ISO 8637:1989
Haemodialysers, haemofilters and haemoconcentrators
Reference number
ISO 8637:1989
Edition 1
1989-07
© ISO 2024
Withdrawn
Withdrawn (Edition 1, 1989)

Abstract

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.

General information

  • Status
     : Withdrawn
    Publication date
     : 1989-07
    Stage
    : Withdrawal of International Standard [95.99]
  • Edition
     : 1
    Number of pages
     : 18
  • Technical Committee :
    ISO/TC 150/SC 2
    ICS :
    11.040.40 
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