{"id":2610,"date":"2026-05-07T08:15:19","date_gmt":"2026-05-07T08:15:19","guid":{"rendered":"https:\/\/www.pharmacopoeiatest.com\/?p=2610"},"modified":"2026-05-07T08:46:47","modified_gmt":"2026-05-07T08:46:47","slug":"iso-8537","status":"publish","type":"post","link":"https:\/\/www.pharmacopoeiatest.com\/da\/iso-8537\/","title":{"rendered":"ISO 8537"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"2610\" class=\"elementor elementor-2610\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0662493 e-flex e-con-boxed e-con e-parent\" data-id=\"0662493\" 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-fc37773 elementor-widget elementor-widget-heading\" data-id=\"fc37773\" 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\">ISO 8537 <br><small><small>Test af funktionaliteten af en insulinspr\u00f8jte<\/small><\/small><\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-25d7b19 e-con-full e-flex e-con e-child\" data-id=\"25d7b19\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d257432 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"d257432\" 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-start=\"314\" data-end=\"683\">ISO 8537 fastl\u00e6gger krav til ydeevne og pr\u00f8vning af <strong data-start=\"378\" data-end=\"417\">sterile engangsinsulinspr\u00f8jter<\/strong>, med eller uden n\u00e5le. Standarden fokuserer p\u00e5 spr\u00f8jtens sikkerhed, funktionalitet, t\u00e6tningsevne, doseringsn\u00f8jagtighed og driftssikkerhed. Producenter og kvalitetslaboratorier anvender ISO 8537 til at kontrollere, at spr\u00f8jterne fungerer ensartet under klinisk brug.<\/p><p data-start=\"685\" data-end=\"1021\">For spr\u00f8jteproducenter forbedrer overholdelse af ISO 8537 produktets p\u00e5lidelighed, underst\u00f8tter ans\u00f8gninger til myndighederne og mindsker risici forbundet med l\u00e6kage, stempeldefekter eller un\u00f8jagtig dosering. For kvalitetskontrolaboratorier giver standarden validerede procedurer til vurdering af spr\u00f8jters ydeevne under kontrollerede forhold.<\/p><p data-start=\"1023\" data-end=\"1207\">Da insulinspr\u00f8jter kr\u00e6ver pr\u00e6cis dosering og stabil t\u00e6tning, <strong data-start=\"1105\" data-end=\"1138\">Test af spr\u00f8jtens funktionalitet<\/strong> spiller en afg\u00f8rende rolle gennem hele produktudviklingen og produktionen.<\/p><p data-start=\"1209\" data-end=\"1536\">Cell Instruments leverer specialiserede testsystemer, der er udviklet til spr\u00f8jteproducenter, laboratorier for medicinsk udstyr og kvalitetsafdelinger inden for farmaceutisk emballage. Disse instrumenter muligg\u00f8r automatiseret kraftm\u00e5ling, vurdering af vakuumintegritet, l\u00e6kagetest og analyse af d\u00f8drum i overensstemmelse med metoderne i ISO 8537.<\/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-5b939f5 elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"5b939f5\" 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<img fetchpriority=\"high\" decoding=\"async\" width=\"500\" height=\"630\" src=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/05\/ISO-8537-Syringe-Functionality-Testing-for-Insulin-Syringes.webp\" class=\"attachment-full size-full wp-image-2613\" alt=\"ISO 8537: Test af funktionalitet for insulinspr\u00f8jter\" srcset=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/05\/ISO-8537-Syringe-Functionality-Testing-for-Insulin-Syringes.webp 500w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/05\/ISO-8537-Syringe-Functionality-Testing-for-Insulin-Syringes-238x300.webp 238w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/05\/ISO-8537-Syringe-Functionality-Testing-for-Insulin-Syringes-10x12.webp 10w\" sizes=\"(max-width: 500px) 100vw, 500px\" \/>\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-77936bb elementor-widget elementor-widget-heading\" data-id=\"77936bb\" 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 8537 \u2013 Test af spr\u00f8jters funktionalitet<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e0637a3 e-grid e-con-full e-con e-child\" data-id=\"e0637a3\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d71bda6 elementor-widget elementor-widget-text-editor\" data-id=\"d71bda6\" 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-start=\"1586\" data-end=\"1769\">ISO 8537 omfatter en r\u00e6kke ydeevneevalueringer, der fastsl\u00e5r, om en spr\u00f8jte kan fungere sikkert og pr\u00e6cist under aspiration og injektion. Standarden omfatter test af:<\/p><ul data-start=\"1771\" data-end=\"1938\"><li data-section-id=\"1oxsryt\" data-start=\"1771\" data-end=\"1802\">Luftl\u00e6kage under aspiration<\/li><li data-section-id=\"b62ksi\" data-start=\"1803\" data-end=\"1837\">V\u00e6skel\u00e6kage under tryk<\/li><li data-section-id=\"143ln9z\" data-start=\"1838\" data-end=\"1862\">Stempelets drivkraft<\/li><li data-section-id=\"1trb4xg\" data-start=\"1863\" data-end=\"1879\">T\u00e6tningens integritet<\/li><li data-section-id=\"77dvwg\" data-start=\"1880\" data-end=\"1899\">D\u00f8dvolumen<\/li><li data-section-id=\"gfc932\" data-start=\"1900\" data-end=\"1938\">L\u00e6kage ved forbindelsen mellem n\u00e5l og dyse<\/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-d841201 elementor-widget elementor-widget-text-editor\" data-id=\"d841201\" 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-start=\"1940\" data-end=\"1978\">Disse test hj\u00e6lper producenterne med at vurdere:<\/p><ul data-start=\"1980\" data-end=\"2145\"><li data-section-id=\"4m7yx6\" data-start=\"1980\" data-end=\"2009\">Konsistens i stempelpakningen<\/li><li data-section-id=\"jtny4m\" data-start=\"2010\" data-end=\"2039\">T\u00f8ndens og dysens integritet<\/li><li data-section-id=\"13p4qmo\" data-start=\"2040\" data-end=\"2067\">Sm\u00f8reevne<\/li><li data-section-id=\"1rxkfq7\" data-start=\"2068\" data-end=\"2093\">Pr\u00e6cision i dosistilf\u00f8rslen<\/li><li data-section-id=\"njxgtt\" data-start=\"2094\" data-end=\"2145\">P\u00e5lideligheden af forbindelsen mellem spr\u00f8jten og n\u00e5len<\/li><\/ul><p data-start=\"2147\" data-end=\"2270\">Moderne laboratorier indf\u00f8rer i stigende grad automatiserede testsystemer for at forbedre repeterbarheden og mindske variationen i operat\u00f8rernes resultater.<\/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-84b6ee2 elementor-widget elementor-widget-heading\" data-id=\"84b6ee2\" 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\">Pr\u00f8vning af spr\u00f8jters t\u00e6thed i henhold til ISO 8537<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d186872 elementor-widget elementor-widget-text-editor\" data-id=\"d186872\" 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-start=\"2324\" data-end=\"2507\"><strong data-start=\"2324\" data-end=\"2348\">Test af spr\u00f8jtel\u00e6kage<\/strong> er en af de vigtigste procedurer, der er beskrevet i ISO 8537. Standarden vurderer b\u00e5de luftl\u00e6kage og v\u00e6skel\u00e6kage under forskellige trykforhold.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-47c3651 e-grid e-con-full e-con e-child\" data-id=\"47c3651\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-bd0c720 e-con-full e-flex e-con e-child\" data-id=\"bd0c720\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-eb605b0 elementor-widget elementor-widget-heading\" data-id=\"eb605b0\" 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\">Luftl\u00e6kage under aspiration<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1310954 elementor-widget elementor-widget-text-editor\" data-id=\"1310954\" 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-start=\"2544\" data-end=\"2684\">Bilag B og bilag F beskriver metoder til p\u00e5visning af luftl\u00e6kage forbi stempelpakningen og spr\u00f8jtedyseforbindelserne under vakuumforhold.<\/p><p data-start=\"2686\" data-end=\"2719\">Proceduren omfatter typisk:<\/p><ol data-start=\"2721\" data-end=\"2926\"><li data-section-id=\"8f51yc\" data-start=\"2721\" data-end=\"2764\">P\u00e5fyldning af spr\u00f8jten med destilleret vand<\/li><li data-section-id=\"11xil91\" data-start=\"2765\" data-end=\"2822\">Tilslutning af spr\u00f8jten til et kompatibelt konisk stik<\/li><li data-section-id=\"1w8sjai\" data-start=\"2823\" data-end=\"2852\">Anvendelse af undertryk<\/li><li data-section-id=\"nzi51v\" data-start=\"2853\" data-end=\"2885\">Overv\u00e5gning af trykstabilitet<\/li><li data-section-id=\"ad7xt5\" data-start=\"2886\" data-end=\"2926\">Observation af l\u00e6kage eller dannelse af bobler<\/li><\/ol><p data-start=\"2928\" data-end=\"3143\">ISO 8537 angiver et vakuumniveau p\u00e5 <strong data-start=\"2965\" data-end=\"3010\">88 kPa under det omgivende atmosf\u00e6riske tryk<\/strong> til vurdering af l\u00e6kage i sugesystemet. Operat\u00f8rerne holder \u00f8je med spr\u00f8jten for at registrere trykfald, dannelse af bobler og l\u00f8srivelse af gummiproppen.<\/p><p data-start=\"3145\" data-end=\"3164\">Denne test kontrollerer:<\/p><ul data-start=\"3166\" data-end=\"3287\"><li data-section-id=\"31dbu3\" data-start=\"3166\" data-end=\"3189\">Stempelpakningens t\u00e6thed<\/li><li data-section-id=\"10m5ixj\" data-start=\"3190\" data-end=\"3222\">T\u00e6tningsevne for n\u00e5lehubben<\/li><li data-section-id=\"17ziab\" data-start=\"3223\" data-end=\"3252\">Dysens tilslutningsstabilitet<\/li><li data-section-id=\"1way5n8\" data-start=\"3253\" data-end=\"3287\">Modstandsdygtighed over for l\u00e6kage ved aspiration<\/li><\/ul>\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-28726d3 e-con-full e-flex e-con e-child\" data-id=\"28726d3\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4cf6b78 elementor-widget elementor-widget-heading\" data-id=\"4cf6b78\" 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\">Vakuuml\u00e6kagetest \u2013 anvendelser inden for medicinalindustrien<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a833751 elementor-widget elementor-widget-text-editor\" data-id=\"a833751\" 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-start=\"3339\" data-end=\"3513\">A <strong data-start=\"3341\" data-end=\"3376\">vakuuml\u00e6kagetest inden for medicinalindustrien<\/strong> Denne procedure er afg\u00f8rende for medicinske spr\u00f8jter, der anvendes til insulinindgivelse, da selv den mindste l\u00e6kage kan p\u00e5virke doseringsn\u00f8jagtigheden eller steriliteten.<\/p><p data-start=\"3515\" data-end=\"3595\">Cell Instruments anbefaler automatiske vakuuml\u00e6kagetestsystemer, der er udstyret med:<\/p><ul data-start=\"3597\" data-end=\"3738\"><li data-section-id=\"le59d7\" data-start=\"3597\" data-end=\"3632\">Vakuumregulatorer med h\u00f8j pr\u00e6cision<\/li><li data-section-id=\"1jdfnmj\" data-start=\"3633\" data-end=\"3662\">Digital trykoverv\u00e5gning<\/li><li data-section-id=\"105a6xv\" data-start=\"3663\" data-end=\"3684\">Analyse af l\u00e6kageforfald<\/li><li data-section-id=\"fca3b5\" data-start=\"3685\" data-end=\"3712\">Programmerbar holdetid<\/li><li data-section-id=\"cixp3u\" data-start=\"3713\" data-end=\"3738\">Software til dataregistrering<\/li><\/ul><p data-start=\"3740\" data-end=\"3896\">Disse systemer forbedrer repeterbarheden i forhold til manuelle metoder til vakuumvurdering og hj\u00e6lper laboratorierne med at overholde GMP- og ISO-dokumentationskravene.<\/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 class=\"elementor-element elementor-element-fa6d2ef elementor-widget elementor-widget-heading\" data-id=\"fa6d2ef\" 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\">Metoder til test af spr\u00f8jtet\u00e6thed<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0cbf91c elementor-widget elementor-widget-text-editor\" data-id=\"0cbf91c\" 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-start=\"3943\" data-end=\"4074\">Den <strong data-start=\"3947\" data-end=\"3978\">test af spr\u00f8jtens t\u00e6thed<\/strong> vurderer, om v\u00e6ske eller luft kan tr\u00e6nge forbi t\u00e6tningsfladerne under kompression eller aspiration.<\/p><p data-start=\"4076\" data-end=\"4122\">ISO 8537, bilag E, omhandler v\u00e6skel\u00e6kage ved:<\/p><ul data-start=\"4124\" data-end=\"4190\"><li data-section-id=\"z11dbz\" data-start=\"4124\" data-end=\"4138\">Stempelpakninger<\/li><li data-section-id=\"1p89988\" data-start=\"4139\" data-end=\"4167\">Tilslutninger til spr\u00f8jtemundstykker<\/li><li data-section-id=\"1aynqcu\" data-start=\"4168\" data-end=\"4190\">N\u00e5l-\/cylinderforbindelser<\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-b34aa1c e-grid e-con-full e-con e-child\" data-id=\"b34aa1c\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7afb7c0 elementor-widget elementor-widget-text-editor\" data-id=\"7afb7c0\" 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-start=\"4365\" data-end=\"4389\">Under testene skaber operat\u00f8rerne et indre tryk p\u00e5 <strong data-start=\"4251\" data-end=\"4277\">300 kPa manometertryk<\/strong> og hold trykket i 30 sekunder, mens du ud\u00f8ver en sidev\u00e6rts kraft p\u00e5 stemplet.<\/p><p data-start=\"4365\" data-end=\"4389\">Proceduren vurderer:<\/p><ul data-start=\"4391\" data-end=\"4508\"><li data-section-id=\"1k1t3bu\" data-start=\"4391\" data-end=\"4420\">Modstandsdygtighed over for deformation af t\u00e6tningen<\/li><li data-section-id=\"vhj5a5\" data-start=\"4421\" data-end=\"4457\">L\u00e6kage under sidebelastning<\/li><li data-section-id=\"1ubek41\" data-start=\"4458\" data-end=\"4485\">Stabilitet i stempelbev\u00e6gelsen<\/li><li data-section-id=\"tj03kp\" data-start=\"4486\" data-end=\"4508\">Forbindelsens integritet<\/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-5283d17 elementor-widget elementor-widget-text-editor\" data-id=\"5283d17\" 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-start=\"4510\" data-end=\"4558\">Et p\u00e5lideligt system til overv\u00e5gning af t\u00e6tningens integritet b\u00f8r sikre:<\/p><ul data-start=\"4560\" data-end=\"4689\"><li data-section-id=\"1ogn8km\" data-start=\"4560\" data-end=\"4588\">Stabil trykgenerering<\/li><li data-section-id=\"81fo7t\" data-start=\"4589\" data-end=\"4617\">Pr\u00e6cis kraftp\u00e5f\u00f8ring<\/li><li data-section-id=\"vtwu91\" data-start=\"4618\" data-end=\"4647\">L\u00e6kagedetektion i realtid<\/li><li data-section-id=\"198rl1a\" data-start=\"4648\" data-end=\"4689\">Overv\u00e5gning af forskydning i h\u00f8j opl\u00f8sning<\/li><\/ul><p data-start=\"4691\" data-end=\"4868\">Cell Instruments tilbyder l\u00f8sninger til m\u00e5ling af trykl\u00e6kage og kontrol af t\u00e6thed, der er velegnede til insulinspr\u00f8jter, Luer-systemer, farmaceutiske beholdere og medicinsk emballage.<\/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-d1592e7 elementor-widget elementor-widget-heading\" data-id=\"d1592e7\" 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\">Test af spr\u00f8jtens glidekraft<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-86fac58 elementor-widget elementor-widget-text-editor\" data-id=\"86fac58\" 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-start=\"4907\" data-end=\"5032\"><strong data-start=\"4907\" data-end=\"4938\">Test af spr\u00f8jtens glidekraft<\/strong> m\u00e5ler den kraft, der kr\u00e6ves for at igangs\u00e6tte og opretholde stempelets bev\u00e6gelse under udst\u00f8dning af v\u00e6ske.<\/p><p data-start=\"5034\" data-end=\"5176\">I bilag C til ISO 8537 fasts\u00e6ttes det, at der skal anvendes en mekanisk testmaskine til at registrere stempelets driftskraft, mens vandet presses ud af spr\u00f8jten.<\/p><p data-start=\"5178\" data-end=\"5206\">Testen m\u00e5ler generelt:<\/p><ul data-start=\"5208\" data-end=\"5305\"><li data-section-id=\"uhip3k\" data-start=\"5208\" data-end=\"5227\">Frigjort kraft<\/li><li data-section-id=\"d3dsxi\" data-start=\"5228\" data-end=\"5241\">Glidekraft<\/li><li data-section-id=\"td0rt7\" data-start=\"5242\" data-end=\"5267\">Gennemsnitlig betjeningskraft<\/li><li data-section-id=\"fqmeyx\" data-start=\"5268\" data-end=\"5305\">S\u00f8rg for ensartet kraftud\u00f8velse gennem hele slaget<\/li><\/ul><p data-start=\"5307\" data-end=\"5456\">En stabil glidekraft er afg\u00f8rende, da for stor kraft kan forringe brugervenligheden, mens for ringe modstand kan forringe doseringskontrollen.<\/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-18cc935 elementor-widget elementor-widget-heading\" data-id=\"18cc935\" 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\">Vigtige faktorer, der p\u00e5virker glidekraften<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-d703620 e-grid e-con-full e-con e-child\" data-id=\"d703620\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5c02067 elementor-widget elementor-widget-text-editor\" data-id=\"5c02067\" 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-start=\"5497\" data-end=\"5556\">Flere parametre har indflydelse p\u00e5 spr\u00f8jtens glideegenskaber:<\/p><ul data-start=\"5558\" data-end=\"5684\"><li data-section-id=\"1futzim\" data-start=\"5558\" data-end=\"5591\">Ensartethed i silikonesm\u00f8ring<\/li><li data-section-id=\"kuh4lo\" data-start=\"5592\" data-end=\"5617\">Gummiproppens materiale<\/li><li data-section-id=\"53gmea\" data-start=\"5618\" data-end=\"5647\">T\u00f8ndens m\u00e5ln\u00f8jagtighed<\/li><li data-section-id=\"5t72bj\" data-start=\"5648\" data-end=\"5666\">Overfladefriktion<\/li><li data-section-id=\"198q7yk\" data-start=\"5667\" data-end=\"5684\">N\u00e5lediameter<\/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-a9cd7bf elementor-widget elementor-widget-text-editor\" data-id=\"a9cd7bf\" 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-start=\"5686\" data-end=\"5745\">Et professionelt system til m\u00e5ling af spr\u00f8jtens trykkraft b\u00f8r omfatte:<\/p><ul data-start=\"5747\" data-end=\"5906\"><li data-section-id=\"ne6nqw\" data-start=\"5747\" data-end=\"5779\">Pr\u00e6cisionsvejecelleteknologi<\/li><li data-section-id=\"1wxb0hx\" data-start=\"5780\" data-end=\"5811\">Bev\u00e6gelsesstyring med konstant hastighed<\/li><li data-section-id=\"h51txm\" data-start=\"5812\" data-end=\"5847\">Analyse af kraft-forskydningskurven<\/li><li data-section-id=\"gjpujf\" data-start=\"5848\" data-end=\"5874\">Justerbare testopstillinger<\/li><li data-section-id=\"19afykk\" data-start=\"5875\" data-end=\"5906\">Elektronisk dataindsamling<\/li><\/ul>\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-ef0db14 elementor-widget elementor-widget-text-editor\" data-id=\"ef0db14\" 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>Cell Instruments anbefaler universelle materialetestsystemer, der er udstyret med specialtilpassede spr\u00f8jteholdere til stempelkraftpr\u00f8vning i henhold til ISO 8537.<\/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-c4d61be elementor-widget elementor-widget-heading\" data-id=\"c4d61be\" 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\">M\u00e5ling af d\u00f8dplads p\u00e5 insulinspr\u00f8jter<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a2c205a elementor-widget elementor-widget-text-editor\" data-id=\"a2c205a\" 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-start=\"6115\" data-end=\"6239\"><strong data-start=\"6115\" data-end=\"6141\">M\u00e5ling af d\u00f8dplads<\/strong> bestemmer den resterende v\u00e6skem\u00e6ngde, der er tilbage i spr\u00f8jten, n\u00e5r stemplet er trykket helt ned.<\/p><p data-start=\"6241\" data-end=\"6394\">Et lavt d\u00f8drum er s\u00e6rligt vigtigt for insulinspr\u00f8jter, da resterende medicin kan p\u00e5virke doseringsn\u00f8jagtigheden og \u00f8ge m\u00e6ngden af medicinaffald.<\/p><p data-start=\"6396\" data-end=\"6484\">ISO 8537, bilag D, beskriver en gravimetrisk pr\u00f8vningsmetode baseret p\u00e5 m\u00e5ling af vandmassen.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3582f04 e-grid e-con-full e-con e-child\" data-id=\"3582f04\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-e4e0eef e-con-full e-flex e-con e-child\" data-id=\"e4e0eef\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ee7135a elementor-widget elementor-widget-heading\" data-id=\"ee7135a\" 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\">Procedure for m\u00e5ling af d\u00f8d plads<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-60271a8 elementor-widget elementor-widget-text-editor\" data-id=\"60271a8\" 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-start=\"6524\" data-end=\"6547\">Fremgangsm\u00e5den omfatter:<\/p><ol data-start=\"6549\" data-end=\"6719\"><li data-section-id=\"5n54cf\" data-start=\"6549\" data-end=\"6578\">Vejning af den tomme spr\u00f8jte<\/li><li data-section-id=\"1po99wn\" data-start=\"6579\" data-end=\"6622\">P\u00e5fyldning af spr\u00f8jten med destilleret vand<\/li><li data-section-id=\"q59tts\" data-start=\"6623\" data-end=\"6656\">At t\u00f8mme vandet helt ud<\/li><li data-section-id=\"1w7zx7c\" data-start=\"6657\" data-end=\"6682\">Genvejning af spr\u00f8jten<\/li><li data-section-id=\"1bth81y\" data-start=\"6683\" data-end=\"6719\">Beregning af tilbageholdt vandm\u00e6ngde<\/li><\/ol><p data-start=\"6721\" data-end=\"6791\">Den resterende vandm\u00e6ngde svarer til spr\u00f8jtens d\u00f8drumsvolumen.<\/p>\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-c8b1057 e-con-full e-flex e-con e-child\" data-id=\"c8b1057\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7c4747c elementor-widget elementor-widget-heading\" data-id=\"7c4747c\" 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\">Betydningen af test i d\u00f8de omr\u00e5der<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ac04fa1 elementor-widget elementor-widget-text-editor\" data-id=\"ac04fa1\" 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-start=\"6831\" data-end=\"6883\">M\u00e5ling af d\u00f8dplads hj\u00e6lper producenter med at vurdere:<\/p><ul data-start=\"6885\" data-end=\"6993\"><li data-section-id=\"1yt1bzi\" data-start=\"6885\" data-end=\"6902\">Doseringsn\u00f8jagtighed<\/li><li data-section-id=\"to7kax\" data-start=\"6903\" data-end=\"6928\">Restkoncentration af l\u00e6gemidlet<\/li><li data-section-id=\"1uwyw95\" data-start=\"6929\" data-end=\"6962\">Strukturel optimering af spr\u00f8jter<\/li><li data-section-id=\"19wzgi9\" data-start=\"6963\" data-end=\"6993\">Effektivitet i udformningen af n\u00e5lehubben<\/li><\/ul><p data-start=\"6995\" data-end=\"7121\">Cell Instruments kan levere integration af pr\u00e6cisionsv\u00e6gte og skr\u00e6ddersyede testplatforme til automatiseret analyse af d\u00f8drum.<\/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 class=\"elementor-element elementor-element-8195461 elementor-widget elementor-widget-heading\" data-id=\"8195461\" 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\">Anbefalet testudstyr til overholdelse af ISO 8537<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-129d4b6 elementor-widget elementor-widget-text-editor\" data-id=\"129d4b6\" 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-start=\"7186\" data-end=\"7244\">For at sikre overholdelse af ISO 8537 anvender laboratorier typisk:<\/p><div class=\"TyagGW_tableContainer\"><div class=\"group TyagGW_tableWrapper flex flex-col-reverse w-fit\" tabindex=\"-1\"><table class=\"w-fit min-w-(--thread-content-width)\" data-start=\"7246\" data-end=\"7579\"><thead data-start=\"7246\" data-end=\"7284\"><tr data-start=\"7246\" data-end=\"7284\"><th class=\"\" data-start=\"7246\" data-end=\"7258\" data-col-size=\"sm\">Testsp\u00f8rgsm\u00e5l<\/th><th class=\"\" data-start=\"7258\" data-end=\"7284\" data-col-size=\"sm\">Anbefalet instrument<\/th><\/tr><\/thead><tbody data-start=\"7295\" data-end=\"7579\"><tr data-start=\"7295\" data-end=\"7342\"><td style=\"text-align: center;\" data-start=\"7295\" data-end=\"7320\" data-col-size=\"sm\">Vakuuml\u00e6kagetest<\/td><td style=\"text-align: center;\" data-start=\"7320\" data-end=\"7342\" data-col-size=\"sm\"><a href=\"https:\/\/www.pharmacopoeiatest.com\/da\/vacuum-leak-tester-for-syringe-plunger-stopper-and-seal\/\">SLT-02 Spr\u00f8jtel\u00e6kagetester<\/a><\/td><\/tr><tr data-start=\"7402\" data-end=\"7456\"><td style=\"text-align: center;\" data-start=\"7402\" data-end=\"7427\" data-col-size=\"sm\">Stempelets drivkraft<\/td><td style=\"text-align: center;\" data-start=\"7427\" data-end=\"7456\" data-col-size=\"sm\"><p class=\"elementor-heading-title elementor-size-default\"><a href=\"https:\/\/www.pharmacopoeiatest.com\/da\/syringes-plunger-glide-force-tester\/\">SSR-01 Spr\u00f8jte glidemodstandstester<\/a><\/p><\/td><\/tr><tr data-start=\"7457\" data-end=\"7513\"><td style=\"text-align: center;\" data-start=\"7457\" data-end=\"7479\" data-col-size=\"sm\">Analyse af d\u00f8dplads<\/td><td style=\"text-align: center;\" data-start=\"7479\" data-end=\"7513\" data-col-size=\"sm\">Gravimetrisk m\u00e5lesystem<\/td><\/tr><tr data-start=\"7514\" data-end=\"7579\"><td style=\"text-align: center;\" data-start=\"7514\" data-end=\"7543\" data-col-size=\"sm\">Test af l\u00e6kager i tilslutninger<\/td><td style=\"text-align: center;\" data-start=\"7543\" data-end=\"7579\" data-col-size=\"sm\"><div class=\"elementor-element elementor-element-9d87235 elementor-widget elementor-widget-heading\" data-id=\"9d87235\" data-element_type=\"widget\" data-widget_type=\"heading.default\"><div class=\"elementor-widget-container\"><p class=\"elementor-heading-title elementor-size-default\"><a href=\"https:\/\/www.pharmacopoeiatest.com\/da\/syringe-plunger-seal-integrity-tester\/\">SPPT-01 T\u00e6thedstester til spr\u00f8jter med positivt tryk<\/a><\/p><\/div><\/div><\/td><\/tr><\/tbody><\/table><\/div><\/div><p data-start=\"7581\" data-end=\"7773\">Cell Instruments leverer skr\u00e6ddersyede automatiseringsl\u00f8sninger til laboratorier, der tester spr\u00f8jter, herunder systemer med flere stationer, datastyringssoftware og integrerede platforme til kvalitetskontrol.<\/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-b08dc9a elementor-widget elementor-widget-heading\" data-id=\"b08dc9a\" 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\">Ofte stillede sp\u00f8rgsm\u00e5l<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3e8bf18 elementor-widget elementor-widget-text-editor\" data-id=\"3e8bf18\" 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><strong>Hvad er ISO 8537?<\/strong><br \/>ISO 8537 er en international standard, der fastl\u00e6gger krav og pr\u00f8vningsmetoder for sterile engangsinsulinspr\u00f8jter med eller uden n\u00e5le.<\/p><p><strong>Hvad er l\u00e6kagetest af spr\u00f8jter i henhold til ISO 8537?<\/strong><br \/>Ved l\u00e6kagetest af spr\u00f8jter unders\u00f8ges, om der tr\u00e6nger luft eller v\u00e6ske ind gennem stempelpakninger, spr\u00f8jtemundstykker og n\u00e5leforbindelser under vakuum- eller trykforhold.<\/p><p><strong>Hvorfor er det vigtigt at teste spr\u00f8jtens glidekraft?<\/strong><br \/>Ved hj\u00e6lp af glidekraftstest kontrolleres det, at stemplet bev\u00e6ger sig j\u00e6vnt og ensartet, hvilket sikrer en pr\u00e6cis insulinafgivelse og korrekt brug af spr\u00f8jten.<\/p><p><strong>Hvad er en test af spr\u00f8jtens t\u00e6thed?<\/strong><br \/>En test af spr\u00f8jtens t\u00e6thed fastsl\u00e5r, om t\u00e6tningsfladerne forhindrer l\u00e6kage under kompression og aspiration.<\/p><p><strong>Hvordan foretages m\u00e5ling af d\u00f8dplads?<\/strong><br \/>Ved m\u00e5ling af d\u00f8drum anvendes en gravimetrisk metode, hvor spr\u00f8jtens masse f\u00f8r og efter udt\u00f8mning af vandet sammenlignes for at bestemme den resterende v\u00e6skevolumen.<\/p><p><strong>Hvilke instrumenter bruges til <a href=\"https:\/\/www.iso.org\/standard\/60510.html\" target=\"_blank\" rel=\"noopener\">ISO 8537<\/a> test?<\/strong><br \/>Blandt de mest almindelige instrumenter kan n\u00e6vnes vakuuml\u00e6kagetestere, universelle pr\u00f8vningsmaskiner, trykfaldssystemer og gravimetrisk m\u00e5leudstyr.<\/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\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>ISO 8537 \u2013 Funktionstest af insulinspr\u00f8jter: ISO 8537 fastl\u00e6gger krav til ydeevne og testning af sterile engangsinsulinspr\u00f8jter, med eller uden n\u00e5le. Standarden fokuserer p\u00e5 spr\u00f8jtens sikkerhed, funktionalitet, t\u00e6tningsevne, doseringsn\u00f8jagtighed og driftssikkerhed. Producenter og kvalitetslaboratorier anvender ISO 8537 til at verificere, at spr\u00f8jterne fungerer ensartet under klinisk brug. [\u2026]<\/p>","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","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-2610","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\/da\/author\/pharmacopoeiatest\/"},"uagb_comment_info":0,"uagb_excerpt":"ISO 8537 Syringe Functionality Testing for Insulin Syringe ISO 8537 specifies the performance and testing requirements for sterile single-use insulin syringes, with or without needles. The standard focuses on syringe safety, functionality, sealing performance, dosage accuracy, and operational reliability. 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