BS EN ISO 8637-2:2018 – TC:2020 Edition
$186.33
Tracked Changes. Extracorporeal systems for blood purification – Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 51 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 29 | National foreword |
| 31 | European foreword |
| 33 | Foreword |
| 34 | Introduction |
| 36 | 1 Scope 2 Normative references |
| 37 | 3 Terms and definitions 4 Requirements 4.1 Biological safety |
| 38 | 4.2 Sterility 4.3 Non-pyrogenicity 4.4 Mechanical characteristics 4.4.1 Structural integrity 4.4.2 Connectors to haemodialyser, haemodiafilter or haemofilter 4.4.3 Connectors to vascular access device 4.4.4 Connectors to ancillary components 4.4.5 Colour coding |
| 40 | 4.4.6 Access ports 4.4.7 Blood pathway volume 4.4.8 Air capture chamber fill level 4.4.9 Transducer protectors 4.4.10 Blood pathway flow dynamics 4.4.11 Pump segment performance |
| 41 | 4.5 Expiry date 4.6 Tubing compliance 5 Test methods 5.1 General 5.2 Biological safety 5.3 Sterility 5.4 Non-pyrogenicity |
| 42 | 5.5 Mechanical characteristics 5.5.1 Structural integrity 5.5.2 Connectors to haemodialyser, haemodiafilter or haemofilter 5.5.3 Connector to vascular access device 5.5.4 Connectors to ancillary components 5.5.5 Colour coding |
| 43 | 5.5.6 Access ports |
| 44 | 5.5.7 Blood pathway volume 5.5.8 Air capture chamber fill level 5.5.9 Transducer protectors 5.5.10 Blood pathway flow dynamics 5.5.11 Pump segment performance |
| 45 | 5.6 Expiry date 5.7 Tubing compliance |
| 46 | 6 Labelling 6.1 Labelling on the device 6.2 Labelling on unit containers 6.3 Labelling on the outer containers |
| 47 | 6.4 Information to be given in the accompanying documentation |
| 49 | Bibliography |
