ASTM F1904-98e1
(Practice)Standard Practice for Testing the Biological Responses to Particles In Vivo
Standard Practice for Testing the Biological Responses to Particles In Vivo
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 remove 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 the test results. For laboratories without established protocols, recommendations are given and indicated with an asterisk.
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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e1
Designation: F 1904 – 98
Standard Practice for
Testing the Biological Responses to Particles In Vivo
This standard is issued under the fixed designation F 1904; 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.
e NOTE—Section 1.1 was editorially revised in June 2000.
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 F 748 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 F 561 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 F 619. 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-
4. Significance and Use
niques. Since there are many possible and established ways of
4.1 This practice is to be used to help assess the biocom-
determining responses, a single standard protocol is not stated.
However, this recommended practice indicates which neces- patibility of materials used in medical devices. It is designed to
testtheeffectofparticlesfromthematerialsonthehosttissues.
sary information should be supplied with test results. For
laboratories without established protocols, recommendations 4.2 The appropriateness of the methods should be carefully
considered by the user since not all materials or applications
are given and indicated with an *.
need be tested by this practice. The validity of these studies in
1.2 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the predicting the human response is not known at this time and
studies such as described here are needed.
responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica- 4.3 Abbreviation Used:
4.3.1 LPS—Lipopolysaccharide (endotoxin).
bility of regulatory limitations prior to use.
4.3.2 LAL—Limulus amebocyte lysate.
2. Referenced Documents
4.3.3 PCR—Polymerase chain reaction.
2.1 ASTM Standards: 4.3.4 CD—Cluster differentiation.
F 561 Practice for Analysis of Retrieved Metallic Ortho- 4.3.5 HLA—Human leukocyte antigens.
paedic Implants
2 5. Responses from In Vivo Systems
F 619 Practice for Extraction of Medical Plastics
5.1 Particles—Define the nature of the particles used:
F 748 Practice for Selecting Generic Biological Test Meth-
ods for Materials and Devices 5.1.1 Source,
5.1.2 Chemistry,
F 1877 Recommended Practice for Characterization of Par-
ticles 5.1.3 Size (mean and range),
5.1.4 Shape,
5.1.5 Surface charge (if known),
This practice is under the jurisdiction ofASTM Committee F-4 on Medical and
5.1.6 Method of sterilization,
Surgical Devicesand is the direct responsibility of Subcommittee F04.16on Bio-
compatibility Test Methods.
Current edition approved June 10, 1998. Published August 1998.
Annual Book of ASTM Standards, Vol 13.01.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn. Contact ASTM
International (www.astm.org) for the latest information.
F 1904
5.1.7 If the presence of bacterial lipopolysaccharide (LPS) identity of lymphocytes and macrophages.An evaluation scale
was determined, specify how this was done and the sensitivity of 0 to 5 with 0 being no cell response, 1 being accumulation
of the method. (LAL testing with a sensitivity of at least 0.06 of a few cells, 2 being a mild response with some cell
EU is recommended), accumulation, 3 being a moderate response, 4 being a large
5.1.8 Concentration of particles used as weight, or number, response, and 5 being a severe response is recommended. It
or surface area/implant, and should also be noted whether the response is focal or diffuse.
5.1.9 Polystyrene particles, spherical, 1 to 5 µm in size 5.3.1.1 Transport of particles to relevant draining organs
should be used as a reference particle. and histologic responses in these organs should be determined,
5.2 Biological System—One or more of these sites should especially when direct injection is used. The relevant organs
be used: would be spleen, liver, kidney, and some cases the lung. The
5.2.1 Air Pouch Model— This is an emerging model to draining nodes should be harvested if identifiable. Some types
simulate synovial tissue. The volume of air and the time ofdebrisaredistinctive(forexample,carbonfibers),butlymph
allowed before introduction of the particles should be speci- nodes and lung commonly contain particles and bits of
fied. This model needs to be validated for length of time of birefringent stuff that may be confused with particles used in
implantation and relevance to other in vivo systems. the experiment. Light microscopy with and without polarized
5.2.2 Cages—Cages made of porous materials such as light can be suggestive of particle migration, but other meth-
stainless steel mesh or porous teflon can be implanted with a ods, (for example, EDAX, may be necessary to confirm the
test material inside the
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