{"id":6648,"date":"2025-05-09T11:42:03","date_gmt":"2025-05-09T03:42:03","guid":{"rendered":"https:\/\/www.qualitester.com\/?page_id=6648"},"modified":"2025-11-13T09:38:29","modified_gmt":"2025-11-13T01:38:29","slug":"iso-7886-1","status":"publish","type":"page","link":"https:\/\/www.qualitester.com\/nb\/standards\/iso-7886-1\/","title":{"rendered":"ISO 7886-1"},"content":{"rendered":"<h1 style=\"text-align: center;\" data-start=\"370\" data-end=\"882\"><small>ISO 7886-1<\/small><\/h1>\n<h1 style=\"text-align: center;\" data-start=\"370\" data-end=\"882\"><small>Test med hypodermisk spr\u00f8yte<\/small><\/h1>\n<p class=\"\" data-start=\"370\" data-end=\"882\">Den <strong data-start=\"349\" data-end=\"363\">ISO 7886-1<\/strong> standarden definerer ytelses- og sikkerhetskravene for <em data-start=\"425\" data-end=\"446\">hypodermiske spr\u00f8yter<\/em> beregnet for engangsbruk, med vekt p\u00e5 aspekter som <em data-start=\"497\" data-end=\"514\">lekkasjemotstand<\/em>, <em data-start=\"516\" data-end=\"528\">d\u00f8dplass<\/em>, og <em data-start=\"534\" data-end=\"547\">glidekraft<\/em>. Produsenter og kvalitetssikringsteam m\u00e5 forst\u00e5 testprosedyrene som er beskrevet i ISO 7886-1 for \u00e5 sikre produktsamsvar og pasientsikkerhet.<\/p>\n<p class=\"\" data-start=\"1369\" data-end=\"1391\">ISO 7886-1 gjelder for:<\/p>\n<ul data-start=\"1393\" data-end=\"1559\">\n<li class=\"\" data-start=\"1393\" data-end=\"1438\">\n<p class=\"\" data-start=\"1395\" data-end=\"1438\">Sterile spr\u00f8yter laget av plastmaterialer.<\/p>\n<\/li>\n<li class=\"\" data-start=\"1439\" data-end=\"1523\">\n<p class=\"\" data-start=\"1441\" data-end=\"1523\">Spr\u00f8yter som brukes med kanyler for subkutan eller intramuskul\u00e6r injeksjon.<\/p>\n<\/li>\n<li class=\"\" data-start=\"1524\" data-end=\"1559\">\n<p class=\"\" data-start=\"1526\" data-end=\"1559\">Spr\u00f8yter beregnet for engangsbruk.<\/p>\n<\/li>\n<\/ul>\n<p class=\"\" data-start=\"1561\" data-end=\"1706\">Denne standarden gj\u00f8r <strong data-start=\"1580\" data-end=\"1593\">gjelder ikke<\/strong> til spr\u00f8yter for insulin (dekket av ISO 8537), tannlegebruk (dekket av ISO 7885) eller spr\u00f8yter til infusjonspumper.<\/p>\n<hr class=\"\" data-start=\"884\" data-end=\"887\" \/>\n<h2 class=\"\" data-start=\"912\" data-end=\"952\">ISO 7886-testing og dens betydning<\/h2>\n<p class=\"\" data-start=\"954\" data-end=\"1117\"><strong data-start=\"954\" data-end=\"968\">ISO 7886-1<\/strong> fokuserer p\u00e5 ytelseskrav og testmetoder for <em data-start=\"1026\" data-end=\"1047\">hypodermiske spr\u00f8yter<\/em>spesielt de som brukes med eller uten kanyler. Disse testene sikrer:<\/p>\n<h3 class=\"\" data-start=\"1861\" data-end=\"1895\">1. <strong data-start=\"1868\" data-end=\"1895\">Design og konstruksjon<\/strong><\/h3>\n<ul data-start=\"1896\" data-end=\"2054\">\n<li class=\"\" data-start=\"1896\" data-end=\"1951\">\n<p class=\"\" data-start=\"1898\" data-end=\"1951\">Gjennomsiktig fat for visuell inspeksjon av innholdet.<\/p>\n<\/li>\n<li class=\"\" data-start=\"1952\" data-end=\"1997\">\n<p class=\"\" data-start=\"1954\" data-end=\"1997\">Gradert skala trykt med permanent blekk.<\/p>\n<\/li>\n<li class=\"\" data-start=\"1998\" data-end=\"2054\">\n<p class=\"\" data-start=\"2000\" data-end=\"2054\">Sikker passform p\u00e5 stempelet for \u00e5 forhindre lekkasje eller at det l\u00f8sner.<\/p>\n<\/li>\n<\/ul>\n<h3 class=\"\" data-start=\"2056\" data-end=\"2082\">2. <strong data-start=\"2063\" data-end=\"2082\">Volumn\u00f8yaktighet<\/strong><\/h3>\n<ul data-start=\"2083\" data-end=\"2260\">\n<li class=\"\" data-start=\"2083\" data-end=\"2192\">\n<p class=\"\" data-start=\"2085\" data-end=\"2192\">Det faktiske leverte volumet m\u00e5 stemme overens med det nominelle volumet som er merket p\u00e5 fatet, innenfor spesifiserte toleranser.<\/p>\n<\/li>\n<li class=\"\" data-start=\"2193\" data-end=\"2260\">\n<p class=\"\" data-start=\"2195\" data-end=\"2260\">N\u00f8yaktigheten er testet ved 10%, 50% og 100% av den nominelle kapasiteten.<\/p>\n<\/li>\n<\/ul>\n<h3 class=\"\" data-start=\"2262\" data-end=\"2286\">3. <strong data-start=\"2269\" data-end=\"2286\">Lekkasjetester<\/strong><\/h3>\n<ul data-start=\"2287\" data-end=\"2457\">\n<li class=\"\" data-start=\"2287\" data-end=\"2384\">\n<p class=\"\" data-start=\"2289\" data-end=\"2384\"><strong data-start=\"2289\" data-end=\"2304\">Luftlekkasje<\/strong> og <strong data-start=\"2309\" data-end=\"2327\">v\u00e6skelekkasje<\/strong> testes under definerte trykk- og volumforhold.<\/p>\n<\/li>\n<li class=\"\" data-start=\"2385\" data-end=\"2457\">\n<p class=\"\" data-start=\"2387\" data-end=\"2457\">Det skal ikke forekomme synlig lekkasje fra fatet eller mellom komponentene.<\/p>\n<\/li>\n<\/ul>\n<h3 class=\"\" data-start=\"2459\" data-end=\"2480\">4. <strong data-start=\"2466\" data-end=\"2480\">Dead Space<\/strong><\/h3>\n<ul data-start=\"2481\" data-end=\"2614\">\n<li class=\"\" data-start=\"2481\" data-end=\"2614\">\n<p class=\"\" data-start=\"2483\" data-end=\"2614\">Volumet som er igjen i spr\u00f8yten etter at stempelet er trykket helt ned, m\u00e5 ikke overstige det angitte maksimumet (vanligvis \u2264 0,07 mL).<\/p>\n<\/li>\n<\/ul>\n<h3 class=\"\" data-start=\"2616\" data-end=\"2643\">5. <strong data-start=\"2623\" data-end=\"2643\">Stempelfunksjon<\/strong><\/h3>\n<ul data-start=\"2644\" data-end=\"2782\">\n<li class=\"\" data-start=\"2644\" data-end=\"2708\">\n<p class=\"\" data-start=\"2646\" data-end=\"2708\">Stempelet skal bevege seg jevnt uten \u00e5 sette seg fast eller skli.<\/p>\n<\/li>\n<li class=\"\" data-start=\"2709\" data-end=\"2782\">\n<p class=\"\" data-start=\"2711\" data-end=\"2782\">Det m\u00e5 ikke forekomme lekkasje eller separasjon under normalt driftstrykk.<\/p>\n<\/li>\n<\/ul>\n<h3 class=\"\" data-start=\"2784\" data-end=\"2827\">6. <strong data-start=\"2791\" data-end=\"2827\">Bruddkraft og separasjonskraft<\/strong><\/h3>\n<ul data-start=\"2828\" data-end=\"2945\">\n<li class=\"\" data-start=\"2828\" data-end=\"2945\">\n<p class=\"\" data-start=\"2830\" data-end=\"2945\">Den maksimale kraften som kreves for \u00e5 knekke stempelet eller skille komponentene fra hverandre, skal ikke ligge under sikkerhetsgrensen.<\/p>\n<\/li>\n<\/ul>\n<h3 class=\"\" data-start=\"2947\" data-end=\"2974\">7. <strong data-start=\"2954\" data-end=\"2974\">Biokompatibilitet<\/strong><\/h3>\n<ul data-start=\"2975\" data-end=\"3080\">\n<li class=\"\" data-start=\"2975\" data-end=\"3080\">\n<p class=\"\" data-start=\"2977\" data-end=\"3080\">Materialer som kommer i kontakt med legemidlet eller injeksjonsstedet, m\u00e5 best\u00e5 biokompatibilitetstester i henhold til ISO 10993-serien.<\/p>\n<\/li>\n<\/ul>\n<p class=\"\" data-start=\"1313\" data-end=\"1462\">Hver test bidrar til \u00e5 avgj\u00f8re om en spr\u00f8yte er trygg, p\u00e5litelig og har jevn ytelse.<\/p>\n<hr class=\"\" data-start=\"1766\" data-end=\"1769\" \/>\n<h2 class=\"\" data-start=\"1568\" data-end=\"1616\">Testmetoder for hypodermiske spr\u00f8yter i ISO 7886-1<\/h2>\n<h3 class=\"\" data-start=\"1618\" data-end=\"1673\">1. Lekkasjetest med hypodermisk spr\u00f8yte under vakuum (vedlegg B)<img fetchpriority=\"high\" decoding=\"async\" class=\"wp-image-6651 alignright\" src=\"https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/05\/ISO-7886-1-Annex-B.webp\" alt=\"ISO 7886-1 Annex B\" width=\"398\" height=\"327\" srcset=\"https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/05\/ISO-7886-1-Annex-B.webp 694w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/05\/ISO-7886-1-Annex-B-300x246.webp 300w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/05\/ISO-7886-1-Annex-B-15x12.webp 15w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/05\/ISO-7886-1-Annex-B-600x493.webp 600w\" sizes=\"(max-width: 398px) 100vw, 398px\" \/><\/h3>\n<p class=\"\" data-start=\"1675\" data-end=\"1866\">Lekkasje forbi stempelstoppen under undertrykk m\u00e5 testes for \u00e5 unng\u00e5 kontaminering eller luftinntrengning. Dette <strong data-start=\"1793\" data-end=\"1825\">lekkasjetest for hypodermiske spr\u00f8yter<\/strong> er avgj\u00f8rende for \u00e5 verifisere lufttettheten.<\/p>\n<ul data-start=\"1868\" data-end=\"2062\">\n<li class=\"\" data-start=\"1868\" data-end=\"1979\">\n<p class=\"\" data-start=\"1870\" data-end=\"1979\"><strong data-start=\"1870\" data-end=\"1881\">Metode:<\/strong> Fyll spr\u00f8yten med vann (minst 25% kapasitet), klem fast stempelet, og p\u00e5f\u00f8r -88 kPa vakuum.<\/p>\n<\/li>\n<li class=\"\" data-start=\"1980\" data-end=\"2062\">\n<p class=\"\" data-start=\"1982\" data-end=\"2062\"><strong data-start=\"1982\" data-end=\"1998\">Observasjon:<\/strong> Inspect for any air leaks or detachment of the plunger stopper.<\/p>\n<\/li>\n<\/ul>\n<p class=\"\" data-start=\"2064\" data-end=\"2229\"><strong data-start=\"2064\" data-end=\"2090\">Anbefalt utstyr:<\/strong><br data-start=\"2090\" data-end=\"2093\" \/>Cell Instruments\u2019 <strong data-start=\"2111\" data-end=\"2141\">SLT-02 <a href=\"https:\/\/www.qualitester.com\/nb\/produkt-2\/syringe-air-leakage-tester-iso-7886-1\/\">Syringe Leak Tester<\/a><\/strong> offers precise vacuum control and automated readings, ensuring compliance with Annex B.<\/p>\n<hr class=\"\" data-start=\"2231\" data-end=\"2234\" \/>\n<h3 class=\"\" data-start=\"2236\" data-end=\"2303\">2. Hypodermic Syringe Liquid Leak Test Under Compression (Annex D)<\/h3>\n<p class=\"\" data-start=\"2305\" data-end=\"2418\">Den <strong data-start=\"2309\" data-end=\"2348\">hypodermic syringe liquid leak test<\/strong> examines syringe integrity under axial and lateral mechanical stress.<\/p>\n<ul data-start=\"2420\" data-end=\"2647\">\n<li class=\"\" data-start=\"2420\" data-end=\"2565\">\n<p class=\"\" data-start=\"2422\" data-end=\"2565\"><strong data-start=\"2422\" data-end=\"2433\">Metode:<\/strong> After sealing the nozzle, a side force is applied to deflect the plunger, followed by axial compression to simulate user operation.<\/p>\n<\/li>\n<li class=\"\" data-start=\"2566\" data-end=\"2647\">\n<p class=\"\" data-start=\"2568\" data-end=\"2647\"><strong data-start=\"2568\" data-end=\"2584\">Observasjon:<\/strong> Monitor for fluid leakage at pressures of 200 kPa and 300 kPa.<\/p>\n<\/li>\n<\/ul>\n<p class=\"\" data-start=\"2649\" data-end=\"2835\"><strong data-start=\"2649\" data-end=\"2675\">Anbefalt utstyr:<\/strong><br data-start=\"2675\" data-end=\"2678\" \/>Bruk <strong data-start=\"2682\" data-end=\"2728\">SPPT-01 <a href=\"https:\/\/www.qualitester.com\/nb\/produkt-2\/syringe-liquid-leakage-tester\/\">Syringe Positive Pressure Tightness Tester<\/a><\/strong>\u00a0from Cell Instruments to apply controlled mechanical forces and monitor for any failure in seal integrity.<\/p>\n<hr class=\"\" data-start=\"2837\" data-end=\"2840\" \/>\n<h3 data-start=\"2842\" data-end=\"2907\">3. Syringe Dead Space Test: Minimizing Medication Waste (Annex C)<\/h3>\n<p class=\"\" data-start=\"2909\" data-end=\"3067\">Dead space refers to the volume of fluid that remains in the syringe after complete expulsion. High dead space can lead to drug wastage and inaccurate dosing.<\/p>\n<ul data-start=\"3069\" data-end=\"3238\">\n<li class=\"\" data-start=\"3069\" data-end=\"3162\">\n<p class=\"\" data-start=\"3071\" data-end=\"3162\"><strong data-start=\"3071\" data-end=\"3082\">Metode:<\/strong> Weigh the empty syringe, then weigh it after being filled and emptied of water.<\/p>\n<\/li>\n<li class=\"\" data-start=\"3163\" data-end=\"3238\">\n<p class=\"\" data-start=\"3165\" data-end=\"3238\"><strong data-start=\"3165\" data-end=\"3181\">Calculation:<\/strong> The difference in weight indicates <strong data-start=\"3217\" data-end=\"3231\">d\u00f8dplass<\/strong> in mL.<\/p>\n<\/li>\n<\/ul>\n<hr class=\"\" data-start=\"3437\" data-end=\"3440\" \/>\n<h3 data-start=\"3442\" data-end=\"3490\">4. Glide Force Test for Syringe Piston (Annex E)<img decoding=\"async\" class=\"wp-image-6652 alignright\" src=\"https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/05\/ISO-7886-1-Annex-E.webp\" alt=\"ISO 7886-1 Annex E\" width=\"272\" height=\"358\" srcset=\"https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/05\/ISO-7886-1-Annex-E.webp 546w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/05\/ISO-7886-1-Annex-E-228x300.webp 228w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/05\/ISO-7886-1-Annex-E-9x12.webp 9w\" sizes=\"(max-width: 272px) 100vw, 272px\" \/><\/h3>\n<p class=\"\" data-start=\"3492\" data-end=\"3683\">Smooth piston movement is critical for user comfort and precise dosage control. The <strong data-start=\"3576\" data-end=\"3596\">glide force test<\/strong> measures the force required to operate the piston consistently across the full stroke.<\/p>\n<ul data-start=\"3685\" data-end=\"3873\">\n<li class=\"\" data-start=\"3685\" data-end=\"3798\">\n<p class=\"\" data-start=\"3687\" data-end=\"3798\"><strong data-start=\"3687\" data-end=\"3698\">Metode:<\/strong> A mechanical testing machine depresses the plunger at a fixed rate, recording real-time resistance.<\/p>\n<\/li>\n<li class=\"\" data-start=\"3799\" data-end=\"3873\">\n<p class=\"\" data-start=\"3801\" data-end=\"3873\"><strong data-start=\"3801\" data-end=\"3813\">Purpose:<\/strong> Verifies the syringe usability and consistency across lots.<\/p>\n<\/li>\n<\/ul>\n<p class=\"\" data-start=\"3875\" data-end=\"4084\"><strong data-start=\"3875\" data-end=\"3901\">Anbefalt utstyr:<\/strong><br data-start=\"3901\" data-end=\"3904\" \/><strong data-start=\"3904\" data-end=\"3958\">Cell Instruments MST-01 <a href=\"https:\/\/www.qualitester.com\/nb\/produkt-2\/sale-syringe-plunger-glide-force-tester\/\">Medisinsk spr\u00f8ytetester<\/a><\/strong>\u00a0is ideal for <strong data-start=\"3972\" data-end=\"3992\">glide force test<\/strong> applications. It records force profiles and complies with ISO 7886-1 accuracy requirements.<\/p>\n<hr class=\"\" data-start=\"4086\" data-end=\"4089\" \/>\n<h2 class=\"\" data-start=\"4091\" data-end=\"4143\">Why Choose Cell Instruments for ISO 7886 Testing?<\/h2>\n<p class=\"\" data-start=\"4145\" data-end=\"4312\">Cell Instruments offers a complete suite of syringe testing solutions to help manufacturers meet and exceed <strong data-start=\"4253\" data-end=\"4267\">ISO 7886-1<\/strong> requirements. Our equipment is designed for:<\/p>\n<ul data-start=\"4313\" data-end=\"4476\">\n<li class=\"\" data-start=\"4313\" data-end=\"4344\">\n<p class=\"\" data-start=\"4315\" data-end=\"4344\">High precision and automation<\/p>\n<\/li>\n<li class=\"\" data-start=\"4345\" data-end=\"4386\">\n<p class=\"\" data-start=\"4347\" data-end=\"4386\">Compliance with international standards<\/p>\n<\/li>\n<li class=\"\" data-start=\"4387\" data-end=\"4422\">\n<p class=\"\" data-start=\"4389\" data-end=\"4422\">Easy operation and data recording<\/p>\n<\/li>\n<li class=\"\" data-start=\"4423\" data-end=\"4476\">\n<p class=\"\" data-start=\"4425\" data-end=\"4476\">Flexible customization to meet specific test setups<\/p>\n<\/li>\n<\/ul>\n<p class=\"\" data-start=\"4478\" data-end=\"4682\">Whether you&#8217;re validating product design or managing batch release testing, <strong data-start=\"4554\" data-end=\"4564\">SLT-01<\/strong>, <strong data-start=\"4566\" data-end=\"4577\">SPPT-01<\/strong>, og <strong data-start=\"4583\" data-end=\"4593\">MST-01<\/strong> deliver reliable and repeatable results tailored to the medical device industry&#8217;s needs.<\/p>\n<hr class=\"\" data-start=\"4684\" data-end=\"4687\" \/>\n<p class=\"\" data-start=\"4704\" data-end=\"5183\">Achieving compliance with <a href=\"https:\/\/www.iso.org\/standard\/64790.html\" target=\"_blank\" rel=\"noopener nofollow\"><strong data-start=\"4730\" data-end=\"4744\">ISO 7886-1<\/strong><\/a> is not just a regulatory hurdle\u2014it\u2019s a commitment to quality and patient safety. By understanding and implementing essential tests like the <strong data-start=\"4885\" data-end=\"4912\">hypodermic syringe test<\/strong>, <strong data-start=\"4914\" data-end=\"4927\">lekkasjetest<\/strong>, <strong data-start=\"4929\" data-end=\"4956\">syringe dead space test<\/strong>, og <strong data-start=\"4962\" data-end=\"4982\">glide force test<\/strong>, manufacturers can confidently release products to the market. Equip your lab with Cell Instruments\u2019 advanced testers to streamline testing and ensure accuracy across all stages of syringe production.<\/p>\n<p class=\"\" data-start=\"5185\" data-end=\"5296\"><strong data-start=\"5185\" data-end=\"5296\">For technical consultations, instrument selection, or customized solutions, contact Cell Instruments today.<\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>ISO 7886-1 Hypodermic Syringe Test The ISO 7886-1 standard defines the performance and safety requirements for hypodermic syringes intended for single use, emphasizing aspects like leak resistance, dead space, and glide force. Manufacturers and quality assurance teams must understand the testing procedures outlined in ISO 7886-1 to ensure product compliance and patient safety. ISO 7886-1 &hellip;<\/p>\n<p class=\"read-more\"> <a class=\"\" href=\"https:\/\/www.qualitester.com\/nb\/standards\/iso-7886-1\/\"> <span class=\"screen-reader-text\">ISO 7886-1<\/span> Les mer \"<\/a><\/p>","protected":false},"author":4,"featured_media":0,"parent":4948,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"default","site-content-layout":"default","ast-global-header-display":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","footnotes":""},"class_list":["post-6648","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.qualitester.com\/nb\/wp-json\/wp\/v2\/pages\/6648","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.qualitester.com\/nb\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.qualitester.com\/nb\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.qualitester.com\/nb\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.qualitester.com\/nb\/wp-json\/wp\/v2\/comments?post=6648"}],"version-history":[{"count":0,"href":"https:\/\/www.qualitester.com\/nb\/wp-json\/wp\/v2\/pages\/6648\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.qualitester.com\/nb\/wp-json\/wp\/v2\/pages\/4948"}],"wp:attachment":[{"href":"https:\/\/www.qualitester.com\/nb\/wp-json\/wp\/v2\/media?parent=6648"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}