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ISO 18242:2016

Cardiovascular implants and extracorporeal systems — Centrifugal blood pumps

Standard Details

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).

General Information

Status : Published
Standard Type: Main
Document No: ISO 18242:2016
Document Year: 2016
Pages: 10
Edition: 1
  • Section Volume:
  • ISO/TC 150/SC 2. Cardiovascular implants and extracorporeal systems
  • ICS:
  • 11.040.40 Implants for surgery, prosthetics and orthotics

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ISO 18242:2016
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