{"id":435219,"date":"2024-10-20T07:48:23","date_gmt":"2024-10-20T07:48:23","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bsi-23-30470631-dc\/"},"modified":"2024-10-26T14:47:39","modified_gmt":"2024-10-26T14:47:39","slug":"bsi-23-30470631-dc","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bsi-23-30470631-dc\/","title":{"rendered":"BSI 23\/30470631 DC"},"content":{"rendered":"
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
---|---|---|---|---|---|---|---|
7<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
8<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
9<\/td>\n | 1 Scope 2 Normative references <\/td>\n<\/tr>\n | ||||||
10<\/td>\n | 3 Terms and definitions (mandatory) <\/td>\n<\/tr>\n | ||||||
13<\/td>\n | 4 Requirements 4.1 Biological safety 4.2 Sterility 4.3 Non-pyrogenicity 4.4 Mechanical characteristics 4.4.1 Structural integrity <\/td>\n<\/tr>\n | ||||||
14<\/td>\n | 4.4.2 Blood compartment integrity 4.4.3 Haemodialyser, haemodiafilter and haemofilter blood compartment connectors <\/td>\n<\/tr>\n | ||||||
15<\/td>\n | 4.4.4 Haemodialyser and haemodiafilter dialysis fluid compartment connector <\/td>\n<\/tr>\n | ||||||
17<\/td>\n | 4.4.5 Haemofilter filtrate connector 4.4.6 Haemoconcentrator blood and filtrate connectors 4.5 Performance characteristics 4.5.1 Solute clearance of haemodialysers and haemodiafilters 4.5.2 Sieving coefficient of haemodialysers, haemodiafilters, haemofilters and haemoconcentrators <\/td>\n<\/tr>\n | ||||||
18<\/td>\n | 4.5.3 Ultrafiltration rate. 4.5.4 Ultrafiltration coefficient 4.5.5 Blood compartment volume 4.5.6 Blood compartment pressure drop 4.5.7 Haemodialyser and haemodiafilter endotoxin transfer 4.5.8 Expiry date <\/td>\n<\/tr>\n | ||||||
19<\/td>\n | 5 Test methods 5.1 General 5.2 Biological safety and haemocompatibility 5.3 Sterility 5.4 Non-pyrogenicity <\/td>\n<\/tr>\n | ||||||
20<\/td>\n | 5.5 Mechanical characteristics 5.5.1 Structural integrity 5.5.2 Blood compartment integrity 5.5.3 Haemodialyser, haemodiafilter and haemofilter blood compartment connectors 5.5.4 Haemodialyser and haemodiafilter dialysis fluid compartment connectors <\/td>\n<\/tr>\n | ||||||
21<\/td>\n | 5.5.5 Haemofilter filtrate connectors 5.5.6 Haemoconcentrator blood and filtrate connectors <\/td>\n<\/tr>\n | ||||||
24<\/td>\n | 5.6 Performance characteristics 5.6.1 Solute clearance of haemodialysers and haemodiafilters <\/td>\n<\/tr>\n | ||||||
27<\/td>\n | 5.6.2 Sieving coefficient of haemodialysers, haemodiafilters, haemofilters and haemoconcentrators <\/td>\n<\/tr>\n | ||||||
29<\/td>\n | 5.6.3 Ultrafiltration rate <\/td>\n<\/tr>\n | ||||||
30<\/td>\n | 5.6.4 Ultrafiltration coefficient 5.6.5 Blood compartment volume 5.6.6 Blood compartment pressure drop <\/td>\n<\/tr>\n | ||||||
31<\/td>\n | 5.6.7 Haemodialyser and haemodiafilter endotoxin transfer 6 Expiry date 7 Labelling 7.1 Labelling on the device 7.2 Labelling on unit containers <\/td>\n<\/tr>\n | ||||||
32<\/td>\n | 7.3 Labelling on the outer containers <\/td>\n<\/tr>\n | ||||||
33<\/td>\n | 7.4 Information to be given in the accompanying documentation <\/td>\n<\/tr>\n | ||||||
35<\/td>\n | 8 Packaging <\/td>\n<\/tr>\n | ||||||
36<\/td>\n | Annex\u20acA (informative) Endotoxin transfer assessment <\/td>\n<\/tr>\n | ||||||
42<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" BS ISO 8637-1. Extracorporeal systems for blood purification – Part 1. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators<\/b><\/p>\n |