{"id":9831,"date":"2026-02-24T15:11:44","date_gmt":"2026-02-24T07:11:44","guid":{"rendered":"https:\/\/www.packqc.com\/standard\/iso-17218\/"},"modified":"2026-03-12T16:59:48","modified_gmt":"2026-03-12T08:59:48","slug":"iso-17218","status":"publish","type":"standard","link":"https:\/\/www.packqc.com\/da\/standard\/iso-17218\/","title":{"rendered":"ISO 17218"},"content":{"rendered":"<h2 class=\"wp-block-heading\">Hvad er ISO 17218?<\/h2>\n\n\n\n<p>ISO 17218, med titlen <em data-start=\"1045\" data-end=\"1091\">\u201cSterile akupunkturn\u00e5le til engangsbrug\u201d<\/em>, beskriver standardiserede metoder til evaluering af akupunkturn\u00e5le. Hovedform\u00e5let er at sikre, at n\u00e5lene er sikre, effektive og p\u00e5lidelige under klinisk brug. Standarden indeholder retningslinjer for testning af <strong data-start=\"1302\" data-end=\"1322\">n\u00e5lens intensitet<\/strong>, <strong data-start=\"1324\" data-end=\"1344\">n\u00e5lens skarphed<\/strong>, og <strong data-start=\"1350\" data-end=\"1381\">N\u00e5lens punkteringsevne<\/strong> for at bekr\u00e6fte, at n\u00e5lene lever op til globale kvalitetsstandarder.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Test med akupunkturn\u00e5le forklaret<\/h2>\n\n\n\n<p>Standarden specificerer metoder til tre vigtige testaspekter:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">1. Test af n\u00e5lens intensitet<\/h3>\n\n\n\n<p>N\u00e5lens intensitet m\u00e5ler n\u00e5lespidsens evne til at modst\u00e5 b\u00f8jning eller brud. I ISO 17218 indeb\u00e6rer dette, at akupunkturn\u00e5len placeres lodret mod en st\u00e5lblok. Kraften \u00f8ges gradvist, indtil den opfylder de numeriske kriterier i afsnit 5.3.5.2. Efter at have holdt belastningen i (5 til 10) sekunder inspiceres n\u00e5lespidsen under 5x forst\u00f8rrelse. N\u00e5len skal forblive lige, uden at b\u00f8je eller h\u00e6nge fast, hvilket sikrer, at den ikke deformeres under faktiske akupunkturbehandlinger.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">2. Test af n\u00e5leskarphed<\/h3>\n\n\n\n<p>Skarphedstesten vurderer den kraft, der skal til, for at n\u00e5lespidsen gennemborer aluminiumsfolie. Efter intensitetstesten forbliver den samme akupunkturn\u00e5l fastgjort i apparatet. N\u00e5len presses derefter mod aluminiumsfolien, indtil den gennemborer den. Apparatet registrerer automatisk gennemtr\u00e6ngningskraften og giver kvantitative data om n\u00e5lens skarphed. En korrekt skarp n\u00e5l kr\u00e6ver mindre kraft for at tr\u00e6nge igennem folien, hvilket afspejler dens glatte og pr\u00e6cise punkteringsevne.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">3. Test med n\u00e5lestik<\/h3>\n\n\n\n<p>Punkteringstest evaluerer, hvor godt en n\u00e5l tr\u00e6nger igennem bl\u00f8dt v\u00e6v eller materialer. ISO 17218 indeholder to metoder:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"2753\" data-end=\"2786\">Kvalitativ metode (metode A)<\/strong>: Her bruges en membran af kirurgiske gummihandsker (i overensstemmelse med ISO 10282), der er sp\u00e6ndt ud over en kop. N\u00e5len trykkes lodret ind i membranen. Hvis bulen er minimal, og modstanden er lav, er n\u00e5len skarp. Denne metode giver en hurtig, visuel kontrol af skarphedens konsistens.<\/li>\n\n\n\n<li><strong data-start=\"3074\" data-end=\"3108\">Kvantitativ metode (metode B)<\/strong>: Her anvendes en polymeriseret polyuretanfilm med en tykkelse p\u00e5 (0,35 \u00b1 0,05) mm og en Shore-h\u00e5rdhed p\u00e5 (85 \u00b1 10) Shore A. N\u00e5len bev\u00e6ges med 100 mm\/min, mens gennemtr\u00e6ngningskraften og forskydningen registreres. N\u00f8glekraftv\u00e6rdierne F0F_0F0, F1F_1F1 og F2F_2F2 afspejler n\u00e5lens gennemtr\u00e6ngnings- og friktionsegenskaber. Denne metode giver meget p\u00e5lidelige data til vurdering af punkteringsevnen og sammenligning af forskellige n\u00e5le.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Bedste praksis for overholdelse af ISO 17218<\/h2>\n\n\n\n<p>Kvalitetskontrol- og testteams skal v\u00e6re omhyggelige:<\/p>\n\n\n\n<p>\u2705 Brug standardiseret testudstyr til at gentage <a href=\"https:\/\/www.iso.org\/standard\/59443.html\" target=\"_blank\" rel=\"noopener nofollow\">ISO 17218<\/a>\u2019s betingelser<br data-start=\"3728\" data-end=\"3731\">\u2705 Registrer testdata n\u00f8jagtigt, herunder eventuelle \u00e6ndringer i kraft under punkteringstestene<br data-start=\"3822\" data-end=\"3825\">\u2705 Sammenlign resultater med dem fra kendte kvalitetsn\u00e5le for at benchmarke ydeevnen<br data-start=\"3903\" data-end=\"3906\">\u2705 Dokumenter og arkiver testresultaterne for sporbarhed og overholdelse af lovgivningen<\/p>\n\n\n\n<p>Ved at f\u00f8lge denne praksis kan producenter og kvalitetskontrolpersonale trygt vurdere deres akupunkturn\u00e5le.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\n\t\t\t\tKontakt os og f\u00e5 en ISO 17218-testl\u00f8sning\t\t\t\t<\/h2>\n\n\n\n<p>P\u00e5 <strong data-start=\"4163\" data-end=\"4183\">Celleinstrumenter<\/strong>, Vi har specialiseret os i at designe og fremstille testudstyr, der overholder internationale standarder som ISO 17218. Vores instrumenter sikrer pr\u00e6cis <strong data-start=\"4338\" data-end=\"4421\">Test af n\u00e5leintensitet, test af n\u00e5leskarphed og test af n\u00e5lestik<\/strong>. Vi leverer ogs\u00e5 tilpassede testl\u00f8sninger til s\u00e6rlige krav, s\u00e5 du kan opfylde markedets skiftende krav med n\u00f8jagtighed og p\u00e5lidelighed.<\/p>\n\n\n\n<p>Uanset om du tester emballage, medicinsk udstyr eller akupunkturn\u00e5le, <strong data-start=\"4642\" data-end=\"4662\">Celleinstrumenter<\/strong> har ekspertisen til at hj\u00e6lpe dig med at opretholde kvalitet, sikkerhed og compliance.<\/p>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>What is ISO 17218? ISO 17218, titled \u201cSterile acupuncture needles for single use\u201d, outlines standardized methods for evaluating acupuncture needles. Its main purpose is to ensure that needles are safe, effective, and reliable during clinical use. The standard includes guidelines for testing needle intensity, needle sharpness, and needle puncture performance to confirm that the needles [&hellip;]<\/p>","protected":false},"featured_media":5491,"parent":0,"template":"","meta":{"_acf_changed":true,"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":"","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":""}}},"standard-category":[],"class_list":["post-9831","standard","type-standard","status-publish","has-post-thumbnail","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.packqc.com\/da\/wp-json\/wp\/v2\/standard\/9831","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/da\/wp-json\/wp\/v2\/standard"}],"about":[{"href":"https:\/\/www.packqc.com\/da\/wp-json\/wp\/v2\/types\/standard"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/da\/wp-json\/wp\/v2\/media\/5491"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/da\/wp-json\/wp\/v2\/media?parent=9831"}],"wp:term":[{"taxonomy":"standard-category","embeddable":true,"href":"https:\/\/www.packqc.com\/da\/wp-json\/wp\/v2\/standard-category?post=9831"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}