What is ISO 18241 - Cardiopulmonary bypass systems-Venous bubble traps about?
ISO 18241 is an international standard that focuses on cardiovascular implants and extracorporeal systems cardiopulmonary bypass systems venous bubble traps.
ISO 18241 specifies requirements for sterile, single-use, venous bubble traps intended to remove air entering the venous line during surgical procedures requiring extracorporeal circulatory support, which may include cardiopulmonary bypass (CPB), extracorporeal membrane oxygenation (ECMO), or venovenous bypass for liver transplantation.
Who is ISO 18241 - Cardiopulmonary bypass systems-Venous bubble traps for?
ISO 18241 on cardiovascular implants and extracorporeal systems cardiopulmonary bypass systems venous bubble traps is useful for:
- Healthcare facilities
- R&D team of healthcare equipment’s
- Manufacturing unit
- Specialist surgeons
Why should you use ISO 18241 - Cardiopulmonary bypass systems-Venous bubble traps?
ISO 18241 is intended to ensure that devices designed to remove air entering the venous line during surgical procedures requiring extracorporeal circulatory support have been adequately tested for both their safety and function and that extracorporeal device characteristics are appropriately disclosed when labelling the device.
ISO 18241 contains procedures to be used for the evaluation of extracorporeal venous bubble traps. Test procedures for the determination of the air removal efficiency, blood cell damage and other performance characteristics are described, although limits for these characteristics are not specified. Ready identification of the performance characteristics should, however, assist you in the selection of a venous bubble trap that will suit the needs of the patient.
ISO 18241 also includes minimum reporting requirements, which will allow you to compare performance characteristics of venous bubble traps of different designs in a standard way.
What’s changed since the last update?
BS ISO 18241:2016+A1:2019 supersedes BS ISO 18241:2016 which has been withdrawn. BS ISO 18241:2016+A1:2019 has been editorially revised.
