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ISO 8637-1:2017

Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

standard by International Organization for Standardization , 11/01/2017

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Full Description

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.

 

Product Details

Published:
11/01/2017
Number of Pages:
30
File Size:
1 file , 480 KB
Same As:
DIN EN ISO 8637-1, CAN/CSA-ISO 8637-1:21, BS EN ISO 8637-1:2020
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. ISO 8637-1:2017

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    Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

    • Most Recent

  2. ISO 8637:2010


    Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

    • Historical Version

  3. ISO 8637:2004


    Cardiovascular implants and artificial organs - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

    • Historical Version