{"id":9825,"date":"2026-02-24T15:11:44","date_gmt":"2026-02-24T07:11:44","guid":{"rendered":"https:\/\/www.packqc.com\/standard\/iso-9626\/"},"modified":"2026-04-16T09:54:22","modified_gmt":"2026-04-16T01:54:22","slug":"iso-9626","status":"publish","type":"standard","link":"https:\/\/www.packqc.com\/da\/standard\/iso-9626\/","title":{"rendered":"ISO 9626"},"content":{"rendered":"<p><\/p>\n\n\n\n<h1 class=\"wp-block-heading\">ISO 9626<\/h1>\n\n\n\n<h2 class=\"wp-block-heading\">Hvad er ISO 9626?<\/h2>\n\n\n\n<p>Den indeholder standardiserede specifikationer for slanger af rustfrit st\u00e5l, der bruges til fremstilling af medicinske kanyler, fra 3,4 mm (10 Gauge) ned til 0,18 mm (34 Gauge). Standarden g\u00e6lder kun for stive slanger og udelukker fleksible varianter p\u00e5 grund af forskellig mekanisk adf\u00e6rd.<\/p>\n\n\n\n<p>De vigtigste omr\u00e5der, der d\u00e6kkes af ISO 9626, omfatter:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><b>Dimensionelle tolerancer<\/b> af n\u00e5leslanger i rustfrit st\u00e5l<\/li>\n\n\n\n<li>Mekaniske egenskaber som f.eks. <b>Stivhed og modstandsdygtighed over for brud<\/b><\/li>\n\n\n\n<li><b>Modstandsdygtighed over for korrosion<\/b> under simulerede fysiologiske forhold<\/li>\n\n\n\n<li>Fremstilling og evaluering af ekstrakter til test af biokompatibilitet<\/li>\n<\/ul>\n\n\n\n<p>Standarden er afg\u00f8rende for producenter, der fremstiller n\u00e5le til injektion, v\u00e6skepr\u00f8vetagning og andre medicinske anvendelser. Overholdelse sikrer ensartet ydeevne, patientsikkerhed og overholdelse af globale reguleringsorganer.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Test af spr\u00f8jten\u00e5le i henhold til ISO 9626<\/h2>\n\n\n\n<p>ISO 9626 beskriver flere vigtige testprocedurer for spr\u00f8jten\u00e5le, der validerer den mekaniske integritet og holdbarhed af kanyleslanger:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Stivhedstest af injektionsn\u00e5l<\/h3>\n\n\n\n<p>Denne test evaluerer n\u00e5leslangens stivhed under en kontrolleret belastning. Proceduren indeb\u00e6rer:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>St\u00f8tter r\u00f8ret p\u00e5 et sp\u00e6nd, der er bestemt af dets m\u00e5lestok<\/li>\n\n\n\n<li>P\u00e5f\u00f8ring af en nedadg\u00e5ende kraft via et stempel med en bestemt geometri<\/li>\n\n\n\n<li>M\u00e5ling af nedb\u00f8jning p\u00e5 midten for at vurdere stivhed<\/li>\n<\/ul>\n\n\n\n<p>Overdreven fleksibilitet kan resultere i d\u00e5rlig h\u00e5ndtering eller un\u00f8jagtige injektioner. Producenterne skal sikre, at n\u00e5len bevarer sin mekaniske stabilitet under forventede kliniske anvendelsesforhold.<\/p>\n\n\n\n<p>Cell Instruments' TS-01 Needle Tubing Stiffness Tester er optimeret til denne anvendelse. Den tilbyder:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u00b10,1 N kraftn\u00f8jagtighed<\/li>\n\n\n\n<li>M\u00e5ling af afb\u00f8jning p\u00e5 mikroniveau<\/li>\n\n\n\n<li>Brugerdefinerede sp\u00e6ndingsindstillinger pr. m\u00e5lerspecifikation<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Test af modstandsdygtighed over for n\u00e5lebrud<\/h3>\n\n\n\n<p>Brudstyrke er afg\u00f8rende for at forhindre, at slangen g\u00e5r i stykker under brug. ISO 9626 foreskriver en cyklisk b\u00f8jningstest, hvor slangen gennemg\u00e5r op til 20 skiftende b\u00f8jninger i en defineret vinkel:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>R\u00f8r med almindelige v\u00e6gge: (25 \u00b11)\u00b0.<\/li>\n\n\n\n<li>Tyndv\u00e6ggede r\u00f8r: (20 \u00b11)\u00b0.<\/li>\n\n\n\n<li>Ekstra-tynde\/ultra-tynde v\u00e6gge: (15 \u00b11)\u00b0.<\/li>\n<\/ul>\n\n\n\n<p>Testen hj\u00e6lper med at vurdere udmattelsesmodstanden under gentagen belastning. Et synligt brud indikerer svigt.<\/p>\n\n\n\n<p>Cell Instruments' NTT-01 Needle Tubing Break Resistance Tester udf\u00f8rer denne test med:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Programmerbare bukkevinkler og -cyklusser<\/li>\n\n\n\n<li>Inventar til visuel inspektion<\/li>\n\n\n\n<li>Justerbar fastsp\u00e6nding til forskellige r\u00f8rdiametre<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Evaluering af korrosionsbestandighed<\/h3>\n\n\n\n<p>Bilag D i ISO 9626 omhandler korrosionsbestandighed og sikrer, at kanyler ikke nedbrydes i kontakt med kropsv\u00e6sker. R\u00f8r af rustfrit st\u00e5l skal kunne modst\u00e5 grubet\u00e6ring og rustdannelse efter neds\u00e6nkning i testopl\u00f8sninger som saltvand.<\/p>\n\n\n\n<p>Selvom det ikke altid er obligatorisk, inkluderer mange producenter korrosionsbestandighed som en del af rutinem\u00e6ssig test af spr\u00f8jten\u00e5le for at mindske risikoen.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Yderligere overvejelser om ISO 9626-test<\/h3>\n\n\n\n<p>Ud over de centrale mekaniske evalueringer kr\u00e6ver ISO 9626 ogs\u00e5:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Pr\u00e6cise dimensionsm\u00e5linger<\/li>\n\n\n\n<li>Identifikation af v\u00e6gtype (RW, TW, ETW, UTW)<\/li>\n\n\n\n<li>Legeringsklassificering i henhold til ISO 15510 eller ASTM A959<\/li>\n\n\n\n<li>Testdokumentation, herunder m\u00e5lest\u00f8rrelse, afb\u00f8jningsv\u00e6rdier og testbetingelser<\/li>\n<\/ul>\n\n\n\n<p>N\u00f8jagtig testning opfylder ikke kun kravene til overholdelse, men styrker ogs\u00e5 produktets p\u00e5lidelighed og brandets omd\u00f8mme.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">ISO 9626-test - afg\u00f8rende for kvalitetskontrol af spr\u00f8jter<\/h2>\n\n\n\n<p>Manglende overholdelse af ISO 9626-standarderne kan f\u00f8re til:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>B\u00f8jning eller brud p\u00e5 n\u00e5len under injektion<\/li>\n\n\n\n<li>Inkonsekvent v\u00e6sketilf\u00f8rsel<\/li>\n\n\n\n<li>\u00d8get risiko for patientskader<\/li>\n\n\n\n<li>Manglende overholdelse af regler og tilbagekaldelser<\/li>\n<\/ul>\n\n\n\n<p>Ved at integrere ISO 9626-kompatibel test af spr\u00f8jten\u00e5le kan producenter og kvalitetssikringsteams:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Valider mekanisk styrke og holdbarhed<\/li>\n\n\n\n<li>Sikre kompatibilitet med lovkrav<\/li>\n\n\n\n<li>Reducer ansvar og antallet af produktfejl<\/li>\n\n\n\n<li>Forbedre kundernes tillid og tilfredshed<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Valg af ISO 9626-testl\u00f8sning<\/h2>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-28f84493 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<figure class=\"wp-block-image\"><a href=\"https:\/\/www.packqc.com\/da\/product\/syringe-tube-stiffness-tester\/\" target=\"_blank\"><img decoding=\"async\" src=\"https:\/\/www.packqc.com\/wp-content\/uploads\/2025\/05\/Syringe-Tube-Stiffness-Tester-ISO-9626-Annex-B.webp\" alt=\"TS-01 Stivhedstester til spr\u00f8jteslanger - ISO 9626 Annex B\"\/><\/a><\/figure>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h3 class=\"wp-block-heading\"><a href=\"https:\/\/www.packqc.com\/da\/product\/syringe-tube-stiffness-tester\/\" target=\"_blank\">TS-01 Stivhedstester til spr\u00f8jten\u00e5le<\/a><\/h3>\n\n\n\n<p>TS-01 Syringe Needle Stiffness Tester fra Cell Instruments er en p\u00e5lidelig l\u00f8sning med h\u00f8j pr\u00e6cision til n\u00f8jagtig vurdering af stivhedsegenskaberne for n\u00e5leslanger i rustfrit st\u00e5l som specificeret i ISO 9626 Annex B. Dette instrument sikrer ensartet kraftp\u00e5virkning og n\u00f8jagtig m\u00e5ling af slangens afb\u00f8jning, hvilket hj\u00e6lper producenter og kvalitetskontrolteams med at opfylde myndighedernes forventninger til test af injektionsn\u00e5lens stivhed.<\/p>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-28f84493 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<figure class=\"wp-block-image\"><a href=\"https:\/\/www.packqc.com\/da\/product\/needle-toughness-tester\/\" target=\"_blank\"><img decoding=\"async\" src=\"https:\/\/www.packqc.com\/wp-content\/uploads\/2025\/04\/Needle-Toughness-Tester-ISO-9626-Breakage-Resistance-Test.webp\" alt=\"NTT-01 n\u00e5lefasthedstester - ISO 9626 test af brudmodstand\"\/><\/a><\/figure>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h3 class=\"wp-block-heading\"><a href=\"https:\/\/www.packqc.com\/da\/product\/needle-toughness-tester\/\" target=\"_blank\">NTT-01 Modstandstester til n\u00e5lebrud<\/a><\/h3>\n\n\n\n<p>NTT-01 Needle Break Resistance Tester er et vigtigt v\u00e6rkt\u00f8j til evaluering af den mekaniske holdbarhed af slanger til medicinske n\u00e5le under gentagne b\u00f8jningskr\u00e6fter i henhold til ISO 9626 Annex C. Denne tester er designet til strenge kvalitetssikringsmilj\u00f8er og simulerer reelle brugsforhold og leverer pr\u00e6cise data om slangens modstandsdygtighed og strukturelle integritet - afg\u00f8rende for at forhindre n\u00e5lesvigt under klinisk anvendelse.<\/p>\n<\/div>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading\">\n\t\t\t\tKontakt os og f\u00e5 en ISO 9626-testl\u00f8sning\t\t\t\t<\/h2>\n\n\n\n<p><strong>ISO 9626<\/strong> spiller en central rolle i <strong>Test af spr\u00f8jten\u00e5le<\/strong> ved at s\u00e6tte benchmarks for<strong> stivhed, brudstyrke og overordnet strukturel integritet<\/strong> af n\u00e5leslanger i rustfrit st\u00e5l. Gennem pr\u00e6cise mekaniske evalueringer kan producenterne sikre, at deres produkter lever op til b\u00e5de lovm\u00e6ssige og funktionelle forventninger.<\/p>\n\n\n\n<p>Cell Instruments's TS-01- og NTT-01-testere tilbyder en omfattende, ISO-tilpasset l\u00f8sning til at opfylde de skiftende krav til kvalitetskontrol af medicinsk udstyr. Invester i bedre overholdelse, reduceret risiko og overlegen ydeevne med Cell Instruments som din partner i test af spr\u00f8jten\u00e5le.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Ofte stillede sp\u00f8rgsm\u00e5l<\/h2>\n\n\n\n<p>1. Hvad er hovedform\u00e5let med standard?<br>ISO 9626 definerer de dimensionelle og mekaniske krav til stive n\u00e5leslanger af rustfrit st\u00e5l, der bruges i medicinsk udstyr for at sikre sikkerhed og ydeevne.<\/p>\n\n\n\n<p>2. Hvilke typer test er omfattet af ISO 9626?<br>Testene omfatter injektionsn\u00e5lens stivhed, n\u00e5lens brudstyrke, korrosionsbestandighed og forberedelse af ekstrakt til evaluering af biokompatibilitet.<\/p>\n\n\n\n<p>3. Hvad er RW-, TW-, ETW- og UTW-slangetyper?<br>Disse henviser til v\u00e6gtykkelseskategorier: Regular Wall (RW), Thin Wall (TW), Extra-Thin Wall (ETW) og Ultra-Thin Wall (UTW), som bestemmer testparametre og b\u00f8jningsvinkler.<\/p>\n\n\n\n<p>4. Hvordan kan Cell Instruments's udstyr hj\u00e6lpe med ISO 9626-test?<br>Cell Instruments\u2019 TS-01 og NTT-01 giver n\u00f8jagtige, gentagelige testbetingelser for stivhed og brudstyrke, hvilket hj\u00e6lper producenter med at overholde <a href=\"https:\/\/www.iso.org\/standard\/60480.html\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">ISO 9626<\/a> standarder.<\/p>\n\n\n\n<p>5. Hvorfor er det vigtigt at teste n\u00e5lens brudstyrke?<br>Det sikrer, at n\u00e5len ikke br\u00e6kker under belastning under brug, hvilket forhindrer fejl i enheden og patientskader.<\/p>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>ISO 9626 What is ISO 9626? It provides standardized specifications for stainless steel tubing used in the manufacture of medical needles, ranging from 3.4 mm (10 Gauge) down to 0.18 mm (34 Gauge). The standard applies only to rigid tubing, excluding flexible variants due to differing mechanical behaviors. Key areas covered by ISO 9626 include: [&hellip;]<\/p>","protected":false},"featured_media":5377,"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":[612],"class_list":["post-9825","standard","type-standard","status-publish","has-post-thumbnail","hentry","standard-category-iso"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.packqc.com\/da\/wp-json\/wp\/v2\/standard\/9825","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\/5377"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/da\/wp-json\/wp\/v2\/media?parent=9825"}],"wp:term":[{"taxonomy":"standard-category","embeddable":true,"href":"https:\/\/www.packqc.com\/da\/wp-json\/wp\/v2\/standard-category?post=9825"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}