ISO 8637:1989 PDF

ISO 8637:1989 specifies requirements for haemodialysers, including those of
coil, hollow-fibre and parallel-plate design, haemofilters and haemoconcentrators
for single use for humans. Requirements for materials of construction and test
methods for biocompatibility, validation of sterility, non-pyrogenicity and
certain performance characteristics are not included.

ISO 8637:1989 does not apply to devices assembled and sterilized by the user,
nor to devices for the extracorporeal blood circuit, plasma filters, haemoperfusion
devices, vascular access devices, blood pumps, pressure monitors of the extracorporeal
circuit, air detection devices or systems to prepare, maintain or monitor dialysing
fluid.