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ASTM International - ASTM F756-08

Standard Practice for Assessment of Hemolytic Properties of Materials

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Organization: ASTM International
Publication Date: 1 December 2008
Status: inactive
Page Count: 5
ICS Code (Laboratory medicine): 11.100
significance And Use:

The presence of hemolytic material in contact with the blood may cause loss of, or damage to, red blood cells and may produce increased levels of free plasma hemoglobin capable of inducing toxic... View More

scope:

1.1 This practice provides a protocol for the assessment of hemolytic properties of materials used in the fabrication of medical devices that will contact blood.

1.2 This practice is intended to evaluate the acute in vitro hemolytic properties of materials intended for use in contact with blood.

1.3 This practice consists of a protocol for a hemolysis test under static conditions with either an extract of the material or direct contact of the material with blood. It is recommended that both tests (extract and direct contact) be performed unless the material application or contact time justifies the exclusion of one of the tests.

1.4 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F 748 may provide guidance for the selection of appropriate methods for testing materials for a specific application.

1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.6 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.

Document History

March 1, 2017
Standard Practice for Assessment of Hemolytic Properties of Materials
1.1 This practice provides a protocol for the assessment of hemolytic properties of materials used in the fabrication of medical devices that will contact blood. 1.2 This practice is intended to...
December 1, 2013
Standard Practice for Assessment of Hemolytic Properties of Materials
1.1 This practice provides a protocol for the assessment of hemolytic properties of materials used in the fabrication of medical devices that will contact blood. 1.2 This practice is intended to...
ASTM F756-08
December 1, 2008
Standard Practice for Assessment of Hemolytic Properties of Materials
1.1 This practice provides a protocol for the assessment of hemolytic properties of materials used in the fabrication of medical devices that will contact blood. 1.2 This practice is intended to...
July 10, 2000
Standard Practice for Assessment of Hemolytic Properties of Materials
1.1 This practice provides a protocol for the assessment of hemolytic properties of materials used in the fabrication of medical devices that will contact blood. 1.2 This practice is intended to...
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