{"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\/hu\/syringes-needle-penetration-test-iso-11040-4\/","title":{"rendered":"Fecskend\u0151k T\u0171behatol\u00e1si teszt ISO 11040-4 F. mell\u00e9klet"},"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\">T\u0171 behatol\u00e1si tesztel\u00e9s<\/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 mell\u00e9klet<\/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>A <strong>fecskend\u0151k t\u0171 behatol\u00e1si teszt<\/strong> az orvostechnikai eszk\u00f6ziparban alapvet\u0151 fontoss\u00e1g\u00fa elj\u00e1r\u00e1s, amely biztos\u00edtja az orvosi alkalmaz\u00e1sokban haszn\u00e1lt t\u0171k \u00e9less\u00e9g\u00e9t \u00e9s hat\u00e9konys\u00e1g\u00e1t. Ez a vizsg\u00e1lat \u00e9rt\u00e9keli a <strong>t\u0171 behatol\u00e1si er\u0151<\/strong> a tesztf\u00f3lia \u00e1tsz\u00far\u00e1s\u00e1hoz, ami azt t\u00fckr\u00f6zi, hogy a t\u0171 milyen k\u00f6nnyen \u00e1thatol az emberi b\u0151r\u00f6n vagy m\u00e1s anyagokon.<\/p><p>A betegbiztons\u00e1g \u00e9s a term\u00e9k megb\u00edzhat\u00f3s\u00e1g\u00e1nak garant\u00e1l\u00e1sa \u00e9rdek\u00e9ben az olyan nemzetk\u00f6zi szabv\u00e1nyok, mint a <strong>ISO 11040-4<\/strong> a fecskend\u0151t\u0171k pontos vizsg\u00e1lati m\u00f3dszereinek felv\u00e1zol\u00e1sa. Ezek a szabv\u00e1nyok seg\u00edtik a gy\u00e1rt\u00f3kat a min\u0151s\u00e9gellen\u0151rz\u00e9s \u00e9s a jogszab\u00e1lyi megfelel\u00e9s fenntart\u00e1s\u00e1ban.<\/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\">Sz\u00fcks\u00e9ges t\u0171sz\u00far\u00e1si tesztberendez\u00e9s<\/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 []\">A <strong>ISO 11040-4<\/strong>, a k\u00f6vetkez\u0151 k\u00e9sz\u00fcl\u00e9k elengedhetetlen a k\u00f6vetkez\u0151k elv\u00e9gz\u00e9s\u00e9hez <a href=\"https:\/\/www.pharmacopoeiatest.com\/hu\/syringe-needle-penetration-test\/\" target=\"_blank\" rel=\"noopener\"><strong>t\u0171 behatol\u00e1s teszt<\/strong><\/a>:<\/p><ul><li data-pm-slice=\"1 3 []\"><strong>Univerz\u00e1lis szak\u00edt\u00f3- \u00e9s nyom\u00f3vizsg\u00e1lati g\u00e9p<\/strong> 10 N-ig terjed\u0151 m\u00e9r\u00e9si tartom\u00e1nyban (vagy ig\u00e9ny szerint) \u00e9s 20 mm\/min \u00e9s 200 mm\/min k\u00f6z\u00f6tti vizsg\u00e1lati sebess\u00e9ggel.<\/li><li data-pm-slice=\"1 3 []\"><strong>T\u0171tart\u00f3<\/strong> a t\u0171 r\u00f6gz\u00edt\u00e9s\u00e9hez a vizsg\u00e1lat sor\u00e1n.<\/li><li data-pm-slice=\"1 3 []\"><strong>Tesztf\u00f3lia<\/strong>, a gy\u00e1rt\u00f3k \u00e9s az \u00fcgyfelek \u00e1ltal elfogadott specifik\u00e1ci\u00f3kkal.<\/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\/hu\/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 fecskend\u0151k t\u0171 behatol\u00e1si tesztberendez\u00e9sek\" alt=\"ISO 11040-4 fecskend\u0151k t\u0171 behatol\u00e1si tesztberendez\u00e9sek\" 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\">Fecskend\u0151k t\u0171 behatol\u00e1s\u00e1nak vizsg\u00e1lati m\u00f3dszere Elj\u00e1r\u00e1s<\/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>R\u00f6gz\u00edtse a tesztf\u00f3li\u00e1t egy fesz\u00fclts\u00e9gmentes tart\u00f3ban.<\/li><li>R\u00f6gz\u00edtse a t\u0171t mer\u0151legesen a tart\u00f3ban, \u00e9s igaz\u00edtsa a hegy\u00e9t a tesztf\u00f3lia geometriai k\u00f6z\u00e9ppontj\u00e1hoz.<\/li><li>Ind\u00edtsa el a vizsg\u00e1latot, \u00e9s hagyja, hogy a t\u0171 szab\u00e1lyozott sebess\u00e9ggel \u00e1thatoljon a f\u00f3li\u00e1n.<\/li><li>A behatol\u00e1si jellemz\u0151k elemz\u00e9s\u00e9hez r\u00f6gz\u00edtse az er\u0151-elmozdul\u00e1s g\u00f6rb\u00e9t.<\/li><li>Ism\u00e9telje meg a vizsg\u00e1latot minden egyes m\u00e9r\u00e9sn\u00e9l egy \u00faj f\u00f3liar\u00e9sszel.<\/li><\/ol><p>A nagyobb mintav\u00e9teli frekvenci\u00e1k, mint p\u00e9ld\u00e1ul az 500 Hz, n\u00f6velik a m\u00e9r\u00e9si pontoss\u00e1got az er\u0151cs\u00facs\u00e9rt\u00e9kek r\u00f6gz\u00edt\u00e9sekor.<\/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\">A t\u0171 behatol\u00e1si erej\u00e9nek legfontosabb param\u00e9terei a tesztel\u00e9s sor\u00e1n<\/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 []\">A behatol\u00e1s sor\u00e1n kifejtett er\u0151 k\u00fcl\u00f6nb\u00f6z\u0151 szakaszokba sorolhat\u00f3:<\/p><ul data-spread=\"false\"><li><strong>Sz\u00far\u00f3er\u0151 (F<sub>0<\/sub>):<\/strong> A t\u0171 hegy\u00e9nek a f\u00f3li\u00e1n val\u00f3 \u00e1thalad\u00e1s\u00e1hoz sz\u00fcks\u00e9ges er\u0151.<\/li><li><strong>V\u00e1g\u00f3er\u0151 (F<sub>1<\/sub>):<\/strong> A v\u00e1g\u00f3\u00e9lek \u00e1ltal kifejtett er\u0151.<\/li><li><strong>Saroker\u0151 (F<sub>2<\/sub>):<\/strong> A t\u0171 sark\u00e1nak \u00e1thalad\u00e1sakor kifejtett er\u0151.<\/li><li><strong>H\u00faz\u00f3er\u0151 behatol\u00e1si er\u0151 (F<sub>3<\/sub>):<\/strong> Az ellen\u00e1ll\u00e1si er\u0151 a teljes behatol\u00e1s ut\u00e1n.<\/li><\/ul><p>E param\u00e9terek \u00e9rt\u00e9kel\u00e9s\u00e9vel a gy\u00e1rt\u00f3k biztos\u00edtani tudj\u00e1k, hogy a t\u0171k megfeleljenek az el\u0151\u00edrt \u00e9less\u00e9gi \u00e9s haszn\u00e1lhat\u00f3s\u00e1gi szabv\u00e1nyoknak.<\/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\">Megfelel\u00e9s az ISO 11040-4 min\u0151s\u00e9gbiztos\u00edt\u00e1si szabv\u00e1nynak<\/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 []\">Az ISO 11040-4 \u00e1tfog\u00f3 ir\u00e1nyelveket hat\u00e1roz meg az el\u0151ret\u00f6lt\u00f6tt fecskend\u0151k vizsg\u00e1lat\u00e1ra, biztos\u00edtva:<\/p><ul><li data-pm-slice=\"1 3 []\">Szabv\u00e1nyos\u00edtott <strong>t\u0171 behatol\u00e1si er\u0151<\/strong> m\u00e9r\u00e9s.<\/li><li data-pm-slice=\"1 3 []\">Konzisztencia a k\u00fcl\u00f6nb\u00f6z\u0151 t\u0171- \u00e9s fecskend\u0151t\u00edpusok k\u00f6z\u00f6tt.<\/li><li data-pm-slice=\"1 3 []\">A glob\u00e1lis orvosi biztons\u00e1gi k\u00f6vetelm\u00e9nyeknek val\u00f3 megfelel\u00e9s.<\/li><li data-pm-slice=\"1 3 []\">A nem megfelel\u0151 t\u0171sz\u00far\u00e1ssal kapcsolatos kock\u00e1zatok cs\u00f6kkent\u00e9se.<\/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 T\u0171 behatol\u00e1svizsg\u00e1lati berendez\u00e9s<\/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 []\">A <strong>NPT-01 t\u0171 behatol\u00e1svizsg\u00e1lati berendez\u00e9s<\/strong> \u00fagy tervezt\u00e9k, hogy megfeleljen <strong>ISO 11040-4<\/strong> megfelel\u0151s\u00e9g, mik\u00f6zben pontos vizsg\u00e1lati megold\u00e1sokat k\u00edn\u00e1l. Jellemz\u0151i:<\/p><ul><li data-pm-slice=\"1 3 []\"><strong>PLC vez\u00e9rl\u00e9s \u00e9s 7 colos HMI \u00e9rint\u0151k\u00e9perny\u0151<\/strong> a k\u00f6nny\u0171 kezelhet\u0151s\u00e9g \u00e9rdek\u00e9ben.<\/li><li data-pm-slice=\"1 3 []\"><strong>L\u00e9p\u00e9ses motor \u00e9s prec\u00edzi\u00f3s goly\u00f3scsavar<\/strong> k\u00f6vetkezetes eredm\u00e9nyek biztos\u00edt\u00e1sa.<\/li><li data-pm-slice=\"1 3 []\"><strong>V\u00e1ltoz\u00f3 vizsg\u00e1lati sebess\u00e9g (1-500 mm\/perc)<\/strong> a rugalmas vizsg\u00e1lati felt\u00e9telekhez.<\/li><li data-pm-slice=\"1 3 []\"><strong>T\u00f6bb mintatart\u00f3 eszk\u00f6z<\/strong> k\u00fcl\u00f6nb\u00f6z\u0151 t\u0171- \u00e9s fecskend\u0151-t\u00edpusok befogad\u00e1s\u00e1ra.<\/li><li data-pm-slice=\"1 3 []\"><strong>Be\u00e9p\u00edtett mikronyomtat\u00f3 \u00e9s RS232 kimenet<\/strong> a hat\u00e9kony adatr\u00f6gz\u00edt\u00e9shez.<\/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 []\">A <strong>fecskend\u0151k t\u0171 behatol\u00e1si teszt<\/strong> l\u00e9tfontoss\u00e1g\u00fa a t\u0171k \u00e9less\u00e9g\u00e9nek, a betegbiztons\u00e1gnak \u00e9s a jogszab\u00e1lyi el\u0151\u00edr\u00e1soknak val\u00f3 megfelel\u00e9snek a biztos\u00edt\u00e1s\u00e1hoz. A k\u00f6vetkez\u0151kkel <strong>ISO 11040-4<\/strong> ir\u00e1nyelvek \u00e9s fejlett vizsg\u00e1lati berendez\u00e9sek, mint p\u00e9ld\u00e1ul a <strong>NPT-01<\/strong>, a gy\u00e1rt\u00f3k jav\u00edthatj\u00e1k a term\u00e9kmin\u0151s\u00e9get, mik\u00f6zben megfelelnek az ipari szabv\u00e1nyoknak.<\/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\/hu\/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. 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