{"id":9298,"date":"2026-02-02T11:23:36","date_gmt":"2026-02-02T03:23:36","guid":{"rendered":"https:\/\/www.packqc.com\/applications\/needle-penetration-test\/"},"modified":"2026-03-16T11:37:31","modified_gmt":"2026-03-16T03:37:31","slug":"needle-penetration-test","status":"publish","type":"applications","link":"https:\/\/www.packqc.com\/lt\/applications\/needle-penetration-test\/","title":{"rendered":"Adatos \u012fsiskverbimo bandymas atliekant medicinos prietais\u0173 ir pakuo\u010di\u0173 bandymus"},"content":{"rendered":"<p>Adatos \u012fsiskverbimo bandymas yra labai svarbus vertinant mechanines poodini\u0173 adat\u0173, i\u0161 anksto u\u017epildyt\u0173 \u0161virk\u0161t\u0173 ir gumini\u0173 u\u017erakt\u0173 savybes. \u0160iuo bandymu u\u017etikrinama, kad adatos b\u016bt\u0173 pakankamai a\u0161trios, o u\u017edarymo \u012ftaisai - tinkamai pralaid\u016bs, i\u0161laikant sandarumo vientisum\u0105. Gamintojams ir kokyb\u0117s kontrol\u0117s specialistams \u0161io bandymo supratimas yra labai svarbus, kad b\u016bt\u0173 laikomasi tarptautini\u0173 standart\u0173, pvz. <strong data-start=\"808\" data-end=\"823\">ISO 11040-4<\/strong>, <strong data-start=\"825\" data-end=\"837\">ISO 7864<\/strong>, ir <a href=\"https:\/\/www.packqc.com\/lt\/product-category\/iso\/iso-8871-5\/\"><strong data-start=\"843\" data-end=\"857\">ISO 8871-5<\/strong><\/a>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Skvarbumo bandymas ir adatos a\u0161trumo bandym\u0173 ap\u017evalga<\/h2>\n\n\n\n<p><strong data-start=\"926\" data-end=\"948\">Skvarbumo bandymas<\/strong>, <strong data-start=\"950\" data-end=\"978\">adatos a\u0161trumo bandymas<\/strong>, ir <strong data-start=\"984\" data-end=\"1026\">gumini\u0173 kam\u0161teli\u0173 skvarbumo bandymas<\/strong> yra svarb\u016bs vertinimai farmacijos ir medicinos prietais\u0173 pramon\u0117je. \u0160iais vertinimais u\u017etikrinamas lengvas \u0161virk\u0161timas, suma\u017einamas pacient\u0173 diskomfortas ir patikrinamas u\u017edarymo sistem\u0173 funkcionalumas.<\/p>\n\n\n\n<p>Pagal ISO 8871-5 <strong data-start=\"1256\" data-end=\"1273\">skvarbumas<\/strong> apibr\u0117\u017eiama kaip j\u0117ga, kurios reikia adata pradurti elastomerin\u012f u\u017edarymo \u012ftais\u0105. Lygiagre\u010diai ISO 7864 ir ISO 11040-4 standartuose apibr\u0117\u017eiama \u012fsiskverbimo j\u0117ga ir pasiprie\u0161inimo j\u0117ga, kuri\u0173 reikia adatai praki\u0161ti pro standartin\u012f substrat\u0105 arba pl\u0117vel\u0119.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Bandym\u0173 principai ir tikslai<\/h2>\n\n\n\n<p>The <strong data-start=\"1546\" data-end=\"1573\">adatos \u012fsiskverbimo testas<\/strong> siekiama \u012fvertinti:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The <strong data-start=\"1597\" data-end=\"1626\">pradin\u0117 \u012fsiskverbimo j\u0117ga<\/strong> (arba prad\u016brimo j\u0117ga), kai adatos galiukas palie\u010dia pagrind\u0105.<\/li>\n\n\n\n<li>The <strong data-start=\"1697\" data-end=\"1724\">pjovimo ir pasiprie\u0161inimo j\u0117gos<\/strong> kai adatos velenas juda \u012f priek\u012f.<\/li>\n\n\n\n<li>Veiklos nuoseklumas keliose imtyse.<\/li>\n<\/ul>\n\n\n\n<p>\u0160is testas yra labai svarbus ne tik d\u0117l <strong data-start=\"1848\" data-end=\"1876\">adatos a\u0161trumo bandymas<\/strong>, bet taip pat tikrina <strong data-start=\"1900\" data-end=\"1936\">gumini\u0173 kam\u0161teli\u0173 skvarbumas<\/strong> naudojami steriliose talpyklose.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Bandym\u0173 standartai ir pritaikomumas<\/h2>\n\n\n\n<p>Bandymai pirmiausia atliekami pagal \u0161iuos tarptautinius standartus:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.iso.org\/standard\/82222.html\" target=\"_blank\" rel=\"noopener nofollow\"><strong data-start=\"2095\" data-end=\"2110\">ISO 11040-4<\/strong><\/a>: I\u0161 anksto u\u017epildyti \u0161virk\u0161tai - apima visas sistemas, \u012fskaitant stiklines arba plastikines statines.<\/li>\n\n\n\n<li><a href=\"https:\/\/www.iso.org\/standard\/60481.html\" target=\"_blank\" rel=\"noopener nofollow\"><strong data-start=\"2195\" data-end=\"2207\">ISO 7864<\/strong><\/a>: Hipodermin\u0117s adatos - pateikiamos did\u017eiausios j\u0117gos ir pasiprie\u0161inimo analiz\u0117s gair\u0117s adatos \u012fvedimo metu.<\/li>\n\n\n\n<li><a href=\"https:\/\/www.iso.org\/standard\/68560.html\" target=\"_blank\" rel=\"noopener nofollow\"><strong data-start=\"2307\" data-end=\"2321\">ISO 8871-5<\/strong><\/a>: Elastomeriniai buteliuk\u0173 u\u017edarymo \u012ftaisai - vertinamas skvarbumas, fragmentacija ir savaiminis u\u017esandarinimas.<\/li>\n<\/ul>\n\n\n\n<p>Testas taikomas:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Adatos, \u012fsmeigtos arba pritvirtintos prie adat\u0173<\/li>\n\n\n\n<li>Guminiai kam\u0161\u010diai<\/li>\n\n\n\n<li>I\u0161 anksto u\u017epildyti \u0161virk\u0161tai ir steril\u016bs mazgai<\/li>\n\n\n\n<li>\u017daliav\u0173 ir gatav\u0173 produkt\u0173 kokyb\u0117s u\u017etikrinimas<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">\u012erangos ir s\u0105rankos reikalavimai<\/h2>\n\n\n\n<p>Suderintas su reikalavimais <strong data-start=\"2664\" data-end=\"2691\">adatos \u012fsiskverbimo testas<\/strong> reikia:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">1. Universali bandym\u0173 ma\u0161ina<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"2742\" data-end=\"2764\">Apkrovos elemento talpa<\/strong>: iki 10 N (arba pagal bandymo diapazon\u0105)<\/li>\n\n\n\n<li><strong data-start=\"2811\" data-end=\"2828\">Grei\u010dio valdymas<\/strong>: paprastai nuo 20 mm\/min iki 200 mm\/min, da\u017eniausiai 100 mm\/min<\/li>\n\n\n\n<li><strong data-start=\"2896\" data-end=\"2913\">M\u0117gini\u0173 \u0117mimo da\u017enis<\/strong>: 500 Hz, kad b\u016bt\u0173 u\u017etikrintas did\u017eiausios j\u0117gos tikslumas<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">2. Adatos laikiklis<\/h3>\n\n\n\n<p>Sukurta siekiant u\u017etikrinti <strong data-start=\"2993\" data-end=\"3015\">vertikalus lyginimas<\/strong> ir tiksli \u012fterpimo kelio kontrol\u0117.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">3. Bandomasis substratas<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"3084\" data-end=\"3093\">Folijos<\/strong> ISO 11040-4 metodui<\/li>\n\n\n\n<li><strong data-start=\"3119\" data-end=\"3143\">Sintetiniai elastomerai<\/strong> pvz:\n<ul class=\"wp-block-list\">\n<li>Latekso guma (40\u00b15 Shore A, 1,0 mm storio)<\/li>\n\n\n\n<li>Poliuretanas (85\u00b110 \u0160oro A, 0,40 mm storio)<\/li>\n\n\n\n<li>Silikono guma arba LDPE pl\u0117vel\u0117 pagal ISO 7864 rekomendacijas<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">4. Substrato laikiklis<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Tur\u0117t\u0173 i\u0161laikyti pastovi\u0105 prispaudimo j\u0117g\u0105 ir i\u0161ry\u0161kinti <strong data-start=\"3401\" data-end=\"3436\">10 mm apskritas \u012fsiskverbimo plotas<\/strong><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">I\u0161sami bandymo proced\u016bra<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"3474\" data-end=\"3503\">Paruo\u0161kite bandin\u012f<\/strong>: \u012e substrato laikikl\u012f be \u012ftempimo \u012fd\u0117kite nauj\u0105 folijos arba elastomero dal\u012f.<\/li>\n\n\n\n<li><strong data-start=\"3590\" data-end=\"3610\">Sumontuokite adat\u0105<\/strong>: Kalibruotu laikikliu pritvirtinkite bandom\u0105j\u0105 adat\u0105 statmenai bandomajam pavir\u0161iui.<\/li>\n\n\n\n<li><strong data-start=\"3699\" data-end=\"3718\">Nustatykite ma\u0161in\u0105<\/strong>: Atlikite judes\u012f pastoviu grei\u010diu (paprastai 100 mm\/min).<\/li>\n\n\n\n<li><strong data-start=\"3779\" data-end=\"3803\">\u012esiskverbti ir \u012fra\u0161yti<\/strong>:\n<ul class=\"wp-block-list\">\n<li>I\u0161matuokite <strong data-start=\"3822\" data-end=\"3841\">did\u017eiausia j\u0117ga (F0)<\/strong> adatos antgaliui<\/li>\n\n\n\n<li>\u017durnalas <strong data-start=\"3870\" data-end=\"3892\">pjovimo j\u0117ga (F1)<\/strong> ir <strong data-start=\"3897\" data-end=\"3916\">kulno j\u0117ga (F2)<\/strong><\/li>\n\n\n\n<li>Priemon\u0117 <strong data-start=\"3930\" data-end=\"3949\">pasiprie\u0161inimo j\u0117ga (F3)<\/strong> visi\u0161kam \u012fsiskverbimui \u012f velen\u0105<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong data-start=\"3980\" data-end=\"3998\">I\u0161traukti adat\u0105<\/strong>: Baigkite cikl\u0105 ir kiekvienam m\u0117giniui naudokite nauj\u0105 viet\u0105.<\/li>\n\n\n\n<li><strong data-start=\"4058\" data-end=\"4075\">Duomen\u0173 analiz\u0117<\/strong>: Sukurkite j\u0117gos priklausomyb\u0117s nuo poslinkio kreiv\u0119, apskai\u010diuokite maksimalios ir pasiprie\u0161inimo j\u0117gos vidurk\u012f ir standartin\u012f nuokryp\u012f.<\/li>\n<\/ul>\n\n\n\n<figure class=\"wp-block-embed is-type-video is-provider-youtube wp-block-embed-youtube wp-embed-aspect-16-9 wp-has-aspect-ratio\"><div class=\"wp-block-embed__wrapper\">\n<div class=\"ast-oembed-container\" style=\"height: 100%;\"><iframe title=\"Riebok\u0161lio kaniul\u0117s adatos sukibimo stiprumo bandymas|\u0160virk\u0161to adatos sukibimo stiprumo bandymas\" width=\"500\" height=\"281\" src=\"https:\/\/www.youtube.com\/embed\/FgYmfLnK5Vg?feature=oembed\" frameborder=\"0\" allow=\"accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share\" referrerpolicy=\"strict-origin-when-cross-origin\" allowfullscreen><\/iframe><\/div>\n<\/div><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">Bandym\u0173 ataskaita ir kokyb\u0117s dokumentai<\/h2>\n\n\n\n<p>I\u0161sami ataskaita apie <strong data-start=\"4254\" data-end=\"4281\">adatos \u012fsiskverbimo testas<\/strong> tur\u0117t\u0173 apimti:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Pagrindo specifikacija ir b\u016bkl\u0117<\/li>\n\n\n\n<li>Adatos specifikacijos (skersmuo, tipas, apdorojimas)<\/li>\n\n\n\n<li>Greitis ir bandymo metodas<\/li>\n\n\n\n<li>\u012esiskverbimo ir pasiprie\u0161inimo j\u0117gos rezultatai<\/li>\n\n\n\n<li>Imties dydis ir statistinis vertinimas<\/li>\n\n\n\n<li>Pasteb\u0117jimai arba nukrypimai<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Kokyb\u0117s kontrol\u0117s taikymas ir nauda<\/h2>\n\n\n\n<p>Vaist\u0173 gamintojams \u0161i\u0173 bandym\u0173 laikymasis padeda:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"4650\" data-end=\"4676\">Teis\u0117s aktais nustatytos parai\u0161kos<\/strong> (pvz., FDA, EMA).<\/li>\n\n\n\n<li><strong data-start=\"4696\" data-end=\"4730\">Produkto sauga ir nuoseklumas<\/strong><\/li>\n\n\n\n<li><strong data-start=\"4733\" data-end=\"4761\">Patobulinta naudotojo patirtis<\/strong> parenterinio pristatymo metu<\/li>\n\n\n\n<li><strong data-start=\"4787\" data-end=\"4813\">Ma\u017eesnis injekcijos skausmas<\/strong> ir pacient\u0173 diskomfortas<\/li>\n<\/ul>\n\n\n\n<p>Siekiant padidinti tikslum\u0105 ir atkuriamum\u0105 <strong data-start=\"4889\" data-end=\"4911\">skvarbumo testas<\/strong>, b\u016btina tur\u0117ti pa\u017eangi\u0173 prietais\u0173.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\n\t\t\t\tSusisiekite su mumis Gaukite \"Bloom\" testavimo sprendim\u0105\t\t\t\t<\/h2>\n\n\n\n<p>The <strong data-start=\"5527\" data-end=\"5554\"><a href=\"https:\/\/www.packqc.com\/lt\/product\/needle-penetration-test-equipment-iso-7864\/\">adatos \u012fsiskverbimas<\/a> testas<\/strong> yra labai svarbus siekiant patvirtinti \u012fpur\u0161kimo sistem\u0173 ir gumini\u0173 u\u017edarymo \u012ftais\u0173 funkcionalum\u0105 ir saug\u0105. Tai turi tiesiogin\u0117s \u012ftakos naudotoj\u0173 patogumui, gaminio vientisumui ir reguliavimo institucij\u0173 patvirtinimui. Taikant standartizuotas proced\u016bras ir naudojant pa\u017eangias bandym\u0173 sistemas, pvz. <strong data-start=\"5821\" data-end=\"5841\">L\u0105steli\u0173 instrumentai<\/strong>, gamintojai gali u\u017etikrintai u\u017etikrinti gamini\u0173 patikimum\u0105 ir atitikt\u012f.<\/p>","protected":false},"excerpt":{"rendered":"<p>Needle penetration test plays a critical role in evaluating the mechanical performance of hypodermic needles, prefilled syringes, and rubber closures. This test ensures that needles possess sufficient sharpness and that closures offer proper penetrability while maintaining sealing integrity. For manufacturers and quality control professionals, understanding this test is essential for compliance with international standards such [&hellip;]<\/p>","protected":false},"featured_media":6744,"parent":0,"template":"","meta":{"_acf_changed":true,"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":""}}},"class_list":["post-9298","applications","type-applications","status-publish","has-post-thumbnail","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.packqc.com\/lt\/wp-json\/wp\/v2\/applications\/9298","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/lt\/wp-json\/wp\/v2\/applications"}],"about":[{"href":"https:\/\/www.packqc.com\/lt\/wp-json\/wp\/v2\/types\/applications"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/lt\/wp-json\/wp\/v2\/media\/6744"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/lt\/wp-json\/wp\/v2\/media?parent=9298"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}