{"id":70,"date":"2025-10-09T02:13:11","date_gmt":"2025-10-09T02:13:11","guid":{"rendered":"https:\/\/engprojects.tcnj.edu\/stepwise\/?page_id=70"},"modified":"2025-10-09T02:33:02","modified_gmt":"2025-10-09T02:33:02","slug":"standards","status":"publish","type":"page","link":"https:\/\/engprojects.tcnj.edu\/stepwise\/standards\/","title":{"rendered":"Standards"},"content":{"rendered":"\n<p><a href=\"https:\/\/www.iso.org\/standard\/79620.html\">ISO 22523:2006<\/a> (International Organisation for Standards)<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Ensures the ankle device meets mechanical strength, durability, and fatigue testing requirements for external orthoses. Directly informs the load-bearing specifications and cyclic stress testing needed for adjustable support stages, preventing failure during gait.<\/li>\n<\/ul>\n\n\n\n<p><a href=\"https:\/\/www.iso.org\/standard\/64750.html\">ISO 10993-18:2020<\/a> (International Organisation for Standards)<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Guides material selection to ensure skin-contact components are non-toxic, hypoallergenic, and free of harmful residues.<\/li>\n<\/ul>\n\n\n\n<p><a href=\"https:\/\/www.iso.org\/standard\/72704.html\">ISO 14971:2019<\/a> (International Organisation for Standards)<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Defines the framework for identifying hazards (over-compression, instability during partial support, mechanical failure) and implementing risk control measures.<\/li>\n<\/ul>\n\n\n\n<p><a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfStandards\/detail.cfm?standard__identification_no=44171\">ASTM\u00a0 F3109-22<\/a> (FDA Standards)<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Relevant for validating any force-sensing system used to monitor patient loading. Ensures accuracy in force\/torque measurements.<\/li>\n<\/ul>\n\n\n\n<p><a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfStandards\/detail.cfm?standard__identification_no=42931\">IEC\u00a0 80601-2-78 Edition 1.0 2019-07<\/a> (FDA Standards)<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>This standard provides safety\/performance benchmarks for rehab\/assistive devices and classifies external ankle braces as \u201cClass 1 (low risk)\u201d devices, guiding the design process.<\/li>\n<\/ul>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>ISO 22523:2006 (International Organisation for Standards) ISO 10993-18:2020 (International Organisation for Standards) ISO 14971:2019 (International Organisation for Standards) ASTM\u00a0 F3109-22 (FDA Standards) IEC\u00a0 80601-2-78 Edition 1.0 2019-07 (FDA Standards)<\/p>\n","protected":false},"author":664,"featured_media":0,"parent":0,"menu_order":5,"comment_status":"closed","ping_status":"closed","template":"","meta":{"ngg_post_thumbnail":0,"footnotes":""},"class_list":["post-70","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/engprojects.tcnj.edu\/stepwise\/wp-json\/wp\/v2\/pages\/70","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/engprojects.tcnj.edu\/stepwise\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/engprojects.tcnj.edu\/stepwise\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/engprojects.tcnj.edu\/stepwise\/wp-json\/wp\/v2\/users\/664"}],"replies":[{"embeddable":true,"href":"https:\/\/engprojects.tcnj.edu\/stepwise\/wp-json\/wp\/v2\/comments?post=70"}],"version-history":[{"count":0,"href":"https:\/\/engprojects.tcnj.edu\/stepwise\/wp-json\/wp\/v2\/pages\/70\/revisions"}],"wp:attachment":[{"href":"https:\/\/engprojects.tcnj.edu\/stepwise\/wp-json\/wp\/v2\/media?parent=70"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}