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EVS-EN ISO 8637-1:2020

Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)

General information

Valid from 04.05.2020
Base Documents
ISO 8637-1:2017; EN ISO 8637-1:2020
ICS Groups
11.040.40 Implants for surgery, prosthetics and orthotics
Directives or regulations
None

Standard history

Status
Date
Type
Name
04.05.2020
Main
EVS-EN ISO 8637-1:2020
04.02.2014
Main
EVS-EN ISO 8637:2014
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.

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Standard monitoring
English (PDF 440 KB)

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English