ASTM F1903-10

This document is not anASTM standard and is intended only to provide the user of anASTM 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:F1903–98 (Reapproved 2003) Designation: F1903 – 10
Standard Practice for
Testing For Biological Responses to Particles in vitroIn
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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 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.
Thisisanemerging,rapidlydevelopingareaandtheinformationgainedfromstandardprotocolsisnecessarytointerpretresponses
and to determine if there is correlation with the 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 these studies is to predict the response in humans, the use of human cells would provide much
information. However, in this practice, the interestuse of safety in laboratory protocols, 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 non-human
the information and non-primate cells is described.recommendations will still apply.
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 and health practices and determine the applicability of regulatory
limitations prior to use.
2. Referenced Documents
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2.1 ASTM Standards:
F619 Practice for Extraction of Medical Plastics
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
3. Summary of Practice
3.1 Biological 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.
3.2 Biological responses to particles may be evaluated using materials or extracts according to Practice F619. These materials
or extracts may be used for in vivo tests or for the in vitro tests. Particles generated by other methods may also be used.
3.3 The purpose of this practice is to assess the response of cells in direct contact with particles and, therefore, this practice is
primarily intended to cover the testing of particles placed into culture with the cells. This practice should be equally appropriate
for the testing of the response to nanoparticles placed in culture, if particles of that size are the particles of interest.
4. 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 macrophages. For safety reasons, the The use of nonhuman, nonprimate cells is
recommended in this practice. For laboratories equipped and approved to work with human blood and tissue, the use of these same
protocols would be advantageous for development of understanding of the interaction of cells and particles.
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This practice is under the jurisdiction ofASTM 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 Nov. 1, 2003. Published December 2003. Originally approved in 1998. Last previous edition approved in 1998 as F1903–98. DOI:
10.1520/F1903-98R03.
Current edition approved June 1, 2010. Published June 2010. Originally approved in 1998. Last previous edition approved in 2003 as F1903 – 98 (2003). DOI:
10.1520/F1903-10.
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For referencedASTM standards,
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