Standard

NS-EN ISO 8637-1:2020

May 2020 Published

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Abstract

ISO 8637-1:2017 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use in humans.ISO 8637-1:2017 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.

Document information

Standard from SN
Published: 18 May 2020
Edition: 2020-04
Version: 1
Document type: NAT
ISBN:

ICS 11.040.40
National Committee CEN/TC 205

Product Relations

Replaces: NS-EN ISO 8637:2014
Adopted from: EN ISO 8637-1:2020 , 0

Product life cycle

Previous product

Withdrawn

NS-EN ISO 8637:2014
Current product

Published

NS-EN ISO 8637-1:2020

NS-EN ISO 8637-1:2020

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