{"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\/sv\/standard\/iso-17218\/","title":{"rendered":"ISO 17218"},"content":{"rendered":"<h2 class=\"wp-block-heading\">Vad \u00e4r ISO 17218?<\/h2>\n\n\n\n<p>ISO 17218, med titeln <em data-start=\"1045\" data-end=\"1091\">\u201cSterila akupunkturn\u00e5lar f\u00f6r eng\u00e5ngsbruk\u201d<\/em>, beskriver standardiserade metoder f\u00f6r utv\u00e4rdering av akupunkturn\u00e5lar. Huvudsyftet \u00e4r att s\u00e4kerst\u00e4lla att n\u00e5larna \u00e4r s\u00e4kra, effektiva och tillf\u00f6rlitliga vid klinisk anv\u00e4ndning. Standarden inneh\u00e5ller riktlinjer f\u00f6r testning av <strong data-start=\"1302\" data-end=\"1322\">n\u00e5lens intensitet<\/strong>, <strong data-start=\"1324\" data-end=\"1344\">n\u00e5lens sk\u00e4rpa<\/strong>, och <strong data-start=\"1350\" data-end=\"1381\">N\u00e5lens punkteringsf\u00f6rm\u00e5ga<\/strong> f\u00f6r att bekr\u00e4fta att n\u00e5larna uppfyller globala kvalitetsstandarder.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">F\u00f6rklaring av akupunkturn\u00e5lstestning<\/h2>\n\n\n\n<p>Standarden specificerar metoder f\u00f6r tre viktiga testaspekter:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">1. Test av n\u00e5lens intensitet<\/h3>\n\n\n\n<p>N\u00e5lens intensitet m\u00e4ter n\u00e5lspetsens f\u00f6rm\u00e5ga att motst\u00e5 b\u00f6jning eller brott. I ISO 17218 inneb\u00e4r detta att akupunkturn\u00e5len placeras vertikalt mot ett st\u00e5lblock. Kraften \u00f6kas gradvis tills den uppfyller de numeriska kriterierna i avsnitt 5.3.5.2. Efter att ha h\u00e5llit belastningen i (5 till 10) sekunder inspekteras n\u00e5lspetsen under 5x f\u00f6rstoring. N\u00e5len m\u00e5ste vara rak, utan b\u00f6jning eller krokning, vilket s\u00e4kerst\u00e4ller att den inte deformeras under akupunkturbehandlingar.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">2. Test av n\u00e5lens sk\u00e4rpa<\/h3>\n\n\n\n<p>Skarphetstestet bed\u00f6mer den kraft som beh\u00f6vs f\u00f6r att n\u00e5lspetsen ska tr\u00e4nga igenom aluminiumfolie. Efter intensitetstestet sitter samma akupunkturn\u00e5l kvar i apparaten. N\u00e5len pressas sedan mot aluminiumfolien tills den genomborrar den. Apparaten registrerar automatiskt genomtr\u00e4ngningskraften, vilket ger kvantitativa data om n\u00e5lens sk\u00e4rpa. En riktigt vass n\u00e5l kr\u00e4ver mindre kraft f\u00f6r att tr\u00e4nga igenom folien, vilket \u00e5terspeglar dess mjuka och exakta punkteringsf\u00f6rm\u00e5ga.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">3. Test med n\u00e5lstick<\/h3>\n\n\n\n<p>Punkteringstest utv\u00e4rderar hur v\u00e4l en n\u00e5l penetrerar mjuk v\u00e4vnad eller material. ISO 17218 tillhandah\u00e5ller tv\u00e5 metoder:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"2753\" data-end=\"2786\">Kvalitativ metod (metod A)<\/strong>: H\u00e4r anv\u00e4nds ett membran av kirurgiska gummihandskar (i enlighet med ISO 10282) som str\u00e4cks \u00f6ver en kopp. N\u00e5len trycks vertikalt in i membranet. Om bucklan \u00e4r minimal och motst\u00e5ndet l\u00e5gt \u00e4r n\u00e5len vass. Denna metod ger en snabb, visuell kontroll av att sk\u00e4rpan \u00e4r konsekvent.<\/li>\n\n\n\n<li><strong data-start=\"3074\" data-end=\"3108\">Kvantitativ metod (metod B)<\/strong>: H\u00e4r anv\u00e4nds en polymeriserad polyuretanfilm med en tjocklek p\u00e5 (0,35 \u00b1 0,05) mm och en Shore-h\u00e5rdhet p\u00e5 (85 \u00b1 10) Shore A. N\u00e5len flyttas med 100 mm\/min medan genomborrningskraften och f\u00f6rskjutningen registreras. De viktiga kraftv\u00e4rdena F0F_0F0, F1F_1F1 och F2F_2F2 \u00e5terspeglar n\u00e5lens genomtr\u00e4ngnings- och friktionsegenskaper. Denna metod ger mycket tillf\u00f6rlitliga data f\u00f6r bed\u00f6mning av punkteringsprestanda och j\u00e4mf\u00f6relse av olika n\u00e5lar.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">B\u00e4sta praxis f\u00f6r efterlevnad av ISO 17218<\/h2>\n\n\n\n<p>Kvalitetskontroll- och testteam b\u00f6r noggrant:<\/p>\n\n\n\n<p>\u2705 Anv\u00e4nd standardiserad testutrustning f\u00f6r att replikera <a href=\"https:\/\/www.iso.org\/standard\/59443.html\" target=\"_blank\" rel=\"noopener nofollow\">ISO 17218<\/a>\u2019s villkor<br data-start=\"3728\" data-end=\"3731\">\u2705 Registrera testdata noggrant, inklusive eventuella f\u00f6r\u00e4ndringar av kraften under punkteringstesterna<br data-start=\"3822\" data-end=\"3825\">\u2705 J\u00e4mf\u00f6r resultat med k\u00e4nda kvalitetsn\u00e5lar f\u00f6r att j\u00e4mf\u00f6ra prestanda<br data-start=\"3903\" data-end=\"3906\">\u2705 Dokumentera och arkivera testresultaten f\u00f6r sp\u00e5rbarhet och regelefterlevnad<\/p>\n\n\n\n<p>Genom att f\u00f6lja dessa metoder kan tillverkare och kvalitetskontrollpersonal tryggt bed\u00f6ma sina akupunkturn\u00e5lar.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\n\t\t\t\tKontakta oss F\u00e5 ISO 17218-testl\u00f6sning\t\t\t\t<\/h2>\n\n\n\n<p>P\u00e5 <strong data-start=\"4163\" data-end=\"4183\">Cellinstrument<\/strong>, \u00e4r vi specialiserade p\u00e5 att konstruera och tillverka testutrustning som uppfyller internationella standarder som ISO 17218. V\u00e5ra instrument s\u00e4kerst\u00e4ller exakt <strong data-start=\"4338\" data-end=\"4421\">testning av n\u00e5lintensitet, n\u00e5lsk\u00e4rpa och n\u00e5lpunktering<\/strong>. Vi erbjuder ocks\u00e5 anpassade testl\u00f6sningar f\u00f6r speciella krav, s\u00e5 att du kan m\u00f6ta marknadens f\u00f6r\u00e4nderliga krav med noggrannhet och tillf\u00f6rlitlighet.<\/p>\n\n\n\n<p>Oavsett om du testar f\u00f6rpackningar, medicintekniska produkter eller akupunkturn\u00e5lar, <strong data-start=\"4642\" data-end=\"4662\">Cellinstrument<\/strong> har den expertis som kr\u00e4vs f\u00f6r att hj\u00e4lpa dig att uppr\u00e4tth\u00e5lla kvalitet, s\u00e4kerhet och efterlevnad.<\/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\/sv\/wp-json\/wp\/v2\/standard\/9831","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/sv\/wp-json\/wp\/v2\/standard"}],"about":[{"href":"https:\/\/www.packqc.com\/sv\/wp-json\/wp\/v2\/types\/standard"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/sv\/wp-json\/wp\/v2\/media\/5491"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/sv\/wp-json\/wp\/v2\/media?parent=9831"}],"wp:term":[{"taxonomy":"standard-category","embeddable":true,"href":"https:\/\/www.packqc.com\/sv\/wp-json\/wp\/v2\/standard-category?post=9831"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}