{"id":277967,"date":"2024-10-19T18:43:38","date_gmt":"2024-10-19T18:43:38","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-8637-22018\/"},"modified":"2024-10-25T15:15:20","modified_gmt":"2024-10-25T15:15:20","slug":"bs-en-iso-8637-22018","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-8637-22018\/","title":{"rendered":"BS EN ISO 8637-2:2018"},"content":{"rendered":"<blockquote>\n<p>WARNING Other requirements and other EU&nbsp;Directives may be applicable to the product(s) falling within the scope of this document.<\/p>\n<\/blockquote>\n<p>This document specifies requirements for the blood circuit for devices used in extracorporeal blood filtration therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration and transducer protectors (integral and non-integral) intended for use in such circuits.<\/p>\n<p>This document does not apply to:<\/p>\n<ul>\n<li>\n<p>haemodialysers, haemodiafilters or haemofilters;<\/p>\n<\/li>\n<li>\n<p>plasmafilters;<\/p>\n<\/li>\n<li>\n<p>haemoperfusion devices;<\/p>\n<\/li>\n<li>\n<p>vascular access devices;<\/p>\n<\/li>\n<li>\n<p>blood pumps;<\/p>\n<\/li>\n<li>\n<p>pressure monitors for the extracorporeal blood circuit;<\/p>\n<\/li>\n<li>\n<p>air detection devices;<\/p>\n<\/li>\n<li>\n<p>systems to prepare, maintain or monitor dialysis fluid;<\/p>\n<\/li>\n<li>\n<p>systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration.<\/p>\n<\/li>\n<\/ul>\n<blockquote>\n<p>NOTE&nbsp;1 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO&nbsp;8637\u20111, and requirements for plasmafilters are specified in ISO&nbsp;8637\u20113.<\/p>\n<\/blockquote>\n<blockquote>\n<p>NOTE&nbsp;2 Extracorporeal blood tubing sets can also be used for other extracorporeal therapies such as haemoperfusion, plasmafiltration and plasma adsorption.<\/p>\n<\/blockquote>\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>National foreword  <\/td>\n<\/tr>\n<tr>\n<td><b>4<b><\/td>\n<td>European foreword  <\/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>Introduction  <\/td>\n<\/tr>\n<tr>\n<td><b>9<b><\/td>\n<td>1 Scope <br \/> 2 Normative references  <\/td>\n<\/tr>\n<tr>\n<td><b>10<b><\/td>\n<td>3 Terms and definitions <br \/> 4 Requirements <br \/> 4.1 Biological safety  <\/td>\n<\/tr>\n<tr>\n<td><b>11<b><\/td>\n<td>4.2 Sterility <br \/> 4.3 Non-pyrogenicity <br \/> 4.4 Mechanical characteristics <br \/> 4.4.1 Structural integrity <br \/> 4.4.2 Connectors to haemodialyser, haemodiafilter or haemofilter <br \/> 4.4.3 Connectors to vascular access device <br \/> 4.4.4 Connectors to ancillary components <br \/> 4.4.5 Colour coding  <\/td>\n<\/tr>\n<tr>\n<td><b>13<b><\/td>\n<td>4.4.6 Access ports <br \/> 4.4.7 Blood pathway volume <br \/> 4.4.8 Air capture chamber fill level <br \/> 4.4.9 Transducer protectors <br \/> 4.4.10 Blood pathway flow dynamics <br \/> 4.4.11 Pump segment performance  <\/td>\n<\/tr>\n<tr>\n<td><b>14<b><\/td>\n<td>4.5 Expiry date <br \/> 4.6 Tubing compliance <br \/> 5 Test methods <br \/> 5.1 General <br \/> 5.2 Biological safety <br \/> 5.3 Sterility <br \/> 5.4 Non-pyrogenicity  <\/td>\n<\/tr>\n<tr>\n<td><b>15<b><\/td>\n<td>5.5 Mechanical characteristics <br \/> 5.5.1 Structural integrity <br \/> 5.5.2 Connectors to haemodialyser, haemodiafilter or haemofilter <br \/> 5.5.3 Connector to vascular access device <br \/> 5.5.4 Connectors to ancillary components <br \/> 5.5.5 Colour coding  <\/td>\n<\/tr>\n<tr>\n<td><b>16<b><\/td>\n<td>5.5.6 Access ports  <\/td>\n<\/tr>\n<tr>\n<td><b>17<b><\/td>\n<td>5.5.7 Blood pathway volume <br \/> 5.5.8 Air capture chamber fill level <br \/> 5.5.9 Transducer protectors <br \/> 5.5.10 Blood pathway flow dynamics <br \/> 5.5.11 Pump segment performance  <\/td>\n<\/tr>\n<tr>\n<td><b>18<b><\/td>\n<td>5.6 Expiry date <br \/> 5.7 Tubing compliance  <\/td>\n<\/tr>\n<tr>\n<td><b>19<b><\/td>\n<td>6 Labelling <br \/> 6.1 Labelling on the device <br \/> 6.2 Labelling on unit containers <br \/> 6.3 Labelling on the outer containers  <\/td>\n<\/tr>\n<tr>\n<td><b>20<b><\/td>\n<td>6.4 Information to be given in the accompanying documentation  <\/td>\n<\/tr>\n<tr>\n<td><b>22<b><\/td>\n<td>Bibliography  <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p><b>Extracorporeal systems for blood purification &#8211; Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters<\/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>2018<\/td>\n<td>24<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":277969,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[141,2641],"product_tag":[],"class_list":{"0":"post-277967","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-40","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\/277967","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\/277969"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=277967"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=277967"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=277967"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}