Reference number
ISO 11658:2012
International Standard
ISO 11658:2012
Cardiovascular implants and extracorporeal systems — Blood/tissue contact surface modifications for extracorporeal perfusion systems
Edition 1
2012-05
Read sample
ISO 11658:2012
50659
Published (Edition 1, 2012)
This publication was last reviewed and confirmed in 2023. Therefore this version remains current.

ISO 11658:2012

ISO 11658:2012
50659
Language
Format
CHF 42
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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.

General information

  •  : Published
     : 2012-05
    : International Standard confirmed [90.93]
  •  : 1
     : 6
  • ISO/TC 150/SC 2
    11.040.40 
  • RSS updates

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

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