ISO 11658:2012

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

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.

Status
: Published

Publication date
: 2012-05
Edition
: 1

Number of pages
: 6
Technical Committee
: ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems
ICS
:
11.040.40 Implants for surgery, prosthetics and orthotics

This standard contributes to the following Sustainable Development Goal:

	Format	Language
std 1 40	PDF
std 2 40	Paper

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