{"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\/sk\/standard\/iso-17218\/","title":{"rendered":"ISO 17218"},"content":{"rendered":"<h2 class=\"wp-block-heading\">\u010co je norma ISO 17218?<\/h2>\n\n\n\n<p>ISO 17218 s n\u00e1zvom <em data-start=\"1045\" data-end=\"1091\">\u201cSteriln\u00e9 akupunkt\u00farne ihly na jedno pou\u017eitie\u201d<\/em>, uv\u00e1dza \u0161tandardizovan\u00e9 met\u00f3dy hodnotenia akupunkt\u00farnych ihiel. Jej hlavn\u00fdm cie\u013eom je zabezpe\u010di\u0165, aby boli ihly po\u010das klinick\u00e9ho pou\u017e\u00edvania bezpe\u010dn\u00e9, \u00fa\u010dinn\u00e9 a spo\u013eahliv\u00e9. Norma obsahuje usmernenia na testovanie <strong data-start=\"1302\" data-end=\"1322\">intenzita ihly<\/strong>, <strong data-start=\"1324\" data-end=\"1344\">ostros\u0165 ihly<\/strong>, a <strong data-start=\"1350\" data-end=\"1381\">v\u00fdkon pri vpichu ihly<\/strong> aby sa potvrdilo, \u017ee ihly sp\u013a\u0148aj\u00fa celosvetov\u00e9 normy kvality.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Vysvetlenie testovania akupunkt\u00farnou ihlou<\/h2>\n\n\n\n<p>Norma \u0161pecifikuje met\u00f3dy pre tri z\u00e1kladn\u00e9 aspekty testovania:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">1. Testovanie intenzity ihly<\/h3>\n\n\n\n<p>Intenzita ihly meria schopnos\u0165 hrotu ihly odol\u00e1va\u0165 ohnutiu alebo zlomeniu. Pod\u013ea normy ISO 17218 sa akupunkt\u00farna ihla umiest\u0148uje vertik\u00e1lne na oce\u013eov\u00fd blok. Sila sa postupne zvy\u0161uje, a\u017e k\u00fdm nespln\u00ed \u010d\u00edseln\u00e9 krit\u00e9ri\u00e1 uveden\u00e9 v \u010dasti 5.3.5.2. Po udr\u017ean\u00ed z\u00e1\u0165a\u017ee po\u010das (5 a\u017e 10) sek\u00fand sa hrot ihly skontroluje pod 5-n\u00e1sobn\u00fdm zv\u00e4\u010d\u0161en\u00edm. Ihla mus\u00ed zosta\u0165 rovn\u00e1, bez ohnutia alebo zah\u00e1knutia, \u010d\u00edm sa zabezpe\u010d\u00ed, \u017ee sa nedeformuje po\u010das skuto\u010dn\u00fdch akupunkt\u00farnych o\u0161etren\u00ed.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">2. Testovanie ostrosti ihiel<\/h3>\n\n\n\n<p>Testovanie ostrosti hodnot\u00ed silu potrebn\u00fa na prepichnutie hlin\u00edkovej f\u00f3lie hrotom ihly. Po testovan\u00ed intenzity zost\u00e1va v pr\u00edstroji upevnen\u00e1 t\u00e1 ist\u00e1 akupunkt\u00farna ihla. Ihla sa potom pritla\u010d\u00ed na hlin\u00edkov\u00fa f\u00f3liu, k\u00fdm ju neprepichne. Pr\u00edstroj automaticky zaznamen\u00e1va silu prepichnutia, \u010d\u00edm poskytuje kvantitat\u00edvne \u00fadaje o ostrosti ihly. Spr\u00e1vne ostr\u00e1 ihla potrebuje na prerazenie f\u00f3lie men\u0161iu silu, \u010do odr\u00e1\u017ea jej hladk\u00fa a presn\u00fa priebojnos\u0165.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">3. Testovanie vpichom ihly<\/h3>\n\n\n\n<p>Testovanie punkcie hodnot\u00ed, ako dobre ihla prenik\u00e1 do m\u00e4kk\u00fdch tkan\u00edv alebo materi\u00e1lov. Norma ISO 17218 stanovuje dve met\u00f3dy:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"2753\" data-end=\"2786\">Kvalitat\u00edvna met\u00f3da (met\u00f3da A)<\/strong>: Pou\u017e\u00edva sa membr\u00e1na z chirurgick\u00fdch gumen\u00fdch rukav\u00edc (v s\u00falade s normou ISO 10282) natiahnut\u00e1 na poh\u00e1rik. Ihla sa zatla\u010d\u00ed vertik\u00e1lne do membr\u00e1ny. Ak je priehlbina minim\u00e1lna a odpor n\u00edzky, ihla je ostr\u00e1. T\u00e1to met\u00f3da pon\u00faka r\u00fdchlu vizu\u00e1lnu kontrolu konzistentnosti ostrosti.<\/li>\n\n\n\n<li><strong data-start=\"3074\" data-end=\"3108\">Kvantitat\u00edvna met\u00f3da (met\u00f3da B)<\/strong>: Pou\u017e\u00edva sa polymerizovan\u00fd polyuret\u00e1nov\u00fd film s hr\u00fabkou (0,35 \u00b1 0,05) mm a tvrdos\u0165ou (85 \u00b1 10) Shore A. Ihla sa pohybuje r\u00fdchlos\u0165ou 100 mm\/min, pri\u010dom sa zaznamen\u00e1va prierazn\u00e1 sila a posun. K\u013e\u00fa\u010dov\u00e9 hodnoty sily F0F_0F0, F1F_1F1 a F2F_2F2 odr\u00e1\u017eaj\u00fa vlastnosti prepichovania a trenia ihly. T\u00e1to met\u00f3da poskytuje ve\u013emi spo\u013eahliv\u00e9 \u00fadaje na pos\u00fadenie priebojnosti a porovnanie r\u00f4znych ihiel.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Osved\u010den\u00e9 postupy na dosiahnutie s\u00faladu s normou ISO 17218<\/h2>\n\n\n\n<p>T\u00edmy kontroly kvality a testovania by mali starostlivo:<\/p>\n\n\n\n<p>\u2705 Pou\u017e\u00edvajte \u0161tandardizovan\u00fd testovac\u00ed pr\u00edstroj na replik\u00e1ciu <a href=\"https:\/\/www.iso.org\/standard\/59443.html\" target=\"_blank\" rel=\"noopener nofollow\">ISO 17218<\/a>\u2019podmienky<br data-start=\"3728\" data-end=\"3731\">\u2705 Presne zaznamen\u00e1vajte \u00fadaje o testoch vr\u00e1tane ak\u00fdchko\u013evek zmien sily po\u010das testov prepichnutia<br data-start=\"3822\" data-end=\"3825\">\u2705 Porovnanie v\u00fdsledkov s v\u00fdsledkami zn\u00e1mych kvalitn\u00fdch ihiel na porovnanie v\u00fdkonnosti<br data-start=\"3903\" data-end=\"3906\">\u2705 zdokumentujte a archivujte v\u00fdsledky testov na \u00fa\u010dely vysledovate\u013enosti a dodr\u017eiavania predpisov<\/p>\n\n\n\n<p>Dodr\u017eiavan\u00edm t\u00fdchto postupov m\u00f4\u017eu v\u00fdrobcovia a pracovn\u00edci kontroly kvality s istotou pos\u00fadi\u0165 svoje akupunkt\u00farne ihly.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\n\t\t\t\tKontaktujte n\u00e1s Z\u00edskajte rie\u0161enie na testovanie pod\u013ea normy ISO 17218\t\t\t\t<\/h2>\n\n\n\n<p>O <strong data-start=\"4163\" data-end=\"4183\">Cell Instruments<\/strong>, \u0161pecializujeme sa na navrhovanie a v\u00fdrobu testovac\u00edch zariaden\u00ed, ktor\u00e9 sp\u013a\u0148aj\u00fa medzin\u00e1rodn\u00e9 normy, ako je ISO 17218. Na\u0161e pr\u00edstroje zabezpe\u010duj\u00fa presnos\u0165 <strong data-start=\"4338\" data-end=\"4421\">testovanie intenzity ihly, testovanie ostrosti ihly a testovanie vpichu ihly<\/strong>. Poskytujeme aj z\u00e1kazkov\u00e9 testovacie rie\u0161enia pre \u0161peci\u00e1lne po\u017eiadavky, ktor\u00e9 v\u00e1m umo\u017enia splni\u0165 vyv\u00edjaj\u00face sa po\u017eiadavky trhu s presnos\u0165ou a spo\u013eahlivos\u0165ou.<\/p>\n\n\n\n<p>\u010ci u\u017e testujete obaly, zdravotn\u00edcke pom\u00f4cky alebo akupunkt\u00farne ihly, <strong data-start=\"4642\" data-end=\"4662\">Cell Instruments<\/strong> m\u00e1 odborn\u00e9 znalosti, ktor\u00e9 v\u00e1m pom\u00f4\u017eu udr\u017ea\u0165 kvalitu, bezpe\u010dnos\u0165 a s\u00falad s predpismi.<\/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\/sk\/wp-json\/wp\/v2\/standard\/9831","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/sk\/wp-json\/wp\/v2\/standard"}],"about":[{"href":"https:\/\/www.packqc.com\/sk\/wp-json\/wp\/v2\/types\/standard"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/sk\/wp-json\/wp\/v2\/media\/5491"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/sk\/wp-json\/wp\/v2\/media?parent=9831"}],"wp:term":[{"taxonomy":"standard-category","embeddable":true,"href":"https:\/\/www.packqc.com\/sk\/wp-json\/wp\/v2\/standard-category?post=9831"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}