{"id":585277,"date":"2024-11-05T20:44:25","date_gmt":"2024-11-05T20:44:25","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/iso-111972019\/"},"modified":"2024-11-05T20:44:25","modified_gmt":"2024-11-05T20:44:25","slug":"iso-111972019","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/iso\/iso-111972019\/","title":{"rendered":"ISO 11197:2019"},"content":{"rendered":"<p><i>IEC 60601-1:2005+A1:2012, 1.1 is replaced by: <\/i><\/p>\n<p>This document applies to the <i>basic<\/i> <i>safety<\/i> and <i>essential<\/i> <i>performance<\/i> of <i>medical<\/i> <i>supply<\/i> <i>units<\/i>, hereafter also referred to as <i>ME<\/i> <i>equipment<\/i>.<\/p>\n<p>This document applies to <i>medical<\/i> <i>supply<\/i> <i>units<\/i> manufactured within a factory or assembled on site, including cabinetry and other <i>enclosures<\/i>, which incorporate <i>patient<\/i> care services. <\/p>\n<p>NOTE 1    A party that assembles on site various components intended for <i>patient<\/i> care services into an <i>enclosure<\/i> is considered the <i>manufacturer<\/i> of the <i>medical<\/i> <i>supply<\/i> <i>unit<\/i>.<\/p>\n<p><i>Hazards<\/i> inherent in the intended function of <i>ME<\/i> <i>equipment<\/i> or <i>ME<\/i> <i>systems<\/i> within the scope of this document are not covered by specific requirements in this standard, except in of IEC 60601-1:2005+A1:2012, 7.2.13 and 8.4.1 (see 201.1.4).<\/p>\n<p>NOTE 2    Refer to IEC 60601-1:2005+A1:2012, 4.2.<\/p>\n","protected":false},"excerpt":{"rendered":"<p><b>Medical supply units<\/b><\/p>\n<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\/iso\/\"><b>ISO<\/b><\/a><\/td>\n<td>2019-11<\/td>\n<td>44<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":585293,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[137,2634],"product_tag":[],"class_list":{"0":"post-585277","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-10","7":"product_cat-iso","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\/585277","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\/585293"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=585277"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=585277"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=585277"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}