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 effects or other effects which may stress the kidneys or other organs.

This practice may not be predictive of events occurring during all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the materials being tested, their potential applications, and the recommendations contained in Practice F 748 .

1. 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.

2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM Standards

E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method

F619 Practice for Extraction of Medical Plastics

F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices

Keywords

biocompatibility; blood compatibility; direct contact; extract; hemoglobin; hemolysis testing; Biocompatibility; Blood materials/applications; Hemolysis assessment; Plasma hemoglobin; Rabbits ;

ICS Code

ICS Number Code 11.100 (Laboratory medicine)

DOI: 10.1520/F0756-08

ASTM International is a member of CrossRef.

ASTM F756