{"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\/ro\/syringes-needle-penetration-test-iso-11040-4\/","title":{"rendered":"Seringi Test de penetrare a acului ISO 11040-4 Anexa 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\">Testarea penetr\u0103rii cu acul<\/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 Anexa 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>testul de penetrare cu seringi \u0219i ace<\/strong> este o procedur\u0103 crucial\u0103 \u00een industria dispozitivelor medicale, asigur\u00e2nd ascu\u021bimea \u0219i eficien\u021ba acelor utilizate \u00een aplica\u021bii medicale. Acest test evalueaz\u0103 <strong>for\u021ba de penetrare a acului<\/strong> necesare pentru a str\u0103punge o folie de testare, reflect\u00e2nd u\u0219urin\u021ba cu care un ac poate penetra pielea uman\u0103 sau alte materiale.<\/p><p>Pentru a garanta siguran\u021ba pacien\u021bilor \u0219i fiabilitatea produselor, standarde interna\u021bionale precum <strong>ISO 11040-4<\/strong> descriu metodologii precise de testare pentru acele de sering\u0103. Aceste standarde ajut\u0103 produc\u0103torii s\u0103 men\u021bin\u0103 controlul calit\u0103\u021bii \u0219i conformitatea cu reglement\u0103rile.<\/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\">Echipament necesar pentru testul de penetrare a acului<\/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 []\">\u00cen conformitate cu <strong>ISO 11040-4<\/strong>, urm\u0103torul aparat este esen\u021bial pentru efectuarea unei <a href=\"https:\/\/www.pharmacopoeiatest.com\/ro\/syringe-needle-penetration-test\/\" target=\"_blank\" rel=\"noopener\"><strong>test de penetrare cu acul<\/strong><\/a>:<\/p><ul><li data-pm-slice=\"1 3 []\"><strong>Ma\u0219in\u0103 universal\u0103 de testare la trac\u021biune \u0219i compresie<\/strong> cu un domeniu de m\u0103surare de p\u00e2n\u0103 la 10 N (sau dup\u0103 cum este necesar) \u0219i o vitez\u0103 de testare \u00eentre 20 mm\/min \u0219i 200 mm\/min.<\/li><li data-pm-slice=\"1 3 []\"><strong>Suport ac<\/strong> pentru a fixa acul \u00een timpul test\u0103rii.<\/li><li data-pm-slice=\"1 3 []\"><strong>Folie de testare<\/strong>, cu specifica\u021bii convenite de produc\u0103tori \u0219i clien\u021bi.<\/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\/ro\/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 seringi echipament de testare a penetr\u0103rii acului\" alt=\"ISO 11040-4 seringi echipament de testare a penetr\u0103rii acului\" 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\">Procedur\u0103 de testare a penetr\u0103rii acului \u00een seringi<\/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>Fixa\u021bi folia de testare \u00eentr-un suport f\u0103r\u0103 tensiune.<\/li><li>Se fixeaz\u0103 acul perpendicular \u00een suport, aliniindu-i v\u00e2rful la centrul geometric al foliei de testare.<\/li><li>Ini\u021bia\u021bi testul \u0219i permite\u021bi acului s\u0103 penetreze folia la o vitez\u0103 controlat\u0103.<\/li><li>\u00cenregistra\u021bi curba for\u021b\u0103-deplasare pentru a analiza caracteristicile de penetrare.<\/li><li>Repeta\u021bi testul cu o nou\u0103 sec\u021biune de folie pentru fiecare m\u0103sur\u0103toare.<\/li><\/ol><p>Ratele de e\u0219antionare mai mari, cum ar fi 500 Hz, \u00eembun\u0103t\u0103\u021besc acurate\u021bea m\u0103sur\u0103torilor atunci c\u00e2nd se \u00eenregistreaz\u0103 valori de v\u00e2rf ale for\u021bei.<\/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\">Parametrii cheie ai for\u021bei de penetrare a acului \u00een timpul test\u0103rii<\/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 []\">For\u021ba exercitat\u0103 \u00een timpul penetr\u0103rii este clasificat\u0103 \u00een diferite etape:<\/p><ul data-spread=\"false\"><li><strong>For\u021ba de str\u0103pungere (F<sub>0<\/sub>):<\/strong> For\u021ba necesar\u0103 pentru a trece v\u00e2rful acului prin folie.<\/li><li><strong>For\u021ba de t\u0103iere (F<sub>1<\/sub>):<\/strong> For\u021ba utilizat\u0103 de t\u0103i\u0219uri.<\/li><li><strong>For\u021ba de c\u0103lc\u00e2i (F<sub>2<\/sub>):<\/strong> For\u021ba exercitat\u0103 atunci c\u00e2nd c\u0103lc\u00e2iul acului trece prin.<\/li><li><strong>For\u021ba de penetrare a rezisten\u021bei (F<sub>3<\/sub>):<\/strong> For\u021ba de rezisten\u021b\u0103 dup\u0103 p\u0103trunderea complet\u0103.<\/li><\/ul><p>Prin evaluarea acestor parametri, produc\u0103torii se pot asigura c\u0103 acele \u00eendeplinesc standardele necesare de acuitate \u0219i utilizare.<\/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\">Conformitatea cu ISO 11040-4 pentru asigurarea calit\u0103\u021bii<\/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 stabile\u0219te linii directoare cuprinz\u0103toare pentru testarea seringilor preumplute, asigur\u00e2nd:<\/p><ul><li data-pm-slice=\"1 3 []\">Standardizate <strong>for\u021ba de penetrare a acului<\/strong> m\u0103surare.<\/li><li data-pm-slice=\"1 3 []\">Coeren\u021b\u0103 \u00eentre diferite tipuri de ace \u0219i seringi.<\/li><li data-pm-slice=\"1 3 []\">Conformitatea cu cerin\u021bele globale de siguran\u021b\u0103 medical\u0103.<\/li><li data-pm-slice=\"1 3 []\">Reducerea riscurilor asociate cu penetrarea necorespunz\u0103toare a acului.<\/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 Echipament de testare a penetr\u0103rii acului<\/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>Echipament de testare a penetr\u0103rii acului NPT-01<\/strong> este conceput pentru a satisface <strong>ISO 11040-4<\/strong> oferind \u00een acela\u0219i timp solu\u021bii precise de testare. Caracteristici:<\/p><ul><li data-pm-slice=\"1 3 []\"><strong>Control PLC \u0219i ecran tactil HMI de 7 inch<\/strong> pentru o operare u\u0219oar\u0103.<\/li><li data-pm-slice=\"1 3 []\"><strong>Motor pas cu pas \u0219i \u0219urub cu bile de precizie<\/strong> asigurarea unor rezultate consecvente.<\/li><li data-pm-slice=\"1 3 []\"><strong>Viteze de testare variabile (1-500mm\/min)<\/strong> pentru condi\u021bii de testare flexibile.<\/li><li data-pm-slice=\"1 3 []\"><strong>Jiguri de fixare a probelor multiple<\/strong> pentru a acomoda diferite tipuri de ace \u0219i seringi.<\/li><li data-pm-slice=\"1 3 []\"><strong>Microimprimant\u0103 \u00eencorporat\u0103 \u0219i ie\u0219ire RS232<\/strong> pentru \u00eenregistrarea eficient\u0103 a datelor.<\/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>testul de penetrare cu seringi \u0219i ace<\/strong> este vital\u0103 pentru asigurarea ascu\u021bimii acului, siguran\u021bei pacientului \u0219i conformit\u0103\u021bii cu reglement\u0103rile. Prin respectarea <strong>ISO 11040-4<\/strong> \u0219i folosind echipamente de testare avansate, cum ar fi <strong>NPT-01<\/strong>, produc\u0103torii pot \u00eembun\u0103t\u0103\u021bi calitatea produselor, respect\u00e2nd \u00een acela\u0219i timp standardele industriei.<\/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>Testarea penetr\u0103rii acului ISO 11040-4 Anexa F Testarea penetr\u0103rii acului seringilor este o procedur\u0103 crucial\u0103 \u00een industria dispozitivelor medicale, asigur\u00e2nd ascu\u021bimea \u0219i eficien\u021ba acelor utilizate \u00een aplica\u021bii medicale. Acest test evalueaz\u0103 for\u021ba de penetrare a acului necesar\u0103 pentru a str\u0103punge o folie de testare, reflect\u00e2nd u\u0219urin\u021ba cu care un ac poate penetra [...]<\/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\/ro\/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\/ro\/wp-json\/wp\/v2\/posts\/1994","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharmacopoeiatest.com\/ro\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pharmacopoeiatest.com\/ro\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/ro\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/ro\/wp-json\/wp\/v2\/comments?post=1994"}],"version-history":[{"count":5,"href":"https:\/\/www.pharmacopoeiatest.com\/ro\/wp-json\/wp\/v2\/posts\/1994\/revisions"}],"predecessor-version":[{"id":2009,"href":"https:\/\/www.pharmacopoeiatest.com\/ro\/wp-json\/wp\/v2\/posts\/1994\/revisions\/2009"}],"wp:attachment":[{"href":"https:\/\/www.pharmacopoeiatest.com\/ro\/wp-json\/wp\/v2\/media?parent=1994"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/ro\/wp-json\/wp\/v2\/categories?post=1994"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/ro\/wp-json\/wp\/v2\/tags?post=1994"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}