{"id":197945,"date":"2024-10-19T12:36:10","date_gmt":"2024-10-19T12:36:10","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-15675-2016\/"},"modified":"2024-10-25T05:09:27","modified_gmt":"2024-10-25T05:09:27","slug":"aami-15675-2016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-15675-2016\/","title":{"rendered":"AAMI 15675 2016"},"content":{"rendered":"<p>Specifies requirements for sterile, single-use, arterial blood line filters intended to filter and remove emboli, debris, blood clots and other potentially hazardous solid and gaseous material from the blood of humans during cardiopulmonary bypass surgery.<\/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 15675:2016; Cardiovascular implants and artificial organs\u2014Cardiopulmonary bypass systems\u2014arterial blood line filters<br \/>\n  <\/td>\n<\/tr>\n<tr>\n<td><b>2<b><\/td>\n<td>Objectives and uses of AAMI standards andrecommended practices  <\/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 <br \/> Copyright information  <\/td>\n<\/tr>\n<tr>\n<td><b>5<b><\/td>\n<td>Contents page  <\/td>\n<\/tr>\n<tr>\n<td><b>6<b><\/td>\n<td>Glossary of equivalent standards  <\/td>\n<\/tr>\n<tr>\n<td><b>7<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 15675:2016  <\/td>\n<\/tr>\n<tr>\n<td><b>9<b><\/td>\n<td>Foreword  <\/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 characteristics <br \/> 4.1.1 Sterility and non-pyrogenicity <br \/> 4.1.2 Biocompatibility <br \/> 4.2 Physical characteristics <br \/> 4.2.1 Blood pathway integrity <br \/> 4.2.2 Blood volume <br \/> 4.2.3 Connectors <br \/> 4.3 Performance characteristics <br \/> 4.3.1 Blood cell damage  <\/td>\n<\/tr>\n<tr>\n<td><b>14<b><\/td>\n<td>4.3.2 Filtration efficiency <br \/> 4.3.3 Flow rate capacity <br \/> 4.3.4 Shelf life <br \/> 4.3.5 Air-handling capability <br \/> 5 Tests and measurements to determine compliance with this document <br \/> 5.1 General <br \/> 5.2 Biological characteristics <br \/> 5.2.1 Sterility and non-pyrogenicity <br \/> 5.2.2 Biocompatibility  <\/td>\n<\/tr>\n<tr>\n<td><b>15<b><\/td>\n<td>5.3 Physical characteristics <br \/> 5.3.1 Blood pathway integrity (sterile final assembly) <br \/> 5.3.2 Blood volume <br \/> 5.3.3 Connectors <br \/> 5.4 Performance characteristics <br \/> 5.4.1 Blood cell damage <br \/> 5.4.1.1 Test media <br \/> 5.4.1.2 Procedure <br \/> Table 1 \u2014 Conditions for in vitro testing of blood cell damage  <\/td>\n<\/tr>\n<tr>\n<td><b>16<b><\/td>\n<td>Table 2 \u2014 Sampling schedule <br \/> 5.4.2 Filtration efficiency <br \/> 5.4.2.1 Test liquid <br \/> 5.4.2.2 Procedure <br \/> 5.4.3 Filter flow rate <br \/> 5.4.3.1 Test liquid <br \/> 5.4.3.2 Procedure <br \/> 5.4.4 Shelf life  <\/td>\n<\/tr>\n<tr>\n<td><b>17<b><\/td>\n<td>5.4.5 Air-handling capability <br \/> 5.4.5.1 Test liquid <br \/> 5.4.5.2 Procedure <br \/> 5.4.5.3 Test results <br \/> 6 Information supplied by the manufacturer <br \/> 6.1 Information on the arterial blood line filter <br \/> 6.2 Information on the packaging <br \/> 6.2.1 Information on the unit container  <\/td>\n<\/tr>\n<tr>\n<td><b>18<b><\/td>\n<td>6.2.2 Information on the shipping container <br \/> 6.3 Information in the accompanying documents  <\/td>\n<\/tr>\n<tr>\n<td><b>19<b><\/td>\n<td>6.4 Information in the accompanying documents in a prominent form <br \/> 7 Packaging  <\/td>\n<\/tr>\n<tr>\n<td><b>20<b><\/td>\n<td>Bibliography  <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p><b>ANSI\/AAMI\/ISO 15675:2016 &#8211; Cardiovascular implants and artificial organs-Cardiopulmonary bypass systems-Arterial blood line filters<\/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>2016<\/td>\n<td>20<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":197949,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-197945","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\/197945","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\/197949"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=197945"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=197945"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=197945"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}