ASTM F1904-98(2008)
(Practice)Standard Practice for Testing the Biological Responses to Particles in vivo
Standard Practice for Testing the Biological Responses to Particles <i>in vivo</i>
SIGNIFICANCE AND USE
This practice is to be used to help assess the biocompatibility of materials used in medical devices. It is designed to test the effect of particles from the materials on the host tissues.
The appropriateness of the methods should be carefully considered by the user since not all materials or applications need be tested by this practice. The validity of these studies in predicting the human response is not known at this time and studies such as described here are needed.
Abbreviation Used:
LPS—Lipopolysaccharide (endotoxin).
LAL—Limulus amebocyte lysate.
PCR—Polymerase chain reaction.
CD—Cluster differentiation.
HLA—Human leukocyte antigens.
SCOPE
1.1 This practice covers the production of wear debris and degradation products from implanted materials that may lead to a cascade of biological responses resulting in damage to adjacent and remote tissues. In order to ascertain the role of particles in stimulating such responses, the nature of the responses, and the consequences of the responses, established protocols are needed. This is an emerging, rapidly developing area and the information gained from standard protocols is necessary to interpret responses. Some of the procedures listed here may, on further testing, not prove to be predictive of clinical responses to particulate debris. However, only the use of standard protocols will establish which are useful techniques. Since there are many possible and established ways of determining responses, a single standard protocol is not stated. However, this recommended practice indicates which necessary information should be supplied with test results. For laboratories without established protocols, recommendations are given and indicated with an *.
1.2 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: F1904 − 98(Reapproved 2008)
Standard Practice for
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Testing the Biological Responses to Particles in vivo
This standard is issued under the fixed designation F1904; 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 3. Summary of Practice
1.1 This practice covers the production of wear debris and 3.1 Biological responses to particles testing may be done
degradationproductsfromimplantedmaterialsthatmayleadto using specimens from animals being tested according to the
a cascade of biological responses resulting in damage to Practice F748 matrix for irritation and sensitivity, or for
adjacent and remote tissues. In order to ascertain the role of implantation. Blood, organs, or tissues from the animals may
particles in stimulating such responses, the nature of the be used. Procedures according to F561 may be used to assess
responses, and the consequences of the responses, established the cellular response.
protocols are needed. This is an emerging, rapidly developing
3.2 Biological responses to particles may be tested using
area and the information gained from standard protocols is
materials or extracts according to Practice F619. These mate-
necessary to interpret responses. Some of the procedures listed
rials or extracts may be used in in vivo tests or for the in vitro
here may, on further testing, not prove to be predictive of
tests. Particles generated by other methods may also be used.
clinical responses to particulate debris. However, only the use
The method of generation must be described.
of standard protocols will establish which are useful tech-
niques. Since there are many possible and established ways of 4. Significance and Use
determining responses, a single standard protocol is not stated.
4.1 This practice is to be used to help assess the biocom-
However, this recommended practice indicates which neces-
patibility of materials used in medical devices. It is designed to
sary information should be supplied with test results. For
testtheeffectofparticlesfromthematerialsonthehosttissues.
laboratories without established protocols, recommendations
4.2 The appropriateness of the methods should be carefully
are given and indicated with an *.
considered by the user since not all materials or applications
1.2 This standard does not purport to address all of the
need be tested by this practice. The validity of these studies in
safety concerns, if any, associated with its use. It is the
predicting the human response is not known at this time and
responsibility of the user of this standard to establish appro-
studies such as described here are needed.
priate safety and health practices and determine the applica-
4.3 Abbreviation Used:
bility of regulatory limitations prior to use.
4.3.1 LPS—Lipopolysaccharide (endotoxin).
4.3.2 LAL—Limulus amebocyte lysate.
2. Referenced Documents
4.3.3 PCR—Polymerase chain reaction.
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2.1 ASTM Standards:
4.3.4 CD—Cluster differentiation.
F561 Practice for Retrieval and Analysis of Medical
4.3.5 HLA—Human leukocyte antigens.
Devices, and Associated Tissues and Fluids
F619 Practice for Extraction of Medical Plastics 5. Responses from In Vivo Systems
F748 PracticeforSelectingGenericBiologicalTestMethods
5.1 Particles—Define the nature of the particles used:
for Materials and Devices
5.1.1 Source,
F1877 Practice for Characterization of Particles
5.1.2 Chemistry,
5.1.3 Size (mean and range),
5.1.4 Shape,
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ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
5.1.5 Surface charge (if known),
Surgical Materials and Devices and is the direct responsibility of Subcommittee
5.1.6 Method of sterilization,
F04.16 on Biocompatibility Test Methods.
5.1.7 If the presence of bacterial lipopolysaccharide (LPS)
Current edition approved Aug. 1, 2008. Published August 2008. Originally
was determined, specify how this was done and the sensitivity
approved in 1998. Last previous edition approved in 2003 as F1904 – 98 (2003).
DOI: 10.1520/F1904-98R08.
of the method. (LAL testing with a sensitivity of at least 0.06
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For referenced ASTM standards, visit the ASTM website, www.astm.org, or
EU is recommended),
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
5.1.8 Concentration of particles used as weight, or number,
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. or surface area/implant, and
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F1904 − 98 (2008)
5.1.9 P
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