{"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\/nb\/syringes-needle-penetration-test-iso-11040-4\/","title":{"rendered":"Spr\u00f8yter N\u00e5linntrengningstest ISO 11040-4 Vedlegg 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\">Penetrasjonstesting 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 Vedlegg 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\u00f8yter n\u00e5leinntrengningstest<\/strong> er en viktig prosedyre i bransjen for medisinsk utstyr, som sikrer skarpheten og effektiviteten til n\u00e5ler som brukes i medisinske applikasjoner. Denne testen evaluerer <strong>n\u00e5leinntrengningskraft<\/strong> som kreves for \u00e5 stikke hull p\u00e5 en testfolie, noe som gjenspeiler hvor lett en n\u00e5l kan trenge gjennom menneskehud eller andre materialer.<\/p><p>For \u00e5 garantere pasientsikkerhet og produktp\u00e5litelighet er internasjonale standarder som <strong>ISO 11040-4<\/strong> beskriver presise testmetoder for spr\u00f8yten\u00e5ler. Disse standardene hjelper produsentene med \u00e5 opprettholde kvalitetskontroll og overholdelse av regelverket.<\/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\u00f8dvendig utstyr for n\u00e5leinntrengningstest<\/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 apparatur avgj\u00f8rende for \u00e5 gjennomf\u00f8re en <a href=\"https:\/\/www.pharmacopoeiatest.com\/nb\/syringe-needle-penetration-test\/\" target=\"_blank\" rel=\"noopener\"><strong>n\u00e5leinntrengningstest<\/strong><\/a>:<\/p><ul><li data-pm-slice=\"1 3 []\"><strong>Universell strekk- og kompresjonstestmaskin<\/strong> med et m\u00e5leomr\u00e5de p\u00e5 opptil 10 N (eller etter behov) og en testhastighet p\u00e5 mellom 20 mm\/min og 200 mm\/min.<\/li><li data-pm-slice=\"1 3 []\"><strong>N\u00e5lholder<\/strong> for \u00e5 sikre n\u00e5len under testing.<\/li><li data-pm-slice=\"1 3 []\"><strong>Testfolie<\/strong>, med spesifikasjoner som produsenter og kunder har blitt enige om.<\/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\/nb\/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\u00f8yter utstyr for penetrasjonstest av n\u00e5ler\" alt=\"ISO 11040-4-spr\u00f8yter utstyr for penetrasjonstest av n\u00e5ler\" 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\">Testmetode for penetrering av spr\u00f8yter med n\u00e5l<\/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>Fest testfolien i en spenningsfri holder.<\/li><li>Fest n\u00e5len vinkelrett i holderen, og rett spissen inn mot det geometriske sentrum av testfolien.<\/li><li>Start testen, og la n\u00e5len trenge gjennom folien med kontrollert hastighet.<\/li><li>Registrer kraft-forskyvningskurven for \u00e5 analysere penetrasjonsegenskapene.<\/li><li>Gjenta testen med en ny del av folien for hver m\u00e5ling.<\/li><\/ol><p>H\u00f8yere samplingsfrekvenser, for eksempel 500 Hz, forbedrer m\u00e5len\u00f8yaktigheten ved registrering av toppkraftverdier.<\/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\">Viktige parametere for n\u00e5leinntrengningskraft ved testing<\/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 []\">Kraften som ut\u00f8ves under penetrering, kategoriseres i ulike stadier:<\/p><ul data-spread=\"false\"><li><strong>Gjennomslagskraft (F<sub>0<\/sub>):<\/strong> Kraften som kreves for \u00e5 f\u00f8re n\u00e5lespissen gjennom folien.<\/li><li><strong>Skj\u00e6rekraft (F<sub>1<\/sub>):<\/strong> Kraften som brukes av skj\u00e6rekantene.<\/li><li><strong>H\u00e6lkraft (F<sub>2<\/sub>):<\/strong> Kraften som ut\u00f8ves n\u00e5r n\u00e5lens h\u00e6l g\u00e5r gjennom.<\/li><li><strong>Draginntrengningskraft (F<sub>3<\/sub>):<\/strong> Motstandskraften etter full penetrering.<\/li><\/ul><p>Ved \u00e5 evaluere disse parameterne kan produsentene sikre at n\u00e5lene oppfyller kravene til skarphet og brukervennlighet.<\/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 av 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 inneholder omfattende retningslinjer for testing av ferdigfylte spr\u00f8yter for \u00e5 sikre:<\/p><ul><li data-pm-slice=\"1 3 []\">Standardisert <strong>n\u00e5leinntrengningskraft<\/strong> m\u00e5ling.<\/li><li data-pm-slice=\"1 3 []\">Konsistens p\u00e5 tvers av ulike typer kanyler og spr\u00f8yter.<\/li><li data-pm-slice=\"1 3 []\">Overholdelse av globale krav til medisinsk sikkerhet.<\/li><li data-pm-slice=\"1 3 []\">Reduksjon av risiko forbundet med feilaktig n\u00e5lepenetrasjon.<\/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 Utstyr for n\u00e5leinntrengningstest<\/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 utstyr for n\u00e5leinntrengningstest<\/strong> er utformet for \u00e5 m\u00f8te <strong>ISO 11040-4<\/strong> samsvar samtidig som den tilbyr presise testl\u00f8sninger. Den har flere funksjoner:<\/p><ul><li data-pm-slice=\"1 3 []\"><strong>PLS-styring og 7-tommers HMI-ber\u00f8ringsskjerm<\/strong> for enkel betjening.<\/li><li data-pm-slice=\"1 3 []\"><strong>Trinnmotor og presisjonskuleskrue<\/strong> sikrer konsistente resultater.<\/li><li data-pm-slice=\"1 3 []\"><strong>Variable testhastigheter (1-500 mm\/min)<\/strong> for fleksible testforhold.<\/li><li data-pm-slice=\"1 3 []\"><strong>Flere pr\u00f8veholderjigger<\/strong> for \u00e5 f\u00e5 plass til ulike typer kanyler og spr\u00f8yter.<\/li><li data-pm-slice=\"1 3 []\"><strong>Innebygd mikroskriver og RS232-utgang<\/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\u00f8yter n\u00e5leinntrengningstest<\/strong> er avgj\u00f8rende for \u00e5 sikre at n\u00e5lene er skarpe, at pasientsikkerheten ivaretas og at regelverket overholdes. Ved \u00e5 f\u00f8lge <strong>ISO 11040-4<\/strong> retningslinjer og bruk av avansert testutstyr som <strong>NPT-01<\/strong>kan produsentene forbedre produktkvaliteten og samtidig oppfylle bransjestandardene.<\/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\/nb\/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\/nb\/wp-json\/wp\/v2\/posts\/1994","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharmacopoeiatest.com\/nb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pharmacopoeiatest.com\/nb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/nb\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/nb\/wp-json\/wp\/v2\/comments?post=1994"}],"version-history":[{"count":5,"href":"https:\/\/www.pharmacopoeiatest.com\/nb\/wp-json\/wp\/v2\/posts\/1994\/revisions"}],"predecessor-version":[{"id":2009,"href":"https:\/\/www.pharmacopoeiatest.com\/nb\/wp-json\/wp\/v2\/posts\/1994\/revisions\/2009"}],"wp:attachment":[{"href":"https:\/\/www.pharmacopoeiatest.com\/nb\/wp-json\/wp\/v2\/media?parent=1994"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/nb\/wp-json\/wp\/v2\/categories?post=1994"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/nb\/wp-json\/wp\/v2\/tags?post=1994"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}