1204392

ISO 8638:2004

Cardiovascular implants and artificial organs - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

standard by International Organization for Standardization , 10/01/2004

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Full Description

ISO 8638:2004 specifies requirements for single-use extracorporeal blood circuits (hereafter referred to as "the device") and (integral and non-integral) transducer protectors which are intended for use in haemodialysis, haemodiafiltration and haemofiltration.

ISO 8638:2004 is not applicable to haemodialysers, haemodiafilters or haemofilters, plasmafilters, haemoperfusion devices, vascular access devices, blood pumps, pressure monitors for the extracorporeal blood circuit, air detection devices, systems to prepare, maintain or monitor dialysing fluid, or systems intended to perform haemofiltration or haemoconcentration.

Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637.

 

Product Details

Published:
10/01/2004
Number of Pages:
12
File Size:
1 file , 280 KB
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. ISO 8637-2:2024


    Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

    • Most Recent

  2. ISO 8637-2:2018


    Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

    • Historical Version

  3. ISO 8637:2010


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

    • Historical Version

  4. ISO 8638:2010


    Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

    • Historical Version

  5. ISO 8637:2004


    Cardiovascular implants and artificial organs - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

    • Historical Version

  6. ISO 8638:2004

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    Cardiovascular implants and artificial organs - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

    • Historical Version