{"id":279631,"date":"2024-10-19T18:52:42","date_gmt":"2024-10-19T18:52:42","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-62366-12015a12020\/"},"modified":"2024-10-25T15:26:45","modified_gmt":"2024-10-25T15:26:45","slug":"bs-en-62366-12015a12020","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-62366-12015a12020\/","title":{"rendered":"BS EN 62366-1:2015+A1:2020"},"content":{"rendered":"<p>This part of IEC&nbsp;62366 specifies a <small style=\"text-transform: uppercase\">process<\/small> for a <small style=\"text-transform: uppercase\">manufacturer<\/small> to analyse, specify, develop and evaluate the <small style=\"text-transform: uppercase\">usability<\/small> of a <small style=\"text-transform: uppercase\">medical device<\/small> as it relates to <small style=\"text-transform: uppercase\">safety<\/small>. This <small style=\"text-transform: uppercase\">usability engineering<\/small> (<small style=\"text-transform: uppercase\">human factors engineering<\/small>) <small style=\"text-transform: uppercase\">process<\/small> permits the <small style=\"text-transform: uppercase\">manufacturer<\/small> to assess and mitigate <small style=\"text-transform: uppercase\">risks<\/small> associated with <small style=\"text-transform: uppercase\">normal use<\/small>, i.e., <small style=\"text-transform: uppercase\">correct use<\/small> and <small style=\"text-transform: uppercase\">use error<\/small>. It can be used to identify but does not assess or mitigate <small style=\"text-transform: uppercase\">risks<\/small> associated with <small style=\"text-transform: uppercase\">abnormal use<\/small>.<\/p>\n<blockquote>\n<p>&nbsp;NOTE&nbsp;1<\/p>\n<p>S<small style=\"text-transform: uppercase\">afety<\/small> is freedom from unacceptable <small style=\"text-transform: uppercase\">risk<\/small>. Unacceptable <small style=\"text-transform: uppercase\">risk<\/small> can arise from <small style=\"text-transform: uppercase\">use error<\/small>, which can lead to exposure to <small style=\"text-transform: uppercase\">hazards<\/small> including loss or degradation of clinical performance.<\/p>\n<\/blockquote>\n<blockquote>\n<p>NOTE&nbsp;2 Guidance on the application of <small style=\"text-transform: uppercase\">usability engineering<\/small> to <small style=\"text-transform: uppercase\">medical devices<\/small> is available in IEC&nbsp;62366\u20112<sup>2<\/sup>, which addresses not only <small style=\"text-transform: uppercase\">safety<\/small> but also aspects of <small style=\"text-transform: uppercase\">usability<\/small> not related to <small style=\"text-transform: uppercase\">safety<\/small>.<\/p>\n<\/blockquote>\n<p>If the <small style=\"text-transform: uppercase\">usability engineering process<\/small> detailed in this International Standard has been complied with, then the <small style=\"text-transform: uppercase\">usability<\/small> of a <small style=\"text-transform: uppercase\">medical device<\/small> as it relates to <small style=\"text-transform: uppercase\">safety<\/small> is presumed to be acceptable, unless there is <small style=\"text-transform: uppercase\">objective evidence<\/small> to the contrary.<\/p>\n<blockquote>\n<p>NOTE&nbsp;3 Such <small style=\"text-transform: uppercase\">objective evidence<\/small> can subsequently originate from <small style=\"text-transform: uppercase\">post-production<\/small> surveillance.<\/p>\n<\/blockquote>\n","protected":false},"excerpt":{"rendered":"<p><b>Medical devices &#8211; Application of usability engineering to medical devices<\/b><\/p>\n<table class=\"shortdes-table\" style=\"width: 100%\" border=\"0\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td>Published By<\/td>\n<td>Publication Date<\/td>\n<td>Number of Pages<\/td>\n<\/tr>\n<tr>\n<td><a href=\"https:\/\/pdfstandards.shop\/product-category\/publishers\/bsi\/\"><b>BSI<\/b><\/a><\/td>\n<td>2020<\/td>\n<td>60<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":279636,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[136,2641],"product_tag":[],"class_list":{"0":"post-279631","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-01","7":"product_cat-bsi","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/279631","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/279636"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=279631"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=279631"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=279631"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}