{"id":457669,"date":"2024-10-20T09:52:36","date_gmt":"2024-10-20T09:52:36","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-8637-22024\/"},"modified":"2024-10-26T18:21:16","modified_gmt":"2024-10-26T18:21:16","slug":"bs-en-iso-8637-22024","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-8637-22024\/","title":{"rendered":"BS EN ISO 8637-2:2024"},"content":{"rendered":"

This document specifies requirements for disposable extracorporeal blood and fluid circuits and accessories used in combination with haemodialysis equipment intended for extracorporeal blood treatment therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration. This document does not apply to: \u2014     haemodialysers, haemodiafilters or haemofilters; \u2014     plasmafilters; \u2014     haemoperfusion devices; \u2014     vascular access devices. NOTE 1        Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1. NOTE 2        Requirements for plasmafilters are specified in ISO 8637-3.<\/p>\n

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nundefined <\/td>\n<\/tr>\n
4<\/td>\nEuropean foreword
Endorsement notice <\/td>\n<\/tr>\n
7<\/td>\nForeword <\/td>\n<\/tr>\n
8<\/td>\nIntroduction <\/td>\n<\/tr>\n
9<\/td>\n1 Scope
2 Normative references <\/td>\n<\/tr>\n
10<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
14<\/td>\n4 Requirements
4.1 General
4.2 Biological safety and haemocompatibility
4.3 Sterility <\/td>\n<\/tr>\n
15<\/td>\n4.4 Non-pyrogenicity
4.5 Mechanical characteristics
4.5.1 Structural integrity
4.5.2 Connectors to haemodialyser, haemodiafilter or haemofilter <\/td>\n<\/tr>\n
18<\/td>\n4.5.3 Connectors to vascular access device
4.5.4 Connectors to ancillary components
4.5.5 Colour coding
4.5.6 Access ports <\/td>\n<\/tr>\n
19<\/td>\n4.5.7 Blood pathway volume
4.5.8 Air capture chamber fill level
4.5.9 Transducer protectors
4.6 Functional characteristics
4.6.1 General
4.6.2 Blood pump system performance <\/td>\n<\/tr>\n
20<\/td>\n4.6.3 Dialysis fluid pump performance
4.6.4 Net fluid removal
4.6.5 Substitution fluid flow rate
4.6.6 Dialysis fluid composition
4.6.7 Dialysis fluid temperature
4.6.8 Substitution fluid temperature
4.6.9 Fluid path occlusion <\/td>\n<\/tr>\n
21<\/td>\n4.6.10 Prevention of air infusion
4.6.11 Pressure monitoring
4.6.12 Blood leak detection
4.7 Expiry date
5 Test methods
5.1 General <\/td>\n<\/tr>\n
22<\/td>\n5.2 Biological safety and haemocompatibility
5.3 Sterility
5.4 Non-pyrogenicity
5.5 Mechanical characteristics
5.5.1 Structural integrity <\/td>\n<\/tr>\n
23<\/td>\n5.5.2 Connectors to haemodialyser, haemodiafilter or haemofilter <\/td>\n<\/tr>\n
28<\/td>\n5.5.3 Connectors to vascular access device
5.5.4 Connectors to ancillary components
5.5.5 Colour coding <\/td>\n<\/tr>\n
29<\/td>\n5.5.6 Access ports
5.5.7 Blood pathway volume
5.5.8 Air capture chamber fill level
5.5.9 Transducer protectors <\/td>\n<\/tr>\n
30<\/td>\n5.6 Functional characteristics
5.6.1 General
5.6.2 Blood pump system performance
5.6.3 Dialysis fluid pump performance
5.6.4 Net fluid removal
5.6.5 Substitution fluid flow rate
5.6.6 Dialysis fluid composition
5.6.7 Dialysis fluid temperature
5.6.8 Substitution fluid temperature <\/td>\n<\/tr>\n
31<\/td>\n5.6.9 Fluid path occlusion
5.6.10 Prevention of air infusion
5.6.11 Pressure monitoring
5.6.12 Blood leak detection
5.7 Expiry date
6 Labelling
6.1 Labelling on the device
6.2 Labelling on unit protective packaging <\/td>\n<\/tr>\n
32<\/td>\n6.3 Labelling on the outer shipping container
6.4 Information to be given in the accompanying documentation <\/td>\n<\/tr>\n
34<\/td>\n7 Packaging <\/td>\n<\/tr>\n
35<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Extracorporeal systems for blood purification – Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2024<\/td>\n36<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":457671,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[141,2641],"product_tag":[],"class_list":{"0":"post-457669","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\/457669","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\/457671"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=457669"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=457669"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=457669"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}