Standard

NS-EN ISO 8637-2:2024

Apr 2024 Published

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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.

Document information

Standard from SN
Published: 19 April 2024
Edition: 2024-04
Version: 1
Document type: NAT
ISBN:

ICS 11.040.20
ICS 11.040.40
National Committee CEN/TC 205

Product Relations

Replaces: NS-EN ISO 8637-2:2018
Refers: IEC 60601-2-16:2018 RLV
Refers: IEC 60601-2-16:2018 ED5
Adopted from: EN ISO 8637-2:2024 , 0

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NS-EN ISO 8637-2:2018
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NS-EN ISO 8637-2:2024

NS-EN ISO 8637-2:2024

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