ASTM-F1841 Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps

ASTM-F1841 - 2019(E1) EDITION - CURRENT
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Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
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Scope

1.1 This recommended 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 6h.

1.2 The values stated in both inch-pound and SI units are to be regarded as the standard. The SI units given in parentheses are for information only.

1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Keywords

blood pump; blood trauma; index of hemolysis; modified index of hemolysis (MIH); normalized index of hemolysis (NIH); ICS Number Code 11.100 (Laboratory medicine)

To find similar documents by ASTM Volume:

13.01 (Medical and Surgical Materials and Devices)

To find similar documents by classification:

11.100 (Laboratory medicine)

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Document Number

ASTM-F1841-19E01

Revision Level

2019(E1) EDITION

Status

Current

Modification Type

New

Publication Date

May 26, 2021

Document Type

Practice

Page Count

7 pages

Committee Number

F04.30