{"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\/bs\/standard\/iso-17218\/","title":{"rendered":"ISO 17218"},"content":{"rendered":"<h2 class=\"wp-block-heading\">\u0160ta je ISO 17218?<\/h2>\n\n\n\n<p>ISO 17218, pod naslovom <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 glavna svrha je osigurati da su igle sigurne, u\u010dinkovite i pouzdane tijekom klini\u010dke upotrebe. 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> da se potvrdi da igle zadovoljavaju globalne standarde kvaliteta.<\/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 testiranja:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">1. Test intenziteta igle<\/h3>\n\n\n\n<p>Intenzitet igle mjeri sposobnost vrha igle da se odupre savijanju ili lomu. U ISO 17218 to podrazumijeva postavljanje akupunkturne igle vertikalno na \u010deli\u010dni blok. Snaga se postepeno pove\u0107ava dok se ne ispune numeri\u010dki kriteriji iz odjeljka 5.3.5.2. Nakon zadr\u017eavanja optere\u0107enja 5 do 10 sekundi, vrh igle se pregleda pod 5x pove\u0107anjem. Igla mora ostati ravna, bez savijanja ili zaka\u010denja, \u010dime se osigurava da se ne\u0107e deformisati tokom 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 procjenjuje silu potrebnu da vrh igle probu\u0161i aluminijsku foliju. Nakon testiranja 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 njenu 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>Testiranje 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 hirur\u0161kih gumnih rukavica (u skladu sa ISO 10282) rastegnutu preko \u0161olje. Igla se vertikalno priti\u0161\u0107e u membranu. Ako je udubljenje minimalno, a otpor nizak, igla je o\u0161tra. Ova metoda nudi brz vizuelni pregled 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 pomjera 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 visoko 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 sa standardom ISO 17218<\/h2>\n\n\n\n<p>Timovi za kontrolu kvaliteta i testiranje bi trebali 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>\u2019uslovi<br data-start=\"3728\" data-end=\"3731\">\u2705 Ta\u010dno zabilje\u017eite podatke testa, uklju\u010duju\u0107i sve promjene sile tokom probijanja.<br data-start=\"3822\" data-end=\"3825\">\u2705 Uporedite rezultate sa rezultatima igala poznatog kvaliteta kako biste mjerili performanse.<br data-start=\"3903\" data-end=\"3906\">\u2705 Dokumentujte 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 kvaliteta mogu s povjerenjem procijeniti svoje igle za akupunkturu.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\n\t\t\t\tKontaktirajte nas   Dobijte rje\u0161enje za ISO 17218 testiranje\t\t\t\t<\/h2>\n\n\n\n<p>At <strong data-start=\"4163\" data-end=\"4183\">Cell Instruments<\/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 za posebne zahtjeve, omogu\u0107avaju\u0107i vam da s precizno\u0161\u0107u i pouzdano\u0161\u0107u zadovoljite rastu\u0107e zahtjeve tr\u017ei\u0161ta.<\/p>\n\n\n\n<p>Bilo da testirate ambala\u017eu, medicinska sredstva ili igle za akupunkturu, <strong data-start=\"4642\" data-end=\"4662\">Cell Instruments<\/strong> posjeduje stru\u010dnost da vam pomogne u odr\u017eavanju kvaliteta, sigurnosti i uskla\u0111enosti.<\/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\/bs\/wp-json\/wp\/v2\/standard\/9831","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/bs\/wp-json\/wp\/v2\/standard"}],"about":[{"href":"https:\/\/www.packqc.com\/bs\/wp-json\/wp\/v2\/types\/standard"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/bs\/wp-json\/wp\/v2\/media\/5491"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/bs\/wp-json\/wp\/v2\/media?parent=9831"}],"wp:term":[{"taxonomy":"standard-category","embeddable":true,"href":"https:\/\/www.packqc.com\/bs\/wp-json\/wp\/v2\/standard-category?post=9831"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}