{"id":381396,"date":"2024-10-20T03:11:21","date_gmt":"2024-10-20T03:11:21","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-iso-181932021\/"},"modified":"2024-10-26T05:47:21","modified_gmt":"2024-10-26T05:47:21","slug":"bs-iso-181932021","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-iso-181932021\/","title":{"rendered":"BS ISO 18193:2021"},"content":{"rendered":"<p>This document specifies requirements for sterile, single-use cannulae for removal and delivery of patients\u2019 blood during cardiopulmonary bypass (CPB) up to 6&nbsp;h duration, extracorporeal lung assist (ECLA with VV, VAV, or AV cannulation strategies), left or right heart bypass (LHB, RHB), cardiopulmonary support (CPS), extracorporeal life support (ECLS with VA cannulation strategy), extracorporeal carbon dioxide removal (ECCO<sub>2<\/sub>R), and other extracorporeal circulation techniques. This standard does not apply to:<\/p>\n<ul>\n<li>\n<p>introducers (e.g., guidewires) as addressed in <span class=\"std\"> <span class=\"std-ref\">ISO&nbsp;11070<\/span><\/span> ,<\/p>\n<\/li>\n<li>\n<p>isolated organ perfusion cannulae, and<\/p>\n<\/li>\n<li>\n<p>intravascular catheters as addressed in <span class=\"std\"> <span class=\"std-ref\">ISO&nbsp;10555-3<\/span><\/span> .<\/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>National foreword  <\/td>\n<\/tr>\n<tr>\n<td><b>7<b><\/td>\n<td>Foreword  <\/td>\n<\/tr>\n<tr>\n<td><b>8<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>12<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 Connectors  <\/td>\n<\/tr>\n<tr>\n<td><b>13<b><\/td>\n<td>4.2.3 Kink resistance <br \/> 4.2.4 Pull strength <br \/> 4.2.5 External surface <br \/> 4.2.6 Integrity (corrosion, abrasion, degradation) <br \/> 4.2.7 Radio-detectability <br \/> 4.2.8 Distance markings <br \/> 4.2.9 Lumen markings <br \/> 4.3 Performance characteristics <br \/> 4.3.1 Pressure drop  <\/td>\n<\/tr>\n<tr>\n<td><b>14<b><\/td>\n<td>4.3.2 Collapse resistance <br \/> 4.3.3 Recirculation <br \/> 4.3.4 Blood cell damage <br \/> 4.3.5 Shelf life <br \/> 5 Tests and measurements for conformity to this document <br \/> 5.1 General  <\/td>\n<\/tr>\n<tr>\n<td><b>15<b><\/td>\n<td>5.2 Biological characteristics <br \/> 5.2.1 Sterility and non-pyrogenicity <br \/> 5.2.2 Biocompatibility <br \/> 5.3 Physical characteristics <br \/> 5.3.1 Blood pathway integrity <br \/> 5.3.2 Connectors <br \/> 5.3.3 Kink resistance  <\/td>\n<\/tr>\n<tr>\n<td><b>16<b><\/td>\n<td>5.3.4 Pull strength <br \/> 5.3.5 Integrity (corrosion, abrasion, degradation) <br \/> 5.3.6 Radio-detectability  <\/td>\n<\/tr>\n<tr>\n<td><b>17<b><\/td>\n<td>5.4 Performance characteristics <br \/> 5.4.1 Pressure drop <br \/> 5.4.2 Collapse resistance <br \/> 5.4.3 Recirculation  <\/td>\n<\/tr>\n<tr>\n<td><b>18<b><\/td>\n<td>5.4.4 Blood cell damage  <\/td>\n<\/tr>\n<tr>\n<td><b>19<b><\/td>\n<td>5.4.5 Shelf life <br \/> 6 Information supplied by the manufacturer <br \/> 6.1 Information to be given on the cannula  <\/td>\n<\/tr>\n<tr>\n<td><b>20<b><\/td>\n<td>6.2 Information to be given on the packaging <br \/> 6.2.1 Unit container <br \/> 6.2.2 Shipping container <br \/> 6.3 Information to be given in the accompanying documents  <\/td>\n<\/tr>\n<tr>\n<td><b>21<b><\/td>\n<td>6.4 Information to be given in the accompanying documents in a prominent form <br \/> 7 Packaging  <\/td>\n<\/tr>\n<tr>\n<td><b>22<b><\/td>\n<td>Annex A (informative) Examples of connectors  <\/td>\n<\/tr>\n<tr>\n<td><b>32<b><\/td>\n<td>Annex B (informative) Test set-up for kink resistance  <\/td>\n<\/tr>\n<tr>\n<td><b>34<b><\/td>\n<td>Annex C (informative) Test set-up for recirculation  <\/td>\n<\/tr>\n<tr>\n<td><b>37<b><\/td>\n<td>Annex D (informative) Test set-up for blood cell damage  <\/td>\n<\/tr>\n<tr>\n<td><b>41<b><\/td>\n<td>Bibliography  <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p><b>Cardiovascular implants and artificial organs. Cannulae for extracorporeal circulation<\/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>2021<\/td>\n<td>42<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":381405,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[141,2641],"product_tag":[],"class_list":{"0":"post-381396","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\/381396","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\/381405"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=381396"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=381396"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=381396"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}