{"id":9831,"date":"2026-02-24T15:11:44","date_gmt":"2026-02-24T07:11:44","guid":{"rendered":"https:\/\/www.packqc.com\/standard\/iso-17218\/"},"modified":"2026-03-12T16:59:48","modified_gmt":"2026-03-12T08:59:48","slug":"iso-17218","status":"publish","type":"standard","link":"https:\/\/www.packqc.com\/hr\/standard\/iso-17218\/","title":{"rendered":"ISO 17218"},"content":{"rendered":"<h2 class=\"wp-block-heading\">\u0160to je ISO 17218?<\/h2>\n\n\n\n<p>ISO 17218, naslovljen <em data-start=\"1045\" data-end=\"1091\">\u201cSterilne igle za akupunkturu za jednokratnu upotrebu\u201d<\/em>, iznosi standardizirane metode za procjenu igala za akupunkturu. Njegova je glavna svrha osigurati da su igle sigurne, u\u010dinkovite i pouzdane tijekom klini\u010dke uporabe. Standard uklju\u010duje smjernice za testiranje <strong data-start=\"1302\" data-end=\"1322\">intenzitet igle<\/strong>, <strong data-start=\"1324\" data-end=\"1344\">o\u0161trina igle<\/strong>, i <strong data-start=\"1350\" data-end=\"1381\">otpornost na probadanje iglom<\/strong> potvrditi da igle zadovoljavaju globalne standarde kvalitete.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Obja\u0161njenje testiranja igala za akupunkturu<\/h2>\n\n\n\n<p>Standard propisuje metode za tri klju\u010dna aspekta ispitivanja:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">1. Testiranje intenziteta igle<\/h3>\n\n\n\n<p>Intenzitet igle mjeri sposobnost vrha igle da se odupre savijanju ili lomu. Prema ISO 17218, to uklju\u010duje postavljanje akupunkturne igle okomito na \u010deli\u010dni blok. Snaga se postupno pove\u0107ava dok ne zadovolji numeri\u010dke kriterije u odjeljku 5.3.5.2. Nakon dr\u017eanja optere\u0107enja 5 do 10 sekundi, vrh igle se pregledava pod 5x pove\u0107anjem. Igla mora ostati ravna, bez savijanja ili zaka\u010denja, \u010dime se osigurava da se ne\u0107e deformirati tijekom stvarnih akupunkturnih tretmana.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">2. Test o\u0161trine igle<\/h3>\n\n\n\n<p>Test o\u0161trine mjeri silu potrebnu da vrh igle probu\u0161i aluminijsku foliju. Nakon testa intenziteta ista akupunkturna igla ostaje pri\u010dvr\u0161\u0107ena u aparatu. Igla se zatim priti\u0161\u0107e na aluminijsku foliju dok je ne probu\u0161i. Aparat automatski bilje\u017ei silu probijanja, pru\u017eaju\u0107i kvantitativne podatke o o\u0161trini igle. Pravilno o\u0161tra igla zahtijeva manju silu za prodiranje kroz foliju, \u0161to odra\u017eava njezinu glatku i preciznu sposobnost probadanja.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">3. Testiranje probijanja iglom<\/h3>\n\n\n\n<p>Ispitivanje probijanja procjenjuje koliko dobro igla prodire u meka tkiva ili materijale. ISO 17218 pru\u017ea dvije metode:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"2753\" data-end=\"2786\">Kvantitativna metoda (Metoda A)<\/strong>: Ovo koristi membranu od kirur\u0161kih gumnih rukavica (u skladu s ISO 10282) rastegnutu preko \u010da\u0161e. Igla se vertikalno priti\u0161\u0107e u membranu. Ako je udubljenje minimalno i otpor nizak, igla je o\u0161tra. Ova metoda nudi brzu vizualnu provjeru dosljednosti o\u0161trine.<\/li>\n\n\n\n<li><strong data-start=\"3074\" data-end=\"3108\">Kvantitativna metoda (Metoda B)<\/strong>: Ovo koristi polimerizirani poliuretanski film debljine (0,35 \u00b1 0,05) mm i Shore tvrdo\u0107e (85 \u00b1 10) Shore A. Igla se pomi\u010de brzinom od 100 mm\/min dok se bilje\u017ee sila probijanja i pomak. Klju\u010dne vrijednosti sila F0F_0F0, F1F_1F1 i F2F_2F2 odra\u017eavaju karakteristike probadanja i trenja igle. Ova metoda pru\u017ea vrlo pouzdane podatke za procjenu performansi probadanja i usporedbu razli\u010ditih igala.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Najbolje prakse za uskla\u0111ivanje s normom ISO 17218<\/h2>\n\n\n\n<p>Timovi za kontrolu kvalitete i testiranje trebaju pa\u017eljivo:<\/p>\n\n\n\n<p>\u2705 Koristite standardizirani testni aparat za replikaciju. <a href=\"https:\/\/www.iso.org\/standard\/59443.html\" target=\"_blank\" rel=\"noopener nofollow\">ISO 17218<\/a>\u2019uvjeti<br data-start=\"3728\" data-end=\"3731\">\u2705 To\u010dno zabilje\u017eite podatke ispitivanja, uklju\u010duju\u0107i sve promjene sile tijekom ispitivanja probijanja.<br data-start=\"3822\" data-end=\"3825\">\u2705 Usporedite rezultate s rezultatima igala poznate kvalitete kako biste mjerili performanse.<br data-start=\"3903\" data-end=\"3906\">\u2705 Dokumentirajte i arhivirajte rezultate testiranja radi sljedivosti i uskla\u0111enosti s propisima<\/p>\n\n\n\n<p>Slijede\u0107i ove prakse, proizvo\u0111a\u010di i osoblje za kontrolu kvalitete mogu s povjerenjem procijeniti svoje igle za akupunkturu.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\n\t\t\t\tKontaktirajte nas   Pribavite rje\u0161enje za testiranje prema ISO 17218\t\t\t\t<\/h2>\n\n\n\n<p>Na <strong data-start=\"4163\" data-end=\"4183\">Stani\u010dni instrumenti<\/strong>, Specijalizirani smo za dizajn i proizvodnju opreme za testiranje koja je u skladu s me\u0111unarodnim standardima poput ISO 17218. Na\u0161i instrumenti osiguravaju precizno <strong data-start=\"4338\" data-end=\"4421\">testiranje intenziteta igle, testiranje o\u0161trine igle i testiranje probadanja iglom<\/strong>. Tako\u0111er pru\u017eamo prilago\u0111ena rje\u0161enja za testiranje posebnih zahtjeva, omogu\u0107uju\u0107i vam da s to\u010dno\u0161\u0107u i pouzdano\u0161\u0107u zadovoljite rastu\u0107e zahtjeve tr\u017ei\u0161ta.<\/p>\n\n\n\n<p>Bilo da testirate ambala\u017eu, medicinske ure\u0111aje ili igle za akupunkturu, <strong data-start=\"4642\" data-end=\"4662\">Stani\u010dni instrumenti<\/strong> posjeduje stru\u010dnost da vam pomogne odr\u017eati kvalitetu, sigurnost i uskla\u0111enost.<\/p>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>What is ISO 17218? ISO 17218, titled \u201cSterile acupuncture needles for single use\u201d, outlines standardized methods for evaluating acupuncture needles. Its main purpose is to ensure that needles are safe, effective, and reliable during clinical use. The standard includes guidelines for testing needle intensity, needle sharpness, and needle puncture performance to confirm that the needles [&hellip;]<\/p>","protected":false},"featured_media":5491,"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":""}}},"standard-category":[],"class_list":["post-9831","standard","type-standard","status-publish","has-post-thumbnail","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.packqc.com\/hr\/wp-json\/wp\/v2\/standard\/9831","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/hr\/wp-json\/wp\/v2\/standard"}],"about":[{"href":"https:\/\/www.packqc.com\/hr\/wp-json\/wp\/v2\/types\/standard"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/hr\/wp-json\/wp\/v2\/media\/5491"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/hr\/wp-json\/wp\/v2\/media?parent=9831"}],"wp:term":[{"taxonomy":"standard-category","embeddable":true,"href":"https:\/\/www.packqc.com\/hr\/wp-json\/wp\/v2\/standard-category?post=9831"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}