{"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\/pl\/syringes-needle-penetration-test-iso-11040-4\/","title":{"rendered":"Strzykawki Test penetracji ig\u0142\u0105 ISO 11040-4 Za\u0142\u0105cznik 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\">Testy penetracyjne ig\u0142\u0105<\/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 Za\u0142\u0105cznik F<\/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>strzykawki test penetracyjny ig\u0142y<\/strong> jest kluczow\u0105 procedur\u0105 w bran\u017cy urz\u0105dze\u0144 medycznych, zapewniaj\u0105c\u0105 ostro\u015b\u0107 i skuteczno\u015b\u0107 igie\u0142 u\u017cywanych w zastosowaniach medycznych. Ten test ocenia <strong>Si\u0142a penetracji ig\u0142y<\/strong> wymagana do przebicia folii testowej, odzwierciedlaj\u0105ca \u0142atwo\u015b\u0107, z jak\u0105 ig\u0142a mo\u017ce przebi\u0107 ludzk\u0105 sk\u00f3r\u0119 lub inne materia\u0142y.<\/p><p>Aby zagwarantowa\u0107 bezpiecze\u0144stwo pacjent\u00f3w i niezawodno\u015b\u0107 produkt\u00f3w, mi\u0119dzynarodowe standardy, takie jak <strong>ISO 11040-4<\/strong> okre\u015blaj\u0105 precyzyjne metodologie testowania igie\u0142 do strzykawek. Normy te pomagaj\u0105 producentom zachowa\u0107 kontrol\u0119 jako\u015bci i zgodno\u015b\u0107 z przepisami.<\/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\">Wymagany sprz\u0119t do testu penetracji ig\u0142\u0105<\/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 []\">Wed\u0142ug <strong>ISO 11040-4<\/strong>nast\u0119puj\u0105ca aparatura jest niezb\u0119dna do przeprowadzenia <a href=\"https:\/\/www.pharmacopoeiatest.com\/pl\/syringe-needle-penetration-test\/\" target=\"_blank\" rel=\"noopener\"><strong>test penetracyjny ig\u0142y<\/strong><\/a>:<\/p><ul><li data-pm-slice=\"1 3 []\"><strong>Uniwersalna maszyna do pr\u00f3b rozci\u0105gania i \u015bciskania<\/strong> z zakresem pomiarowym do 10 N (lub zgodnie z wymaganiami) i pr\u0119dko\u015bci\u0105 testow\u0105 od 20 mm\/min do 200 mm\/min.<\/li><li data-pm-slice=\"1 3 []\"><strong>Uchwyt ig\u0142y<\/strong> aby zabezpieczy\u0107 ig\u0142\u0119 podczas testowania.<\/li><li data-pm-slice=\"1 3 []\"><strong>Folia testowa<\/strong>ze specyfikacjami uzgodnionymi przez producent\u00f3w i klient\u00f3w.<\/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\/pl\/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 strzykawki sprz\u0119t do test\u00f3w penetracyjnych igie\u0142\" alt=\"ISO 11040-4 strzykawki sprz\u0119t do test\u00f3w penetracyjnych igie\u0142\" 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\">Strzykawki Metoda testu penetracji ig\u0142\u0105 Procedura<\/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>Zamocuj foli\u0119 testow\u0105 w uchwycie bez napr\u0119\u017ce\u0144.<\/li><li>Zamocuj ig\u0142\u0119 prostopadle w uchwycie, wyr\u00f3wnuj\u0105c jej ko\u0144c\u00f3wk\u0119 do geometrycznego \u015brodka folii testowej.<\/li><li>Rozpocznij test i pozw\u00f3l igle przebi\u0107 foli\u0119 z kontrolowan\u0105 pr\u0119dko\u015bci\u0105.<\/li><li>Zapisz krzyw\u0105 si\u0142a-przemieszczenie, aby przeanalizowa\u0107 charakterystyk\u0119 penetracji.<\/li><li>Powt\u00f3rz test z nowym odcinkiem folii dla ka\u017cdego pomiaru.<\/li><\/ol><p>Wy\u017csze cz\u0119stotliwo\u015bci pr\u00f3bkowania, takie jak 500 Hz, zwi\u0119kszaj\u0105 dok\u0142adno\u015b\u0107 pomiaru podczas rejestrowania szczytowych warto\u015bci si\u0142y.<\/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\">Kluczowe parametry si\u0142y penetracji ig\u0142y w testach<\/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 []\">Si\u0142a wywierana podczas penetracji jest podzielona na r\u00f3\u017cne etapy:<\/p><ul data-spread=\"false\"><li><strong>Si\u0142a przebicia (F<sub>0<\/sub>):<\/strong> Si\u0142a wymagana do przej\u015bcia ko\u0144c\u00f3wki ig\u0142y przez foli\u0119.<\/li><li><strong>Si\u0142a ci\u0119cia (F<sub>1<\/sub>):<\/strong> Si\u0142a u\u017cywana przez kraw\u0119dzie tn\u0105ce.<\/li><li><strong>Si\u0142a pi\u0119ty (F<sub>2<\/sub>):<\/strong> Si\u0142a wywierana, gdy pi\u0119ta ig\u0142y przechodzi.<\/li><li><strong>Si\u0142a wleczenia (F<sub>3<\/sub>):<\/strong> Si\u0142a oporu po pe\u0142nej penetracji.<\/li><\/ul><p>Oceniaj\u0105c te parametry, producenci mog\u0105 zapewni\u0107, \u017ce ig\u0142y spe\u0142niaj\u0105 wymagane standardy ostro\u015bci i u\u017cyteczno\u015bci.<\/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\">Zgodno\u015b\u0107 z norm\u0105 ISO 11040-4 dotycz\u0105c\u0105 zapewnienia jako\u015bci<\/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 []\">Norma ISO 11040-4 okre\u015bla kompleksowe wytyczne dotycz\u0105ce testowania ampu\u0142kostrzykawek, zapewniaj\u0105c:<\/p><ul><li data-pm-slice=\"1 3 []\">Znormalizowany <strong>Si\u0142a penetracji ig\u0142y<\/strong> pomiar.<\/li><li data-pm-slice=\"1 3 []\">Sp\u00f3jno\u015b\u0107 mi\u0119dzy r\u00f3\u017cnymi typami igie\u0142 i strzykawek.<\/li><li data-pm-slice=\"1 3 []\">Zgodno\u015b\u0107 z globalnymi wymogami bezpiecze\u0144stwa medycznego.<\/li><li data-pm-slice=\"1 3 []\">Zmniejszenie ryzyka zwi\u0105zanego z niew\u0142a\u015bciw\u0105 penetracj\u0105 ig\u0142y.<\/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\">Sprz\u0119t do test\u00f3w penetracji ig\u0142\u0105 NPT-01<\/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>Sprz\u0119t do test\u00f3w penetracyjnych NPT-01<\/strong> zosta\u0142 zaprojektowany, aby spe\u0142ni\u0107 <strong>ISO 11040-4<\/strong> zgodno\u015b\u0107, oferuj\u0105c jednocze\u015bnie precyzyjne rozwi\u0105zania testowe. Funkcje:<\/p><ul><li data-pm-slice=\"1 3 []\"><strong>Sterowanie PLC i 7-calowy ekran dotykowy HMI<\/strong> dla \u0142atwej obs\u0142ugi.<\/li><li data-pm-slice=\"1 3 []\"><strong>Silnik krokowy i precyzyjna \u015bruba kulowa<\/strong> zapewniaj\u0105c sp\u00f3jne wyniki.<\/li><li data-pm-slice=\"1 3 []\"><strong>Zmienne pr\u0119dko\u015bci testowania (1-500 mm\/min)<\/strong> dla elastycznych warunk\u00f3w testowania.<\/li><li data-pm-slice=\"1 3 []\"><strong>Przyrz\u0105dy do mocowania wielu pr\u00f3bek<\/strong> aby pomie\u015bci\u0107 r\u00f3\u017cne typy igie\u0142 i strzykawek.<\/li><li data-pm-slice=\"1 3 []\"><strong>Wbudowana mikrodrukarka i wyj\u015bcie RS232<\/strong> dla wydajnego rejestrowania danych.<\/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>strzykawki test penetracyjny ig\u0142y<\/strong> ma kluczowe znaczenie dla zapewnienia ostro\u015bci igie\u0142, bezpiecze\u0144stwa pacjent\u00f3w i zgodno\u015bci z przepisami. Przestrzegaj\u0105c <strong>ISO 11040-4<\/strong> wytycznych i przy u\u017cyciu zaawansowanego sprz\u0119tu testuj\u0105cego, takiego jak <strong>NPT-01<\/strong>Producenci mog\u0105 poprawi\u0107 jako\u015b\u0107 produkt\u00f3w, spe\u0142niaj\u0105c jednocze\u015bnie standardy bran\u017cowe.<\/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\/pl\/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\/pl\/wp-json\/wp\/v2\/posts\/1994","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharmacopoeiatest.com\/pl\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pharmacopoeiatest.com\/pl\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/pl\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/pl\/wp-json\/wp\/v2\/comments?post=1994"}],"version-history":[{"count":5,"href":"https:\/\/www.pharmacopoeiatest.com\/pl\/wp-json\/wp\/v2\/posts\/1994\/revisions"}],"predecessor-version":[{"id":2009,"href":"https:\/\/www.pharmacopoeiatest.com\/pl\/wp-json\/wp\/v2\/posts\/1994\/revisions\/2009"}],"wp:attachment":[{"href":"https:\/\/www.pharmacopoeiatest.com\/pl\/wp-json\/wp\/v2\/media?parent=1994"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/pl\/wp-json\/wp\/v2\/categories?post=1994"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/pl\/wp-json\/wp\/v2\/tags?post=1994"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}