This standard specifies the requirements for the extracorporal blood circuit applied in the haemodialysis in a single use. Design materials, test methods for biocompatibility, restrictions of sterilisation and some performance characteristics are not included. Furtherly it does not cover the hardware of neither haemodialysers, haemofilters and haemoconcentrators nor blood pumps, pressure monitors, air detectors, etc. systems, etc.
Life cycle
NOW
WITHDRAWN ISO 8638:1989 95.99
Withdrawal of Standard 12 tet 2004
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