{"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\/sl\/standard\/iso-17218\/","title":{"rendered":"ISO 17218"},"content":{"rendered":"<h2 class=\"wp-block-heading\">Kaj je ISO 17218?<\/h2>\n\n\n\n<p>ISO 17218 z naslovom <em data-start=\"1045\" data-end=\"1091\">\"Sterilne akupunkturne igle za enkratno uporabo\"<\/em>, opisuje standardizirane metode za ocenjevanje akupunkturnih igel. Njen glavni namen je zagotoviti, da so igle med klini\u010dno uporabo varne, u\u010dinkovite in zanesljive. Standard vklju\u010duje smernice za testiranje <strong data-start=\"1302\" data-end=\"1322\">intenzivnost igle<\/strong>, <strong data-start=\"1324\" data-end=\"1344\">ostrina igle<\/strong>, in <strong data-start=\"1350\" data-end=\"1381\">u\u010dinkovitost vboda igle<\/strong> za potrditev, da igle izpolnjujejo svetovne standarde kakovosti.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pojasnjeno testiranje z akupunkturno iglo<\/h2>\n\n\n\n<p>Standard dolo\u010da metode za tri bistvene vidike presku\u0161anja:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">1. Testiranje intenzivnosti igle<\/h3>\n\n\n\n<p>Intenzivnost igle meri sposobnost igle, da se upre upogibanju ali zlomu. V standardu ISO 17218 to vklju\u010duje postavitev akupunkturne igle navpi\u010dno ob jekleni blok. Sila se postopoma pove\u010duje, dokler ne dose\u017ee \u0161tevil\u010dnih meril iz oddelka 5.3.5.2. Po (5 do 10) sekundah zadr\u017eevanja obremenitve se konica igle pregleda pod 5-kratno pove\u010davo. Igla mora ostati ravna, brez upogibanja ali zatikanja, kar zagotavlja, da se med dejanskim zdravljenjem z akupunkturo ne bo deformirala.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">2. Preizkus ostrine igle<\/h3>\n\n\n\n<p>S presku\u0161anjem ostrine se oceni sila, ki je potrebna, da konica igle prebode aluminijasto folijo. Po testiranju jakosti ostane ista akupunkturna igla pritrjena v aparaturo. Iglo nato pritisnemo ob aluminijasto folijo, dokler je ne prebode. Aparat samodejno zabele\u017ei silo prebadanja in tako zagotovi kvantitativne podatke o ostrini igle. Ustrezno ostra igla potrebuje manj\u0161o silo za prebadanje folije, kar odra\u017ea njeno gladko in natan\u010dno sposobnost prebadanja.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">3. Testiranje z vbodom igle<\/h3>\n\n\n\n<p>S testiranjem vbodov se oceni, kako dobro igla prodre skozi mehka tkiva ali materiale. Standard ISO 17218 dolo\u010da dve metodi:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"2753\" data-end=\"2786\">Kvalitativna metoda (metoda A)<\/strong>: Pri tem se uporablja membrana iz kirur\u0161kih gumijastih rokavic (v skladu s standardom ISO 10282), napeta na skodelico. Igla se navpi\u010dno potisne v membrano. \u010ce je vdolbina minimalna in upor majhen, je igla ostra. Ta metoda omogo\u010da hitro vizualno preverjanje doslednosti ostrine.<\/li>\n\n\n\n<li><strong data-start=\"3074\" data-end=\"3108\">Kvantitativna metoda (metoda B)<\/strong>: Pri tem se uporablja polimerizirana poliuretanska folija debeline (0,35 \u00b1 0,05) mm in trdote (85 \u00b1 10) Shore A. Igla se premika s hitrostjo 100 mm\/min, pri \u010demer se bele\u017eita prebadalna sila in premik. Klju\u010dne vrednosti sil F0F_0F0, F1F_1F1 in F2F_2F2 odra\u017eajo zna\u010dilnosti prebadanja in trenja igle. Ta metoda zagotavlja zelo zanesljive podatke za ocenjevanje u\u010dinkovitosti prebadanja in primerjavo razli\u010dnih igel.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Najbolj\u0161e prakse za skladnost s standardom ISO 17218<\/h2>\n\n\n\n<p>Ekipe za nadzor kakovosti in testiranje morajo skrbno:<\/p>\n\n\n\n<p>\u2705 Uporabite standardizirano testno napravo za ponovitev <a href=\"https:\/\/www.iso.org\/standard\/59443.html\" target=\"_blank\" rel=\"noopener nofollow\">ISO 17218<\/a>pogoji<br data-start=\"3728\" data-end=\"3731\">\u2705 Natan\u010dno bele\u017eite podatke o preskusih, vklju\u010dno z vsemi spremembami sile med preskusi vboda.<br data-start=\"3822\" data-end=\"3825\">\u2705 Primerjajte rezultate z rezultati znanih igel kakovosti za primerjavo uspe\u0161nosti<br data-start=\"3903\" data-end=\"3906\">\u2705 Dokumentiranje in arhiviranje rezultatov preskusov za sledljivost in skladnost s predpisi<\/p>\n\n\n\n<p>Z upo\u0161tevanjem teh praks lahko proizvajalci in osebje za nadzor kakovosti zanesljivo ocenijo svoje akupunkturne igle.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\n\t\t\t\tKontaktirajte nas Pridobite re\u0161itev za testiranje ISO 17218\t\t\t\t<\/h2>\n\n\n\n<p>pri <strong data-start=\"4163\" data-end=\"4183\">Celi\u010dni instrumenti<\/strong>, smo specializirani za na\u010drtovanje in proizvodnjo opreme za presku\u0161anje, ki je skladna z mednarodnimi standardi, kot je ISO 17218. Na\u0161i instrumenti zagotavljajo natan\u010dno <strong data-start=\"4338\" data-end=\"4421\">testiranje intenzivnosti igle, testiranje ostrine igle in testiranje vboda igle.<\/strong>. Zagotavljamo tudi re\u0161itve za testiranje po meri za posebne zahteve, ki vam omogo\u010dajo, da natan\u010dno in zanesljivo izpolnjujete spreminjajo\u010de se zahteve trga.<\/p>\n\n\n\n<p>Ne glede na to, ali testirate embala\u017eo, medicinske pripomo\u010dke ali akupunkturne igle, <strong data-start=\"4642\" data-end=\"4662\">Celi\u010dni instrumenti<\/strong> ima strokovno znanje in izku\u0161nje, s katerimi vam lahko pomaga ohranjati kakovost, varnost in skladnost.<\/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\/sl\/wp-json\/wp\/v2\/standard\/9831","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/sl\/wp-json\/wp\/v2\/standard"}],"about":[{"href":"https:\/\/www.packqc.com\/sl\/wp-json\/wp\/v2\/types\/standard"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/sl\/wp-json\/wp\/v2\/media\/5491"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/sl\/wp-json\/wp\/v2\/media?parent=9831"}],"wp:term":[{"taxonomy":"standard-category","embeddable":true,"href":"https:\/\/www.packqc.com\/sl\/wp-json\/wp\/v2\/standard-category?post=9831"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}