ASTM F1904-14
(Practice)Standard Practice for Testing the Biological Responses to Particles in vivo
Standard Practice for Testing the Biological Responses to Particles <emph type="bdit" >in vivo</emph>
SIGNIFICANCE AND USE
4.1 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.
4.2 The appropriateness of the methods should be carefully considered by the user since not all materials or applications need to 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 those described here are needed.
4.3 Abbreviations Used:
4.3.1 CD—Cluster differentiation.
4.3.2 DNA—Deoxyribonucleic acid.
4.3.3 EDS—Energy dispersive X-ray spectroscopy.
4.3.4 EU—Endotoxin unit.
4.3.5 HLA—Human leukocyte antigens.
4.3.6 LAL—Limulus amebocyte lysate.
4.3.7 LPS—Lipopolysaccharide (endotoxin).
4.3.8 RNA—Ribonucleic acid.
SCOPE
1.1 This practice covers the production of wear particles 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 asterisk (*).
1.2 This standard is not designed to provide a comprehensive assessment of the systemic toxicity, carcinogenicity, teratogenicity, or mutagenicity of the material.
1.3 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.
General Information
Buy Standard
Standards Content (Sample)
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
Designation: F1904 − 14
Standard Practice for
1
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 F748 Practice for Selecting Generic Biological Test Methods
for Materials and Devices
1.1 This practice covers the production of wear particles and
F1877 Practice for Characterization of Particles
degradation products from implanted materials that may lead to
a cascade of biological responses resulting in damage to
3. Summary of Practice
adjacent and remote tissues. In order to ascertain the role of
3.1 Biological responses to particles testing may be done
particles in stimulating such responses, the nature of the
using specimens from animals being tested in accordance with
responses, and the consequences of the responses, established
the Practice F748 matrix for irritation and sensitivity, or for
protocols are needed. This is an emerging, rapidly developing
implantation. If particles were implanted during the testing
area and the information gained from standard protocols is
procedures or generated during the experimental time period,
necessary to interpret responses. Some of the procedures listed
the response to those particles may form a part of the overall
here may, on further testing, not prove to be predictive of
investigation of response to particles. Blood, organs, or tissues
clinical responses to particulate debris. However, only the use
from the animals may be used.
of standard protocols will establish which are useful tech-
niques. Since there are many possible and established ways of
3.2 Biological responses to particles may be tested using the
determining responses, a single standard protocol is not stated.
actual particulate materials or extracts in accordance with
However, this recommended practice indicates which neces-
Practice F619. The increased surface area of small particles
sary information should be supplied with test results. For
may enhance the amount of extracted substances but, since the
laboratories without established protocols, recommendations
response to particles may be related to the physical size, shape
are given and indicated with an asterisk (*).
and composition, the use of only extracts will not completely
address the question of the impact of particle formation on the
1.2 This standard is not designed to provide a comprehen-
tissue response and actual implantation or other testing of
sive assessment of the systemic toxicity, carcinogenicity,
particles should be included as a part of the characterization of
teratogenicity, or mutagenicity of the material.
tissue response when particle generation is likely during actual
1.3 This standard does not purport to address all of the
usage. These materials or extracts may be used in in vivo tests
safety concerns, if any, associated with its use. It is the
or for the in vitro tests. Particles generated by other methods
responsibility of the user of this standard to establish appro-
may also be used. The method of generation shall be described.
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
4. Significance and Use
4.1 This practice is to be used to help assess the biocom-
2. Referenced Documents
patibility of materials used in medical devices. It is designed to
2
2.1 ASTM Standards:
test the effect of particles from the materials on the host tissues.
F561 Practice for Retrieval and Analysis of Medical
4.2 The appropriateness of the methods should be carefully
Devices, and Associated Tissues and Fluids
considered by the user since not all materials or applications
F619 Practice for Extraction of Medical Plastics
need to 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 those described here are needed.
1
This practice is under the jurisdiction of ASTM Committee F04 on Medical and
Surgical Materials and Devices and is the direct responsibility of Subcommittee
4.3 Abbreviations Used:
F04.16 on Biocompatibility Test Methods.
4.3.1 CD—Cluster differentiation.
Current edition approved March 1, 2014. Published May 2014. Originally
4.3.2 DNA—Deoxyribonucleic acid.
approved in 1998. Last previous edition approved in 2008 as F1904 – 98 (2008).
DOI: 10.1520/F1904-14.
4.3.3 EDS—Energy dispersive X-ray spectroscopy.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
4.3.4 EU—Endotoxin unit.
contact ASTM Customer Service at service@astm.org. For Annual B
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM 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: F1904 − 98 (Reapproved 2008) F1904 − 14
Standard Practice for
1
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
1.1 This practice covers the production of wear debrisparticles 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 *.asterisk (*).
1.2 This standard is not designed to provide a comprehensive assessment of the systemic toxicity, carcinogenicity,
teratogenicity, or mutagenicity of the material.
1.3 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:
F561 Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
F619 Practice for Extraction of Medical Plastics
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F1877 Practice for Characterization of Particles
3. Summary of Practice
3.1 Biological responses to particles testing may be done using specimens from animals being tested according to in accordance
with the Practice F748 matrix for irritation and sensitivity, or for implantation. Blood, organs, or tissues from the animals may be
used. Procedures according toIf particles were implanted during the testing procedures or generated during the experimental F561
may be used to assess the cellular response.time period, the response to those particles may form a part of the overall investigation
of response to particles. Blood, organs, or tissues from the animals may be used.
3.2 Biological responses to particles may be tested using the actual particulate materials or extracts according to in accordance
with Practice F619. The increased surface area of small particles may enhance the amount of extracted substances but, since the
response to particles may be related to the physical size, shape and composition, the use of only extracts will not completely
address the question of the impact of particle formation on the tissue response and actual implantation or other testing of particles
should be included as a part of the characterization of tissue response when particle generation is likely during actual usage. These
materials or extracts may be used in in vivo tests or for the in vitro tests. Particles generated by other methods may also be used.
The method of generation mustshall be described.
1
This practice is under the jurisdiction of ASTM 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 Aug. 1, 2008March 1, 2014. Published August 2008May 2014. Originally approved in 1998. Last previous edition approved in 20032008 as
F1904 – 98 (2003).(2008). DOI: 10.1520/F1904-98R08.10.1520/F1904-14.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.