NA 176

DIN Standards Committee Health Technologies

Project

Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO/DIS 8637-2:2025); German and English version prEN ISO 8637-2:2025

Abstract

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: - haemodialysers, haemodiafilters or haemofilters; - plasmafilters; - haemoperfusion devices; - 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.

Begin

2025-03-03

WI

00205415

Planned document number

DIN EN ISO 8637-2

Project number

17600144

Responsible national committee

NA 176-04-06 AA - Extracorporeal circuits, equipment and disposables  

Responsible european committee

CEN/TC 205 - Non-active medical devices  

Responsible international committee

ISO/TC 150/SC 2/WG 5 - Renal replacement, detoxification and apheresis  

draft standard

Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO/DIS 8637-2:2025); German and English version prEN ISO 8637-2:2025
2025-08
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previous edition(s)

Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-2:2024); German version EN ISO 8637-2:2024
2024-09

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Contact

Dipl.-Ing. (FH)

Petra Bischoff

Alexander-Wellendorff-Str. 2
75172 Pforzheim

Tel.: +49 7231 9188-31
Fax: +49 7231 9188-33

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