en kontrolleret hastighed.<\/li><li>Optag kraft-forskydningskurven for at analysere indtr\u00e6ngningsegenskaberne.<\/li><li>Gentag testen med et nyt stykke folie for hver m\u00e5ling.<\/li><\/ol><p>H\u00f8jere samplingsfrekvenser, f.eks. 500 Hz, forbedrer m\u00e5len\u00f8jagtigheden ved registrering af spidskraftv\u00e6rdier.<\/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\">N\u00f8gleparametre for n\u00e5leindtr\u00e6ngningskraft i testning<\/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 []\">Den kraft, der ud\u00f8ves under indtr\u00e6ngning, kategoriseres i forskellige stadier:<\/p><ul data-spread=\"false\"><li><strong>Gennemtr\u00e6ngende kraft (F<sub>0<\/sub>):<\/strong> Den kraft, der skal til for at f\u00f8re n\u00e5lespidsen gennem folien.<\/li><li><strong>Sk\u00e6rekraft (F<sub>1<\/sub>):<\/strong> Den kraft, der bruges af sk\u00e6rekanterne.<\/li><li><strong>H\u00e6lkraft (F<sub>2<\/sub>):<\/strong> Den kraft, der ud\u00f8ves, n\u00e5r n\u00e5lens h\u00e6l g\u00e5r igennem.<\/li><li><strong>Tr\u00e6kindtr\u00e6ngningskraft (F<sub>3<\/sub>):<\/strong> Modstandskraften efter fuld gennemtr\u00e6ngning.<\/li><\/ul><p>Ved at evaluere disse parametre kan producenterne sikre, at n\u00e5lene opfylder de n\u00f8dvendige standarder for skarphed og anvendelighed.<\/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\">Overholdelse af ISO 11040-4 for kvalitetssikring<\/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 opstiller omfattende retningslinjer for test af forfyldte spr\u00f8jter, der sikrer:<\/p><ul><li data-pm-slice=\"1 3 []\">Standardiseret <strong>N\u00e5lens indtr\u00e6ngningskraft<\/strong> m\u00e5ling.<\/li><li data-pm-slice=\"1 3 []\">Konsistens p\u00e5 tv\u00e6rs af forskellige kanyle- og spr\u00f8jtetyper.<\/li><li data-pm-slice=\"1 3 []\">Overholdelse af globale krav til medicinsk sikkerhed.<\/li><li data-pm-slice=\"1 3 []\">Reduktion af risici forbundet med ukorrekt n\u00e5lepenetration.<\/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 Testudstyr til n\u00e5lepenetration<\/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 []\">Den <strong>NPT-01 udstyr til n\u00e5lepenetrationstest<\/strong> er designet til at opfylde <strong>ISO 11040-4<\/strong> compliance og tilbyder samtidig pr\u00e6cise testl\u00f8sninger. Den har mange funktioner:<\/p><ul><li data-pm-slice=\"1 3 []\"><strong>PLC-kontrol og 7-tommers HMI-ber\u00f8ringssk\u00e6rm<\/strong> for nem betjening.<\/li><li data-pm-slice=\"1 3 []\"><strong>Stepmotor og pr\u00e6cisionskugleskrue<\/strong> sikrer ensartede resultater.<\/li><li data-pm-slice=\"1 3 []\"><strong>Variable testhastigheder (1-500 mm\/min)<\/strong> for fleksible testbetingelser.<\/li><li data-pm-slice=\"1 3 []\"><strong>Jigs til fastholdelse af flere pr\u00f8ver<\/strong> s\u00e5 der er plads til forskellige kanyle- og spr\u00f8jtetyper.<\/li><li data-pm-slice=\"1 3 []\"><strong>Indbygget mikroprinter og RS232-udgang<\/strong> for effektiv dataregistrering.<\/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 []\">Den <strong>spr\u00f8jter n\u00e5l penetrationstest<\/strong> er afg\u00f8rende for at sikre n\u00e5lens skarphed, patientsikkerheden og overholdelse af lovgivningen. Ved at f\u00f8lge <strong>ISO 11040-4<\/strong> retningslinjer og brug af avanceret testudstyr som f.eks. <strong>NPT-01<\/strong>kan producenterne forbedre produktkvaliteten og samtidig opfylde branchens standarder.<\/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\/da\/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\/da\/wp-json\/wp\/v2\/posts\/1994","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharmacopoeiatest.com\/da\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pharmacopoeiatest.com\/da\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/da\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/da\/wp-json\/wp\/v2\/comments?post=1994"}],"version-history":[{"count":5,"href":"https:\/\/www.pharmacopoeiatest.com\/da\/wp-json\/wp\/v2\/posts\/1994\/revisions"}],"predecessor-version":[{"id":2009,"href":"https:\/\/www.pharmacopoeiatest.com\/da\/wp-json\/wp\/v2\/posts\/1994\/revisions\/2009"}],"wp:attachment":[{"href":"https:\/\/www.pharmacopoeiatest.com\/da\/wp-json\/wp\/v2\/media?parent=1994"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/da\/wp-json\/wp\/v2\/categories?post=1994"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/da\/wp-json\/wp\/v2\/tags?post=1994"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}