{"id":1994,"date":"2025-04-02T06:13:33","date_gmt":"2025-04-02T06:13:33","guid":{"rendered":"https:\/\/www.pharmacopoeiatest.com\/?p=1994"},"modified":"2025-04-02T06:30:46","modified_gmt":"2025-04-02T06:30:46","slug":"syringes-needle-penetration-test-iso-11040-4","status":"publish","type":"post","link":"https:\/\/www.pharmacopoeiatest.com\/et\/syringes-needle-penetration-test-iso-11040-4\/","title":{"rendered":"S\u00fcstalde n\u00f5ela l\u00e4bistavuse test ISO 11040-4 lisa F"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"1994\" class=\"elementor elementor-1994\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d8f0949 e-flex e-con-boxed e-con e-parent\" data-id=\"d8f0949\" 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-af89456 elementor-widget elementor-widget-heading\" data-id=\"af89456\" 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\">N\u00f5ela sissetungi testimine<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-75ecf40 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"75ecf40\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-20ce2df elementor-widget elementor-widget-heading\" data-id=\"20ce2df\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">ISO 11040-4 F lisa<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-c9ca423 e-flex e-con-boxed e-con e-parent\" data-id=\"c9ca423\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-41f75ef e-con-full e-flex e-con e-child\" data-id=\"41f75ef\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5114c7b elementor-widget elementor-widget-text-editor\" data-id=\"5114c7b\" 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>The <strong>s\u00fcstlad n\u00f5ela l\u00e4bitungimise test<\/strong> on oluline protseduur meditsiiniseadmete t\u00f6\u00f6stuses, tagades meditsiinirakendustes kasutatavate n\u00f5elte teravuse ja t\u00f5hususe. Selle testiga hinnatakse <strong>n\u00f5ela sissetungi j\u00f5ud<\/strong> mis on vajalik testfooliumi l\u00e4bistamiseks, mis peegeldab, kui kergesti n\u00f5el suudab l\u00e4bistada inimese nahka v\u00f5i muid materjale.<\/p><p>Patsiendi ohutuse ja toote usaldusv\u00e4\u00e4rsuse tagamiseks on rahvusvahelised standardid, nagu n\u00e4iteks <strong>ISO 11040-4<\/strong> visandada s\u00fcstlan\u00f5elte t\u00e4pne katsemeetodoloogia. Need standardid aitavad tootjatel s\u00e4ilitada kvaliteedikontrolli ja \u00f5igusnormidele vastavust.<\/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-1c4a1c1 elementor-widget elementor-widget-heading\" data-id=\"1c4a1c1\" 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\">N\u00f5eltestimise seadmed Vajalikud seadmed<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-405b6c1 elementor-widget elementor-widget-text-editor\" data-id=\"405b6c1\" 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-pm-slice=\"1 3 []\">Vastavalt <strong>ISO 11040-4<\/strong>, on j\u00e4rgmine seade oluline, et viia l\u00e4bi <a href=\"https:\/\/www.pharmacopoeiatest.com\/et\/syringe-needle-penetration-test\/\" target=\"_blank\" rel=\"noopener\"><strong>n\u00f5eltest<\/strong><\/a>:<\/p><ul><li data-pm-slice=\"1 3 []\"><strong>Universaalne t\u00f5mbe- ja survekatse masin<\/strong> m\u00f5\u00f5tmisvahemikuga kuni 10 N (v\u00f5i vastavalt vajadusele) ja katsekiirusega vahemikus 20 mm\/min kuni 200 mm\/min.<\/li><li data-pm-slice=\"1 3 []\"><strong>N\u00f5elahoidja<\/strong> n\u00f5ela kinnitamiseks testimise ajal.<\/li><li data-pm-slice=\"1 3 []\"><strong>Katsefoolium<\/strong>, mille spetsifikatsioonid on kokku lepitud tootjate ja klientide vahel.<\/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-3315f97 elementor-widget elementor-widget-image\" data-id=\"3315f97\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.pharmacopoeiatest.com\/et\/syringe-needle-penetration-test\/\">\n\t\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/elementor\/thumbs\/ISO-11040-4-syringes-needle-penetration-test-equipment-r3r52op9pahd5s2kzyk3xzbhif0hy69cozbct55ytk.webp\" title=\"ISO 11040-4 s\u00fcstlad n\u00f5ela l\u00e4bitungimise testimise seadmed\" alt=\"ISO 11040-4 s\u00fcstlad n\u00f5ela l\u00e4bitungimise testimise seadmed\" loading=\"lazy\" \/>\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ff15e94 elementor-widget elementor-widget-heading\" data-id=\"ff15e94\" 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\">S\u00fcstalde n\u00f5ela l\u00e4bitungimise katsemeetodi menetlus<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fe76308 elementor-widget elementor-widget-text-editor\" data-id=\"fe76308\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ol><li>Kinnitage katsekile pingevabasse hoidikusse.<\/li><li>Kinnitage n\u00f5el hoidikusse risti, suunates selle otsa katsekile geomeetrilise keskme suunas.<\/li><li>Alustage katse ja laske n\u00f5elal l\u00e4bida fooliumi kontrollitud kiirusega.<\/li><li>Registreerige j\u00f5u ja nihke vaheline k\u00f5ver, et anal\u00fc\u00fcsida l\u00e4bitungi omadusi.<\/li><li>Korrake katset iga m\u00f5\u00f5tmise puhul uue fooliumiosaga.<\/li><\/ol><p>Suuremad prooviv\u00f5tusagedused, n\u00e4iteks 500 Hz, suurendavad m\u00f5\u00f5tmise t\u00e4psust j\u00f5u tippv\u00e4\u00e4rtuste salvestamisel.<\/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-60ebd0c elementor-widget elementor-widget-heading\" data-id=\"60ebd0c\" 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\">Peamised n\u00f5ela sissetungi j\u00f5u parameetrid testimisel<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0f1cf32 elementor-widget elementor-widget-text-editor\" data-id=\"0f1cf32\" 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-pm-slice=\"1 1 []\">Penetratsiooni ajal rakendatav j\u00f5ud liigitatakse erinevatesse etappidesse:<\/p><ul data-spread=\"false\"><li><strong>L\u00e4bistav j\u00f5ud (F<sub>0<\/sub>):<\/strong> J\u00f5ud, mis on vajalik n\u00f5ela otsa l\u00e4bimiseks l\u00e4bi fooliumi.<\/li><li><strong>L\u00f5ikamisj\u00f5ud (F<sub>1<\/sub>):<\/strong> L\u00f5iketerade poolt kasutatav j\u00f5ud.<\/li><li><strong>Kandev\u00f5ime (F<sub>2<\/sub>):<\/strong> J\u00f5ud, mis avaldub n\u00f5ela kanna l\u00e4bimisel.<\/li><li><strong>T\u00f5mbej\u00f5ud (F<sub>3<\/sub>):<\/strong> Vastupidavusj\u00f5ud p\u00e4rast t\u00e4ielikku tungimist.<\/li><\/ul><p>Neid parameetreid hinnates saavad tootjad tagada, et n\u00f5elad vastavad n\u00f5utavatele teravuse ja kasutatavuse standarditele.<\/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-84d059d elementor-widget elementor-widget-heading\" data-id=\"84d059d\" 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\">Vastavus ISO 11040-4 kvaliteeditagamise n\u00f5uetele<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7a670d9 elementor-widget elementor-widget-text-editor\" data-id=\"7a670d9\" 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-pm-slice=\"1 3 []\">ISO 11040-4 s\u00e4testab p\u00f5hjalikud suunised eelt\u00e4idetud s\u00fcstlate testimiseks, tagades:<\/p><ul><li data-pm-slice=\"1 3 []\">Standardiseeritud <strong>n\u00f5ela sissetungi j\u00f5ud<\/strong> m\u00f5\u00f5tmine.<\/li><li data-pm-slice=\"1 3 []\">Erinevate n\u00f5ela- ja s\u00fcstlat\u00fc\u00fcpide j\u00e4rjepidevus.<\/li><li data-pm-slice=\"1 3 []\">Vastavus \u00fclemaailmsetele meditsiinilise ohutuse n\u00f5uetele.<\/li><li data-pm-slice=\"1 3 []\">Ebakorrektse n\u00f5ela sissetungiga seotud riskide v\u00e4hendamine.<\/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-5e1f022 elementor-widget elementor-widget-heading\" data-id=\"5e1f022\" 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\">NPT-01 N\u00f5ela l\u00e4bistamise testimise seadmed<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-53d8fee elementor-widget elementor-widget-text-editor\" data-id=\"53d8fee\" 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-pm-slice=\"1 3 []\">The <strong>NPT-01 n\u00f5ela l\u00e4bistamise testimise seadmed<\/strong> on kavandatud vastama <strong>ISO 11040-4<\/strong> vastavust, pakkudes samal ajal t\u00e4pseid testimislahendusi. Selle funktsioonid:<\/p><ul><li data-pm-slice=\"1 3 []\"><strong>PLC-juhtimine ja 7-tolline HMI puuteekraan<\/strong> lihtsaks kasutamiseks.<\/li><li data-pm-slice=\"1 3 []\"><strong>Samm-mootor ja t\u00e4ppispea-kuuliruvi<\/strong> tagades j\u00e4rjepidevad tulemused.<\/li><li data-pm-slice=\"1 3 []\"><strong>Erinevad katsekiirused (1-500mm\/min)<\/strong> paindlikeks katsetamistingimusteks.<\/li><li data-pm-slice=\"1 3 []\"><strong>Mitme proovi hoidmise seadeldised<\/strong> erinevate n\u00f5ela- ja s\u00fcstlat\u00fc\u00fcpide jaoks.<\/li><li data-pm-slice=\"1 3 []\"><strong>Sisseehitatud mikroprinter ja RS232 v\u00e4ljund<\/strong> andmete t\u00f5husaks salvestamiseks.<\/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-f7e5035 elementor-widget elementor-widget-text-editor\" data-id=\"f7e5035\" 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-pm-slice=\"1 1 []\">The <strong>s\u00fcstlad n\u00f5ela l\u00e4bitungimise test<\/strong> on oluline n\u00f5elte teravuse, patsiendi ohutuse ja \u00f5igusnormidele vastavuse tagamiseks. J\u00e4rgides <strong>ISO 11040-4<\/strong> suunised ja kasutades t\u00e4iustatud katseseadmeid, nagu n\u00e4iteks <strong>NPT-01<\/strong>, saavad tootjad parandada toodete kvaliteeti, j\u00e4rgides samal ajal t\u00f6\u00f6stusstandardeid.<\/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\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>N\u00f5ela l\u00e4bistamiskatse ISO 11040-4 lisa F S\u00fcstalde n\u00f5ela l\u00e4bistamiskatse on meditsiiniseadmete t\u00f6\u00f6stuses \u00e4\u00e4rmiselt oluline protseduur, mis tagab meditsiinilistes rakendustes kasutatavate n\u00f5elte teravuse ja t\u00f5hususe. Selle katsega hinnatakse katsefooliumi l\u00e4bistamiseks vajalikku n\u00f5ela l\u00e4bistamisj\u00f5udu, mis peegeldab seda, kui kergesti n\u00f5el suudab tungida inimese [\u2026]<\/p>","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_uag_custom_page_level_css":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","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-1994","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\/et\/author\/pharmacopoeiatest\/"},"uagb_comment_info":0,"uagb_excerpt":"Needle Penetration Testing ISO 11040-4 Annex F The syringes needle penetration test is a crucial procedure in the medical device industry, ensuring the sharpness and effectiveness of needles used in medical applications. This test evaluates the needle penetration force required to pierce a test foil, reflecting the ease with which a needle can penetrate human&hellip;","_links":{"self":[{"href":"https:\/\/www.pharmacopoeiatest.com\/et\/wp-json\/wp\/v2\/posts\/1994","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharmacopoeiatest.com\/et\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pharmacopoeiatest.com\/et\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/et\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/et\/wp-json\/wp\/v2\/comments?post=1994"}],"version-history":[{"count":5,"href":"https:\/\/www.pharmacopoeiatest.com\/et\/wp-json\/wp\/v2\/posts\/1994\/revisions"}],"predecessor-version":[{"id":2009,"href":"https:\/\/www.pharmacopoeiatest.com\/et\/wp-json\/wp\/v2\/posts\/1994\/revisions\/2009"}],"wp:attachment":[{"href":"https:\/\/www.pharmacopoeiatest.com\/et\/wp-json\/wp\/v2\/media?parent=1994"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/et\/wp-json\/wp\/v2\/categories?post=1994"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/et\/wp-json\/wp\/v2\/tags?post=1994"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}