{"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\/hu\/standard\/iso-17218\/","title":{"rendered":"ISO 17218"},"content":{"rendered":"<h2 class=\"wp-block-heading\">Mi az ISO 17218?<\/h2>\n\n\n\n<p>ISO 17218, c\u00edme <em data-start=\"1045\" data-end=\"1091\">\u201cSteril akupunkt\u00far\u00e1s t\u0171k egyszeri haszn\u00e1latra\u201d<\/em>, szabv\u00e1nyos\u00edtott m\u00f3dszereket v\u00e1zol fel az akupunkt\u00far\u00e1s t\u0171k \u00e9rt\u00e9kel\u00e9s\u00e9re. F\u0151 c\u00e9lja annak biztos\u00edt\u00e1sa, hogy a t\u0171k biztons\u00e1gosak, hat\u00e9konyak \u00e9s megb\u00edzhat\u00f3ak legyenek a klinikai haszn\u00e1lat sor\u00e1n. A szabv\u00e1ny tartalmazza a k\u00f6vetkez\u0151 vizsg\u00e1latokra vonatkoz\u00f3 ir\u00e1nymutat\u00e1sokat <strong data-start=\"1302\" data-end=\"1322\">t\u0171 intenzit\u00e1sa<\/strong>, <strong data-start=\"1324\" data-end=\"1344\">t\u0171 \u00e9less\u00e9ge<\/strong>, \u00e9s <strong data-start=\"1350\" data-end=\"1381\">t\u0171sz\u00far\u00e1si teljes\u00edtm\u00e9ny<\/strong> annak meger\u0151s\u00edt\u00e9s\u00e9re, hogy a t\u0171k megfelelnek a glob\u00e1lis min\u0151s\u00e9gi el\u0151\u00edr\u00e1soknak.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Akupunkt\u00far\u00e1s t\u0171vizsg\u00e1lat magyar\u00e1zata<\/h2>\n\n\n\n<p>A szabv\u00e1ny h\u00e1rom alapvet\u0151 vizsg\u00e1lati szempontra \u00edr el\u0151 m\u00f3dszereket:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">1. T\u0171 intenzit\u00e1s\u00e1nak vizsg\u00e1lata<\/h3>\n\n\n\n<p>A t\u0171 intenzit\u00e1sa a t\u0171 hegy\u00e9nek hajl\u00edt\u00e1ssal vagy t\u00f6r\u00e9ssel szembeni ellen\u00e1ll\u00f3 k\u00e9pess\u00e9g\u00e9t m\u00e9ri. Az ISO 17218 szabv\u00e1ny szerint ehhez az akupunkt\u00far\u00e1s t\u0171t f\u00fcgg\u0151legesen egy ac\u00e9lt\u00f6mbbe kell helyezni. Az er\u0151t fokozatosan n\u00f6velik, am\u00edg el nem \u00e9ri az 5.3.5.5.2. szakaszban szerepl\u0151 numerikus krit\u00e9riumokat. Miut\u00e1n a terhel\u00e9st (5-10) m\u00e1sodpercig tartott\u00e1k, a t\u0171 hegy\u00e9t 5x nagy\u00edt\u00e1ssal vizsg\u00e1lj\u00e1k. A t\u0171nek egyenesnek kell maradnia, nem szabad elhajolnia vagy megakadnia, biztos\u00edtva, hogy a t\u00e9nyleges akupunkt\u00far\u00e1s kezel\u00e9sek sor\u00e1n ne deform\u00e1l\u00f3djon.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">2. T\u0171 \u00e9less\u00e9g\u00e9nek vizsg\u00e1lata<\/h3>\n\n\n\n<p>Az \u00e9less\u00e9g vizsg\u00e1lata azt vizsg\u00e1lja, hogy a t\u0171 hegye milyen er\u0151vel k\u00e9pes \u00e1tsz\u00farni az alum\u00edniumf\u00f3li\u00e1t. Az intenzit\u00e1svizsg\u00e1lat ut\u00e1n ugyanaz az akupunkt\u00far\u00e1s t\u0171 marad a k\u00e9sz\u00fcl\u00e9kben r\u00f6gz\u00edtve. Ezut\u00e1n a t\u0171t addig nyomj\u00e1k az alum\u00edniumf\u00f3li\u00e1hoz, am\u00edg \u00e1t nem sz\u00farja azt. A k\u00e9sz\u00fcl\u00e9k automatikusan r\u00f6gz\u00edti a sz\u00far\u00f3er\u0151t, \u00edgy kvantitat\u00edv adatokat szolg\u00e1ltat a t\u0171 \u00e9less\u00e9g\u00e9r\u0151l. A megfelel\u0151en \u00e9les t\u0171nek kisebb er\u0151re van sz\u00fcks\u00e9ge a f\u00f3lia \u00e1tsz\u00far\u00e1s\u00e1hoz, ami t\u00fckr\u00f6zi a t\u0171 sima \u00e9s pontos sz\u00far\u00e1si k\u00e9pess\u00e9g\u00e9t.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">3. T\u0171sz\u00far\u00e1sos vizsg\u00e1lat<\/h3>\n\n\n\n<p>A sz\u00far\u00e1svizsg\u00e1lat azt \u00e9rt\u00e9keli, hogy a t\u0171 milyen j\u00f3l hatol \u00e1t a l\u00e1gy sz\u00f6veteken vagy anyagokon. Az ISO 17218 k\u00e9t m\u00f3dszert \u00edr el\u0151:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"2753\" data-end=\"2786\">Min\u0151s\u00e9gi m\u00f3dszer (A m\u00f3dszer)<\/strong>: Ez egy cs\u00e9sz\u00e9re fesz\u00edtett seb\u00e9szeti gumikeszty\u0171 membr\u00e1nt haszn\u00e1l (ISO 10282 szabv\u00e1nynak megfelel\u0151en). A t\u0171t f\u00fcgg\u0151legesen a membr\u00e1nba nyomj\u00e1k. Ha a horpad\u00e1s minim\u00e1lis \u00e9s az ellen\u00e1ll\u00e1s alacsony, a t\u0171 \u00e9les. Ez a m\u00f3dszer gyors, vizu\u00e1lis ellen\u0151rz\u00e9st biztos\u00edt az \u00e9less\u00e9g konzisztenci\u00e1j\u00e1nak ellen\u0151rz\u00e9s\u00e9re.<\/li>\n\n\n\n<li><strong data-start=\"3074\" data-end=\"3108\">Kvantitat\u00edv m\u00f3dszer (B m\u00f3dszer)<\/strong>: Ehhez egy polimeriz\u00e1lt poliuret\u00e1n f\u00f3li\u00e1t haszn\u00e1lnak, amelynek vastags\u00e1ga (0,35 \u00b1 0,05) mm \u00e9s Shore kem\u00e9nys\u00e9ge (85 \u00b1 10) Shore A. A t\u0171t 100 mm\/perc sebess\u00e9ggel mozgatj\u00e1k, mik\u00f6zben a sz\u00far\u00f3er\u0151t \u00e9s az elmozdul\u00e1st r\u00f6gz\u00edtik. Az F0F_0F0, F1F_1F1 \u00e9s F2F_2F2 kulcser\u0151\u00e9rt\u00e9kek a t\u0171 sz\u00far\u00e1si \u00e9s s\u00farl\u00f3d\u00e1si jellemz\u0151it t\u00fckr\u00f6zik. Ez a m\u00f3dszer rendk\u00edv\u00fcl megb\u00edzhat\u00f3 adatokat szolg\u00e1ltat a sz\u00far\u00e1si teljes\u00edtm\u00e9ny \u00e9rt\u00e9kel\u00e9s\u00e9hez \u00e9s a k\u00fcl\u00f6nb\u00f6z\u0151 t\u0171k \u00f6sszehasonl\u00edt\u00e1s\u00e1hoz.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Legjobb gyakorlatok az ISO 17218 szabv\u00e1nynak val\u00f3 megfelel\u00e9shez<\/h2>\n\n\n\n<p>A min\u0151s\u00e9gellen\u0151rz\u0151 \u00e9s tesztel\u0151 csapatoknak gondosan kell:<\/p>\n\n\n\n<p>\u2705 Haszn\u00e1ljon szabv\u00e1nyos\u00edtott tesztk\u00e9sz\u00fcl\u00e9ket a replik\u00e1l\u00e1shoz. <a href=\"https:\/\/www.iso.org\/standard\/59443.html\" target=\"_blank\" rel=\"noopener nofollow\">ISO 17218<\/a>\u2019felt\u00e9telei<br data-start=\"3728\" data-end=\"3731\">\u2705 Pontosan r\u00f6gz\u00edtse a vizsg\u00e1lati adatokat, bele\u00e9rtve a sz\u00far\u00e1si vizsg\u00e1latok sor\u00e1n fell\u00e9p\u0151 er\u0151v\u00e1ltoz\u00e1sokat is<br data-start=\"3822\" data-end=\"3825\">\u2705 Hasonl\u00edtsa \u00f6ssze az eredm\u00e9nyeket az ismert min\u0151s\u00e9gi t\u0171k eredm\u00e9nyeivel a teljes\u00edtm\u00e9ny \u00f6sszehasonl\u00edt\u00e1sa \u00e9rdek\u00e9ben.<br data-start=\"3903\" data-end=\"3906\">\u2705 Dokument\u00e1lja \u00e9s archiv\u00e1lja a vizsg\u00e1lati eredm\u00e9nyeket a nyomon k\u00f6vethet\u0151s\u00e9g \u00e9s a jogszab\u00e1lyi megfelel\u00e9s \u00e9rdek\u00e9ben.<\/p>\n\n\n\n<p>Ezeket a gyakorlatokat k\u00f6vetve a gy\u00e1rt\u00f3k \u00e9s a min\u0151s\u00e9gellen\u0151rz\u00e9st v\u00e9gz\u0151 szem\u00e9lyzet magabiztosan \u00e9rt\u00e9kelheti akupunkt\u00far\u00e1s t\u0171it.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\n\t\t\t\tKapcsolatfelv\u00e9tel ISO 17218 vizsg\u00e1lati megold\u00e1s\t\t\t\t<\/h2>\n\n\n\n<p>at <strong data-start=\"4163\" data-end=\"4183\">Cell Instruments<\/strong>, olyan vizsg\u00e1l\u00f3berendez\u00e9sek tervez\u00e9s\u00e9re \u00e9s gy\u00e1rt\u00e1s\u00e1ra szakosodtunk, amelyek megfelelnek az olyan nemzetk\u00f6zi szabv\u00e1nyoknak, mint az ISO 17218. M\u0171szereink biztos\u00edtj\u00e1k a pontos <strong data-start=\"4338\" data-end=\"4421\">t\u0171intenzit\u00e1s-vizsg\u00e1lat, t\u0171hegyess\u00e9g-vizsg\u00e1lat \u00e9s t\u0171sz\u00far\u00e1s-vizsg\u00e1lat<\/strong>. Egyedi tesztel\u00e9si megold\u00e1sokat is k\u00edn\u00e1lunk a speci\u00e1lis k\u00f6vetelm\u00e9nyekhez, lehet\u0151v\u00e9 t\u00e9ve, hogy a v\u00e1ltoz\u00f3 piaci ig\u00e9nyeknek pontoss\u00e1ggal \u00e9s megb\u00edzhat\u00f3s\u00e1ggal feleljen meg.<\/p>\n\n\n\n<p>Ak\u00e1r csomagol\u00e1st, ak\u00e1r orvosi eszk\u00f6z\u00f6ket vagy akupunkt\u00far\u00e1s t\u0171ket tesztel, <strong data-start=\"4642\" data-end=\"4662\">Cell Instruments<\/strong> rendelkezik azzal a szak\u00e9rtelemmel, amely seg\u00edt \u00d6nnek a min\u0151s\u00e9g, a biztons\u00e1g \u00e9s a megfelel\u0151s\u00e9g fenntart\u00e1s\u00e1ban.<\/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\/hu\/wp-json\/wp\/v2\/standard\/9831","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/hu\/wp-json\/wp\/v2\/standard"}],"about":[{"href":"https:\/\/www.packqc.com\/hu\/wp-json\/wp\/v2\/types\/standard"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/hu\/wp-json\/wp\/v2\/media\/5491"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/hu\/wp-json\/wp\/v2\/media?parent=9831"}],"wp:term":[{"taxonomy":"standard-category","embeddable":true,"href":"https:\/\/www.packqc.com\/hu\/wp-json\/wp\/v2\/standard-category?post=9831"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}