Status : Published (Under review)

This standard was last reviewed and confirmed in 2023. Therefore this version remains current.
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Abstract

This International Standard specifies requirements for the physical, biological and performance testing of

biocompatible modifications on extracorporeal devices. This International Standard is applicable to components

of heart-lung bypass equipment and of extracorporeal life support equipment that carry blood and have

modifications on the blood and tissue-contacting surfaces of the device.

The assumption is that these devices will be used at conventional ranges of hypothermia and normothermia. If

hyperthermia (>37 °C) applications are indicated, then testing is performed over the indicated range.

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General information

  • Status
     : Published
    Publication date
     : 2012-05
    Stage
    : International Standard confirmed [90.93]
  • Edition
     : 1
    Number of pages
     : 6
  • Technical Committee :
    ISO/TC 150/SC 2
    ICS :
    11.040.40 
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Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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