{"id":2022,"date":"2025-04-09T05:01:05","date_gmt":"2025-04-09T05:01:05","guid":{"rendered":"https:\/\/www.pharmacopoeiatest.com\/?p=2022"},"modified":"2025-04-11T06:36:55","modified_gmt":"2025-04-11T06:36:55","slug":"needle-bonding-strength-test-iso-11040-4","status":"publish","type":"post","link":"https:\/\/www.pharmacopoeiatest.com\/nb\/needle-bonding-strength-test-iso-11040-4\/","title":{"rendered":"Test av n\u00e5lbindingens styrke ISO 11040-4 vedlegg G1"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"2022\" class=\"elementor elementor-2022\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-88e81b0 e-flex e-con-boxed e-con e-parent\" data-id=\"88e81b0\" 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-15151de elementor-widget elementor-widget-heading\" data-id=\"15151de\" 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\">Test av n\u00e5lbindingens styrke<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3dc2194 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"3dc2194\" 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-d585eff elementor-widget elementor-widget-heading\" data-id=\"d585eff\" 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 G1<\/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-10ec79b e-flex e-con-boxed e-con e-parent\" data-id=\"10ec79b\" 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-7045eb5 elementor-widget elementor-widget-text-editor\" data-id=\"7045eb5\" 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 class=\"\" data-start=\"372\" data-end=\"916\">I industrien for medisinsk utstyr, spesielt for ferdigfylte spr\u00f8yter med p\u00e5satte kanyler, er <em data-start=\"482\" data-end=\"505\">n\u00e5lens uttrekkskraft<\/em> testen er avgj\u00f8rende for \u00e5 verifisere at n\u00e5len og spr\u00f8yten sitter godt sammen. I henhold til <strong data-start=\"609\" data-end=\"633\">ISO 11040-4 Vedlegg G1<\/strong>Denne mekaniske testen er avgj\u00f8rende for \u00e5 vurdere sikkerheten, p\u00e5liteligheten og samsvaret med regelverket for spr\u00f8ytesystemer. Korrekt gjennomf\u00f8ring av denne testen sikrer at kanyler ikke l\u00f8sner under normale eller stressende bruksforhold, noe som er avgj\u00f8rende for b\u00e5de klinisk bruk og pasientsikkerhet.<\/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-53f39ac elementor-widget elementor-widget-heading\" data-id=\"53f39ac\" 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\">Betydningen av n\u00e5lens uttrekkskraft<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-232a548 elementor-widget elementor-widget-text-editor\" data-id=\"232a548\" 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 class=\"\" data-start=\"982\" data-end=\"1259\"><em data-start=\"982\" data-end=\"1005\">N\u00e5lens uttrekkskraft<\/em> refererer til den maksimale aksiale kraften som kreves for \u00e5 l\u00f8sne n\u00e5len fra en spr\u00f8yte. D\u00e5rlig binding mellom n\u00e5l og nav kan f\u00f8re til at n\u00e5len l\u00f8sner under injeksjon, noe som kan for\u00e5rsake skader, doseringsfeil eller kontaminering. Denne testen spiller en viktig rolle i valideringen av <strong data-start=\"1139\" data-end=\"1166\">n\u00e5lbindingens styrke<\/strong> under produksjonen, slik at den oppfyller forh\u00e5ndsdefinerte ytelsesstandarder under <strong data-start=\"1243\" data-end=\"1258\">ISO 11040-4<\/strong>.<\/p>\t\t\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<div class=\"elementor-element elementor-element-8452827 e-flex e-con-boxed e-con e-parent\" data-id=\"8452827\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-570817b e-con-full e-flex e-con e-child\" data-id=\"570817b\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-413bd47 elementor-widget elementor-widget-heading\" data-id=\"413bd47\" 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\">Testmetoder i ISO 11040-4 vedlegg G1<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fcd29af elementor-widget elementor-widget-text-editor\" data-id=\"fcd29af\" 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 class=\"\" data-start=\"1587\" data-end=\"1757\">For \u00e5 gjennomf\u00f8re <em data-start=\"1604\" data-end=\"1627\">n\u00e5lens uttrekkskraft<\/em> testes p\u00e5 riktig m\u00e5te, m\u00e5 produsentene f\u00f8lge <strong data-start=\"1673\" data-end=\"1697\">ISO 11040-4 Vedlegg G1<\/strong> fremgangsm\u00e5te. Nedenfor f\u00f8lger en oversikt over den standardiserte metoden.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-a860fa6 e-con-full e-flex e-con e-child\" data-id=\"a860fa6\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-996cc40 e-con-full e-flex e-con e-child\" data-id=\"996cc40\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2456c08 elementor-widget elementor-widget-heading\" data-id=\"2456c08\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Testoppsett og krav til utstyr<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b295a09 elementor-widget elementor-widget-text-editor\" data-id=\"b295a09\" 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 class=\"\" data-start=\"1807\" data-end=\"1924\">Kjerneutstyret omfatter en <strong data-start=\"1837\" data-end=\"1890\">universell strekk- og kompresjonstestmaskin<\/strong> som oppfyller f\u00f8lgende betingelser:<\/p><ul data-start=\"1926\" data-end=\"2220\"><li class=\"\" data-start=\"1926\" data-end=\"1996\"><p class=\"\" data-start=\"1928\" data-end=\"1996\"><strong data-start=\"1928\" data-end=\"1942\">Lastcelle:<\/strong> Maks. 500 N (eller tilsvarende basert p\u00e5 pr\u00f8vens styrke)<\/p><\/li><li class=\"\" data-start=\"1997\" data-end=\"2048\"><p class=\"\" data-start=\"1999\" data-end=\"2048\"><strong data-start=\"1999\" data-end=\"2014\">Test hastighet:<\/strong> 50 mm\/min (anbefalt standard)<\/p><\/li><li class=\"\" data-start=\"2049\" data-end=\"2097\"><p class=\"\" data-start=\"2051\" data-end=\"2097\"><strong data-start=\"2051\" data-end=\"2069\">Pr\u00f8vetakingsfrekvens:<\/strong> \u2265500 Hz for toppn\u00f8yaktighet<\/p><\/li><li class=\"\" data-start=\"2098\" data-end=\"2157\"><p class=\"\" data-start=\"2100\" data-end=\"2157\"><strong data-start=\"2100\" data-end=\"2126\">N\u00e5legripeinnretning:<\/strong> Sikkert grep uten \u00e5 skli<\/p><\/li><li class=\"\" data-start=\"2158\" data-end=\"2220\"><p class=\"\" data-start=\"2160\" data-end=\"2220\"><strong data-start=\"2160\" data-end=\"2179\">Spr\u00f8yteholder:<\/strong> St\u00f8tter spr\u00f8yten ved hjelp av flens eller skulder<\/p><\/li><\/ul><p class=\"\" data-start=\"2222\" data-end=\"2499\">Cell Instruments' <strong data-start=\"2240\" data-end=\"2275\">MPT-01 Tester for medisinsk emballasje<\/strong> er en utmerket l\u00f8sning for dette form\u00e5let. Den er utviklet for testing av medisinsk emballasje og utstyr, og har justerbar testhastighet, PLC-styrt presisjon og konfigurerbare klemmer som er skreddersydd for evaluering av spr\u00f8yter og kanyler.<\/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<div class=\"elementor-element elementor-element-d9546da elementor-widget elementor-widget-image\" data-id=\"d9546da\" 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\/category\/product\/syringe-test\/\">\n\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"442\" height=\"1024\" src=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/Needle-Bonding-Strength-Testing-ISO-11040-4-Annex-G1-442x1024.webp\" class=\"attachment-large size-large wp-image-2024\" alt=\"Styrkepr\u00f8ving av n\u00e5lebinding ISO 11040-4 Annex G1\" srcset=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/Needle-Bonding-Strength-Testing-ISO-11040-4-Annex-G1-442x1024.webp 442w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/Needle-Bonding-Strength-Testing-ISO-11040-4-Annex-G1-130x300.webp 130w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/Needle-Bonding-Strength-Testing-ISO-11040-4-Annex-G1-768x1779.webp 768w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/Needle-Bonding-Strength-Testing-ISO-11040-4-Annex-G1-663x1536.webp 663w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/Needle-Bonding-Strength-Testing-ISO-11040-4-Annex-G1-884x2048.webp 884w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/Needle-Bonding-Strength-Testing-ISO-11040-4-Annex-G1-scaled.webp 1105w\" sizes=\"(max-width: 442px) 100vw, 442px\" \/>\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>\n\t\t\t\t<div class=\"elementor-element elementor-element-27af015 elementor-widget elementor-widget-heading\" data-id=\"27af015\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Klargj\u00f8ring og h\u00e5ndtering av pr\u00f8ver<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f39f978 elementor-widget elementor-widget-text-editor\" data-id=\"f39f978\" 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<ul><li class=\"\" data-start=\"2543\" data-end=\"2625\"><p class=\"\" data-start=\"2545\" data-end=\"2625\">Bruk <strong data-start=\"2549\" data-end=\"2585\">steriliserte, sammensatte spr\u00f8yter<\/strong> klar for fylling med en stukket n\u00e5l.<\/p><\/li><li class=\"\" data-start=\"2626\" data-end=\"2718\"><p class=\"\" data-start=\"2628\" data-end=\"2718\">S\u00f8rg for at testpr\u00f8vene gjenspeiler de faktiske produksjonsforholdene for \u00e5 sikre at resultatene er relevante.<\/p><\/li><li class=\"\" data-start=\"2719\" data-end=\"2827\"><p class=\"\" data-start=\"2721\" data-end=\"2827\">Unng\u00e5 forh\u00e5ndsbelastninger f\u00f8r m\u00e5lingen starter - still inn veiecellen til <em data-start=\"2792\" data-end=\"2798\">null<\/em> uten ekstra trykk.<\/p><\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-c6fdd34 e-con-full e-flex e-con e-child\" data-id=\"c6fdd34\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-793e953 e-con-full e-flex e-con e-child\" data-id=\"793e953\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b7b4771 elementor-widget elementor-widget-heading\" data-id=\"b7b4771\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Fremgangsm\u00e5te for testing av n\u00e5lebindingens styrke<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6e44f24 elementor-widget elementor-widget-text-editor\" data-id=\"6e44f24\" 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 class=\"\" data-start=\"2870\" data-end=\"2924\"><p class=\"\" data-start=\"2873\" data-end=\"2924\">Monter spr\u00f8yten vertikalt i testfiksturen.<\/p><\/li><li class=\"\" data-start=\"2925\" data-end=\"2975\"><p class=\"\" data-start=\"2928\" data-end=\"2975\">Hold godt fast i n\u00e5len for \u00e5 hindre at den sklir.<\/p><\/li><li class=\"\" data-start=\"2976\" data-end=\"3028\"><p class=\"\" data-start=\"2979\" data-end=\"3028\">Sett veiecellen til null f\u00f8r du p\u00e5f\u00f8rer belastning.<\/p><\/li><li class=\"\" data-start=\"3029\" data-end=\"3071\"><p class=\"\" data-start=\"3032\" data-end=\"3071\">Start uttrekkstesten med 50 mm\/min.<\/p><\/li><li class=\"\" data-start=\"3072\" data-end=\"3122\"><p class=\"\" data-start=\"3075\" data-end=\"3122\">Fortsett til n\u00e5len l\u00f8sner eller knekker.<\/p><\/li><li class=\"\" data-start=\"3123\" data-end=\"3172\"><p class=\"\" data-start=\"3126\" data-end=\"3172\">Ta opp <strong data-start=\"3137\" data-end=\"3169\">kraft vs. forskyvningskurve<\/strong>.<\/p><\/li><li class=\"\" data-start=\"3173\" data-end=\"3256\"><p class=\"\" data-start=\"3176\" data-end=\"3256\">Legg merke til <strong data-start=\"3185\" data-end=\"3207\">maksimal toppkraft<\/strong>, som representerer <em data-start=\"3230\" data-end=\"3253\">n\u00e5lens uttrekkskraft<\/em>.<\/p><\/li><\/ol>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-9c468e4 e-con-full e-flex e-con e-child\" data-id=\"9c468e4\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4f65822 elementor-widget elementor-widget-heading\" data-id=\"4f65822\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Rapportering av resultatene<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d2e072e elementor-widget elementor-widget-text-editor\" data-id=\"d2e072e\" 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 class=\"\" data-start=\"3290\" data-end=\"3357\">I henhold til ISO 11040-4 vedlegg G1 skal testrapporten inneholde:<\/p><ul data-start=\"3359\" data-end=\"3509\"><li class=\"\" data-start=\"3359\" data-end=\"3385\"><p class=\"\" data-start=\"3361\" data-end=\"3385\">Maksimal krafttopp (N)<\/p><\/li><li class=\"\" data-start=\"3386\" data-end=\"3418\"><p class=\"\" data-start=\"3388\" data-end=\"3418\">Graf over kraft vs. forskyvning<\/p><\/li><li class=\"\" data-start=\"3419\" data-end=\"3442\"><p class=\"\" data-start=\"3421\" data-end=\"3442\">Testhastighet (mm\/min)<\/p><\/li><li class=\"\" data-start=\"3443\" data-end=\"3462\"><p class=\"\" data-start=\"3445\" data-end=\"3462\">Eksempel p\u00e5 antall<\/p><\/li><li class=\"\" data-start=\"3463\" data-end=\"3509\"><p class=\"\" data-start=\"3465\" data-end=\"3509\">Eventuelle avvik, observasjoner eller uregelmessigheter<\/p><\/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-753fbcc elementor-widget elementor-widget-text-editor\" data-id=\"753fbcc\" 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>For avansert databehandling kan <strong data-start=\"3545\" data-end=\"3555\">MPT-01<\/strong> st\u00f8tter resultatvisualisering, sanntidsvisning og valgfri RS232-utgang eller integrering av mikroskriver.<\/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<\/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-61b109f e-flex e-con-boxed e-con e-parent\" data-id=\"61b109f\" 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-1ddd053 elementor-widget elementor-widget-heading\" data-id=\"1ddd053\" 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\">V\u00e5r Needle Bonding Strength Tester?<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-17dbcca elementor-widget elementor-widget-text-editor\" data-id=\"17dbcca\" 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 class=\"\" data-start=\"4323\" data-end=\"4503\">Med ekspertise innen testing av medisinsk utstyr og emballasje, <strong data-start=\"4379\" data-end=\"4409\">Cell Instruments Co, Ltd.<\/strong> tilbyr skreddersydde l\u00f8sninger for <em data-start=\"4440\" data-end=\"4463\">n\u00e5lens uttrekkskraft<\/em> evalueringer. V\u00e5r MPT-01-tester gj\u00f8r det mulig:<\/p><ul data-start=\"4505\" data-end=\"4762\"><li class=\"\" data-start=\"4505\" data-end=\"4534\"><p class=\"\" data-start=\"4507\" data-end=\"4534\">H\u00f8y n\u00f8yaktighet (0,5% F.S.)<\/p><\/li><li class=\"\" data-start=\"4535\" data-end=\"4592\"><p class=\"\" data-start=\"4537\" data-end=\"4592\">Multifunksjonalitet for trekk- og kompresjonstester<\/p><\/li><li class=\"\" data-start=\"4593\" data-end=\"4657\"><p class=\"\" data-start=\"4595\" data-end=\"4657\">Spesialtilpasset design for spr\u00f8yte- og kanylekonfigurasjoner<\/p><\/li><li class=\"\" data-start=\"4658\" data-end=\"4701\"><p class=\"\" data-start=\"4660\" data-end=\"4701\">Programmerbare, repeterbare testprotokoller<\/p><\/li><li class=\"\" data-start=\"4702\" data-end=\"4762\"><p class=\"\" data-start=\"4704\" data-end=\"4762\">Overholdelse av <a href=\"https:\/\/www.iso.org\/standard\/82222.html\" target=\"_blank\" rel=\"noopener\">ISO 11040-4<\/a> og andre relevante standarder<\/p><\/li><\/ul><p class=\"\" data-start=\"4764\" data-end=\"4917\">Enten du er spr\u00f8yteprodusent eller kvalitetskontrollspesialist, st\u00f8tter vi dine regulatoriske behov og testutfordringer med p\u00e5litelige l\u00f8sninger.<\/p>\t\t\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<div class=\"elementor-element elementor-element-de82dd4 e-flex e-con-boxed e-con e-parent\" data-id=\"de82dd4\" 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-cd205c0 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"cd205c0\" 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-a40b489 elementor-widget elementor-widget-heading\" data-id=\"a40b489\" 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\">Vanlige sp\u00f8rsm\u00e5l<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c0c3e38 elementor-widget elementor-widget-toggle\" data-id=\"c0c3e38\" data-element_type=\"widget\" data-widget_type=\"toggle.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-toggle\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2021\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-2021\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewbox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewbox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">1. Hvilken betydning har testing av n\u00e5lens uttrekkskraft?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2021\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-2021\"><p>Denne testen evaluerer den mekaniske fikseringen av n\u00e5len til spr\u00f8yten for \u00e5 sikre at den ikke l\u00f8sner under bruk, slik at sikkerhets- og ytelsesstandardene opprettholdes.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2022\" class=\"elementor-tab-title\" data-tab=\"2\" role=\"button\" aria-controls=\"elementor-tab-content-2022\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewbox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewbox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">2. Hvilken standard beskriver n\u00e5lebindingstesten?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2022\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"region\" aria-labelledby=\"elementor-tab-title-2022\"><p>ISO 11040-4, spesielt vedlegg G1, definerer metodikken for \u00e5 utf\u00f8re tester av uttrekkskraften p\u00e5 spr\u00f8yter med stakkede n\u00e5ler.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2023\" class=\"elementor-tab-title\" data-tab=\"3\" role=\"button\" aria-controls=\"elementor-tab-content-2023\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewbox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewbox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">3. Hvor mange pr\u00f8ver er n\u00f8dvendig for testing av n\u00e5lens uttrekkskraft?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2023\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"region\" aria-labelledby=\"elementor-tab-title-2023\"><p>Antallet avhenger av dine interne valideringsprotokoller og kundeavtaler, men flere pr\u00f8ver anbefales av hensyn til statistisk p\u00e5litelighet.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2024\" class=\"elementor-tab-title\" data-tab=\"4\" role=\"button\" aria-controls=\"elementor-tab-content-2024\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewbox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewbox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">4. Hvilke krav stilles til utstyret for denne testen?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2024\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"4\" role=\"region\" aria-labelledby=\"elementor-tab-title-2024\"><p>Det kreves en universaltestmaskin med en kapasitet p\u00e5 500 N, testhastighet p\u00e5 50 mm\/min, egnede gripere og h\u00f8y samplingsfrekvens (\u2265500 Hz).<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2025\" class=\"elementor-tab-title\" data-tab=\"5\" role=\"button\" aria-controls=\"elementor-tab-content-2025\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewbox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewbox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">5. Kan Cell Instruments' MPT-01 tilpasses for denne testen?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2025\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"5\" role=\"region\" aria-labelledby=\"elementor-tab-title-2025\"><p>Ja, MPT-01 tilbyr tilpassbare fiksturer, programmerbare innstillinger og automatiseringsfunksjoner som er skreddersydd for n\u00e5lbindingstester og andre tester av medisinsk utstyr.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\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 Bonding Strength Test ISO 11040-4 Annex G1 In the medical device industry, especially for prefilled syringes with staked needles, the needle pull-out force test is essential for verifying the bonding integrity between the needle and the syringe. According to ISO 11040-4 Annex G1, this mechanical test is critical to assess the safety, reliability, and [&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":"","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-2022","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 Bonding Strength Test ISO 11040-4 Annex G1 In the medical device industry, especially for prefilled syringes with staked needles, the needle pull-out force test is essential for verifying the bonding integrity between the needle and the syringe. According to ISO 11040-4 Annex G1, this mechanical test is critical to assess the safety, reliability, and&hellip;","_links":{"self":[{"href":"https:\/\/www.pharmacopoeiatest.com\/nb\/wp-json\/wp\/v2\/posts\/2022","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=2022"}],"version-history":[{"count":5,"href":"https:\/\/www.pharmacopoeiatest.com\/nb\/wp-json\/wp\/v2\/posts\/2022\/revisions"}],"predecessor-version":[{"id":2034,"href":"https:\/\/www.pharmacopoeiatest.com\/nb\/wp-json\/wp\/v2\/posts\/2022\/revisions\/2034"}],"wp:attachment":[{"href":"https:\/\/www.pharmacopoeiatest.com\/nb\/wp-json\/wp\/v2\/media?parent=2022"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/nb\/wp-json\/wp\/v2\/categories?post=2022"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/nb\/wp-json\/wp\/v2\/tags?post=2022"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}