scope:

This International Standard specifies requirements for haemodialysers, including those of coil, hollow fibre and parallel plate design, haemofilters and haemoconcentrators for single use for humans.

Materials of construction and test methods for biocompatibility, validation of sterility, non-pyrogenicity and some performance characteristics are not specified; the rationale for these omissions is given in the Introduction.

This International Standard does not apply to devices assembled and sterilized by the user, 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.

NOTE - Requirements for the extracorporeal blood circuit for haemodialysers, haernofilters and haemoconcentrators are specified in IS0 8638.