ISO 11658:2012
ISO 11658:2012 Cardiovascular implants and extracorporeal systems – Blood/tissue contact surface modifications for extracorporeal perfusion systems
CDN $82.00
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.
Edition
1
Published Date
2012-05-11
Status
PUBLISHED
Pages
6
Language
English
Format
Secure PDF
Secure – PDF details
- Save your file locally or view it via a web viewer
- Viewing permissions are restricted exclusively to the purchaser
- Device limits - 3
- Printing – Enabled only to print (1) copy
See more about our Environmental Commitment
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.
Previous Editions
Can’t find what you are looking for?
Please contact us at:
Related Documents
-
ISO 16840:2023 Wheelchair seating – Part 14: Concepts related to managing external forces to maintain tissue integrity
CDN $124.00 Add to cart -
ISO 20712:2024 Water safety signs and beach safety flags – Part 3: Guidance for use
CDN $251.00 Add to cart -
ISO 16972:2020 Respiratory protective devices – Vocabulary and graphical symbols
CDN $82.00 Add to cart -
ISO 1956:1982 Fruits and vegetables – Morphological and structural terminology
CDN $251.00 Add to cart
