{"id":464780,"date":"2024-10-20T10:36:52","date_gmt":"2024-10-20T10:36:52","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-iso-286202020\/"},"modified":"2024-10-26T19:34:14","modified_gmt":"2024-10-26T19:34:14","slug":"bs-iso-286202020","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-iso-286202020\/","title":{"rendered":"BS ISO 28620:2020"},"content":{"rendered":"<p>This document specifies essential requirements and related test methods for non-electrically driven portable infusion devices, thereafter called \u201cdevice\u201d.<\/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<div class=\"non-normative-note\">\n<div class=\"note-label\">\n  NOTE\n <\/div>\n<p>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<\/div>\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<ul>\n<li>\n<p>electrically driven or electrically controlled infusion pumps that are covered by <span class=\"std\"> <span class=\"std-ref\">IEC&nbsp;60601-2-24<\/span><\/span> ,<\/p>\n<\/li>\n<li>\n<p>devices for single patient use intended to deliver discrete volumes (bolus) of medicinal product that are covered by the <span class=\"std\"> <span class=\"std-ref\">ISO&nbsp;11608 series<\/span><\/span> ,<\/p>\n<\/li>\n<li>\n<p>implantable devices,<\/p>\n<\/li>\n<li>\n<p>enteral devices,<\/p>\n<\/li>\n<li>\n<p>transdermal delivery devices, and<\/p>\n<\/li>\n<li>\n<p>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<\/li>\n<\/ul>\n<h4>PDF Catalog<\/h4>\n<table border=\"1px\" class=\"des-table\">\n<tr>\n<th>PDF Pages<\/th>\n<th>PDF Title<\/th>\n<\/tr>\n<tr>\n<td><b>2<b><\/td>\n<td>undefined  <\/td>\n<\/tr>\n<tr>\n<td><b>6<b><\/td>\n<td>Foreword  <\/td>\n<\/tr>\n<tr>\n<td><b>7<b><\/td>\n<td>1 Scope <br \/> 2 Normative references  <\/td>\n<\/tr>\n<tr>\n<td><b>8<b><\/td>\n<td>3 Terms and definitions  <\/td>\n<\/tr>\n<tr>\n<td><b>9<b><\/td>\n<td>4 General requirements <br \/> 4.1 Components  <\/td>\n<\/tr>\n<tr>\n<td><b>10<b><\/td>\n<td>4.2 Materials <br \/> 4.3 Design and characteristics <br \/> 4.3.1 General <br \/> 4.3.2 Fittings <br \/> 4.3.3 Filter <br \/> 4.3.4 Tubing <br \/> 4.3.5 Reservoir <br \/> 4.4 Sterility and non-pyrogenicity  <\/td>\n<\/tr>\n<tr>\n<td><b>11<b><\/td>\n<td>5 Operating requirements <br \/> 5.1 Flow rate <br \/> 5.2 Bolus, if applicable <br \/> 6 Test methods <br \/> 6.1 Test conditions <br \/> 6.1.1 General <br \/> 6.1.2 Apparatus and reagents <br \/> 6.1.3 Operating conditions  <\/td>\n<\/tr>\n<tr>\n<td><b>12<b><\/td>\n<td>6.2 Determination of the flow rate <br \/> 6.2.1 Principle <br \/> 6.2.2 Apparatus <br \/> 6.2.3 Procedure  <\/td>\n<\/tr>\n<tr>\n<td><b>13<b><\/td>\n<td>6.2.4 Expression of results <br \/> 6.3 Resistance to pressure <br \/> 6.4 Drop test method  <\/td>\n<\/tr>\n<tr>\n<td><b>14<b><\/td>\n<td>6.5 Water-tightness of the components of the device <br \/> 6.6 Resistance to traction of the entire device <br \/> 6.7 Bolus volume <br \/> 6.8 Refill time  <\/td>\n<\/tr>\n<tr>\n<td><b>15<b><\/td>\n<td>6.9 Test for efficiency of the fluid filter <br \/> 6.9.1 Preparation of the test fluid <br \/> 6.9.2 Procedure  <\/td>\n<\/tr>\n<tr>\n<td><b>16<b><\/td>\n<td>6.9.3 Expression of results <br \/> 7 Information to be listed on packaging and\/or product  <\/td>\n<\/tr>\n<tr>\n<td><b>17<b><\/td>\n<td>8 Accompanying documents  <\/td>\n<\/tr>\n<tr>\n<td><b>18<b><\/td>\n<td>Bibliography  <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p><b>Medical devices. Non-electrically driven portable infusion 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>20<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":464789,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[138,2641],"product_tag":[],"class_list":{"0":"post-464780","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-20","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\/464780","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\/464789"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=464780"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=464780"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=464780"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}