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

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Categories: 11.040.40 - Implants for surgery, prosthetics and orthotics, BSI

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Description

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:

introducers (e.g., guidewires) as addressed in ISO 11070;
isolated organ perfusion cannulae;
intravascular catheters as addressed in ISO 10555-3.

Additional information

Status	Definitive
Pages	41
Publication Date	2020-03-18
Standard Number	20/30408361 DC
Title	BS ISO 18193. Cardiovascular implants and artificial organs. Cannulae for extracorporeal circulation
Identical National Standard Of	ISO/DIS 18193
Descriptors	Surgical implants, Implants (surgical), Cardiovascular system, Artificial organs, Tests
Publisher	BSI
Committee	CH/150/2
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics

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BSI 20/30408361 DC:2020 Edition

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