ISO 7199:2016
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
- Standard No.
- ISO 7199:2016
- Release Date
- 2016
- Published By
- International Organization for Standardization (ISO)
- Status
- Replace By
- ISO 7199:2016/Amd 1:2020
- Latest
- ISO 7199:2016/Amd 1:2020
ISO 7199:2016 Referenced Document
- 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 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
- ISO 14971:2007 Medical devices - Application of risk management to medical devices
- ISO 15675:2016 Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
- 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 594-2:1998 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
- ISO 8637:2010 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
- ISO/TS 23810:2012 Cardiovascular implants and artificial organs - Checklist for preoperative extracorporeal circulation equipment setup
ISO 7199:2016 history
- 2020 ISO 7199:2016/Amd 1:2020 Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators) — Amendment 1: Connectors
- 2016 ISO 7199:2016 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
- 2012 ISO 7199:2009/Amd 1:2012 Clarifications for test methodologies, labelling, and sampling schedule
- 2009 ISO 7199:2009 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
- 1996 ISO 7199:1996 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
