ISO-18193 › Cardiovascular implants and artificial organs - Cannulae for extracorporeal circulation

ISO-18193 - 1ST EDITION - CURRENT


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This document specifies requirements for sterile, single-use cannulae for removal and delivery of patientsâ' 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:

â..    introducers (e.g., guidewires) as addressed in ISO 11070,

â..    isolated organ perfusion cannulae, and

â..    intravascular catheters as addressed in ISO 10555-3.

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11.040.40 (Implants for surgery, prosthetics and orthotics Including pacemakers Ophthalmic implants, see 11.040.70)

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Document Number

ISO 18193:2021

Revision Level

1ST EDITION

Status

Current

Publication Date

Aug. 1, 2021

Committee Number

ISO/TC 150/SC 2