{"id":2059,"date":"2025-04-22T02:54:20","date_gmt":"2025-04-22T02:54:20","guid":{"rendered":"https:\/\/www.pharmacopoeiatest.com\/?p=2059"},"modified":"2025-04-22T03:29:50","modified_gmt":"2025-04-22T03:29:50","slug":"flange-breakage-resistance-iso-11040-4","status":"publish","type":"post","link":"https:\/\/www.pharmacopoeiatest.com\/hu\/flange-breakage-resistance-iso-11040-4\/","title":{"rendered":"Karimabet\u00f6r\u00e9si ellen\u00e1ll\u00e1s - ISO 11040-4 C1 mell\u00e9klet"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"2059\" class=\"elementor elementor-2059\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-99d088f e-flex e-con-boxed e-con e-parent\" data-id=\"99d088f\" 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-43cc8ff elementor-widget elementor-widget-heading\" data-id=\"43cc8ff\" 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\">Karimasz t\u00f6r\u00e9s\u00e1ll\u00f3s\u00e1g<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f9d7284 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"f9d7284\" 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-1129df5 elementor-widget elementor-widget-heading\" data-id=\"1129df5\" 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 C1 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-b7ccfb2 e-flex e-con-boxed e-con e-parent\" data-id=\"b7ccfb2\" 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-254e154 elementor-widget elementor-widget-text-editor\" data-id=\"254e154\" 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 class=\"\" data-start=\"477\" data-end=\"932\"><em data-start=\"477\" data-end=\"505\">Karimabet\u00f6r\u00e9s-ellen\u00e1ll\u00e1s<\/em> kritikus min\u0151s\u00e9gi jellemz\u0151 az el\u0151ret\u00f6lt\u00f6tt fecskend\u0151k gy\u00e1rt\u00e1sa sor\u00e1n. Ez a vizsg\u00e1lat a fecskend\u0151hord\u00f3 perem\u00e9nek mechanikai szil\u00e1rds\u00e1g\u00e1t hat\u00e1rozza meg - azt a r\u00e9szt, amelynek a klinikai haszn\u00e1lat sor\u00e1n alkalmazott er\u0151knek kell ellen\u00e1llnia. Mivel az eg\u00e9szs\u00e9g\u00fcgyi el\u0151\u00edr\u00e1sok vil\u00e1gszerte szigorodnak, a mechanikai teljes\u00edtm\u00e9nyre vonatkoz\u00f3 szabv\u00e1nyok betart\u00e1sa a <a href=\"https:\/\/www.pharmacopoeiatest.com\/hu\/flange-breakage-resistance-iso-11040-4\/\"><strong data-start=\"819\" data-end=\"843\">ISO 11040-4 C1 mell\u00e9klet<\/strong><\/a> alapvet\u0151 fontoss\u00e1g\u00fa az \u00fcvegfecskend\u0151k \u00e9s a steriliz\u00e1lt, alul-\u00f6sszeszerelt fecskend\u0151k gy\u00e1rt\u00f3i sz\u00e1m\u00e1ra.<\/p><p class=\"\" data-start=\"934\" data-end=\"1146\">A Cell Instruments, a prec\u00edzi\u00f3s vizsg\u00e1l\u00f3berendez\u00e9sek vezet\u0151 gy\u00e1rt\u00f3ja robusztus megold\u00e1sokat k\u00edn\u00e1l, hogy biztos\u00edtsa, hogy az \u00d6n <em data-start=\"1037\" data-end=\"1054\">fecskend\u0151s vizsg\u00e1lat<\/em> megfelel a nemzetk\u00f6zi szabv\u00e1nyoknak, mik\u00f6zben maximaliz\u00e1lja a pontoss\u00e1got \u00e9s a m\u0171k\u00f6d\u00e9si hat\u00e9konys\u00e1got.<\/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-ededb4f elementor-widget elementor-widget-heading\" data-id=\"ededb4f\" 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 \u00e9s alkalmaz\u00e1sa a fecskend\u0151vizsg\u00e1latban<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a1f63cd elementor-widget elementor-widget-text-editor\" data-id=\"a1f63cd\" 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 class=\"\" data-start=\"1223\" data-end=\"1586\"><a href=\"https:\/\/www.pharmacopoeiatest.com\/hu\/iso-11040-4\/\"><strong data-start=\"1223\" data-end=\"1238\">ISO 11040-4<\/strong><\/a> szab\u00e1lyozza az injekci\u00f3s \u00fcveghord\u00f3kat, k\u00fcl\u00f6n\u00f6s tekintettel a szerkezeti integrit\u00e1sra \u00e9s a funkcionalit\u00e1sra. A  oldalon <em data-start=\"1346\" data-end=\"1368\">ISO 11040-4 C1 mell\u00e9klet<\/em>, konkr\u00e9t ir\u00e1nymutat\u00e1sokat \u00e1llap\u00edtanak meg a k\u00f6vetkez\u0151k \u00e9rt\u00e9kel\u00e9s\u00e9re <em data-start=\"1418\" data-end=\"1446\">peremt\u00f6r\u00e9s\u00e1ll\u00f3s\u00e1g<\/em>. A vizsg\u00e1lat c\u00e9lja, hogy szimul\u00e1lja azokat a k\u00f6r\u00fclm\u00e9nyeket, amelyek k\u00f6z\u00f6tt a fecskend\u0151 karim\u00e1ja elt\u00f6rhet a kezel\u00e9s vagy az automatiz\u00e1lt t\u00f6lt\u00e9si folyamatok sor\u00e1n.<\/p><p class=\"\" data-start=\"1588\" data-end=\"1752\">A szabv\u00e1ny nem csak a v\u00e9gleges fecskend\u0151hord\u00f3kra, hanem a steriliz\u00e1lt, felt\u00f6lt\u00e9sre k\u00e9sz, r\u00e9szegys\u00e9gekb\u0151l \u00f6ssze\u00e1ll\u00edtott fecskend\u0151kre is vonatkozik, biztos\u00edtva az ell\u00e1t\u00e1si l\u00e1ncban az egys\u00e9gess\u00e9get.<\/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-d261813 elementor-widget elementor-widget-heading\" data-id=\"d261813\" 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\">Mi\u00e9rt fontos a peremt\u00f6r\u00e9s-ellen\u00e1ll\u00e1s vizsg\u00e1lata<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3f45136 elementor-widget elementor-widget-text-editor\" data-id=\"3f45136\" 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 class=\"\" data-start=\"1811\" data-end=\"2112\">A fecskend\u0151k sz\u00e1mos mechanikai ig\u00e9nybev\u00e9telnek vannak kit\u00e9ve a sz\u00e1ll\u00edt\u00e1s, t\u00e1rol\u00e1s, t\u00f6lt\u00e9s \u00e9s bead\u00e1s sor\u00e1n. A perem, a fecskend\u0151cs\u0151 v\u00e9g\u00e9n l\u00e9v\u0151 szerkezeti elem, ismert gyenge pont. Ha a perem meghib\u00e1sodik, az vesz\u00e9lyeztetheti a sterilit\u00e1st, az adagol\u00e1s pontoss\u00e1g\u00e1t \u00e9s v\u00e9gs\u0151 soron a beteg biztons\u00e1g\u00e1t.<\/p><p class=\"\" data-start=\"2114\" data-end=\"2168\">Pontos <em data-start=\"2123\" data-end=\"2151\">peremt\u00f6r\u00e9s\u00e1ll\u00f3s\u00e1g<\/em> a tesztel\u00e9s seg\u00edt:<\/p><ul><li data-start=\"2171\" data-end=\"2216\">Tervez\u00e9si \u00e9s gy\u00e1rt\u00e1si folyamatok valid\u00e1l\u00e1sa<\/li><li data-start=\"2171\" data-end=\"2216\">Megfeleljen a jogszab\u00e1lyi el\u0151\u00edr\u00e1soknak<\/li><li data-start=\"2171\" data-end=\"2216\">Cs\u00f6kkentse a term\u00e9k meghib\u00e1sod\u00e1s\u00e1nak kock\u00e1zat\u00e1t a terepen<\/li><li data-start=\"2171\" data-end=\"2216\">Bizalom\u00e9p\u00edt\u00e9s a szab\u00e1lyoz\u00f3 szervekkel \u00e9s az \u00fcgyfelekkel<\/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-3fd48bf elementor-widget elementor-widget-heading\" data-id=\"3fd48bf\" 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 C1 mell\u00e9klet C1 karimaszakad\u00e1ssal szembeni t\u00f6r\u00e9s\u00e1ll\u00f3s\u00e1gi vizsg\u00e1lati m\u00f3dszer<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-ef26935 e-con-full e-flex e-con e-child\" data-id=\"ef26935\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-25fc654 e-con-full e-flex e-con e-child\" data-id=\"25fc654\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1372d22 elementor-widget elementor-widget-heading\" data-id=\"1372d22\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Sz\u00fcks\u00e9ges peremt\u00f6r\u00e9si ellen\u00e1ll\u00e1s tesztel\u0151<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c3c025e elementor-widget elementor-widget-text-editor\" data-id=\"c3c025e\" 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 class=\"\" data-start=\"2399\" data-end=\"2565\">Az al\u00e1bbiakban v\u00e1zolt m\u00f3dszer <strong data-start=\"2422\" data-end=\"2446\">ISO 11040-4 C1 mell\u00e9klet<\/strong> a fecskend\u0151h\u00fcvely perem\u00e9re szab\u00e1lyozott nyom\u00f3er\u0151 kifejt\u00e9s\u00e9b\u0151l \u00e1ll, am\u00edg az meg nem t\u00f6rik. \u00cdgy t\u00f6rt\u00e9nik ez:<\/p><ul data-start=\"2590\" data-end=\"2834\"><li class=\"\" data-start=\"2590\" data-end=\"2707\"><p class=\"\" data-start=\"2592\" data-end=\"2707\"><strong data-start=\"2592\" data-end=\"2645\">Univerz\u00e1lis szak\u00edt\u00f3- \u00e9s nyom\u00f3vizsg\u00e1lati g\u00e9p<\/strong> (pl. Cell Instruments <em>Fecskend\u0151 tesztel\u0151<\/em>)<\/p><\/li><li class=\"\" data-start=\"2708\" data-end=\"2766\"><p class=\"\" data-start=\"2710\" data-end=\"2766\"><strong data-start=\"2710\" data-end=\"2728\">Fecskend\u0151 tart\u00f3<\/strong> megfelel\u0151 anyagb\u00f3l, p\u00e9ld\u00e1ul PEEK-b\u0151l k\u00e9sz\u00fclt<\/p><\/li><li class=\"\" data-start=\"2767\" data-end=\"2834\"><p class=\"\" data-start=\"2769\" data-end=\"2834\"><strong data-start=\"2769\" data-end=\"2784\">Rakod\u00f3csap<\/strong>, lehet\u0151leg poliacet\u00e1l, rozsdamentes ac\u00e9lmaggal<\/p><\/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-a1e99e9 elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"a1e99e9\" 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<img fetchpriority=\"high\" decoding=\"async\" width=\"488\" height=\"1024\" src=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Syringe-Leakage-Testing-488x1024.webp\" class=\"attachment-large size-large wp-image-2048\" alt=\"ISO 11040-4 fecskend\u0151 sziv\u00e1rg\u00e1svizsg\u00e1lat\" srcset=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Syringe-Leakage-Testing-488x1024.webp 488w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Syringe-Leakage-Testing-143x300.webp 143w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Syringe-Leakage-Testing-768x1613.webp 768w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Syringe-Leakage-Testing-731x1536.webp 731w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Syringe-Leakage-Testing-975x2048.webp 975w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Syringe-Leakage-Testing-scaled.webp 1219w\" sizes=\"(max-width: 488px) 100vw, 488px\" \/>\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>\n\t\t<div class=\"elementor-element elementor-element-d45498c e-con-full e-flex e-con e-child\" data-id=\"d45498c\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-91d25ab elementor-widget elementor-widget-heading\" data-id=\"91d25ab\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">ISO 11040-4 C1 mell\u00e9klet C1 vizsg\u00e1lati elj\u00e1r\u00e1s<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-922228a elementor-widget elementor-widget-text-editor\" data-id=\"922228a\" 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 class=\"\" data-start=\"2858\" data-end=\"2884\"><strong data-start=\"2858\" data-end=\"2882\">1. Vizsg\u00e1lati mint\u00e1k el\u0151k\u00e9sz\u00edt\u00e9se<br \/><\/strong><span style=\"font-size: 16px;\">Ker\u00fclje az el\u0151zetes sokkol\u00f3 tesztel\u00e9st. Minden egyes fecskend\u0151t \u00e9s tart\u00f3t szemrev\u00e9telez\u00e9ssel ellen\u0151rizni kell a s\u00e9r\u00fcl\u00e9sek szempontj\u00e1b\u00f3l.<\/span><\/p><p class=\"\" data-start=\"2975\" data-end=\"2986\"><strong data-start=\"2975\" data-end=\"2984\">2. Vizsg\u00e1l\u00f3g\u00e9p be\u00e1ll\u00edt\u00e1sa<br \/><\/strong><span style=\"font-size: 16px;\">Helyezze a fecskend\u0151h\u00fcvelyt a tart\u00f3ba. Igaz\u00edtsa a t\u00f6lt\u0151csapot a fecskend\u0151 v\u00e1ll\u00e1nak k\u00f6zel\u00e9ben a k\u00f6vetkez\u0151k szerint <\/span><strong style=\"font-size: 16px;\" data-start=\"3091\" data-end=\"3105\">C.2. \u00e1bra<\/strong><span style=\"font-size: 16px;\"> az ISO-szabv\u00e1ny.<\/span><\/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-1c20220 elementor-widget__width-inherit elementor-widget elementor-widget-image\" data-id=\"1c20220\" 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<img decoding=\"async\" width=\"451\" height=\"297\" src=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Annex-C1.png\" class=\"attachment-large size-large wp-image-2064\" alt=\"ISO 11040-4 mell\u00e9klet C1 karimaszakad\u00e1s-ellen\u00e1ll\u00e1s\" srcset=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Annex-C1.png 451w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Annex-C1-300x198.png 300w\" sizes=\"(max-width: 451px) 100vw, 451px\" \/>\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-0bc0e73 elementor-widget elementor-widget-text-editor\" data-id=\"0bc0e73\" 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 class=\"\" data-start=\"3131\" data-end=\"3151\"><strong data-start=\"3131\" data-end=\"3149\">3. A tesztel\u00e9s v\u00e9grehajt\u00e1sa<\/strong><\/p><ul><li data-start=\"3131\" data-end=\"3151\">\u00c1ll\u00edtsa a g\u00e9p sebess\u00e9g\u00e9t <strong data-start=\"3182\" data-end=\"3196\">100 mm\/min<\/strong> (vagy meg\u00e1llapod\u00e1s szerint).<\/li><li data-start=\"3131\" data-end=\"3151\">Ind\u00edtsa el a vizsg\u00e1latot, \u00e9s alkalmazza az er\u0151t, am\u00edg a karima el nem t\u00f6rik.<\/li><li data-start=\"3131\" data-end=\"3151\">Rekord <strong style=\"font-size: 16px;\" data-start=\"3302\" data-end=\"3328\">er\u0151 vs. elmozdul\u00e1s<\/strong><span style=\"font-size: 16px;\"> g\u00f6rbe l\u00e9trehoz\u00e1s\u00e1hoz.<\/span><\/li><\/ul><p class=\"\" data-start=\"3131\" data-end=\"3151\"><strong data-start=\"3352\" data-end=\"3369\">4. Adatelemz\u00e9s<br \/><\/strong>Hat\u00e1rozza meg a cs\u00facser\u0151t a g\u00f6rb\u00e9n - ez az \u00e9rt\u00e9k a <em data-start=\"3442\" data-end=\"3470\">peremt\u00f6r\u00e9s\u00e1ll\u00f3s\u00e1g<\/em>.<\/p><p class=\"\" data-start=\"3478\" data-end=\"3493\"><strong data-start=\"3478\" data-end=\"3491\">5. Jelent\u00e9s<br \/><\/strong><span style=\"font-size: 16px;\">Tartalmazza a vizsg\u00e1lati sebess\u00e9get, a mint\u00e1k sz\u00e1m\u00e1t, a cs\u00facs\u00e9rt\u00e9keket \u00e9s az esetleges rendelleness\u00e9geket. Biztos\u00edtsa, hogy a dokument\u00e1ci\u00f3 megfeleljen az ISO nyomonk\u00f6vethet\u0151s\u00e9gi k\u00f6vetelm\u00e9nyeinek.<\/span><\/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<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a9006f3 elementor-widget elementor-widget-heading\" data-id=\"a9006f3\" 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\u0151 teszter a Cell Instruments-t\u0151l<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e501b92 e-con-full e-flex e-con e-child\" data-id=\"e501b92\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-7a2147d e-con-full e-flex e-con e-child\" data-id=\"7a2147d\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-67dcd66 elementor-widget elementor-widget-heading\" data-id=\"67dcd66\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Fecskend\u0151 tesztel\u0151 g\u00e9p f\u0151 el\u0151nyei<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fb2553c elementor-widget elementor-widget-text-editor\" data-id=\"fb2553c\" 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<ul><li data-start=\"4049\" data-end=\"4092\">Kompatibilis a fecskend\u0151-specifikus r\u00f6gz\u00edt\u0151kkel<\/li><li data-start=\"4049\" data-end=\"4092\">Az er\u0151-elmozdul\u00e1s val\u00f3s idej\u0171 grafikus \u00e1br\u00e1zol\u00e1sa<\/li><li data-start=\"4049\" data-end=\"4092\">\u00c1ll\u00edthat\u00f3 sebess\u00e9gek \u00e9s terhel\u00e9si tartom\u00e1nyok<\/li><li data-start=\"4049\" data-end=\"4092\">Be\u00e9p\u00edtett mikronyomtat\u00f3 \u00e9s opcion\u00e1lis RS232 port a z\u00f6kken\u0151mentes adatexporthoz<\/li><\/ul><p class=\"\" data-start=\"4258\" data-end=\"4427\">A rendszer modul\u00e1ris fel\u00e9p\u00edt\u00e9s\u00e9nek k\u00f6sz\u00f6nhet\u0151en ide\u00e1lis az olyan v\u00e1llalatok sz\u00e1m\u00e1ra, amelyek \u00e1tfog\u00f3 <em data-start=\"4336\" data-end=\"4353\">fecskend\u0151s vizsg\u00e1lat<\/em>, bele\u00e9rtve <em data-start=\"4365\" data-end=\"4393\">peremt\u00f6r\u00e9s\u00e1ll\u00f3s\u00e1g<\/em> \u00e9s egy\u00e9b mechanikai \u00e9rt\u00e9kel\u00e9sek.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-9b6dbd6 e-con-full e-flex e-con e-child\" data-id=\"9b6dbd6\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2c4684f elementor-widget elementor-widget-heading\" data-id=\"2c4684f\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Fecskend\u0151 tesztel\u0151 g\u00e9p legjobb gyakorlatai<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f42b687 elementor-widget elementor-widget-text-editor\" data-id=\"f42b687\" 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<ul><li data-start=\"4495\" data-end=\"4556\"><strong data-start=\"4495\" data-end=\"4526\">Nagyfrekvenci\u00e1s mintav\u00e9telez\u00e9s haszn\u00e1lata<\/strong> (\u2265500 Hz) a cs\u00facspontoss\u00e1g \u00e9rdek\u00e9ben<\/li><li data-start=\"4495\" data-end=\"4556\"><strong style=\"font-size: 16px;\" data-start=\"4559\" data-end=\"4584\">A teszt \u00f6sszehangol\u00e1s\u00e1nak ellen\u0151rz\u00e9se<\/strong><span style=\"font-size: 16px;\"> minden egyes futtat\u00e1s el\u0151tt a t\u00e9ves leolvas\u00e1sok elker\u00fcl\u00e9se \u00e9rdek\u00e9ben<\/span><\/li><li data-start=\"4495\" data-end=\"4556\"><strong style=\"font-size: 16px;\" data-start=\"4629\" data-end=\"4655\">Kopott alkatr\u00e9szek cser\u00e9je<\/strong><span style=\"font-size: 16px;\"> (t\u00f6lt\u0151csap, tart\u00f3) rendszeresen a k\u00f6vetkezetess\u00e9g fenntart\u00e1sa \u00e9rdek\u00e9ben<\/span><\/li><li data-start=\"4495\" data-end=\"4556\"><strong style=\"font-size: 16px;\" data-start=\"4716\" data-end=\"4739\">Dokument\u00e1ljon mindent<\/strong><span style=\"font-size: 16px;\">, m\u00e9g a kisebb elt\u00e9r\u00e9sek is, a nyomon k\u00f6vethet\u0151s\u00e9g jav\u00edt\u00e1sa \u00e9rdek\u00e9ben<\/span><\/li><li data-start=\"4495\" data-end=\"4556\"><strong style=\"font-size: 16px;\" data-start=\"4792\" data-end=\"4822\">Egy\u00fcttm\u0171k\u00f6d\u00e9s az \u00fcgyfelekkel<\/strong><span style=\"font-size: 16px;\"> a vizsg\u00e1lati sebess\u00e9gekr\u0151l \u00e9s a berendez\u00e9sek kalibr\u00e1l\u00e1s\u00e1r\u00f3l val\u00f3 megegyez\u00e9s<\/span><\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\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-20579e3 elementor-widget elementor-widget-text-editor\" data-id=\"20579e3\" 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 class=\"\" data-start=\"4897\" data-end=\"5170\">A peremt\u00f6r\u00e9s-ellen\u00e1ll\u00e1s vizsg\u00e1lata nem csup\u00e1n egy megfelel\u0151s\u00e9gi jel\u00f6l\u0151n\u00e9gyzet - a fecskend\u0151gy\u00e1rt\u00f3k sz\u00e1m\u00e1ra a term\u00e9kmin\u0151s\u00e9g-ellen\u0151rz\u00e9s l\u00e9tfontoss\u00e1g\u00fa r\u00e9sze. A vizsg\u00e1lati gyakorlatok \u00f6sszehangol\u00e1s\u00e1val a <strong data-start=\"5075\" data-end=\"5099\"><a href=\"https:\/\/www.iso.org\/standard\/82222.html\" target=\"_blank\" rel=\"noopener\">ISO 11040-4<\/a> C1. mell\u00e9klet<\/strong>, biztos\u00edthatja a term\u00e9k tart\u00f3ss\u00e1g\u00e1t, biztons\u00e1g\u00e1t \u00e9s szab\u00e1lyoz\u00e1si elfogadotts\u00e1g\u00e1t.<\/p><p class=\"\" data-start=\"5172\" data-end=\"5418\"><a href=\"https:\/\/www.pharmacopoeiatest.com\/hu\/\" target=\"_blank\" rel=\"noopener\"><strong data-start=\"5172\" data-end=\"5192\">Cell Instruments<\/strong><\/a> az \u00d6n megb\u00edzhat\u00f3 partnere a tesztel\u00e9si kiv\u00e1l\u00f3s\u00e1g el\u00e9r\u00e9s\u00e9ben. A <strong>Fecskend\u0151 tesztel\u0151<\/strong>\u00a0seg\u00edt racionaliz\u00e1lni a fecskend\u0151vizsg\u00e1lati munkafolyamatokat, mik\u00f6zben biztos\u00edtja a modern eg\u00e9szs\u00e9g\u00fcgyi szabv\u00e1nyok \u00e1ltal megk\u00f6vetelt pontoss\u00e1got \u00e9s megfelel\u0151s\u00e9get.<\/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-b3e233b elementor-widget elementor-widget-text-editor\" data-id=\"b3e233b\" 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 class=\"\" data-start=\"5420\" data-end=\"5503\">Hagyja, hogy t\u00e1mogassuk a nagy teljes\u00edtm\u00e9ny\u0171, szab\u00e1lyoknak megfelel\u0151 term\u00e9kek fel\u00e9 vezet\u0151 \u00faton.<\/p>\t\t\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>Flange Breakage Resistance ISO 11040-4 Annex C1 Flange breakage resistance is a critical quality attribute in prefilled syringe manufacturing. This test determines the mechanical strength of the syringe barrel\u2019s flange\u2014the portion that must withstand applied forces during clinical use. As healthcare regulations tighten globally, meeting the mechanical performance standards outlined in ISO 11040-4 Annex C1 [&hellip;]<\/p>","protected":false},"author":2,"featured_media":0,"comment_status":"closed","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":"","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-2059","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":"Flange Breakage Resistance ISO 11040-4 Annex C1 Flange breakage resistance is a critical quality attribute in prefilled syringe manufacturing. This test determines the mechanical strength of the syringe barrel\u2019s flange\u2014the portion that must withstand applied forces during clinical use. As healthcare regulations tighten globally, meeting the mechanical performance standards outlined in ISO 11040-4 Annex C1&hellip;","_links":{"self":[{"href":"https:\/\/www.pharmacopoeiatest.com\/hu\/wp-json\/wp\/v2\/posts\/2059","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharmacopoeiatest.com\/hu\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pharmacopoeiatest.com\/hu\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/hu\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/hu\/wp-json\/wp\/v2\/comments?post=2059"}],"version-history":[{"count":5,"href":"https:\/\/www.pharmacopoeiatest.com\/hu\/wp-json\/wp\/v2\/posts\/2059\/revisions"}],"predecessor-version":[{"id":2072,"href":"https:\/\/www.pharmacopoeiatest.com\/hu\/wp-json\/wp\/v2\/posts\/2059\/revisions\/2072"}],"wp:attachment":[{"href":"https:\/\/www.pharmacopoeiatest.com\/hu\/wp-json\/wp\/v2\/media?parent=2059"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/hu\/wp-json\/wp\/v2\/categories?post=2059"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/hu\/wp-json\/wp\/v2\/tags?post=2059"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}