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About This Item

 

Full Description

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard.

This document specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use in humans.

Cross References:
ISO 10993-1
ISO 10993-11
ISO 10993-4
ISO 10993-7
ISO 80369-7
ISO 7000
ISO 14937
ISO 8637-2
ISO 15223-1
ISO 13485
ISO 17665-1
ISO 11137-3
ISO/TS 17665-2
ISO 15223-2
ISO 11135
ISO 11137-2
ISO 11137-1


All current amendments available at time of purchase are included with the purchase of this document.
 

Document History

  1. BS EN ISO 8637-1:2020

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    Extracorporeal systems for blood purification-Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

    • Most Recent
  2. BS EN ISO 8637:2014


    Cardiovascular implants and extracorporeal systems. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

    • Historical Version
  3. BS EN 1283:1996


    Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits

    • Historical Version
  4. BS 7297-2:1990


    Haemodialysers and related equipment-Specification for extracorporeal circuits for use with haemodialysers, haemofilters and haemoconcentrators

    • Historical Version
  5. BS 7297-1:1990


    Haemodialysers and related equipment-Specification for haemodialysers, haemofilters and haemoconcentrators

    • Historical Version