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DIN EN ISO 8637-2

Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)

active, Most Current
Organization: DIN
Publication Date: 1 December 2018
Status: active
Page Count: 28
ICS Code (Transfusion, infusion and injection equipment): 11.040.20
scope:

WARNING - Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this document.

This document specifies requirements for the blood circuit for devices used in extracorporeal blood filtration therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration and transducer protectors (integral and non-integral) intended for use in such circuits.

This document does not apply to:

- haemodialysers, haemodiafilters or haemofilters;

- 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.

NOTE 1 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1, and requirements for plasmafilters are specified in ISO 8637-3.

NOTE 2 Extracorporeal blood tubing sets can also be used for other extracorporeal therapies such as haemoperfusion, plasmafiltration and plasma adsorption.

Document History

DIN EN ISO 8637-2
December 1, 2018
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this document. This document specifies requirements for the blood circuit for...
May 1, 2016
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO/DIS 8637-2:2016); German and English version prEN ISO 8637-2:2016
A description is not available for this item.

References

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