{"id":2815,"date":"2024-09-03T14:56:12","date_gmt":"2024-09-03T12:56:12","guid":{"rendered":"https:\/\/endolab.org\/?post_type=hip-implants&#038;p=2815"},"modified":"2025-12-08T11:52:44","modified_gmt":"2025-12-08T10:52:44","slug":"iso-21535","status":"publish","type":"hip-implants","link":"https:\/\/endolab.org\/de\/hip-implants\/iso-21535\/","title":{"rendered":"ISO\u00a021535"},"content":{"rendered":"<p><strong>ISO&nbsp;21535:<\/strong>&nbsp;Non-active surgical implants &#8211; Joint replacement implants &#8211; Specific requirements for hip-joint implants &nbsp;<\/p>\n\n\n\n<p>ISO 21535 has been fundamentally revised. It now serves as the go-to standard for all hip devices, and includes the relevant ASTM procedures. For submission to regulatory bodies worldwide, ISO 21535 (the so-called &#8220;hip umbrella standard&#8221;) is now the applicable guideline.<\/p>\n\n\n\n<p>Additionally, the standard outlines the evaluation process for test results, which involves a multi-stage procedure. In particular, it requires the use of a reference implant (predicate device), which presents manufacturers with fundamentally new requirements.<\/p>\n\n\n\n<p>Our specialists will be happy to assist you in selecting the worst-case combinations for testing and to be tested and in developing a test plan that meets the requirements of ISO 21535. \u00a0<\/p>\n\n\n\n<div style=\"height:60px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>","protected":false},"featured_media":0,"template":"","meta":{"_acf_changed":true,"_uag_custom_page_level_css":""},"class_list":["post-2815","hip-implants","type-hip-implants","status-publish","hentry"],"acf":[],"uagb_featured_image_src":{"full":false,"thumbnail":false,"medium":false,"medium_large":false,"large":false,"1536x1536":false,"2048x2048":false,"trp-custom-language-flag":false},"uagb_author_info":{"display_name":"Bastian Kaddick","author_link":"https:\/\/endolab.org\/de\/author\/"},"uagb_comment_info":0,"uagb_excerpt":"ISO&nbsp;21535:&nbsp;Non-active surgical implants &#8211; Joint replacement implants &#8211; Specific requirements for hip-joint implants &nbsp; ISO 21535 has been fundamentally revised. It now serves as the go-to standard for all hip devices, and includes the relevant ASTM procedures. For submission to regulatory bodies worldwide, ISO 21535 (the so-called &#8220;hip umbrella standard&#8221;) is now the applicable guideline.&hellip;","_links":{"self":[{"href":"https:\/\/endolab.org\/de\/wp-json\/wp\/v2\/hip-implants\/2815","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/endolab.org\/de\/wp-json\/wp\/v2\/hip-implants"}],"about":[{"href":"https:\/\/endolab.org\/de\/wp-json\/wp\/v2\/types\/hip-implants"}],"wp:attachment":[{"href":"https:\/\/endolab.org\/de\/wp-json\/wp\/v2\/media?parent=2815"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}