{"id":17114,"date":"2025-08-07T14:57:30","date_gmt":"2025-08-07T12:57:30","guid":{"rendered":"https:\/\/www.healtis.com\/?p=17114"},"modified":"2026-04-08T16:43:29","modified_gmt":"2026-04-08T14:43:29","slug":"mr-image-artifacts-assessment-all-you-need-to-know","status":"publish","type":"post","link":"https:\/\/www.healtis.com\/en\/mr-image-artifacts-assessment-all-you-need-to-know\/","title":{"rendered":"MR Image Artifacts Assessment : All you need to know"},"content":{"rendered":"<p>In medical imaging, alterations in images are referred to as artifacts. In MRI, the presence of a device made of ferromagnetic, paramagnetic, or conductive materials systematically leads to the formation of artifacts.<\/p>\n<p>These typically appear as areas of signal void (black zones) around the device, and sometimes as image distortions. In most cases, artifacts don&#8217;t pose a major risk, but they can obscure important anatomical structures and interfere with diagnostic interpretation.<\/p>\n<p>Let\u2019s take a closer look at how these artifacts are assessed on implants.<\/p>\n<p><img decoding=\"async\" class=\"alignnone size-full wp-image-17104\" src=\"https:\/\/www.healtis.com\/w2020\/wp-content\/uploads\/2025\/08\/SP_Artefact_250807.jpg\" alt=\"\" width=\"515\" height=\"343\" \/><\/p>\n<h2>What\u2019s the process for evaluating MR image artifacts?<\/h2>\n<p>For passive implanted devices, the ASTM F2119 standard defines a method for evaluating artifacts. This standard is referenced in many others, including ISO 10974 and the FDA\u2019s \u201c<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/testing-and-labeling-medical-devices-safety-magnetic-resonance-mr-environment\">Testing and Labeling Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment<\/a>\u201d guide, which cite it as a possible method for assessing artifacts on active implants.<\/p>\n<p><img decoding=\"async\" class=\"alignnone size-full wp-image-17107\" src=\"https:\/\/www.healtis.com\/w2020\/wp-content\/uploads\/2025\/08\/Artefact_250807.bmp\" alt=\"\" width=\"256\" height=\"256\" \/><\/p>\n<p>Artifacts are evaluated through testing: we acquire images with the device in place, following the protocol outlined in ASTM F2119, using MRI systems operating at 1.5 T and\/or 3 T. These images are then compared to reference images taken without the device, in order to assess the extent of the artifacts caused by its presence. Artifacts are typically evaluated at each magnetic field strength (1.5T and 3T) for which MRI compatibility is claimed in the device\u2019s labeling.<\/p>\n<p><strong>HEALTIS is ISO\/IEC 17025 accredited to perform tests in accordance with the ASTM F2119 standard <\/strong>(Cofrac Testing Accreditation, N\u00b0 1-6320, scope available on <a href=\"http:\/\/www.cofrac.fr\">www.cofrac.fr<\/a>).<\/p>\n<h2>Worst-case artifact testing: how to define it?<\/h2>\n<p><img decoding=\"async\" class=\"alignnone size-full wp-image-15652\" src=\"https:\/\/www.healtis.com\/w2020\/wp-content\/uploads\/2019\/10\/image_page_formation_250121.jpg\" alt=\"\" width=\"1920\" height=\"1076\" srcset=\"https:\/\/www.healtis.com\/w2020\/wp-content\/uploads\/2019\/10\/image_page_formation_250121.jpg 1920w, https:\/\/www.healtis.com\/w2020\/wp-content\/uploads\/2019\/10\/image_page_formation_250121-600x336.jpg 600w, https:\/\/www.healtis.com\/w2020\/wp-content\/uploads\/2019\/10\/image_page_formation_250121-1000x560.jpg 1000w, https:\/\/www.healtis.com\/w2020\/wp-content\/uploads\/2019\/10\/image_page_formation_250121-768x430.jpg 768w, https:\/\/www.healtis.com\/w2020\/wp-content\/uploads\/2019\/10\/image_page_formation_250121-1536x861.jpg 1536w\" sizes=\"(max-width: 1920px) 100vw, 1920px\" \/><\/p>\n<p>The ASTM F2119 standard does not require artifact evaluation to be performed specifically on the configuration that generates the worst-case artifact. However, the FDA guide titled \u201c<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/testing-and-labeling-medical-devices-safety-magnetic-resonance-mr-environment\">Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environmen<\/a>t\u201d suggests that the largest medical device, or the one containing the greatest amount of magnetic material, can generally be considered the worst-case configuration.<\/p>\n<h2>How should test results be interpreted?<\/h2>\n<p>As noted in the FDA\u2019s recommendations, there are generally no formal acceptance criteria for image artifacts. The purpose of this evaluation is to provide healthcare professionals with useful information in the device labeling, allowing them to assess the benefit-risk balance of performing an MRI scan on a patient with the device.<\/p>\n<h2>We&#8217;re here to support you<\/h2>\n<p>At Healtis, we guide you through every step of your study : whether it&#8217;s artifact assessment in MRI or a comprehensive assessment of all risks associated with introducing your medical device into the MRI environment.<\/p>\n<p>Questions about your project? Feel free to reach out to us anytime via <a href=\"https:\/\/www.healtis.com\/en\/contact\/\">our contact page<\/a> or at sales@healtis.com.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>In medical imaging, alterations in images are referred to as artifacts. In MRI, the presence of a device made of ferromagnetic, paramagnetic, or conductive materials systematically leads to the formation of artifacts. These typically appear as areas of signal void (black zones) around the device, and sometimes as image distortions. In most cases, artifacts don&#8217;t [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[3,52],"tags":[],"class_list":["post-17114","post","type-post","status-publish","format-standard","hentry","category-uncategorized","category-veille-reglementaire"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>MR Image Artifacts Assessment : All you need to know - Healtis MRI Safety<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.healtis.com\/en\/mr-image-artifacts-assessment-all-you-need-to-know\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MR Image Artifacts Assessment : All you need to know - Healtis MRI Safety\" \/>\n<meta property=\"og:description\" content=\"In medical imaging, alterations in images are referred to as artifacts. In MRI, the presence of a device made of ferromagnetic, paramagnetic, or conductive materials systematically leads to the formation of artifacts. These typically appear as areas of signal void (black zones) around the device, and sometimes as image distortions. 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