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Norm
ÖNORM EN ISO 8637-2
Issue date: 2018 11 15
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)
This document specifies requirements for the blood circuit for devices used in extracorporeal blood filtration therapies such as, but not limited to, haemodialysis, haemo...
Withdrawn: 2024 09 15
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 27 Pages
Language:
German
| English
| Download GER/ENG
Currently valid:
Optionally co-design standards:
ICS
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.
ÖNORM EN ISO 8637-2
2024 09 15
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for ...
Norm
ÖNORM EN ISO 8637-2
2018 11 15
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialys...
Norm
↖
ÖNORM EN ISO 8638
2014 03 01
Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers...
Norm
ÖNORM EN 1283
1996 10 01
Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
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Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-2:2024)
Norm
Issue date :
2018 07 20
Extracorporeal systems for blood purification — Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters