{"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\/nn\/standard\/iso-17218\/","title":{"rendered":"ISO 17218"},"content":{"rendered":"<h2 class=\"wp-block-heading\">What is ISO 17218?<\/h2>\n\n\n\n<p>ISO 17218, titled <em data-start=\"1045\" data-end=\"1091\">\u201cSterile acupuncture needles for single use\u201d<\/em>, 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 <strong data-start=\"1302\" data-end=\"1322\">needle intensity<\/strong>, <strong data-start=\"1324\" data-end=\"1344\">needle sharpness<\/strong>, and <strong data-start=\"1350\" data-end=\"1381\">needle puncture performance<\/strong> to confirm that the needles meet global quality standards.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Acupuncture Needle Testing Explained<\/h2>\n\n\n\n<p>The standard specifies methods for three essential testing aspects:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">1. Needle Intensity Testing<\/h3>\n\n\n\n<p>Needle intensity measures a needle tip\u2019s ability to resist bending or breakage. In ISO 17218, this involves placing the acupuncture needle vertically against a steel block. The force is gradually increased until it meets the numerical criteria in section 5.3.5.2. After holding the load for (5 to 10) seconds, the needle tip is inspected under 5x magnification. The needle must remain straight, with no bending or hooking, ensuring that it won\u2019t deform during actual acupuncture treatments.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">2. Needle Sharpness Testing<\/h3>\n\n\n\n<p>Sharpness testing assesses the force needed for the needle tip to pierce aluminium foil. After intensity testing, the same acupuncture needle remains fixed in the apparatus. The needle is then pressed against the aluminium foil until it pierces it. The apparatus automatically records the piercing force, providing quantitative data on the needle\u2019s sharpness. A properly sharp needle requires less force to penetrate the foil, reflecting its smooth and precise puncture capability.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">3. Needle Puncture Testing<\/h3>\n\n\n\n<p>Puncture testing evaluates how well a needle penetrates soft tissues or materials. ISO 17218 provides two methods:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"2753\" data-end=\"2786\">Qualitative Method (Method A)<\/strong>: This uses a membrane of surgical rubber gloves (compliant with ISO 10282) stretched over a cup. The needle is pressed vertically into the membrane. If the dent is minimal and resistance is low, the needle is sharp. This method offers a quick, visual check for sharpness consistency.<\/li>\n\n\n\n<li><strong data-start=\"3074\" data-end=\"3108\">Quantitative Method (Method B)<\/strong>: This uses a polymerized polyurethane film with a thickness of (0.35 \u00b1 0.05) mm and a Shore Hardness of (85 \u00b1 10) Shore A. The needle is moved at 100 mm\/min while the piercing force and displacement are recorded. The key force values F0F_0F0\u200b, F1F_1F1\u200b, and F2F_2F2\u200b reflect the piercing and frictional characteristics of the needle. This method provides highly reliable data for assessing puncture performance and comparing different needles.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Best Practices for Complying with ISO 17218<\/h2>\n\n\n\n<p>Quality control and testing teams should carefully:<\/p>\n\n\n\n<p>\u2705 Use standardized test apparatus to replicate <a href=\"https:\/\/www.iso.org\/standard\/59443.html\" target=\"_blank\" rel=\"noopener nofollow\">ISO 17218<\/a>\u2019s conditions<br data-start=\"3728\" data-end=\"3731\">\u2705 Record the test data accurately, including any changes in force during the puncture tests<br data-start=\"3822\" data-end=\"3825\">\u2705 Compare results with those of known quality needles to benchmark performance<br data-start=\"3903\" data-end=\"3906\">\u2705 Document and archive the test results for traceability and regulatory compliance<\/p>\n\n\n\n<p>By following these practices, manufacturers and quality control personnel can confidently assess their acupuncture needles.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\n\t\t\t\tContact Us Get ISO 17218 Testing Solution\t\t\t\t<\/h2>\n\n\n\n<p>At <strong data-start=\"4163\" data-end=\"4183\">Cell Instruments<\/strong>, we specialize in designing and manufacturing testing equipment that complies with international standards like ISO 17218. Our instruments ensure precise <strong data-start=\"4338\" data-end=\"4421\">needle intensity testing, needle sharpness testing, and needle puncture testing<\/strong>. We also provide custom testing solutions for special requirements, enabling you to meet evolving market demands with accuracy and reliability.<\/p>\n\n\n\n<p>Whether you\u2019re testing packaging, medical devices, or acupuncture needles, <strong data-start=\"4642\" data-end=\"4662\">Cell Instruments<\/strong> has the expertise to help you maintain quality, safety, and compliance.<\/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\/nn\/wp-json\/wp\/v2\/standard\/9831","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/nn\/wp-json\/wp\/v2\/standard"}],"about":[{"href":"https:\/\/www.packqc.com\/nn\/wp-json\/wp\/v2\/types\/standard"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/nn\/wp-json\/wp\/v2\/media\/5491"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/nn\/wp-json\/wp\/v2\/media?parent=9831"}],"wp:term":[{"taxonomy":"standard-category","embeddable":true,"href":"https:\/\/www.packqc.com\/nn\/wp-json\/wp\/v2\/standard-category?post=9831"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}