{"id":98,"date":"2023-09-22T01:38:59","date_gmt":"2023-09-22T01:38:59","guid":{"rendered":"https:\/\/engprojects.tcnj.edu\/chroma-scan-health\/?page_id=98"},"modified":"2023-11-17T21:40:05","modified_gmt":"2023-11-17T21:40:05","slug":"requirement-5","status":"publish","type":"page","link":"https:\/\/engprojects.tcnj.edu\/chroma-scan-health\/requirement-5\/","title":{"rendered":"Requirement 5"},"content":{"rendered":"\n<figure class=\"wp-block-image size-full is-resized is-style-rounded\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/engprojects.tcnj.edu\/chroma-scan-health\/wp-content\/uploads\/sites\/249\/2023\/09\/Clean_disinfect_paperTowel.png\" alt=\"\" class=\"wp-image-99\" width=\"337\" height=\"338\" srcset=\"https:\/\/engprojects.tcnj.edu\/chroma-scan-health\/wp-content\/uploads\/sites\/249\/2023\/09\/Clean_disinfect_paperTowel.png 417w, https:\/\/engprojects.tcnj.edu\/chroma-scan-health\/wp-content\/uploads\/sites\/249\/2023\/09\/Clean_disinfect_paperTowel-300x300.png 300w, https:\/\/engprojects.tcnj.edu\/chroma-scan-health\/wp-content\/uploads\/sites\/249\/2023\/09\/Clean_disinfect_paperTowel-150x150.png 150w\" sizes=\"auto, (max-width: 337px) 100vw, 337px\" \/><\/figure>\n\n\n\n<p style=\"font-size:14px\"><strong><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-dark-purple-color\">Figure shows a hand with a purple glove on sanitizing a surface<\/mark><\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Device must be able to be sanitiz<\/strong>ed<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td>&nbsp;<\/td><td><strong>Requirement<\/strong><\/td><td><strong>Specification<\/strong><\/td><\/tr><tr><td><br><strong>5<\/strong><\/td><td>Device must be sanitizable.<\/td><td>Use EPA approved disinfectants (Regulation No. 34810-37-5813)Isopropyl alcohol (70\u2013 90%)<\/td><\/tr><tr><td><strong>Justification<\/strong><\/td><td>Non-critical medical device is expected to come into contact with patients\u2019 urine.<sup>1<\/sup><\/td><td>FDA recommends thorough cleaning and low level disinfection <sup>2<\/sup> with EPA-registered disinfectants.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Verification: <\/strong>Swab test for cleaning validation.<\/p>\n\n\n\n<h2 class=\"wp-block-heading has-medium-font-size\">Example of EPA disinfectants:<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>EPA-registered disinfectants: Clorox-Plant Based Disinfecting Wipes (Regulation No. 34810-37-5813).\n<ul class=\"wp-block-list\">\n<li>Ethyl or isopropyl alcohol (70\u2013 90%).<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<div style=\"height:80px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p><strong>References: <\/strong><\/p>\n\n\n\n<p>[1] GUIDANCE, D. Draft Guidance for Industry and FDA Staff Processing\/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.&nbsp;<\/p>\n\n\n\n<p>[2] Rutala, W. A., &amp; Weber, D. J. (2008). Guideline for disinfection and sterilization in healthcare facilities, 2008<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Figure shows a hand with a purple glove on sanitizing a surface Device must be able to be sanitized &nbsp; Requirement Specification 5 Device must be sanitizable. Use EPA approved disinfectants (Regulation No. 34810-37-5813)Isopropyl alcohol (70\u2013 90%) Justification Non-critical medical device is expected to come into contact with patients\u2019 urine.1 FDA recommends thorough cleaning and &hellip; <a href=\"https:\/\/engprojects.tcnj.edu\/chroma-scan-health\/requirement-5\/\" class=\"more-link\">Continue reading <span class=\"screen-reader-text\">Requirement 5<\/span><\/a><\/p>\n","protected":false},"author":494,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"ngg_post_thumbnail":0,"footnotes":""},"class_list":["post-98","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/engprojects.tcnj.edu\/chroma-scan-health\/wp-json\/wp\/v2\/pages\/98","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/engprojects.tcnj.edu\/chroma-scan-health\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/engprojects.tcnj.edu\/chroma-scan-health\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/engprojects.tcnj.edu\/chroma-scan-health\/wp-json\/wp\/v2\/users\/494"}],"replies":[{"embeddable":true,"href":"https:\/\/engprojects.tcnj.edu\/chroma-scan-health\/wp-json\/wp\/v2\/comments?post=98"}],"version-history":[{"count":0,"href":"https:\/\/engprojects.tcnj.edu\/chroma-scan-health\/wp-json\/wp\/v2\/pages\/98\/revisions"}],"wp:attachment":[{"href":"https:\/\/engprojects.tcnj.edu\/chroma-scan-health\/wp-json\/wp\/v2\/media?parent=98"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}