20090729 BSEN 980-20089.pdf

准标网载
The file is downloaded from
Designation: F 756 – 00
Standard Practice for
Assessment of Hemolytic Properties of Materials1
This standard is issued under the fixed designation F 756; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope parison of the hemolytic
This practice provides a protocol for the assessment of index produced by a test pared with that produced
hemolytic properties of materials used in the fabrication of by a standard reference material such as polyethylene at the
medical devices that will contact blood. same test conditions.
This practice is intended to evaluate the acute in vitro direct contact test—a test for the hemolytic property
hemolytic properties of materials intended for use in contact performed with the test material in direct contact with the
with blood. blood.
This practice consists of a protocol for a hemolysis test extract test—a test for the hemolytic property per-
under static conditions with either an extract of the material or formed with an isotonic extract of the test material, as
direct contact of the material with blood. described in F 619, in contact with the blood.
This practice is one of several developed for the hemolysis—destruction of erythrocytes resulting in
assessment of the patibility of materials. Practice F 748 the liberation of hemoglobin into the plasma or suspension
may provide guidance for the selection of appropriate methods medium.
for testing materials for a specific application. negative control—a material, such as a polyethylene,
This standard does not purport to address all of the that produces little or no hemolysis (<2 % after subtraction of
safety conc