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Norm

ISO 8637-2:2018

Ausgabedatum: 2018 07 20

Extracorporeal systems for blood purification — Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

This document specifies requirements for the blood circuit for devices used in extracorporeal blood filtration therapies such as, but not limited to, haemodialysis, haemo...
ZURÜCKGEZOGEN: 2024 04 08
Herausgeber:
International Organization for Standardization
Format:
Digital | 14 Seiten
Sprache:
Englisch
Aktuell Gültig:

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.

ISO 8637-2:2024
2024 04 08
Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid circuits for ...
Norm
ISO 8637-2:2018
2018 07 20
Extracorporeal systems for blood purification — Part 2: Extracorporeal blood circuit for haemodialys...
Norm
ISO 8638:2010
2010 06 28
Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for haemodialysers...
Norm
ISO 8638:2004
2004 10 12
Cardiovascular implants and artificial organs — Extracorporeal blood circuit for haemodialysers, hae...
Norm
ISO 8638:1989
1989 09 21
Extracorporeal blood circuit for haemodialysers, haemofilters and haemoconcentrators
Norm
Historie aufklappen
Norm
ISO 8637-2:2024
Ausgabedatum : 2024 04 08
Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators