ASTM F756-08
(Practice)Standard Practice for Assessment of Hemolytic Properties of Materials
Standard Practice for Assessment of Hemolytic Properties of Materials
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.
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.
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Designation: F756 − 08
StandardPractice for
1
Assessment of Hemolytic Properties of Materials
ThisstandardisissuedunderthefixeddesignationF756;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope for Materials and Devices
1.1 This practice provides a protocol for the assessment of
3. Terminology
hemolytic properties of materials used in the fabrication of
3.1 Definitions:
medical devices that will contact blood.
3.1.1 plasma hemoglobin—amount of hemoglobin in the
1.2 This practice is intended to evaluate the acute in vitro
plasma.
hemolytic properties of materials intended for use in contact
3.1.2 % hemolysis—free plasma hemoglobin concentration
with blood.
(mg/mL) divided by the total hemoglobin concentration (mg/
1.3 This practice consists of a protocol for a hemolysis test
mL) present multiplied by 100. This is synonymous with
under static conditions with either an extract of the material or
hemolytic index.
direct contact of the material with blood. It is recommended
3.1.3 comparative hemolysis—comparison of the hemolytic
that both tests (extract and direct contact) be performed unless
index produced by a test material with that produced by a
the material application or contact time justifies the exclusion
standard reference material such as polyethylene under the
of one of the tests.
same test conditions.
1.4 This practice is one of several developed for the
3.1.4 direct contact test—testforhemolysisperformedwith
assessment of the biocompatibility of materials. Practice F748
the test material in direct contact with the blood.
may provide guidance for the selection of appropriate methods
3.1.5 extract test—test for hemolysis performed with an
for testing materials for a specific application.
isotonic extract of the test material, as described in Practice
1.5 The values stated in SI units are to be regarded as
F619, in contact with the blood.
standard. No other units of measurement are included in this
3.1.6 hemolysis—destructionoferythrocytesresultinginthe
standard.
liberation of hemoglobin into the plasma or suspension me-
1.6 This standard does not purport to address all of the
dium.
safety concerns, if any, associated with its use. It is the
3.1.7 negative control—material, such as polyethylene, that
responsibility of the user of this standard to establish appro-
produces little or no hemolysis (<2 % after subtraction of the
priate safety and health practices and determine the applica-
blank) in the test procedure. It is desirable that the control
bility of regulatory limitations prior to use.
specimens have the same configuration as the test samples.
2. Referenced Documents
3.1.8 positive control—materials capable of consistently
2 producing a hemolytic index (above the negative control) of at
2.1 ASTM Standards:
least 5% (see 10.3). Although positive control materials have
E691Practice for Conducting an Interlaboratory Study to
not been validated for this practice, washed Buna N rubber
Determine the Precision of a Test Method
(Aero Rubber Company; ARC-45010, 0.031 in. thick sheet)
F619Practice for Extraction of Medical Plastics
and vinyl plastisol (Plasti-Coat; 0.025 to 0.075 in. thick sheet,
F748PracticeforSelectingGenericBiologicalTestMethods
3
color: DB1541-medium blue 300) produced hemolysis levels
above 90% when using extracts obtained at 121°C for 1 h
4
during limited interlaboratory round robin evaluations. In
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
Surgical Materials and Devicesand is the direct responsibility of Subcommittee
F04.16 on Biocompatibility Test Methods.
3
Current edition approved Dec. 1, 2008. Published March 2009. Originally Aero Rubber Company, 8100 W. 185th St., Tinley Park, IL 60487, http://
approved in 1982. Last previous edition approved in 2000 as F756–00. DOI: www.aerorubber.com; Plasti-Coat, 137 Brookside Dr., Waterbury, CT 06708,
10.1520/F0756-08. http://www.plasti-coat.com. See Note 1.
2 4
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Malczewski, R, Jackson,A, Lee, M, Malinauskas, R, Merritt, K, Peterson, L.,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM “Standardizing an in vitro Hemolysis Assay for Screening Materials Used in
Standards volume information, refer to the standard’s Document Summary page on Medical Devices ,” Society for Biomaterials, Tampa, FL, Apr. 2002 (Extended
the ASTM website. abstract).
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F756 − 08
direct contact test
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This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation:F756–00 Designation:F756–08
Standard Practice for
1
Assessment of Hemolytic Properties of Materials
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 (´) indicates an editorial change since the last revision or reapproval.
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.
1.3This 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.
1.3 Thispracticeconsistsofaprotocolforahemolysistestunderstaticconditionswitheitheranextractofthematerialordirect
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 Thispracticeisoneofseveraldevelopedfortheassessmentofthebiocompatibilityofmaterials.PracticeF 748mayprovide
guidance for the selection of appropriate methods for testing materials for a specific application.
1.5This 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.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 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. 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
2
2.1 ASTM Standards:
E 691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
F 619 Practice for Extraction of Medical Plastics
F 748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
3. Terminology
3.1 Definitions:
3.1.1 plasma hemoglobin—the amount—amount of hemoglobin in the plasma.
3.1.2 % hemolysis—the quotient of the free plasma hemoglobin (mg/ml) released as a result of contact with test material or
extract divided by the total hemoglobin (mg/ml) present in the blood solution multiplied by 100. (This is synonymous with
hemolytic index). —free plasma hemoglobin concentration (mg/mL) divided by the total hemoglobin concentration (mg/mL)
present multiplied by 100. This is synonymous with hemolytic index.
3.1.3 comparative hemolysis—comparison of the hemolytic index produced by a test material compared with that produced by
a standard reference material such as polyethylene atunder the same test conditions.
3.1.4 direct contact test—a test —test for the hemolytic propertyhemolysis performed with the test material in direct contact
with the blood.
1
This practice is under the jurisdiction ofASTM Committee F-4 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.16
on Biocompatibility.
Current edition approved July 10, 2000. Published October 2000. Originally published as F 756 – 82. Last previous edition F 756 – 93.
1
This practice is under the jurisdiction ofASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.16
on Biocompatibility Test Methods.
Current edition approved Dec. 1, 2008. Published March 2009. Originally approved in 1982. Last previous edition approved in 2000 as F 756 – 00.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
, Vol 13.01.volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 1942
...
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