{"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\/nb\/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>Funksjonstesting av insulinspr\u00f8yter<\/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 angir ytelses- og testkrav for <strong data-start=\"378\" data-end=\"417\">sterile engangsinsulinspr\u00f8yter<\/strong>, med eller uten n\u00e5ler. Standarden fokuserer p\u00e5 spr\u00f8ytenes sikkerhet, funksjonalitet, tetningsevne, doseringsn\u00f8yaktighet og driftssikkerhet. Produsenter og kvalitetslaboratorier bruker ISO 8537 for \u00e5 kontrollere at spr\u00f8ytene fungerer jevnt og trutt under klinisk bruk.<\/p><p data-start=\"685\" data-end=\"1021\">For spr\u00f8yteprodusenter bidrar overholdelse av ISO 8537 til \u00e5 \u00f8ke produktets p\u00e5litelighet, st\u00f8tte s\u00f8knader til myndighetene og redusere risikoen forbundet med lekkasje, stempelfeil eller un\u00f8yaktig dosering. For kvalitetskontrollaboratorier gir standarden validerte prosedyrer for \u00e5 vurdere spr\u00f8ytenes ytelse under kontrollerte forhold.<\/p><p data-start=\"1023\" data-end=\"1207\">Siden insulinspr\u00f8yter krever presis dosering og stabil tetningsevne, <strong data-start=\"1105\" data-end=\"1138\">testing av spr\u00f8ytens funksjonalitet<\/strong> spiller en avgj\u00f8rende rolle gjennom hele produktutviklingen og produksjonen.<\/p><p data-start=\"1209\" data-end=\"1536\">Cell Instruments leverer spesialiserte testsystemer utviklet for spr\u00f8yteprodusenter, laboratorier for medisinsk utstyr og kvalitetsavdelinger innen farmas\u00f8ytisk emballasje. Disse instrumentene muliggj\u00f8r automatisert kraftm\u00e5ling, vurdering av vakuumintegritet, lekkasjetesting og analyse av d\u00f8drom i samsvar med metodene 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: Funksjonstesting av insulinspr\u00f8yter\" 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 Funksjonstesting av spr\u00f8yter<\/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 flere ytelsestester som avgj\u00f8r om en spr\u00f8yte kan brukes sikkert og n\u00f8yaktig under oppsuging og injeksjon. Standarden omfatter testing av:<\/p><ul data-start=\"1771\" data-end=\"1938\"><li data-section-id=\"1oxsryt\" data-start=\"1771\" data-end=\"1802\">Luftlekkasje under aspirasjon<\/li><li data-section-id=\"b62ksi\" data-start=\"1803\" data-end=\"1837\">V\u00e6skelekkasje under trykk<\/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\">Tetningens tetthet<\/li><li data-section-id=\"77dvwg\" data-start=\"1880\" data-end=\"1899\">D\u00f8dvolum<\/li><li data-section-id=\"gfc932\" data-start=\"1900\" data-end=\"1938\">Lekkasje ved tilkoblingen mellom 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 testene hjelper produsentene med \u00e5 vurdere:<\/p><ul data-start=\"1980\" data-end=\"2145\"><li data-section-id=\"4m7yx6\" data-start=\"1980\" data-end=\"2009\">Konsistensen i stempelpakningen<\/li><li data-section-id=\"jtny4m\" data-start=\"2010\" data-end=\"2039\">T\u00f8nne- og dyseintegritet<\/li><li data-section-id=\"13p4qmo\" data-start=\"2040\" data-end=\"2067\">Sm\u00f8reeffektivitet<\/li><li data-section-id=\"1rxkfq7\" data-start=\"2068\" data-end=\"2093\">N\u00f8yaktighet ved dosering<\/li><li data-section-id=\"njxgtt\" data-start=\"2094\" data-end=\"2145\">P\u00e5liteligheten i forbindelsen mellom spr\u00f8yte og n\u00e5l<\/li><\/ul><p data-start=\"2147\" data-end=\"2270\">Moderne laboratorier tar i stadig st\u00f8rre grad i bruk automatiserte testsystemer for \u00e5 forbedre repeterbarheten og redusere variasjoner knyttet til operat\u00f8ren.<\/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\">Tetthetspr\u00f8ving av spr\u00f8yter 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\">Lekkasjetesting av spr\u00f8yter<\/strong> er en av de viktigste prosedyrene som er beskrevet i ISO 8537. Standarden vurderer b\u00e5de luftlekkasje og v\u00e6skelekkasje under ulike trykkforhold.<\/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\">Luftlekkasje under aspirasjon<\/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\">Vedlegg B og vedlegg F beskriver metoder for \u00e5 p\u00e5vise luftlekkasje forbi stempelpakningen og spr\u00f8ytedysens tilkoblinger under vakuumforhold.<\/p><p data-start=\"2686\" data-end=\"2719\">Fremgangsm\u00e5ten omfatter vanligvis:<\/p><ol data-start=\"2721\" data-end=\"2926\"><li data-section-id=\"8f51yc\" data-start=\"2721\" data-end=\"2764\">Fyll spr\u00f8yten med destillert vann<\/li><li data-section-id=\"11xil91\" data-start=\"2765\" data-end=\"2822\">Koble spr\u00f8yten til en kompatibel konisk kobling<\/li><li data-section-id=\"1w8sjai\" data-start=\"2823\" data-end=\"2852\">P\u00e5f\u00f8ring av undertrykk<\/li><li data-section-id=\"nzi51v\" data-start=\"2853\" data-end=\"2885\">Overv\u00e5king av trykkstabilitet<\/li><li data-section-id=\"ad7xt5\" data-start=\"2886\" data-end=\"2926\">\u00c5 observere lekkasje eller dannelse av bobler<\/li><\/ol><p data-start=\"2928\" data-end=\"3143\">ISO 8537 angir et vakuumniv\u00e5 p\u00e5 <strong data-start=\"2965\" data-end=\"3010\">88 kPa under atmosf\u00e6risk trykk<\/strong> for vurdering av lekkasje ved aspirasjon. Operat\u00f8rene observerer spr\u00f8yten for \u00e5 se etter trykkfall, dannelse av bobler og l\u00f8srivelse av gummiproppen.<\/p><p data-start=\"3145\" data-end=\"3164\">Denne testen kontrollerer:<\/p><ul data-start=\"3166\" data-end=\"3287\"><li data-section-id=\"31dbu3\" data-start=\"3166\" data-end=\"3189\">Stempelpakningens tetthet<\/li><li data-section-id=\"10m5ixj\" data-start=\"3190\" data-end=\"3222\">Tetningsevnen til n\u00e5lehylsen<\/li><li data-section-id=\"17ziab\" data-start=\"3223\" data-end=\"3252\">Stabilitet i dysetilkoblingen<\/li><li data-section-id=\"1way5n8\" data-start=\"3253\" data-end=\"3287\">Motstand mot aspirasjonslekkasje<\/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\">Vakuumlekkasjetest \u2013 farmas\u00f8ytiske anvendelser<\/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\">vakuumlekkasjetest for farmas\u00f8ytisk bruk<\/strong> Denne prosedyren er avgj\u00f8rende for medisinske spr\u00f8yter som brukes til insulinadministrering, fordi selv sm\u00e5 lekkasjer kan p\u00e5virke doseringsn\u00f8yaktigheten eller steriliteten.<\/p><p data-start=\"3515\" data-end=\"3595\">Cell Instruments anbefaler automatiserte systemer for vakuumlekkasjetesting som er utstyrt med:<\/p><ul data-start=\"3597\" data-end=\"3738\"><li data-section-id=\"le59d7\" data-start=\"3597\" data-end=\"3632\">Vakuumregulatorer med h\u00f8y presisjon<\/li><li data-section-id=\"1jdfnmj\" data-start=\"3633\" data-end=\"3662\">Digital trykkoverv\u00e5king<\/li><li data-section-id=\"105a6xv\" data-start=\"3663\" data-end=\"3684\">Analyse av lekkasjens avklingning<\/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\">Programvare for dataregistrering<\/li><\/ul><p data-start=\"3740\" data-end=\"3896\">Disse systemene forbedrer repeterbarheten sammenlignet med manuelle metoder for vakuumvurdering og bidrar til at laboratoriene oppfyller GMP- og ISO-kravene til dokumentasjon.<\/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\">Testmetoder for \u00e5 kontrollere spr\u00f8ytepakningens tetthet<\/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 av spr\u00f8ytepakningens tetthet<\/strong> vurderer om v\u00e6ske eller luft kan trenge forbi tetningsflater under kompresjon eller aspirasjon.<\/p><p data-start=\"4076\" data-end=\"4122\">ISO 8537, vedlegg E, omhandler v\u00e6skelekkasje 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\">Tilkoblinger for spr\u00f8ytemunnstykker<\/li><li data-section-id=\"1aynqcu\" data-start=\"4168\" data-end=\"4190\">N\u00e5l-\/sylindertilkoblinger<\/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 testingen skaper operat\u00f8rene et indre trykk p\u00e5 <strong data-start=\"4251\" data-end=\"4277\">300 kPa manometertrykk<\/strong> og hold trykket i 30 sekunder mens du ut\u00f8ver en sideveis kraft p\u00e5 stempelet.<\/p><p data-start=\"4365\" data-end=\"4389\">Prosedyren vurderer:<\/p><ul data-start=\"4391\" data-end=\"4508\"><li data-section-id=\"1k1t3bu\" data-start=\"4391\" data-end=\"4420\">Motstand mot deformasjon av tetningen<\/li><li data-section-id=\"vhj5a5\" data-start=\"4421\" data-end=\"4457\">Lekkasje under sidebelastning<\/li><li data-section-id=\"1ubek41\" data-start=\"4458\" data-end=\"4485\">Stabilitet i stempelbevegelsen<\/li><li data-section-id=\"tj03kp\" data-start=\"4486\" data-end=\"4508\">Tilkoblingsintegritet<\/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\u00e5litelig system for kontroll av tetningsintegritet b\u00f8r sikre:<\/p><ul data-start=\"4560\" data-end=\"4689\"><li data-section-id=\"1ogn8km\" data-start=\"4560\" data-end=\"4588\">Stabil trykkdannelse<\/li><li data-section-id=\"81fo7t\" data-start=\"4589\" data-end=\"4617\">N\u00f8yaktig kraftp\u00e5f\u00f8ring<\/li><li data-section-id=\"vtwu91\" data-start=\"4618\" data-end=\"4647\">Lekkasjedeteksjon i sanntid<\/li><li data-section-id=\"198rl1a\" data-start=\"4648\" data-end=\"4689\">Overv\u00e5king av forskyvning med h\u00f8y oppl\u00f8sning<\/li><\/ul><p data-start=\"4691\" data-end=\"4868\">Cell Instruments tilbyr l\u00f8sninger for trykklekkasje og tetningsintegritet som er egnet for insulinspr\u00f8yter, Luer-systemer, legemiddelbeholdere og medisinsk emballasje.<\/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\">Testing av spr\u00f8ytens glidestyrke<\/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\">Testing av spr\u00f8ytens glidekraft<\/strong> m\u00e5ler kraften som kreves for \u00e5 sette i gang og opprettholde stempelbevegelsen under utst\u00f8ting av v\u00e6ske.<\/p><p data-start=\"5034\" data-end=\"5176\">ISO 8537, vedlegg C, angir bruk av en mekanisk testmaskin for \u00e5 registrere stempelets driftskraft mens vannet presses ut av spr\u00f8yten.<\/p><p data-start=\"5178\" data-end=\"5206\">Testen m\u00e5ler vanligvis:<\/p><ul data-start=\"5208\" data-end=\"5305\"><li data-section-id=\"uhip3k\" data-start=\"5208\" data-end=\"5227\">L\u00f8srivningskraft<\/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\">Gjennomsnittlig driftskraft<\/li><li data-section-id=\"fqmeyx\" data-start=\"5268\" data-end=\"5305\">S\u00f8rg for jevn kraftut\u00f8velse gjennom hele bevegelsen<\/li><\/ul><p data-start=\"5307\" data-end=\"5456\">En stabil glidekraft er avgj\u00f8rende, da for stor kraft kan redusere brukervennligheten, mens for liten motstand kan svekke 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\">Viktige faktorer som 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 parametere p\u00e5virker spr\u00f8ytenes glideegenskaper:<\/p><ul data-start=\"5558\" data-end=\"5684\"><li data-section-id=\"1futzim\" data-start=\"5558\" data-end=\"5591\">Jevn fordeling av silikonsm\u00f8remiddel<\/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\">Dimensjonsn\u00f8yaktighet for l\u00f8p<\/li><li data-section-id=\"5t72bj\" data-start=\"5648\" data-end=\"5666\">Overflatefriksjon<\/li><li data-section-id=\"198q7yk\" data-start=\"5667\" data-end=\"5684\">N\u00e5ldiameter<\/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 profesjonelt system for m\u00e5ling av spr\u00f8ytekraft b\u00f8r omfatte:<\/p><ul data-start=\"5747\" data-end=\"5906\"><li data-section-id=\"ne6nqw\" data-start=\"5747\" data-end=\"5779\">Presisjonslastcelleteknologi<\/li><li data-section-id=\"1wxb0hx\" data-start=\"5780\" data-end=\"5811\">Bevegelseskontroll med konstant hastighet<\/li><li data-section-id=\"h51txm\" data-start=\"5812\" data-end=\"5847\">Analyse av kraft-forskyvningskurven<\/li><li data-section-id=\"gjpujf\" data-start=\"5848\" data-end=\"5874\">Justerbare testoppsett<\/li><li data-section-id=\"19afykk\" data-start=\"5875\" data-end=\"5906\">Datastyrt datainnsamling<\/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 materialpr\u00f8vingssystemer utstyrt med spesialtilpassede spr\u00f8ytefester for stempelkraftpr\u00f8ving 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 av d\u00f8dvolum for insulinspr\u00f8yter<\/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 av d\u00f8dvolum<\/strong> bestemmer det gjenv\u00e6rende v\u00e6skevolumet i spr\u00f8yten etter at stempelet er trykket helt ned.<\/p><p data-start=\"6241\" data-end=\"6394\">Et lite d\u00f8drom er spesielt viktig for insulinspr\u00f8yter, fordi rester av medisinen kan p\u00e5virke doseringsn\u00f8yaktigheten og f\u00f8re til \u00f8kt medisinsk avfall.<\/p><p data-start=\"6396\" data-end=\"6484\">ISO 8537, vedlegg D, beskriver en gravimetrisk testmetode basert p\u00e5 m\u00e5ling av vannmasse.<\/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\">M\u00e5leprosedyre for d\u00f8dt rom<\/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\u00e5ten inneb\u00e6rer f\u00f8lgende:<\/p><ol data-start=\"6549\" data-end=\"6719\"><li data-section-id=\"5n54cf\" data-start=\"6549\" data-end=\"6578\">Vekting av den tomme spr\u00f8yten<\/li><li data-section-id=\"1po99wn\" data-start=\"6579\" data-end=\"6622\">Fyll spr\u00f8yten med destillert vann<\/li><li data-section-id=\"q59tts\" data-start=\"6623\" data-end=\"6656\">Fjerne vannet helt<\/li><li data-section-id=\"1w7zx7c\" data-start=\"6657\" data-end=\"6682\">\u00c5 veie spr\u00f8yten p\u00e5 nytt<\/li><li data-section-id=\"1bth81y\" data-start=\"6683\" data-end=\"6719\">Beregning av vannvolumet som holdes tilbake<\/li><\/ol><p data-start=\"6721\" data-end=\"6791\">Den gjenv\u00e6rende vannmengden tilsvarer volumet av spr\u00f8ytenes d\u00f8drom.<\/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 av testing av d\u00f8dplass<\/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 av d\u00f8dvolum hjelper produsenter med \u00e5 vurdere:<\/p><ul data-start=\"6885\" data-end=\"6993\"><li data-section-id=\"1yt1bzi\" data-start=\"6885\" data-end=\"6902\">Doseringsn\u00f8yaktighet<\/li><li data-section-id=\"to7kax\" data-start=\"6903\" data-end=\"6928\">Restkonsentrasjon av legemidlet<\/li><li data-section-id=\"1uwyw95\" data-start=\"6929\" data-end=\"6962\">Strukturell optimalisering av spr\u00f8yter<\/li><li data-section-id=\"19wzgi9\" data-start=\"6963\" data-end=\"6993\">Effektivitet i utformingen av n\u00e5leholderen<\/li><\/ul><p data-start=\"6995\" data-end=\"7121\">Cell Instruments kan tilby integrering av presisjonsvekt og skreddersydde testplattformer for automatisert analyse av d\u00f8drom.<\/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\">Anbefalt testutstyr for \u00e5 oppfylle kravene i 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 \u00e5 sikre samsvar med ISO 8537 bruker laboratorier vanligvis:<\/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\">Testoppgave<\/th><th class=\"\" data-start=\"7258\" data-end=\"7284\" data-col-size=\"sm\">Anbefalt 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\">Vakuumlekkasjetesting<\/td><td style=\"text-align: center;\" data-start=\"7320\" data-end=\"7342\" data-col-size=\"sm\"><a href=\"https:\/\/www.pharmacopoeiatest.com\/nb\/vacuum-leak-tester-for-syringe-plunger-stopper-and-seal\/\">SLT-02 Lekkasjetester for spr\u00f8yter<\/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\/nb\/syringes-plunger-glide-force-tester\/\">SSR-01 Spr\u00f8yte glidemotstandstester<\/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 av d\u00f8dplass<\/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\">Testing av tilkoblingslekkasjer<\/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\/nb\/syringe-plunger-seal-integrity-tester\/\">SPPT-01 Tetthetstester for overtrykk p\u00e5 spr\u00f8yte<\/a><\/p><\/div><\/div><\/td><\/tr><\/tbody><\/table><\/div><\/div><p data-start=\"7581\" data-end=\"7773\">Cell Instruments tilbyr skreddersydde automatiseringsl\u00f8sninger for laboratorier som utf\u00f8rer spr\u00f8ytetesting, blant annet systemer med flere stasjoner, programvare for datah\u00e5ndtering og integrerte plattformer for kvalitetskontroll.<\/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\">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-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>Hva er ISO 8537?<\/strong><br \/>ISO 8537 er en internasjonal standard som fastsetter krav og pr\u00f8vingsmetoder for sterile engangsinsulinspr\u00f8yter, med eller uten n\u00e5ler.<\/p><p><strong>Hva er lekkasjetesting av spr\u00f8yter i henhold til ISO 8537?<\/strong><br \/>Lekkasjetesting av spr\u00f8yter m\u00e5ler luft- eller v\u00e6skelekkasje gjennom stempelpakninger, spr\u00f8ytemunnstykker og n\u00e5letilkoblinger under vakuum- eller trykkforhold.<\/p><p><strong>Hvorfor er det viktig \u00e5 teste glidekraften til spr\u00f8yter?<\/strong><br \/>Glidekrafttesting sikrer at stempelet beveger seg jevnt og jevnt, noe som garanterer n\u00f8yaktig insulinavgivelse og at spr\u00f8yten fungerer som den skal.<\/p><p><strong>Hva er en test av spr\u00f8yteforseglingens integritet?<\/strong><br \/>En test av spr\u00f8yteforseglingens tetthet avgj\u00f8r om forseglingene hindrer lekkasje under kompresjon og aspirasjon.<\/p><p><strong>Hvordan utf\u00f8res m\u00e5ling av d\u00f8dvolum?<\/strong><br \/>Ved m\u00e5ling av d\u00f8dvolum benyttes en gravimetrisk metode der spr\u00f8ytenes masse f\u00f8r og etter utt\u00f8mming av vann sammenlignes for \u00e5 bestemme gjenv\u00e6rende v\u00e6skevolum.<\/p><p><strong>Hvilke instrumenter brukes til <a href=\"https:\/\/www.iso.org\/standard\/60510.html\" target=\"_blank\" rel=\"noopener\">ISO 8537<\/a> testing?<\/strong><br \/>Vanlige instrumenter omfatter vakuumlekkasjetestere, universelle testmaskiner, trykkfallssystemer og gravimetrisk m\u00e5leutstyr.<\/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 Funksjonstesting av insulinspr\u00f8yter \u2013 ISO 8537 fastsetter ytelses- og testkrav for sterile engangsinsulinspr\u00f8yter, med eller uten n\u00e5ler. Standarden fokuserer p\u00e5 spr\u00f8ytenes sikkerhet, funksjonalitet, tetningsevne, doseringsn\u00f8yaktighet og driftssikkerhet. Produsenter og kvalitetslaboratorier bruker ISO 8537 for \u00e5 verifisere at spr\u00f8ytene fungerer konsistent under klinisk bruk. [\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\/nb\/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. Manufacturers and quality laboratories use ISO 8537 to verify that syringes perform consistently during clinical use.&hellip;","_links":{"self":[{"href":"https:\/\/www.pharmacopoeiatest.com\/nb\/wp-json\/wp\/v2\/posts\/2610","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=2610"}],"version-history":[{"count":5,"href":"https:\/\/www.pharmacopoeiatest.com\/nb\/wp-json\/wp\/v2\/posts\/2610\/revisions"}],"predecessor-version":[{"id":2624,"href":"https:\/\/www.pharmacopoeiatest.com\/nb\/wp-json\/wp\/v2\/posts\/2610\/revisions\/2624"}],"wp:attachment":[{"href":"https:\/\/www.pharmacopoeiatest.com\/nb\/wp-json\/wp\/v2\/media?parent=2610"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/nb\/wp-json\/wp\/v2\/categories?post=2610"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/nb\/wp-json\/wp\/v2\/tags?post=2610"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}