{"id":464720,"date":"2024-10-20T10:36:29","date_gmt":"2024-10-20T10:36:29","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-8637-12020\/"},"modified":"2024-10-26T19:33:25","modified_gmt":"2024-10-26T19:33:25","slug":"bs-en-iso-8637-12020","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-8637-12020\/","title":{"rendered":"BS EN ISO 8637-1:2020"},"content":{"rendered":"<blockquote>\n<p>WARNING Other requirements and other EU&nbsp;Directives may be applicable to the product(s) falling within the scope of this standard.<\/p>\n<\/blockquote>\n<p>This document specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as \u201cthe device\u201d, for use in humans.<\/p>\n<p>This document does not apply to:<\/p>\n<ul>\n<li>\n<p>extracorporeal blood circuits;<\/p>\n<\/li>\n<li>\n<p>plasmafilters;<\/p>\n<\/li>\n<li>\n<p>haemoperfusion devices;<\/p>\n<\/li>\n<li>\n<p>vascular access devices;<\/p>\n<\/li>\n<li>\n<p>blood pumps;<\/p>\n<\/li>\n<li>\n<p>pressure monitors for the extracorporeal blood circuit;<\/p>\n<\/li>\n<li>\n<p>air detection devices;<\/p>\n<\/li>\n<li>\n<p>systems to prepare, maintain or monitor dialysis fluid;<\/p>\n<\/li>\n<li>\n<p>systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration;<\/p>\n<\/li>\n<li>\n<p>reprocessing procedures and equipment.<\/p>\n<\/li>\n<\/ul>\n<blockquote>\n<p>NOTE Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters are specified in ISO&nbsp;8637\u20112.<\/p>\n<\/blockquote>\n<blockquote>\n<p>WARNING Other requirements and other EU&nbsp;Directives may be applicable to the product(s) falling within the scope of this standard.<\/p>\n<\/blockquote>\n<p>This document specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as \u201cthe device\u201d, for use in humans.<\/p>\n<p>This document does not apply to:<\/p>\n<ul>\n<li>\n<p>extracorporeal blood circuits;<\/p>\n<\/li>\n<li>\n<p>plasmafilters;<\/p>\n<\/li>\n<li>\n<p>haemoperfusion devices;<\/p>\n<\/li>\n<li>\n<p>vascular access devices;<\/p>\n<\/li>\n<li>\n<p>blood pumps;<\/p>\n<\/li>\n<li>\n<p>pressure monitors for the extracorporeal blood circuit;<\/p>\n<\/li>\n<li>\n<p>air detection devices;<\/p>\n<\/li>\n<li>\n<p>systems to prepare, maintain or monitor dialysis fluid;<\/p>\n<\/li>\n<li>\n<p>systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration;<\/p>\n<\/li>\n<li>\n<p>reprocessing procedures and equipment.<\/p>\n<\/li>\n<\/ul>\n<blockquote>\n<p>NOTE Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters are specified in ISO&nbsp;8637\u20112.<\/p>\n<\/blockquote>\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>undefined  <\/td>\n<\/tr>\n<tr>\n<td><b>5<b><\/td>\n<td>European foreword <br \/> Endorsement notice  <\/td>\n<\/tr>\n<tr>\n<td><b>8<b><\/td>\n<td>Foreword  <\/td>\n<\/tr>\n<tr>\n<td><b>9<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>14<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  <\/td>\n<\/tr>\n<tr>\n<td><b>15<b><\/td>\n<td>4.4.2 Blood compartment integrity <br \/> 4.4.3 Haemodialyser, haemodiafilter and haemofilter blood compartment ports  <\/td>\n<\/tr>\n<tr>\n<td><b>18<b><\/td>\n<td>4.4.4 Haemodialyser and haemodiafilter dialysis fluid compartment ports <br \/> 4.4.5 Haemofilter filtrate ports <br \/> 4.4.6 Haemoconcentrator blood and filtrate ports <br \/> 4.5 Performance characteristics <br \/> 4.5.1 Solute clearance of haemodialysers and haemodiafilters  <\/td>\n<\/tr>\n<tr>\n<td><b>19<b><\/td>\n<td>4.5.2 Sieving coefficient of haemodiafilters, haemofilters and haemoconcentrators <br \/> 4.5.3 Ultrafiltration coefficient <br \/> 4.5.4 Volume of the blood compartment <br \/> 4.5.5 Pressure drop of the blood compartment <br \/> 4.6 Expiry date <br \/> 5 Test methods <br \/> 5.1 General  <\/td>\n<\/tr>\n<tr>\n<td><b>20<b><\/td>\n<td>5.2 Biological safety <br \/> 5.3 Sterility <br \/> 5.4 Non-pyrogenicity <br \/> 5.5 Mechanical characteristics <br \/> 5.5.1 Structural integrity  <\/td>\n<\/tr>\n<tr>\n<td><b>21<b><\/td>\n<td>5.5.2 Blood compartment integrity <br \/> 5.5.3 Haemodialyser, haemodiafilter and haemofilter blood compartment ports <br \/> 5.5.4 Haemodialyser and haemodiafilter dialysis fluid compartment ports <br \/> 5.5.5 Haemofilter filtrate ports <br \/> 5.5.6 Haemoconcentrator blood and filtrate ports  <\/td>\n<\/tr>\n<tr>\n<td><b>23<b><\/td>\n<td>5.6 Performance characteristics <br \/> 5.6.1 Clearance  <\/td>\n<\/tr>\n<tr>\n<td><b>25<b><\/td>\n<td>5.6.2 Sieving coefficient of haemodiafilters, haemofilters and haemoconcentrators  <\/td>\n<\/tr>\n<tr>\n<td><b>26<b><\/td>\n<td>5.6.3 Ultrafiltration coefficient  <\/td>\n<\/tr>\n<tr>\n<td><b>27<b><\/td>\n<td>5.6.4 Volume of the blood compartment <br \/> 5.6.5 Pressure drop of the blood compartment <br \/> 5.7 Expiry date <br \/> 6 Labelling <br \/> 6.1 Labelling on the device  <\/td>\n<\/tr>\n<tr>\n<td><b>28<b><\/td>\n<td>6.2 Labelling on unit containers <br \/> 6.3 Labelling on the outer containers  <\/td>\n<\/tr>\n<tr>\n<td><b>29<b><\/td>\n<td>6.4 Information to be given in the accompanying documentation  <\/td>\n<\/tr>\n<tr>\n<td><b>32<b><\/td>\n<td>Bibliography  <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p><b>Extracorporeal systems for blood purification &#8211; Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators<\/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>2024<\/td>\n<td>34<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":464730,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[141,2641],"product_tag":[],"class_list":{"0":"post-464720","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\/464720","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\/464730"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=464720"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=464720"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=464720"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}