ISO 8637-1:2024
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The latest, up-to-date edition.
Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
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English
31-05-2024
This document specifies requirements and test methods for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans.
This document does not apply to:
reprocessing procedures and equipment.
NOTE1 Requirements for extracorporeal blood circuits for haemodialysers, haemodiafilters and haemofilters are specified in ISO8637-2.
NOTE2 Requirements for plasmafilters are specified in ISO8637-3.
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