ISO 11658:2012

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 38	PDF
std 2 38	Paper

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