BS ISO 11658:2012

$102.76

Cardiovascular implants and extracorporeal systems. Blood/tissue contact surface modifications for extracorporeal perfusion systems

Published By	Publication Date	Number of Pages
BSI	2012	16

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Categories: 11.040.40 - Implants for surgery, prosthetics and orthotics, BSI

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Description

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.

Additional information

Status	Confirmed
Pages	16
Publication Date	2012-05-31
ISBN	978 0 580 71492 4
Standard Number	BS ISO 11658:2012
Title	Cardiovascular implants and extracorporeal systems. Blood/tissue contact surface modifications for extracorporeal perfusion systems
Identical National Standard Of	ISO 11658:2012
Descriptors	Prosthetic devices, Documents, Drugs, Clinical testing, Blood vessels, Instructions for use, Design, Cardiology, Drug administration, Circulatory system, Marking, Safety measures, Biological analysis and testing, Implants (surgical), Medical equipment
Publisher	BSI
Committee	CH/150/2
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics

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BS ISO 11658:2012

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