ISO 8637-2:2024

Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

Digital Document2024 edition2024Purchase Options

Referenced standards

IEC 60601-2-16:2018ISO 10993-1ISO 10993-11ISO 10993-4ISO 11607-1ISO 11607-2ISO 11737-2ISO 20417ISO 7864ISO 80369-20:2015ISO 80369-7
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ISO 8637-2:2024

Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

This document specifies requirements for disposable extracorporeal blood and fluid circuits and accessories used in combination with haemodialysis equipment intended for extracorporeal blood treatment therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration.

This document does not apply to:

—???? haemodialysers, haemodiafilters or haemofilters;

—???? plasmafilters;

—???? haemoperfusion devices;

—???? vascular access devices.

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

NOTE?2??????? Requirements for plasmafilters are specified in ISO?8637-3.

Edition2024
Standard Part No2
Published Date2024
Published ByInternational Standardization Organisation
Page Count27