ISO 18242:2016
Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps
- Standard No.
- ISO 18242:2016
- Release Date
- 2016
- Published By
- International Organization for Standardization (ISO)
- Status
- Replace By
- ISO 18242:2016/Amd 1:2023
- Latest
- ISO 18242:2016/Amd 1:2023
ISO 18242:2016 Referenced Document
- ASTM F1830-97 Standard Practice for Selection of Blood for In Vitro Evaluation of Blood Pumps
- ISO 10993-11:2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 10993-4:2002 Biological evaluation of medical devices - Part 4: Selection of test for interactions with blood
- ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- 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 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 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
- ISO 11658:2012 Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion 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
ISO 18242:2016 history
- 2023 ISO 18242:2016/Amd 1:2023 Cardiovascular implants and extracorporeal systems — Centrifugal blood pumps — Amendment 1: Worst-case conditions for testing
- 2016 ISO 18242:2016 Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps
