60.60 Standard published Aug 13, 2021
ISO
ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems
International Standard
11.040.40 Implants for surgery, prosthetics and orthotics
Published
This document 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. This standard does not apply to:
— introducers (e.g., guidewires) as addressed in ISO 11070,
— isolated organ perfusion cannulae, and
— intravascular catheters as addressed in ISO 10555-3.
PUBLISHED
ISO 18193:2021
60.60
Standard published
Aug 13, 2021
IN_DEVELOPMENT
ISO 18193:2021/DAmd 1
