{"id":374192,"date":"2024-10-20T02:37:25","date_gmt":"2024-10-20T02:37:25","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-8637-2-2018\/"},"modified":"2024-10-26T04:35:04","modified_gmt":"2024-10-26T04:35:04","slug":"aami-8637-2-2018","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-8637-2-2018\/","title":{"rendered":"AAMI 8637 2 2018"},"content":{"rendered":"<p>AAMI adoption: This first edition of ISO 8637-2:2018 cancels and replaces the third edition (ISO 8638:2010), which has been technically revised.<\/p>\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>1<b><\/td>\n<td>ANSI\/AAMI\/ISO 8637-2:2018; Extracorporeal systems for blood purification\u2014Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters  <\/td>\n<\/tr>\n<tr>\n<td><b>3<b><\/td>\n<td>Title page  <\/td>\n<\/tr>\n<tr>\n<td><b>4<b><\/td>\n<td>AAMI Standard  <\/td>\n<\/tr>\n<tr>\n<td><b>5<b><\/td>\n<td>Copyright information <br \/> Contents  <\/td>\n<\/tr>\n<tr>\n<td><b>6<b><\/td>\n<td>Committee representation  <\/td>\n<\/tr>\n<tr>\n<td><b>8<b><\/td>\n<td>Background of AAMI adoption of ISO 8637-2:2018  <\/td>\n<\/tr>\n<tr>\n<td><b>9<b><\/td>\n<td>Foreword  <\/td>\n<\/tr>\n<tr>\n<td><b>10<b><\/td>\n<td>Introduction  <\/td>\n<\/tr>\n<tr>\n<td><b>11<b><\/td>\n<td>1 Scope <br \/> 2 Normative references  <\/td>\n<\/tr>\n<tr>\n<td><b>12<b><\/td>\n<td>3 Terms and definitions  <\/td>\n<\/tr>\n<tr>\n<td><b>13<b><\/td>\n<td>4 Requirements <br \/> 4.1 Biological safety <br \/> 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>14<b><\/td>\n<td>Figure 1 \u2014 Main fitting dimensions of extracorporeal blood circuit connector to blood ports of haemodialyser, haemodiafilter or haemofilter  <\/td>\n<\/tr>\n<tr>\n<td><b>15<b><\/td>\n<td>4.4.6 Access ports <br \/> 4.4.6.1 Needle access ports <br \/> 4.4.6.2 Needleless 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 \/> 4.4.9.1 Integral transducer protectors <br \/> 4.4.9.2 Non-integral transducer protectors <br \/> 4.4.10 Blood pathway flow dynamics <br \/> 4.4.11 Pump segment performance <br \/> 4.5 Expiry date  <\/td>\n<\/tr>\n<tr>\n<td><b>16<b><\/td>\n<td>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 <br \/> 5.5 Mechanical characteristics <br \/> 5.5.1 Structural integrity <br \/> 5.5.1.1 Positive pressure  <\/td>\n<\/tr>\n<tr>\n<td><b>17<b><\/td>\n<td>5.5.1.2 Negative pressure <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>18<b><\/td>\n<td>Figure 2 \u2014 Gauge for measuring length of engagement of the male cone of blood inlet and outlet ports <br \/> 5.5.6 Access ports <br \/> 5.5.6.1 Needle access ports  <\/td>\n<\/tr>\n<tr>\n<td><b>19<b><\/td>\n<td>5.5.6.2 Needleless access ports <br \/> 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>20<b><\/td>\n<td>Figure 3 \u2014 Test device used for ISO blood port connectors <br \/> 5.6 Expiry date <br \/> 5.7 Tubing compliance  <\/td>\n<\/tr>\n<tr>\n<td><b>21<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>22<b><\/td>\n<td>6.4 Information to be given in the accompanying documentation  <\/td>\n<\/tr>\n<tr>\n<td><b>24<b><\/td>\n<td>Bibliography  <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p><b>ANSI\/AAMI\/ISO 8637-2: 2018, Extracorporeal systems for blood purification-Part 2: 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\/aami\/\"><b>AAMI<\/b><\/a><\/td>\n<td>2018<\/td>\n<td>24<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":374200,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-374192","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-aami","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/374192","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\/374200"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=374192"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=374192"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=374192"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}