ASTM F1904-98(2003)
(Practice)Standard Practice for Testing the Biological Responses to Particles In Vivo
Standard Practice for Testing the Biological Responses to Particles In Vivo
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:
4.3.1 LPS—Lipopolysaccharide (endotoxin).
4.3.2 LAL—Limulus amebocyte lysate.
4.3.3 PCR—Polymerase chain reaction.
4.3.4 CD—Cluster differentiation.
4.3.5 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 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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Designation:F1904–98 (Reapproved 2003)
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.
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 *.
1.2 This standard does not purport to address all of the need be tested by this practice. The validity of these studies in
predicting the human response is not known at this time and
safety concerns, if any, associated with its use. It is the
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
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 Practice for Characterization of Particles
5.1.3 Size (mean and range),
5.1.4 Shape,
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
5.1.5 Surface charge (if known),
Surgical Devices and is the direct responsibility of Subcommittee F04.16 on
5.1.6 Method of sterilization,
Biocompatibility Test Methods.
Current edition approved Nov. 1, 2003. Published December 2003. Originally
5.1.7 If the presence of bacterial lipopolysaccharide (LPS)
e1
approved in 1998. Last previous edition approved in 1998 as F 1904 – 98
was determined, specify how this was done and the sensitivity
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
of the method. (LAL testing with a sensitivity of at least 0.06
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
EU is recommended),
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
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F1904–98 (2003)
5.1.8 Concentration of particles used as weight, or number, scale of 0 to 5 with 0 being no cell response, 1 being
or surface area/implant, and accumulationofafewcells,2beingamildresponsewithsome
cellaccumulation,3beingamoderateresponse,4beingalarge
5.1.9 Polystyrene particles, spherical, 1 to 5 µm in size
should be used as a reference particle. response, and 5 being a severe response is recommended. It
should also be noted whether the response is focal or diffuse.
5.2 Biological System—One or more of these sites should
5.3.1.1 Transport of particles to relevant draining organs
be used:
and histologic responses in these organs should be determined,
5.2.1 Air Pouch Model— This is an emerging model to
especially when direct injection is used. The relevant organs
simulate synovial tissue. The volume of air and the time
would be spleen, liver, kidney, and some cases the lung. The
allowed before introduction of the particles should be speci-
draining nodes should be harvested if identifiable. Some types
fied. This model needs to be validated for length of time of
ofdebrisaredistinctive(forexample,carbonfibers),butlymph
implantation and relevance to other in vivo systems.
nodes and lung commonly contain particles and bits of
5.2.2 Cages—Cages made of porous materials such as
birefringent stuff that may be confused with particles used in
stainless steel mesh or porous teflon can be implanted with a
the experiment. Light microscopy with and without polarized
test material inside the cage. These may be implanted subcu-
light can be suggestive of particle migration, but other m
...
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