🔥🔥 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.

🔍
BS EN ISO 8637-1:2020:2024 Edition

BS EN ISO 8637-1:2020:2024 Edition

$167.15

Extracorporeal systems for blood purification – Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

Published By Publication Date Number of Pages
BSI 2024 34
PDF Format Searchable Printable Preview Now
Guaranteed Safe Checkout
Categories: ,

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]

WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard.

This document specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans.

This document does not apply to:

  • extracorporeal blood circuits;

  • plasmafilters;

  • haemoperfusion devices;

  • vascular access devices;

  • blood pumps;

  • pressure monitors for the extracorporeal blood circuit;

  • air detection devices;

  • systems to prepare, maintain or monitor dialysis fluid;

  • systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration;

  • reprocessing procedures and equipment.

NOTE Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637‑2.

WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard.

This document specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans.

This document does not apply to:

  • extracorporeal blood circuits;

  • plasmafilters;

  • haemoperfusion devices;

  • vascular access devices;

  • blood pumps;

  • pressure monitors for the extracorporeal blood circuit;

  • air detection devices;

  • systems to prepare, maintain or monitor dialysis fluid;

  • systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration;

  • reprocessing procedures and equipment.

NOTE Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637‑2.

PDF Catalog

PDF Pages PDF Title
2 undefined
5 European foreword
Endorsement notice
8 Foreword
9 Introduction
11 1 Scope
2 Normative references
12 3 Terms and definitions
14 4 Requirements
4.1 Biological safety
4.2 Sterility
4.3 Non-pyrogenicity
4.4 Mechanical characteristics
4.4.1 Structural integrity
15 4.4.2 Blood compartment integrity
4.4.3 Haemodialyser, haemodiafilter and haemofilter blood compartment ports
18 4.4.4 Haemodialyser and haemodiafilter dialysis fluid compartment ports
4.4.5 Haemofilter filtrate ports
4.4.6 Haemoconcentrator blood and filtrate ports
4.5 Performance characteristics
4.5.1 Solute clearance of haemodialysers and haemodiafilters
19 4.5.2 Sieving coefficient of haemodiafilters, haemofilters and haemoconcentrators
4.5.3 Ultrafiltration coefficient
4.5.4 Volume of the blood compartment
4.5.5 Pressure drop of the blood compartment
4.6 Expiry date
5 Test methods
5.1 General
20 5.2 Biological safety
5.3 Sterility
5.4 Non-pyrogenicity
5.5 Mechanical characteristics
5.5.1 Structural integrity
21 5.5.2 Blood compartment integrity
5.5.3 Haemodialyser, haemodiafilter and haemofilter blood compartment ports
5.5.4 Haemodialyser and haemodiafilter dialysis fluid compartment ports
5.5.5 Haemofilter filtrate ports
5.5.6 Haemoconcentrator blood and filtrate ports
23 5.6 Performance characteristics
5.6.1 Clearance
25 5.6.2 Sieving coefficient of haemodiafilters, haemofilters and haemoconcentrators
26 5.6.3 Ultrafiltration coefficient
27 5.6.4 Volume of the blood compartment
5.6.5 Pressure drop of the blood compartment
5.7 Expiry date
6 Labelling
6.1 Labelling on the device
28 6.2 Labelling on unit containers
6.3 Labelling on the outer containers
29 6.4 Information to be given in the accompanying documentation
32 Bibliography

Related products

BS EN ISO 8637-1:2020
$167.15