{"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\/cs\/standard\/iso-17218\/","title":{"rendered":"ISO 17218"},"content":{"rendered":"<h2 class=\"wp-block-heading\">Co je to norma ISO 17218?<\/h2>\n\n\n\n<p>ISO 17218 s n\u00e1zvem <em data-start=\"1045\" data-end=\"1091\">\u201cSteriln\u00ed akupunkturn\u00ed jehly na jedno pou\u017eit\u00ed\u201d<\/em>, popisuje standardizovan\u00e9 metody hodnocen\u00ed akupunkturn\u00edch jehel. Jej\u00edm hlavn\u00edm \u00fa\u010delem je zajistit, aby jehly byly p\u0159i klinick\u00e9m pou\u017eit\u00ed bezpe\u010dn\u00e9, \u00fa\u010dinn\u00e9 a spolehliv\u00e9. Norma obsahuje pokyny pro testov\u00e1n\u00ed <strong data-start=\"1302\" data-end=\"1322\">intenzita jehly<\/strong>, <strong data-start=\"1324\" data-end=\"1344\">ostrost jehly<\/strong>a <strong data-start=\"1350\" data-end=\"1381\">v\u00fdkonnost vpichu jehly<\/strong> potvrdit, \u017ee jehly spl\u0148uj\u00ed celosv\u011btov\u00e9 standardy kvality.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Vysv\u011btlen\u00ed testov\u00e1n\u00ed akupunkturn\u00ed jehlou<\/h2>\n\n\n\n<p>Norma specifikuje metody pro t\u0159i z\u00e1kladn\u00ed aspekty zkou\u0161en\u00ed:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">1. Testov\u00e1n\u00ed intenzity jehly<\/h3>\n\n\n\n<p>Intenzita jehly m\u011b\u0159\u00ed schopnost hrotu jehly odol\u00e1vat ohybu nebo zlomen\u00ed. Podle normy ISO 17218 se akupunkturn\u00ed jehla p\u0159ikl\u00e1d\u00e1 svisle k ocelov\u00e9mu bloku. S\u00edla se postupn\u011b zvy\u0161uje, dokud nespln\u00ed \u010d\u00edseln\u00e1 krit\u00e9ria uveden\u00e1 v odd\u00edle 5.3.5.2. Po udr\u017een\u00ed z\u00e1t\u011b\u017ee po dobu (5 a\u017e 10) sekund se hrot jehly zkontroluje pod p\u011btin\u00e1sobn\u00fdm zv\u011bt\u0161en\u00edm. Jehla mus\u00ed z\u016fstat rovn\u00e1, bez ohnut\u00ed nebo zah\u00e1knut\u00ed, co\u017e zaji\u0161\u0165uje, \u017ee se b\u011bhem skute\u010dn\u00fdch akupunkturn\u00edch o\u0161et\u0159en\u00ed nedeformuje.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">2. Testov\u00e1n\u00ed ostrosti jehel<\/h3>\n\n\n\n<p>Zkou\u0161ka ostrosti hodnot\u00ed s\u00edlu pot\u0159ebnou k tomu, aby hrot jehly prop\u00edchl hlin\u00edkovou f\u00f3lii. Po testov\u00e1n\u00ed intenzity z\u016fst\u00e1v\u00e1 v p\u0159\u00edstroji upevn\u011bna stejn\u00e1 akupunkturn\u00ed jehla. Jehla je pot\u00e9 p\u0159itla\u010dov\u00e1na k hlin\u00edkov\u00e9 f\u00f3lii, dokud ji neprop\u00edchne. P\u0159\u00edstroj automaticky zaznamen\u00e1v\u00e1 propichovac\u00ed s\u00edlu a poskytuje kvantitativn\u00ed \u00fadaje o ostrosti jehly. Spr\u00e1vn\u011b ostr\u00e1 jehla pot\u0159ebuje k proniknut\u00ed f\u00f3li\u00ed men\u0161\u00ed s\u00edlu, co\u017e odr\u00e1\u017e\u00ed jej\u00ed hladkou a p\u0159esnou propichovac\u00ed schopnost.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">3. Testov\u00e1n\u00ed vpichem jehly<\/h3>\n\n\n\n<p>Testov\u00e1n\u00ed punkce hodnot\u00ed, jak dob\u0159e jehla pronik\u00e1 m\u011bkk\u00fdmi tk\u00e1n\u011bmi nebo materi\u00e1ly. Norma ISO 17218 uv\u00e1d\u00ed dv\u011b metody:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"2753\" data-end=\"2786\">Kvalitativn\u00ed metoda (metoda A)<\/strong>: Pou\u017e\u00edv\u00e1 se membr\u00e1na z chirurgick\u00fdch gumov\u00fdch rukavic (v souladu s normou ISO 10282) nata\u017een\u00e1 na kal\u00ed\u0161ek. Jehla se vtla\u010d\u00ed vertik\u00e1ln\u011b do membr\u00e1ny. Pokud je d\u016flek minim\u00e1ln\u00ed a odpor n\u00edzk\u00fd, je jehla ostr\u00e1. Tato metoda nab\u00edz\u00ed rychlou vizu\u00e1ln\u00ed kontrolu konzistence ostrosti.<\/li>\n\n\n\n<li><strong data-start=\"3074\" data-end=\"3108\">Kvantitativn\u00ed metoda (metoda B)<\/strong>: Pou\u017e\u00edv\u00e1 se polymerizovan\u00e1 polyuretanov\u00e1 f\u00f3lie o tlou\u0161\u0165ce (0,35 \u00b1 0,05) mm a tvrdosti (85 \u00b1 10) Shore A. Jehla se pohybuje rychlost\u00ed 100 mm\/min, p\u0159i\u010dem\u017e se zaznamen\u00e1v\u00e1 propichovac\u00ed s\u00edla a posun. Kl\u00ed\u010dov\u00e9 hodnoty s\u00edly F0F_0F0, F1F_1F1 a F2F_2F2 odr\u00e1\u017eej\u00ed propichovac\u00ed a t\u0159ec\u00ed charakteristiky jehly. Tato metoda poskytuje vysoce spolehliv\u00e9 \u00fadaje pro hodnocen\u00ed propichovac\u00edch vlastnost\u00ed a porovn\u00e1v\u00e1n\u00ed r\u016fzn\u00fdch jehel.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Osv\u011bd\u010den\u00e9 postupy pro dodr\u017eov\u00e1n\u00ed normy ISO 17218<\/h2>\n\n\n\n<p>T\u00fdmy kontroly kvality a testov\u00e1n\u00ed by m\u011bly pe\u010dliv\u011b:<\/p>\n\n\n\n<p>\u2705 Pou\u017eijte standardizovan\u00fd testovac\u00ed p\u0159\u00edstroj k replikaci <a href=\"https:\/\/www.iso.org\/standard\/59443.html\" target=\"_blank\" rel=\"noopener nofollow\">ISO 17218<\/a>\u2019podm\u00ednky<br data-start=\"3728\" data-end=\"3731\">\u2705 P\u0159esn\u011b zaznamen\u00e1vejte \u00fadaje o zkou\u0161k\u00e1ch, v\u010detn\u011b p\u0159\u00edpadn\u00fdch zm\u011bn s\u00edly b\u011bhem zkou\u0161ek vpichu.<br data-start=\"3822\" data-end=\"3825\">\u2705 Porovn\u00e1n\u00ed v\u00fdsledk\u016f s v\u00fdsledky zn\u00e1m\u00fdch kvalitn\u00edch jehel za \u00fa\u010delem porovn\u00e1n\u00ed v\u00fdkonnosti.<br data-start=\"3903\" data-end=\"3906\">\u2705 Dokumentujte a archivujte v\u00fdsledky test\u016f pro \u00fa\u010dely zp\u011btn\u00e9 vysledovatelnosti a shody s p\u0159edpisy.<\/p>\n\n\n\n<p>Dodr\u017eov\u00e1n\u00edm t\u011bchto postup\u016f mohou v\u00fdrobci a pracovn\u00edci kontroly kvality s jistotou posuzovat sv\u00e9 akupunkturn\u00ed jehly.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\n\t\t\t\tKontaktujte n\u00e1s Z\u00edskejte \u0159e\u0161en\u00ed pro testov\u00e1n\u00ed podle normy ISO 17218\t\t\t\t<\/h2>\n\n\n\n<p>Na <strong data-start=\"4163\" data-end=\"4183\">Bun\u011b\u010dn\u00e9 n\u00e1stroje<\/strong>, specializujeme se na navrhov\u00e1n\u00ed a v\u00fdrobu zku\u0161ebn\u00edch za\u0159\u00edzen\u00ed, kter\u00e1 spl\u0148uj\u00ed mezin\u00e1rodn\u00ed normy, jako je ISO 17218. Na\u0161e p\u0159\u00edstroje zaji\u0161\u0165uj\u00ed p\u0159esn\u00e9 <strong data-start=\"4338\" data-end=\"4421\">testov\u00e1n\u00ed intenzity jehly, testov\u00e1n\u00ed ostrosti jehly a testov\u00e1n\u00ed vpichu jehly.<\/strong>. Nab\u00edz\u00edme tak\u00e9 zak\u00e1zkov\u00e1 testovac\u00ed \u0159e\u0161en\u00ed pro speci\u00e1ln\u00ed po\u017eadavky, kter\u00e1 v\u00e1m umo\u017en\u00ed p\u0159esn\u011b a spolehliv\u011b splnit vyv\u00edjej\u00edc\u00ed se po\u017eadavky trhu.<\/p>\n\n\n\n<p>A\u0165 u\u017e testujete obaly, l\u00e9ka\u0159sk\u00e9 p\u0159\u00edstroje nebo akupunkturn\u00ed jehly, <strong data-start=\"4642\" data-end=\"4662\">Bun\u011b\u010dn\u00e9 n\u00e1stroje<\/strong> m\u00e1 odborn\u00e9 znalosti, kter\u00e9 v\u00e1m pomohou udr\u017eet kvalitu, bezpe\u010dnost a shodu s p\u0159edpisy.<\/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\/cs\/wp-json\/wp\/v2\/standard\/9831","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/cs\/wp-json\/wp\/v2\/standard"}],"about":[{"href":"https:\/\/www.packqc.com\/cs\/wp-json\/wp\/v2\/types\/standard"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/cs\/wp-json\/wp\/v2\/media\/5491"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/cs\/wp-json\/wp\/v2\/media?parent=9831"}],"wp:term":[{"taxonomy":"standard-category","embeddable":true,"href":"https:\/\/www.packqc.com\/cs\/wp-json\/wp\/v2\/standard-category?post=9831"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}