ASTM F1841-97 (Reapproved 2017)

Standard Practice For Assessment Of Hemolysis In Continuous Flow Blood Pumps

F1841-97 (Reapproved 2017)

Standard Organization: ASTM

ASTM F1841-97 (Reapproved 2017)
Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps

Recognition NumberCardiovascular
Recognition Date2019-01-14
Recognition List051
Recognition Number3-56
Extent Complete standard
Standards Orgs ASTM ASTM International http://www.astm.org/
STG Cardiovascular
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Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

This practice covers a protocol for the assessment of the hemolytic properties of continuous flow blood pumps used in extracorporeal or implantable circulatory assist. An assessment is made based on the pump's effects on the erythrocytes over a certain period of time. For this assessment, a recirculation test is performed with a pump for 6 h.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§870.4370 Pump, Blood, Cardiopulmonary Bypass, Roller Type Class 2 DWB
§870.4360 Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Class 2 KFM

FDA Guidance:

There is no relevant guidance developed at this time.


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