🔥🔥 Don’t Miss Out on Our End of Autumn Sale. If you have any questions, feel free to click the bottom right corner to contact our customer service..

Concat us[email protected]
Shopping Cart

No products in the cart.

🔍
BSI 23/30470631 DC:2023 Edition

BSI 23/30470631 DC:2023 Edition

$13.70

BS ISO 8637-1. Extracorporeal systems for blood purification – Part 1. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

Published By Publication Date Number of Pages
BSI 2023 42
PDF Format Searchable Printable Preview Now
Guaranteed Safe Checkout
Category:

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

PDF Catalog

PDF Pages PDF Title
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
10 3 Terms and definitions (mandatory)
13 4 Requirements
4.1 Biological safety
4.2 Sterility
4.3 Non-pyrogenicity
4.4 Mechanical characteristics
4.4.1 Structural integrity
14 4.4.2 Blood compartment integrity
4.4.3 Haemodialyser, haemodiafilter and haemofilter blood compartment connectors
15 4.4.4 Haemodialyser and haemodiafilter dialysis fluid compartment connector
17 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
18 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
19 5 Test methods
5.1 General
5.2 Biological safety and haemocompatibility
5.3 Sterility
5.4 Non-pyrogenicity
20 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
21 5.5.5 Haemofilter filtrate connectors
5.5.6 Haemoconcentrator blood and filtrate connectors
24 5.6 Performance characteristics
5.6.1 Solute clearance of haemodialysers and haemodiafilters
27 5.6.2 Sieving coefficient of haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
29 5.6.3 Ultrafiltration rate
30 5.6.4 Ultrafiltration coefficient
5.6.5 Blood compartment volume
5.6.6 Blood compartment pressure drop
31 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
32 7.3 Labelling on the outer containers
33 7.4 Information to be given in the accompanying documentation
35 8 Packaging
36 Annex€A (informative) Endotoxin transfer assessment
42 Bibliography

Related products

BSI 23/30470631 DC
$13.70