ASTM F1903-18
(Practice)Standard Practice for Testing for Cellular Responses to Particles in vitro
Standard Practice for Testing for Cellular Responses to Particles <emph type="bdit" >in vitro</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 released from medical devices and biomaterials on macrophages or other cells.
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.
4.3 Abbreviations:
4.3.1 FCS (FBS)—Fetal Calf Serum (Fetal Bovine Serum)
4.3.2 FGFs—Fibroblast Growth Factors
4.3.3 HBSS—Hank’s Balanced Salt Solution
4.3.4 HEPES—A buffering salt (4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid)
4.3.5 IL17—Interleukin 17
4.3.6 IL18—Interleukin 18
4.3.7 IL1β—Interleukin 1 beta
4.3.8 IL6—Interleukin 6
4.3.9 IL8—Interleukin 8
4.3.10 LAL—Limulus Amebocyte Lysate
4.3.11 LPS—lipopolysaccharide (endotoxin)
4.3.12 MCP1—Monocyte Chemotactic Protein-1
4.3.13 MMPs—Matrix Metalloproteinases
4.3.14 NO—Nitric Oxide
4.3.15 PBS—Phosphate Buffered Saline
4.3.16 PGE2—Prostaglandin E2
4.3.17 RPMI 1640—Specific Growth Medium (Roswell Park Memorial Institute)
4.3.18 TGFβ—Transforming growth factor beta
4.3.19 TNFα–—Tumor Necrosis Factor alpha
4.3.20 VEGF—Vascular Endothelial Growth Factor
SCOPE
1.1 This practice covers the assessment of cellular responses to 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 cellular responses to particles and to determine if these correlate with in vivo responses. Since there are many possible and established ways of determining responses, a single standard protocol is not stated. However, well described protocols are needed to compare results from different investigators using the same materials and to compare biological responses for evaluating (ranking) different materials. For laboratories without established protocols, recommendations are given and indicated with an asterisk (*).
1.2 Since the purpose of the following test procedures is to predict the response in human tissues, the use of human (preferably macrophage lineage) cells is recommended. However, the use of non-macrophage cell lineage or the use of cells from non-human and non-primate sources may be acceptable. The source of the cells or the cell line used should be justified based on the cellular responses under test and/or tissue of interest. Non-human cells should not be used if there is evidence of possible cross-species difference for specific test results as the results of this in vitro test may not correspond to actual human response.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F1903 − 18
Standard Practice for
1
Testing for Cellular Responses to Particles in vitro
This standard is issued under the fixed designation F1903; 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 priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use.
1.1 Thispracticecoverstheassessmentofcellularresponses
1.5 This international standard was developed in accor-
to wear particles and degradation products from implanted
dance with internationally recognized principles on standard-
materials that may lead to a cascade of biological responses
ization established in the Decision on Principles for the
resulting in damage to adjacent and remote tissues. In order to
Development of International Standards, Guides and Recom-
ascertain the role of particles in stimulating such responses, the
mendations issued by the World Trade Organization Technical
nature of the responses, and the consequences of the responses,
Barriers to Trade (TBT) Committee.
established protocols are needed. This is an emerging, rapidly
developing area, and the information gained from standard
2. Referenced Documents
protocols is necessary to interpret cellular responses to par-
2
2.1 ASTM Standards:
ticlesandtodetermineifthesecorrelatewithinvivoresponses.
F619 Practice for Extraction of Medical Plastics
Since there are many possible and established ways of deter-
F748 PracticeforSelectingGenericBiologicalTestMethods
mining responses, a single standard protocol is not stated.
for Materials and Devices
However, well described protocols are needed to compare
F1877 Practice for Characterization of Particles
results from different investigators using the same materials
and to compare biological responses for evaluating (ranking)
3. Summary of Practice
different materials. For laboratories without established
protocols, recommendations are given and indicated with an
3.1 Cellular responses to particles may be evaluated using
asterisk (*). specimens from animals being tested according to the Practice
F748 matrix for irritation and sensitivity, or for implantation.
1.2 Since the purpose of the following test procedures is to
Blood, organs, or tissues from the animals may be used.
predict the response in human tissues, the use of human
(preferably macrophage lineage) cells is recommended.
3.2 Cellular responses to particles may be evaluated using
However, the use of non-macrophage cell lineage or the use of
materials or extracts according to Practice F619. These mate-
cells from non-human and non-primate sources may be accept-
rials or extracts may be used for in vivo tests or for the in vitro
able. The source of the cells or the cell line used should be
tests. Particles generated by methods (for example, derived
justifiedbasedonthecellularresponsesundertestand/ortissue
from in vitro mechanical testing or retrieved from ex vivo
of interest. Non-human cells should not be used if there is
peri-implant tissues either from clinical retrievals or animal
evidence of possible cross-species difference for specific test
models) may also be used as long as they have characteristics
results as the results of this in vitro test may not correspond to
similar to those produced by the implant or device being tested
actual human response.
with appropriate justification.
1.3 The values stated in SI units are to be regarded as
3.3 The purpose of this practice is to assess the response of
standard. No other units of measurement are included in this
cells in direct contact with particles and therefore, this practice
standard.
is primarily intended to cover the testing of particles placed
into culture with the cells. This practice should be equally
1.4 This standard does not purport to address all of the
appropriate for the testing of the response to nanoparticles
safety concerns, if any, associated with its use. It is the
placed in culture, if particles of that size are the particles of
responsibility of the user of this standard to establish appro-
interest. The size range of particles (among other particle
characteristics) should be clearly defined and stratification of
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
Surgical Materials and Devices and is the direct responsibility of Subcommittee
2
F04.16 on Biocompatibility Test Methods. For referenced ASTM standards, visit the ASTM website, www.astm.org, o
...
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: F1903 − 10 F1903 − 18
Standard Practice for
Testing For Biologicalfor Cellular Responses to Particles In
1
Vitroin vitro
This standard is issued under the fixed designation F1903; 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 debrisassessment of cellular responses to 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 cellular responses to particles and to determine if there is correlation with the these
correlate with in vivo responses. Since there are many possible and established ways of determining responses, a single standard
protocol is not stated. However, well described protocols are needed to compare results from different investigators using the same
materials and to compare biological responses for evaluating (ranking) different materials. For laboratories without established
protocols, recommendations are given and indicated with an asterisk*.asterisk (*).
1.2 Since the purpose of these studies the following test procedures is to predict the response in humans, human tissues, the use
of human cells would provide much information. However, in this practice, (preferably macrophage lineage) cells is recommended.
However, the use of non-macrophage cell lineage or the use of cells from non-human and non-primate cells is described. If the
user should wish to employ cell lines from humans, cell lines are available from ATCC and most of the information and
recommendations will still apply.sources may be acceptable. The source of the cells or the cell line used should be justified based
on the cellular responses under test and/or tissue of interest. Non-human cells should not be used if there is evidence of possible
cross-species difference for specific test results as the results of this in vitro test may not correspond to actual human response.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2
2.1 ASTM Standards:
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 BiologicalCellular responses to particles may be evaluated using specimens from animals being tested according to the
Practice F748 matrix for irritation and sensitivity, or for implantation. Blood, organs, or tissues from the animals may be used.
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 June 1, 2010Oct. 1, 2018. Published June 2010October 2018. Originally approved in 1998. Last previous edition approved in 20032010 as
F1903 – 98 (2003).F1903 – 10. DOI: 10.1520/F1903-10.10.1520/F1903-18.
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.
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