What is ISO 18193 about?
ISO 18193 addresses Cardiovascular implants and artificial organs and specifies requirements for sterile, single-use cannulae for removal and delivery of patients’ blood during cardiopulmonary bypass (CPB) up to 6 h duration, extracorporeal lung assist (ECLA with VV, VAV, or AV cannulation strategies), left or right heart bypass (LHB, RHB), cardiopulmonary support (CPS), extracorporeal life support (ECLS with VA cannulation strategy), extracorporeal carbon dioxide removal (ECCO2R), and other extracorporeal circulation techniques.
ISO 18193 does not apply to introducers (e.g., guidewires) as addressed in ISO 11070, isolated organ perfusion cannulae, and intravascular catheters as addressed in ISO 105553.
Who is ISO 18193 for?
ISO 18193 on cardiovascular implants and artificial organs is applicable to-
- Manufacturers of cardiovascular implants and artificial organs
- Developers and engineers of cardiovascular implants and artificial organs
- Research facilities
- Healthcare centres
Why should you use ISO 18193?
ISO 18193 guidelines describe procedures to be used for the evaluation of ECC cannulae. Type test procedures for determination of the cannulae performance and blood cell damage are described, although limits for these characteristics are not specified. Ready identification of the performance characteristics should, however, assist the user in the selection of cannulae that suits the needs of the patient.
ISO 18193 guidelines help ensure that cannulae designed to enable extracorporeal circulation (ECC) have been adequately tested for both their safety and function and that cannulae characteristics are appropriately disclosed when labelling the device which will ensure patients health and safety.