{"id":611649,"date":"2024-11-05T22:56:54","date_gmt":"2024-11-05T22:56:54","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/iso-286202020\/"},"modified":"2024-11-05T22:56:54","modified_gmt":"2024-11-05T22:56:54","slug":"iso-286202020","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/iso\/iso-286202020\/","title":{"rendered":"ISO 28620:2020"},"content":{"rendered":"<p>This document specifies essential requirements and related test methods for non-electrically driven portable infusion devices, thereafter called &#034;device&#034;.<\/p>\n<p>It is applicable to devices designed for continuous (fixed or adjustable) flow and\/or for bolus neuraxial and intravascular or hypodermic applications.<\/p>\n<p>NOTE    Sites for the neuraxial application include the spine, intrathecal or subarachnoid space, ventricles of the brain and the epi-, extra- or peri-dural space. Neuraxial application anaesthetics can be administered regionally, affecting a large part of the body, such as a limb, and include plexus blocks, such as the branchial plexus blocks or single nerve blocks. Neuraxial application procedures include continuous infusion of wounds with local anaesthetic agents.<\/p>\n<p>These devices can be used in health care and non-health care settings. They can be applied or administered by health care professionals or by the intended patient.<\/p>\n<p>These devices can be pre-filled by the manufacturer or filled before use by a health care professional or the intended patient.<\/p>\n<p>This document does not apply to<\/p>\n<p>\u2014     electrically driven or electrically controlled infusion pumps that are covered by IEC 60601-2-24,<\/p>\n<p>\u2014     devices for single patient use intended to deliver discrete volumes (bolus) of medicinal product that are covered by the ISO 11608 series,<\/p>\n<p>\u2014     implantable devices,<\/p>\n<p>\u2014     enteral devices,<\/p>\n<p>\u2014     transdermal delivery devices, and<\/p>\n<p>\u2014     devices where the energy for infusion is not provided by the device or through active intervention by the patient (e.g. devices only powered by gravity).<\/p>\n","protected":false},"excerpt":{"rendered":"<p><b>Medical devices \u2014 Non-electrically driven portable infusion devices<\/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>2020-01<\/td>\n<td>18<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":611661,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[138,2634],"product_tag":[],"class_list":{"0":"post-611649","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-20","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\/611649","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\/611661"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=611649"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=611649"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=611649"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}