{"id":2139,"date":"2025-06-03T08:40:20","date_gmt":"2025-06-03T08:40:20","guid":{"rendered":"https:\/\/www.pharmacopoeiatest.com\/?p=2139"},"modified":"2026-01-13T07:49:16","modified_gmt":"2026-01-13T07:49:16","slug":"hypodermic-needle-sharpness-testing","status":"publish","type":"post","link":"https:\/\/www.pharmacopoeiatest.com\/lt\/hypodermic-needle-sharpness-testing\/","title":{"rendered":"Poodini\u0173 adat\u0173 a\u0161trumo tikrinimas"},"content":{"rendered":"<h1 class=\"wp-block-heading has-text-align-center\">ISO 7864 poodini\u0173 adat\u0173 a\u0161trumo bandymas<\/h1>\n\n\n\n<div class=\"wp-block-stackable-columns stk-block-columns stk-block stk-3e28f64\" data-block-id=\"3e28f64\"><div class=\"stk-row stk-inner-blocks stk-block-content stk-content-align stk-3e28f64-column\">\n<div class=\"wp-block-stackable-column stk-block-column stk-column stk-block stk-52adcfa\" data-v=\"4\" data-block-id=\"52adcfa\"><style>@media screen and (min-width:768px){.stk-52adcfa{flex:1 1 calc(70.6% - var(--stk-column-gap,0px) * 1 \/ 2 ) !important}}<\/style><div class=\"stk-column-wrapper stk-block-column__content stk-container stk-52adcfa-container stk--no-background stk--no-padding\"><div class=\"stk-block-content stk-inner-blocks stk-52adcfa-inner-blocks\">\n<h2 class=\"wp-block-heading\">\u012evadas<\/h2>\n\n\n\n<p><strong>Adatos a\u0161trumo bandymas<\/strong> labai svarbus vertinant poodines adatas, u\u017etikrinant, kad jos atitikt\u0173 saugos ir veiksmingumo standartus medicininio naudojimo metu. Vadovaudamasis <strong>ISO 7864<\/strong>, \u0161iuo tyrimu \u012fvertinami svarbiausi adatos parametrai, kad b\u016bt\u0173 patvirtinta atitiktis ir i\u0161vengta nereikalingo skausmo ar audini\u0173 pa\u017eeidimo injekcijos metu. \u0160iame straipsnyje aptarsime, kaip atlikti i\u0161sam\u0173 <strong>adatos a\u0161trumo bandymas<\/strong> proced\u016br\u0105, \u012fskaitant geriausi\u0105 praktik\u0105, susijusi\u0105 su <strong><a href=\"https:\/\/www.pharmacopoeiatest.com\/lt\/syringe-needle-penetration-test\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u012fsiskverbimo adatos testas<\/a><\/strong> ir <strong>poodini\u0173 adat\u0173 tyrimai<\/strong> kad atitikt\u0173 ISO 7864 reikalavimus.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Adatos a\u0161trumo bandymo svarbos supratimas<\/h2>\n\n\n\n<p>A\u0161trios adatos yra labai svarbios medicinoje, kad b\u016bt\u0173 u\u017etikrintas kuo ma\u017eesnis diskomfortas, ma\u017eesn\u0117 audini\u0173 \u017eala ir veiksmingas vaist\u0173 tiekimas. <strong>Adatos a\u0161trumo bandymas<\/strong> vertinamas adatos geb\u0117jimas \u012fsiskverbti \u012f \u012fvairius pagrindus naudojant minimali\u0105 j\u0117g\u0105, matuojant ir did\u017eiausi\u0105 \u012fsiskverbimo, ir pasiprie\u0161inimo j\u0117g\u0105. U\u017etikrindami atitikt\u012f ISO 7864 standartui, gamintojai gali tiekti saugius ir patikimus medicinos prietaisus, padedan\u010dius u\u017etikrinti pacient\u0173 komfort\u0105 ir saugum\u0105.<\/p>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-stackable-column stk-block-column stk-column stk-block stk-070da0f\" data-v=\"4\" data-block-id=\"070da0f\"><style>@media screen and (min-width:768px){.stk-070da0f{flex:1 1 calc(29.4% - var(--stk-column-gap,0px) * 1 \/ 2 ) !important}}<\/style><div class=\"stk-column-wrapper stk-block-column__content stk-container stk-070da0f-container stk--no-background stk--no-padding\"><div class=\"has-text-align-center stk-block-content stk-inner-blocks stk-070da0f-inner-blocks\">\n<figure class=\"wp-block-image size-full\"><img fetchpriority=\"high\" decoding=\"async\" width=\"519\" height=\"924\" src=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/06\/Hypodermic-Needle-Sharpness-Testing-ISO-7864.webp\" alt=\"\" class=\"wp-image-2141\" srcset=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/06\/Hypodermic-Needle-Sharpness-Testing-ISO-7864.webp 519w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/06\/Hypodermic-Needle-Sharpness-Testing-ISO-7864-169x300.webp 169w\" sizes=\"(max-width: 519px) 100vw, 519px\" \/><\/figure>\n<\/div><\/div><\/div>\n<\/div><\/div>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Pagrindiniai ISO 7864 standarto elementai, susij\u0119 su adatos a\u0161trumo bandymu<\/h2>\n\n\n\n<p><strong>ISO 7864<\/strong> nustatomi reikalavimai ir bandymo metodai <strong>vienkartin\u0117s poodin\u0117s adatos<\/strong>daugiausia d\u0117mesio skiriant tiksliam adatos veikimui. Konkre\u010diai ISO 7864 D priede apra\u0161omi <strong>\u012fsiskverbimo adatos testas<\/strong> metodika, pagal kuri\u0105 vertinama ir <strong>did\u017eiausia \u012fsiskverbimo j\u0117ga<\/strong> ir <strong>pasiprie\u0161inimo j\u0117ga<\/strong> \u012fdedant \u012f kontroliuojam\u0105 substrat\u0105.<\/p>\n\n\n\n<p>ISO 7864 metodas u\u017etikrina bandym\u0173 nuoseklum\u0105 ir atkuriamum\u0105, tod\u0117l gamintojai gali pasitik\u0117ti savo produkt\u0173 kokybe ir sauga.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Penetracijos adatos bandymas ir poodin\u0117s adatos bandymas<\/h2>\n\n\n\n<p>Svetain\u0117 <strong>\u012fsiskverbimo adatos testas<\/strong> yra esmin\u0117 <strong>poodini\u0173 adat\u0173 tyrimai<\/strong>. J\u012f sudaro \u0161ie komponentai ir etapai:<\/p>\n\n\n\n<p><strong>1. J\u0117gos matavimo aparatas<\/strong><br>J\u0117gos matuoklis su apkrovos elementu fiksuoja bandymo metu adat\u0105 veikian\u010dias j\u0117gas. Prietaisas taip pat patikimai laiko ir judina adat\u0105 <strong>standartinis bandymo greitis - 100 mm\/min.<\/strong> tiksliam matavimui.<\/p>\n\n\n\n<p><strong>2. Substrato parinkimas<\/strong><br>\u012evair\u016bs substratai imituoja \u017emogaus audinius ir yra patikima tyrimo terp\u0117. Da\u017eniausiai naudojami \u0161ie substratai:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Nat\u016bralus latekso kau\u010diukas (40 \u00b1 5 Shore A)<\/li>\n\n\n\n<li>Poliuretanas (85 \u00b1 10 \u0160oro A)<\/li>\n\n\n\n<li>Silikono guma (50 \u00b1 5 Shore A)<\/li>\n\n\n\n<li>Polietilenin\u0117 LDPE pl\u0117vel\u0117 (50 \u00b1 5 mikron\u0173)<\/li>\n<\/ul>\n\n\n\n<p>Pasirinktas substratas turi b\u016bti patvirtintas, kad rezultatai b\u016bt\u0173 nuosekl\u016bs.<\/p>\n\n\n\n<p><strong>3. Substrato laikiklis<\/strong><br>Gerai suprojektuotas substrato laikiklis su lygiagre\u010diomis plok\u0161tel\u0117mis patikimai prispaud\u017eia substrat\u0105. . <strong>apskritas atviras \u012fsiskverbimo plotas (nominalus skersmuo: 10 mm)<\/strong> leid\u017eia atlikti tikslius bandymus ir u\u017etikrina tiksl\u0173 duomen\u0173 rinkim\u0105.<\/p>\n\n\n\n<p><strong>4. \u012esiskverbimo gylis<\/strong><br>Adata \u012fki\u0161ama \u012f tok\u012f gyl\u012f, kuris yra lygus <strong>80% vardinio ilgio<\/strong> (pvz., 4 mm, jei adata 5 mm). Po kiekvieno bandymo turi b\u016bti naudojamas naujas substrato plotas, kad b\u016bt\u0173 i\u0161vengta \u0161ali\u0161kumo.<\/p>\n\n\n\n<p><strong>5. Bandym\u0173 aplinka<\/strong><br>Bandymai tur\u0117t\u0173 b\u016bti atliekami kontroliuojamoje aplinkoje (18-28 \u00b0C; 25-75% RH), kad b\u016bt\u0173 i\u0161vengta kintamumo.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Adatos a\u0161trumo bandym\u0173 atlikimas<\/h2>\n\n\n\n<p>Atlikti i\u0161sam\u0173 <strong>adatos a\u0161trumo bandymas<\/strong>, atlikite \u0161iuos veiksmus:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Paruo\u0161kite bandinius ir substrat\u0105<\/strong>, juos bent 24 valandas kondicionuojant standartin\u0117mis aplinkos laboratorin\u0117mis s\u0105lygomis.<\/li>\n\n\n\n<li><strong>Sumontuokite adat\u0105<\/strong> ant j\u0117gos matavimo prietaiso.<\/li>\n\n\n\n<li><strong>Pagrindo tvirtinimas<\/strong> \u012f laikikl\u012f, u\u017etikrindami, kad jis b\u016bt\u0173 vienoje linijoje su skverbimosi taikinio sritimi.<\/li>\n\n\n\n<li><strong>\u012esiskverbimo testo prad\u017eia<\/strong> judindami adat\u0105 100 mm\/min grei\u010diu, kol pasiekiamas norimas \u012fsiskverbimo gylis.<\/li>\n\n\n\n<li><strong>I\u0161traukite adat\u0105<\/strong> ir u\u017era\u0161ykite vis\u0105 j\u0117gos profil\u012f.<\/li>\n<\/ul>\n\n\n\n<p>Jei d\u0117l netinkamo i\u0161lyginimo adata atsitrenkia \u012f substrato laikikl\u012f, bandym\u0105 nutraukite ir pakartokite j\u012f su tinkamai i\u0161lygintu bandiniu.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Duomen\u0173 rinkimas ir analiz\u0117<\/h2>\n\n\n\n<p>Svetain\u0117 <strong>j\u0117gos profilis<\/strong> bandym\u0173 metu sukurtame teste u\u017efiksuoti du pagrindiniai parametrai:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Did\u017eiausia \u012fsiskverbimo j\u0117ga<\/strong>: Did\u017eiausia j\u0117ga, kurios reikia norint pradurti pagrind\u0105.<\/li>\n\n\n\n<li><strong>Vilkimo j\u0117ga<\/strong>: Vidutin\u0117 trinties j\u0117ga, veikianti adat\u0105, kai ji juda per pagrind\u0105.<\/li>\n<\/ul>\n\n\n\n<p>Apskai\u010diuoti <strong>vidurkis ir standartinis nuokrypis<\/strong> \u0161ie parametrai u\u017etikrina tikslias ataskaitas. ISO 7864 rekomenduoja bandym\u0173 duomenims patvirtinti naudoti statisti\u0161kai reik\u0161mingas imtis.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Adatos a\u0161trumo bandymo rezultat\u0173 pateikimas<\/h2>\n\n\n\n<p>I\u0161samus <strong>adatos a\u0161trumo bandymas<\/strong> ataskaitoje tur\u0117t\u0173 b\u016bti:<br>\u2705 Vidutinis ir standartinis nuokrypis <strong>did\u017eiausia \u012fsiskverbimo j\u0117ga<\/strong><br>\u2705 Vidutinis ir standartinis nuokrypis <strong>pasiprie\u0161inimo j\u0117ga<\/strong><br>\u2705 Bandym\u0173 aplinkos ir naudojam\u0173 substrat\u0173 apra\u0161ymas<br>\u2705 Atitikties ISO 7864 reikalavimams patvirtinimas<\/p>\n\n\n\n<p>Tokios i\u0161samios ataskaitos u\u017etikrina testavimo proceso skaidrum\u0105 ir patikimum\u0105.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p><strong>Kod\u0117l verta rinktis \"Cell Instruments\" adat\u0173 a\u0161trumui tikrinti?<\/strong><br>Svetain\u0117je <strong>\"Cell Instruments<\/strong>, mes specializuojam\u0117s pa\u017eangi\u0173 med\u017eiag\u0173 tyrimo prietais\u0173, \u012fskaitant \u012frang\u0105, gamybos ir tiekimo srityje. <strong>adatos a\u0161trumo bandymas<\/strong>. M\u016bs\u0173 patikimi bandym\u0173 sprendimai padeda gamintojams atitikti ISO 7864 reikalavimus ir u\u017etikrinti gamini\u0173 saug\u0105 bei pacient\u0173 komfort\u0105. Taip pat teikiame individualius bandym\u0173 ir automatizavimo sprendimus, atitinkan\u010dius j\u016bs\u0173 unikalius poreikius, ir padedan\u010dius tokioms pramon\u0117s \u0161akoms kaip medicina, farmacija ir kokyb\u0117s kontrol\u0117.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p><strong>Adatos a\u0161trumo bandymas<\/strong> yra b\u016btinas \u017eingsnis siekiant u\u017etikrinti, kad medicinin\u0117s adatos atitikt\u0173 tarptautinius saugos ir veiksmingumo standartus. Laikydamiesi ai\u0161ki\u0173 ISO 7864 rekomendacij\u0173 ir naudodami tiksli\u0105 bandymo \u012frang\u0105, gamintojai gali u\u017etikrinti, kad j\u0173 poodin\u0117s adatos atitinka auk\u0161\u010diausius kokyb\u0117s ir patikimumo standartus. Susisiekite <strong>\"Cell Instruments<\/strong> \u0161iandien su\u017einokite, kaip galime pad\u0117ti j\u016bs\u0173 testavimo poreikiams!<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p><strong>DUK apie adatos a\u0161trumo tikrinim\u0105<\/strong><\/p>\n\n\n\n<p><strong>1 klausimas: Koks yra adatos a\u0161trumo bandymo tikslas?<\/strong><br>A1: \u012evertinama adatos \u012fvedimo ir tempimo j\u0117ga, kad b\u016bt\u0173 u\u017etikrintas minimalus skausmas ir audini\u0173 pa\u017eeidimas, taip pagerinant paciento komfort\u0105.<\/p>\n\n\n\n<p><strong>2 klausimas: Kokie standartai reglamentuoja adat\u0173 a\u0161trumo bandymus?<\/strong><br>A2: <a href=\"https:\/\/www.iso.org\/standard\/60481.html\" target=\"_blank\" rel=\"noreferrer noopener\">ISO 7864<\/a> apra\u0161omos reikalaujamos proced\u016bros ir atlikimo kriterijai, taikomi atliekant poodini\u0173 adat\u0173 tyrimus.<\/p>\n\n\n\n<p><strong>3 klausimas: Kokie substratai naudojami bandymams?<\/strong><br>A3: \u012eprasti pagrindai yra nat\u016bralaus latekso kau\u010diukas, poliuretanas, silikono kau\u010diukas ir LDPE pl\u0117vel\u0117s.<\/p>\n\n\n\n<p><strong>4 klausimas: Kaip apskai\u010diuojama pasiprie\u0161inimo j\u0117ga atliekant adatos a\u0161trumo bandymus?<\/strong><br>A4: Jis nustatomas apskai\u010diuojant vidutin\u0119 trinties j\u0117g\u0105 i\u0161 80% \u012fsiskverbimo gylio srities j\u0117gos profilyje.<\/p>\n\n\n\n<p><strong>5 klausimas: Ar \"Cell Instruments\" gali pateikti nestandartinius adat\u0173 a\u0161trumo testavimo sprendimus?<\/strong><br>A5: Taip, si\u016blome specialiai pritaikyt\u0105 bandym\u0173 \u012frang\u0105 ir automatizavimo sprendimus, kad patenkintume j\u016bs\u0173 konkre\u010dius gamini\u0173 bandym\u0173 poreikius.<\/p>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>ISO 7864 poodini\u0173 adat\u0173 a\u0161trumo bandymas Pagrindiniai ISO 7864 standarto elementai, susij\u0119 su adat\u0173 a\u0161trumo bandymu ISO 7864 standarte nustatyti reikalavimai ir bandymo metodai, taikomi vienkartin\u0117ms poodin\u0117ms adatoms, daugiausia d\u0117mesio skiriant tiksliam adatos veikimui. Konkre\u010diai ISO 7864 D priede apra\u0161yta adatos \u012fsiskverbimo bandymo metodika, pagal kuri\u0105 matuojama did\u017eiausia \u012fsiskverbimo j\u0117ga ir pasiprie\u0161inimo j\u0117ga.<\/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":"","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-2139","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\/lt\/author\/pharmacopoeiatest\/"},"uagb_comment_info":0,"uagb_excerpt":"ISO 7864 Hypodermic Needle Sharpness Testing Key Elements of ISO 7864 for Needle Sharpness Testing ISO 7864 sets out the requirements and test methods for hypodermic needles for single use, focusing on precise needle performance. Specifically, Annex D of ISO 7864 outlines the penetration needle test methodology, which measures both peak penetration force and drag&hellip;","_links":{"self":[{"href":"https:\/\/www.pharmacopoeiatest.com\/lt\/wp-json\/wp\/v2\/posts\/2139","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharmacopoeiatest.com\/lt\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pharmacopoeiatest.com\/lt\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/lt\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/lt\/wp-json\/wp\/v2\/comments?post=2139"}],"version-history":[{"count":5,"href":"https:\/\/www.pharmacopoeiatest.com\/lt\/wp-json\/wp\/v2\/posts\/2139\/revisions"}],"predecessor-version":[{"id":2502,"href":"https:\/\/www.pharmacopoeiatest.com\/lt\/wp-json\/wp\/v2\/posts\/2139\/revisions\/2502"}],"wp:attachment":[{"href":"https:\/\/www.pharmacopoeiatest.com\/lt\/wp-json\/wp\/v2\/media?parent=2139"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/lt\/wp-json\/wp\/v2\/categories?post=2139"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/lt\/wp-json\/wp\/v2\/tags?post=2139"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}