{"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\/ro\/standard\/iso-17218\/","title":{"rendered":"ISO 17218"},"content":{"rendered":"<h2 class=\"wp-block-heading\">Ce este ISO 17218?<\/h2>\n\n\n\n<p>ISO 17218, intitulat <em data-start=\"1045\" data-end=\"1091\">\u201cAce de acupunctur\u0103 sterile pentru utilizare unic\u0103\u201d<\/em>, descrie metodele standardizate de evaluare a acelor de acupunctur\u0103. Scopul s\u0103u principal este de a se asigura c\u0103 acele sunt sigure, eficiente \u0219i fiabile \u00een timpul utiliz\u0103rii clinice. Standardul include orient\u0103ri pentru testarea <strong data-start=\"1302\" data-end=\"1322\">intensitatea acului<\/strong>, <strong data-start=\"1324\" data-end=\"1344\">ascu\u021bimea acului<\/strong>, \u0219i <strong data-start=\"1350\" data-end=\"1381\">performan\u021ba de perforare a acului<\/strong> pentru a confirma c\u0103 acele \u00eendeplinesc standardele globale de calitate.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Explicarea test\u0103rii cu acul de acupunctur\u0103<\/h2>\n\n\n\n<p>Standardul specific\u0103 metode pentru trei aspecte esen\u021biale de testare:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">1. Testarea intensit\u0103\u021bii acului<\/h3>\n\n\n\n<p>Intensitatea acului m\u0103soar\u0103 capacitatea v\u00e2rfului acului de a rezista la \u00eendoire sau rupere. \u00cen ISO 17218, aceasta implic\u0103 plasarea acului de acupunctur\u0103 vertical pe un bloc de o\u021bel. For\u021ba este crescut\u0103 treptat p\u00e2n\u0103 c\u00e2nd \u00eendepline\u0219te criteriile numerice din sec\u021biunea 5.3.5.2. Dup\u0103 men\u021binerea for\u021bei timp de (5-10) secunde, v\u00e2rful acului este inspectat la o magnificare de 5x. Acul trebuie s\u0103 r\u0103m\u00e2n\u0103 drept, f\u0103r\u0103 \u00eendoire sau ag\u0103\u021bare, asigur\u00e2ndu-se c\u0103 nu se va deforma \u00een timpul tratamentelor de acupunctur\u0103 reale.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">2. Testarea ascu\u021beniei acului<\/h3>\n\n\n\n<p>Testarea ascu\u021bimii evalueaz\u0103 for\u021ba necesar\u0103 pentru ca v\u00e2rful acului s\u0103 str\u0103pung\u0103 folia de aluminiu. Dup\u0103 testarea intensit\u0103\u021bii, acela\u0219i ac de acupunctur\u0103 r\u0103m\u00e2ne fixat \u00een aparat. Acul este apoi presat \u00eempotriva foliei de aluminiu p\u00e2n\u0103 c\u00e2nd o str\u0103punge. Aparatul \u00eenregistreaz\u0103 automat for\u021ba de str\u0103pungere, furniz\u00e2nd date cantitative privind ascu\u021bimea acului. Un ac bine ascu\u021bit necesit\u0103 mai pu\u021bin\u0103 for\u021b\u0103 pentru a penetra folia, reflect\u00e2nd capacitatea sa de perforare lin\u0103 \u0219i precis\u0103.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">3. Testarea prin punc\u021bie cu ac<\/h3>\n\n\n\n<p>\u00cencercarea de perforare evalueaz\u0103 c\u00e2t de bine p\u0103trunde un ac \u00een \u021besuturi sau materiale moi. ISO 17218 prevede dou\u0103 metode:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"2753\" data-end=\"2786\">Metoda calitativ\u0103 (metoda A)<\/strong>: Aceasta utilizeaz\u0103 o membran\u0103 de m\u0103nu\u0219i chirurgicale din cauciuc (\u00een conformitate cu ISO 10282) \u00eentins\u0103 peste o cup\u0103. Acul este presat vertical \u00een membran\u0103. Dac\u0103 amprenta este minim\u0103 \u0219i rezisten\u021ba este sc\u0103zut\u0103, acul este ascu\u021bit. Aceast\u0103 metod\u0103 ofer\u0103 o verificare vizual\u0103 rapid\u0103 a consisten\u021bei ascu\u021bi\u0219ului.<\/li>\n\n\n\n<li><strong data-start=\"3074\" data-end=\"3108\">Metoda cantitativ\u0103 (metoda B)<\/strong>: Se utilizeaz\u0103 o pelicul\u0103 poliuretanic\u0103 polimerizat\u0103 cu o grosime de (0,35 \u00b1 0,05) mm \u0219i o duritate Shore de (85 \u00b1 10) Shore A. Acul este deplasat cu 100 mm\/min \u00een timp ce for\u021ba de str\u0103pungere \u0219i deplasarea sunt \u00eenregistrate. Valorile cheie ale for\u021bei F0F_0F0, F1F_1F1 \u0219i F2F_2F2 reflect\u0103 caracteristicile de str\u0103pungere \u0219i fric\u021biune ale acului. Aceast\u0103 metod\u0103 ofer\u0103 date extrem de fiabile pentru evaluarea performan\u021bei de perforare \u0219i compararea diferitelor ace.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Cele mai bune practici pentru conformarea cu ISO 17218<\/h2>\n\n\n\n<p>Echipele de control al calit\u0103\u021bii \u0219i de testare ar trebui s\u0103 fie atente:<\/p>\n\n\n\n<p>\u2705 Utiliza\u021bi aparate de testare standardizate pentru a reproduce <a href=\"https:\/\/www.iso.org\/standard\/59443.html\" target=\"_blank\" rel=\"noopener nofollow\">ISO 17218<\/a>\u2019Condi\u021biile \"s<br data-start=\"3728\" data-end=\"3731\">\u2705 \u00cenregistra\u021bi cu exactitate datele testelor, inclusiv orice modificare a for\u021bei \u00een timpul testelor de punc\u021bie<br data-start=\"3822\" data-end=\"3825\">\u2705 Compara\u021bi rezultatele cu cele ale acelor de calitate cunoscute pentru a evalua performan\u021bele<br data-start=\"3903\" data-end=\"3906\">\u2705 Documenta\u021bi \u0219i arhiva\u021bi rezultatele testelor pentru trasabilitate \u0219i conformitate cu reglement\u0103rile<\/p>\n\n\n\n<p>Prin respectarea acestor practici, produc\u0103torii \u0219i personalul de control al calit\u0103\u021bii \u00ee\u0219i pot evalua cu \u00eencredere acele de acupunctur\u0103.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\n\t\t\t\tContacta\u021bi-ne pentru a ob\u021bine solu\u021bia de testare ISO 17218\t\t\t\t<\/h2>\n\n\n\n<p>La <strong data-start=\"4163\" data-end=\"4183\">Instrumente celulare<\/strong>, suntem specializa\u021bi \u00een proiectarea \u0219i fabricarea de echipamente de testare care respect\u0103 standardele interna\u021bionale precum ISO 17218. Instrumentele noastre asigur\u0103 o precizie <strong data-start=\"4338\" data-end=\"4421\">testarea intensit\u0103\u021bii acului, testarea ascu\u021beniei acului \u0219i testarea perfor\u0103rii acului<\/strong>. De asemenea, oferim solu\u021bii de testare personalizate pentru cerin\u021be speciale, permi\u021b\u00e2ndu-v\u0103 s\u0103 satisface\u021bi cerin\u021bele pie\u021bei \u00een continu\u0103 evolu\u021bie cu acurate\u021be \u0219i fiabilitate.<\/p>\n\n\n\n<p>Fie c\u0103 testa\u021bi ambalaje, dispozitive medicale sau ace de acupunctur\u0103, <strong data-start=\"4642\" data-end=\"4662\">Instrumente celulare<\/strong> are expertiza necesar\u0103 pentru a v\u0103 ajuta s\u0103 men\u021bine\u021bi calitatea, siguran\u021ba \u0219i conformitatea.<\/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\/ro\/wp-json\/wp\/v2\/standard\/9831","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/standard"}],"about":[{"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/types\/standard"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/media\/5491"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/media?parent=9831"}],"wp:term":[{"taxonomy":"standard-category","embeddable":true,"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/standard-category?post=9831"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}