ISO-18242 › Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps

ISO-18242 - 1ST EDITION - CURRENT


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 1ST EDITION - Sept. 1, 2016
 FOR 1ST EDITION AMENDMENT 1 SEE - Aug. 1, 2023

ISO 18242:2016 specifies requirements for sterile, single-use, extracorporeal centrifugal blood pumps, whether coated, non-surface modified, or surface-modified, intended for producing blood flow during extracorporeal circulation. Such blood flow is most commonly used to provide systemic perfusion during cardiopulmonary bypass, but also has applications for veno-venous bypass, kinetic-assisted venous drainage, or extracorporeal membrane oxygenation.

It does not apply to

- centrifugal pumps used as ventricular assist devices, and

- other components of extracorporeal circuits (e.g. blood tubing, pump console/driver).

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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 18242:2016

Revision Level

1ST EDITION

Status

Current

Publication Date

Sept. 1, 2016

Committee Number

ISO/TC 150/SC 2