ISO 18242:2016
Current
The latest, up-to-date edition.
Cardiovascular implants and extracorporeal systems — Centrifugal blood pumps
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English
15-08-2016
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ISO 18242:2016 specifies requirements for sterile, single-use, extracorporeal centrifugal blood pumps, whether coated, non-surface modified, or surface-modified, intended for producing blood flow during extracorporeal circulation. Such blood flow is most commonly used to provide systemic perfusion during cardiopulmonary bypass, but also has applications for veno-venous bypass, kinetic-assisted venous drainage, or extracorporeal membrane oxygenation.
It does not apply to
- centrifugal pumps used as ventricular assist devices, and
- other components of extracorporeal circuits (e.g. blood tubing, pump console/driver).
| Committee |
ISO/TC 150/SC 2
|
| DevelopmentNote |
Supersedes ISO/DIS 18242. (08/2016)
|
| DocumentType |
Standard
|
| Pages |
10
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Standards | Relationship |
| DS ISO 18242 : 2016 | Identical |
| NEN ISO 18242 : 2016 | Identical |
| ANSI/AAMI/ISO 18242:2016 | Identical |
| BS ISO 18242:2016 | Identical |
| ISO 11137-1:2006 | Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 10993-4:2017 | Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood |
| ISO 11607-2:2006 | Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
| ISO 11135:2014 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 11658:2012 | Cardiovascular implants and extracorporeal systems — Blood/tissue contact surface modifications for extracorporeal perfusion systems |
| ISO 10993-11:2017 | Biological evaluation of medical devices — Part 11: Tests for systemic toxicity |
| ISO 10993-7:2008 | Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
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