{"id":278111,"date":"2024-10-19T18:44:21","date_gmt":"2024-10-19T18:44:21","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-71992016a12020\/"},"modified":"2024-10-25T15:16:19","modified_gmt":"2024-10-25T15:16:19","slug":"bs-en-iso-71992016a12020","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-71992016a12020\/","title":{"rendered":"BS EN ISO 7199:2016+A1:2020"},"content":{"rendered":"<p>This document specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans.<\/p>\n<p>This document also applies to heat exchangers and arterial filters that are integral parts of the oxygenator.<\/p>\n<p>This document also applies to external equipment unique to the use of the oxygenator.<\/p>\n<p>This document does not apply to<\/p>\n<ul>\n<li>\n<p>implanted oxygenators,<\/p>\n<\/li>\n<li>\n<p>liquid oxygenators,<\/p>\n<\/li>\n<li>\n<p>extracorporeal circuits (blood tubing),<\/p>\n<\/li>\n<li>\n<p>separate heat exchangers,<\/p>\n<\/li>\n<li>\n<p>separate ancillary devices, and<\/p>\n<\/li>\n<li>\n<p>separate arterial line filter.<\/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>4<b><\/td>\n<td>European foreword  <\/td>\n<\/tr>\n<tr>\n<td><b>6<b><\/td>\n<td>Endorsement notice <br \/> Endorsement notice  <\/td>\n<\/tr>\n<tr>\n<td><b>7<b><\/td>\n<td>Annex ZA (informative) Relationship between this European standard and the essential requirements of Directive 93\/42\/EEC [OJ L 169] aimed to be covered  <\/td>\n<\/tr>\n<tr>\n<td><b>13<b><\/td>\n<td>Foreword  <\/td>\n<\/tr>\n<tr>\n<td><b>14<b><\/td>\n<td>Introduction  <\/td>\n<\/tr>\n<tr>\n<td><b>15<b><\/td>\n<td>1 Scope <br \/> 2 Normative references  <\/td>\n<\/tr>\n<tr>\n<td><b>16<b><\/td>\n<td>3 Terms and definitions  <\/td>\n<\/tr>\n<tr>\n<td><b>17<b><\/td>\n<td>4 Requirements <br \/> 4.1 Biological characteristics <br \/> 4.1.1 Sterility and non-pyrogenicity <br \/> 4.1.2 Biocompatibility  <\/td>\n<\/tr>\n<tr>\n<td><b>18<b><\/td>\n<td>4.2 Physical characteristics <br \/> 4.2.1 Blood pathway integrity <br \/> 4.2.2 Heat exchanger fluid pathway integrity <br \/> 4.2.3 Blood volumes <br \/> 4.2.4 Connectors <br \/> 4.3 Performance characteristics <br \/> 4.3.1 Oxygen and carbon dioxide transfer rates <br \/> 4.3.2 Heat exchanger performance factor <br \/> 4.3.3 Integral arterial filtration efficiency <br \/> 4.3.4 Integral arterial filter flow rate capacity  <\/td>\n<\/tr>\n<tr>\n<td><b>19<b><\/td>\n<td>4.3.5 Integral arterial filter air handling capability <br \/> 4.3.6 Blood cell damage <br \/> 4.3.7 Time-dependent performance changes <br \/> 4.3.8 Shelf life <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  <\/td>\n<\/tr>\n<tr>\n<td><b>20<b><\/td>\n<td>5.2.2 Biocompatibility <br \/> 5.3 Physical characteristics <br \/> 5.3.1 Blood pathway integrity <br \/> 5.3.2 Heat exchanger water pathway integrity <br \/> 5.3.3 Blood volumes <br \/> 5.3.4 Connectors  <\/td>\n<\/tr>\n<tr>\n<td><b>21<b><\/td>\n<td>5.4 Performance characteristics <br \/> 5.4.1 Oxygen and carbon dioxide transfer rates  <\/td>\n<\/tr>\n<tr>\n<td><b>22<b><\/td>\n<td>5.4.2 Heat exchanger performance factor <br \/> 5.4.2.3 Equation <br \/> 5.4.3 Blood cell damage <br \/> 5.4.4 Shelf life  <\/td>\n<\/tr>\n<tr>\n<td><b>23<b><\/td>\n<td>5.4.5 Filtration efficiency <br \/> 5.4.6 Integral arterial filter flow rate <br \/> 5.4.7 Air-handling capability of integral arterial filter  <\/td>\n<\/tr>\n<tr>\n<td><b>24<b><\/td>\n<td>6 Information supplied by the manufacturer <br \/> 6.1 Information on the oxygenator  <\/td>\n<\/tr>\n<tr>\n<td><b>25<b><\/td>\n<td>6.2 Information on the packaging <br \/> 6.2.1 Unit container <br \/> 6.2.2 Shipping container <br \/> 6.3 Information in the accompanying documents  <\/td>\n<\/tr>\n<tr>\n<td><b>26<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>27<b><\/td>\n<td>Annex A (informative) Examples of connectors  <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p><b>Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators)<\/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>2020<\/td>\n<td>36<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":278114,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[141,2641],"product_tag":[],"class_list":{"0":"post-278111","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\/278111","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\/278114"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=278111"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=278111"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=278111"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}