{"id":277892,"date":"2024-10-19T18:43:12","date_gmt":"2024-10-19T18:43:12","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-iso-156762016\/"},"modified":"2024-10-25T15:14:45","modified_gmt":"2024-10-25T15:14:45","slug":"bs-iso-156762016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-iso-156762016\/","title":{"rendered":"BS ISO 15676:2016"},"content":{"rendered":"<p>This document specifies requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). This document is applicable to all medical tubing intended for cardiopulmonary bypass (CPB) and\/or extracorporeal membrane oxygenation (ECMO), but specific requirements and tests are included for tubing intended for use with peristaltic pumps during (short-term, i.e. &lt;6&nbsp;h duration) CPB surgery or (long-term, i.e. &gt;24&nbsp;h) ECMO procedures. The sterility and non-pyrogenicity provisions of this document are applicable to tubing packs labelled as \u201csterile\u201d.<\/p>\n<p>This document is applicable only to the tubing aspects for multifunctional systems that may have integral components such as blood gas exchangers (oxygenators), reservoirs, blood filters, defoamers, blood pumps, etc.<\/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>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  <\/td>\n<\/tr>\n<tr>\n<td><b>11<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 General <br \/> 4.2.2 Dimensions <br \/> 4.2.3 Material properties <br \/> 4.3 Performance characteristics <br \/> 4.3.1 Priming volume  <\/td>\n<\/tr>\n<tr>\n<td><b>12<b><\/td>\n<td>4.3.2 Life to failure testing <br \/> 4.3.3 Spallation <br \/> 4.3.4 Shelf life <br \/> 5 Tests and measurements <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>13<b><\/td>\n<td>5.3 Physical characteristics <br \/> 5.3.1 Blood pathway integrity <br \/> 5.3.2 Connections <br \/> 5.3.3 Tubing material property testing <br \/> 5.4 Performance characteristics <br \/> 5.4.1 Tubing life <br \/> 5.4.2 Spallation in tubing used in roller pumps  <\/td>\n<\/tr>\n<tr>\n<td><b>14<b><\/td>\n<td>5.4.3 Shelf life <br \/> 6 Information supplied by the manufacturer <br \/> 6.1 Information on the tubing pack <br \/> 6.1.1 Information on the unit container <br \/> 6.1.2 Information on the shipping container  <\/td>\n<\/tr>\n<tr>\n<td><b>15<b><\/td>\n<td>6.2 Information on the accompanying documents <br \/> 6.3 Information in the accompanying documents in a prominent form <br \/> 6.4 Information to be provided by manufacturer upon request <br \/> 7 Packaging  <\/td>\n<\/tr>\n<tr>\n<td><b>16<b><\/td>\n<td>Bibliography  <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p><b>Cardiovascular implants and artificial organs. Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)<\/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>2016<\/td>\n<td>20<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":277896,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[141,2641],"product_tag":[],"class_list":{"0":"post-277892","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\/277892","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\/277896"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=277892"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=277892"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=277892"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}