BSI 20/30408361 DC:2020 Edition
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BS ISO 18193. Cardiovascular implants and artificial organs. Cannulae for extracorporeal circulation
Published By | Publication Date | Number of Pages |
BSI | 2020 | 41 |
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 will not apply to:
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introducers (e.g., guidewires) as addressed in ISO 11070;
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isolated organ perfusion cannulae;
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intravascular catheters as addressed in ISO 10555-3.