ASTM F756-00
Historical Standard: ASTM F756-00 Standard Practice for Assessment of Hemolytic Properties of Materials
SUPERSEDED (see Active link, below)
ASTM F756
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.
1.4 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 may provide guidance for the selection of appropriate methods for testing materials for a specific application.
1.5 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.
1.6 Identification of a supplier of materials or reagents is for the convenience of the user and does not imply single source. Appropriate materials and reagents may be obtained from many commercial supply houses.
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/F0756-00
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