{"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>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;]<\/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}]}}