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ASTM F748-06

(Practice)

Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

SIGNIFICANCE AND USE
The objective of this practice is to recommend sufficient biological testing to establish a reasonable level of confidence concerning the biological response to a material or device, while at the same time avoiding unnecessary testing.
This practice is intended to provide guidance to the materials investigator in selecting the proper procedures to be carried out for the screening of new or modified materials. Because each material and each implant situation involves its own unique circumstances, these recommendations should be modified as necessary and do not constitute the only testing that will be required for a material nor should these guidelines be interpreted as minimum requirements for any particular situation. While an attempt has been made to provide recommendation for different implant circumstances, some of the recommended testing may not be necessary or reasonable for a specific material or application.
SCOPE
1.1 This practice recommends generic biological test methods for materials and devices according to end-use applications. While chemical testing for extractable additives and residual monomers or residues from processing aids is necessary for most implant materials, such testing is not included as part of this practice. The reader is cautioned that the area of materials biocompatibility testing is a rapidly evolving field, and improved methods are evolving rapidly, so this practice is by necessity only a guideline. A thorough knowledge of current techniques and research is critical to a complete evaluation of new materials.
1.2 These test protocols are intended to apply to materials and medical devices for human application. Biological evaluation of materials and devices, and related subjects such as pyrogen testing, batch testing of production lots, and so on, are also discussed. Tests include those performed on materials, end products, and extracts. Rationale and comments on current state of the art are included for all test procedures described.
1.3 The biocompatibility of materials used in single or multicomponent medical devices for human use depends to a large degree on the particular nature of the end-use application. Biological reactions that are detrimental to the success of a material in one device application may have little or no bearing on the successful use of the material for a different application. It is, therefore, not possible to specify a set of biocompatibility test methods which will be necessary and sufficient to establish biocompatibility for all materials and applications.
1.4 The evaluation of tissue engineered medical products (TEMPs) may, in some cases, involve different or additional testing beyond those suggested for non-tissue-based materials and devices. Where appropriate, these differences are discussed in this practice and additional tests described.
1.5 The ethical use of research animals places the obligation on the individual investigator to determine the most efficient methods for performing the necessary testing without undue use of animals. Where adequate prior data exists to substantiate certain types of safety information, these guidelines should not be interpreted to mean that testing should be unnecessarily repeated.
1.6 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

Status
Historical
Publication Date
30-Nov-2006
ICS
07.080 - Biology. Botany. Zoology
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.16 - Biocompatibility Test Methods
Current Stage
Ref Project

Relations

Replaces
ASTM F748-04 - Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
Effective Date
01-Dec-2006
Replaced By
ASTM F748-06(2010) - Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
Effective Date
01-Jun-2010
Referred By
ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
Effective Date
01-Dec-2006
Referred By
ASTM F2808-23 - Standard Test Method for Performing Behind-the-Knee (BTK) Test for Evaluating Skin Irritation Response to Products and Materials That Come Into Repeated or Extended Contact with Skin
Effective Date
01-Dec-2006
Referred By
ASTM F1813-21 - Standard Specification for Wrought Titanium-12Molybdenum-6Zirconium-2Iron Alloy for Surgical Implant (UNS R58120)
Effective Date
01-Dec-2006
Referred By
ASTM F750-20 - Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse
Effective Date
01-Dec-2006
Referred By
ASTM F1984-99(2018) - Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
Effective Date
01-Dec-2006
Referred By
ASTM F1672-14(2019) - Standard Specification for Resurfacing Patellar Prosthesis (Withdrawn 2023)
Effective Date
01-Dec-2006
Referred By
ASTM F2887-23 - Standard Specification for Total Elbow Prostheses
Effective Date
01-Dec-2006
Referred By
ASTM E2524-22 - Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles
Effective Date
01-Dec-2006
Referred By
ASTM F749-20 - Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
Effective Date
01-Dec-2006
Referred By
ASTM F1855-00(2019) - Standard Specification for Polyoxymethylene (Acetal) for Medical Applications
Effective Date
01-Dec-2006
Referred By
ASTM F2097-20 - Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
Effective Date
01-Dec-2006
Referred By
ASTM F624-09(2015)e1 - Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications
Effective Date
01-Dec-2006
Referred By
ASTM F2026-23 - Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
Effective Date
01-Dec-2006

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ASTM F748-06 - Standard Practice for Selecting Generic Biological Test Methods for Materials and DevicesASTM F748-06 - Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
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ASTM F748-06 - Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
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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:F748–06
Standard Practice for
Selecting Generic Biological Test Methods for Materials and
1
Devices
ThisstandardisissuedunderthefixeddesignationF748;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope useofanimals.Whereadequatepriordataexiststosubstantiate
certain types of safety information, these guidelines should not
1.1 This practice recommends generic biological test meth-
be interpreted to mean that testing should be unnecessarily
ods for materials and devices according to end-use applica-
repeated.
tions. While chemical testing for extractable additives and
1.6 This standard does not purport to address all of the
residual monomers or residues from processing aids is neces-
safety concerns, if any, associated with its use. It is the
sary for most implant materials, such testing is not included as
responsibility of the user of this standard to establish appro-
part of this practice. The reader is cautioned that the area of
priate safety and health practices and determine the applica-
materials biocompatibility testing is a rapidly evolving field,
bility of regulatory limitations prior to use.
and improved methods are evolving rapidly, so this practice is
bynecessityonlyaguideline.Athoroughknowledgeofcurrent
2. Referenced Documents
techniques and research is critical to a complete evaluation of
2
2.1 ASTM Standards:
new materials.
E1202 Guide for Development of Micronucleus Assay
1.2 These test protocols are intended to apply to materials
Standards
and medical devices for human application. Biological evalu-
E1262 Guide for Performance of Chinese Hamster Ovary
ation of materials and devices, and related subjects such as
Cell/Hypoxanthine Guanine Phosphoribosyl Transferase
pyrogen testing, batch testing of production lots, and so on, are
Gene Mutation Assay
alsodiscussed.Testsincludethoseperformedonmaterials,end
E1263 Guide for Conduct of MicronucleusAssays in Mam-
products, and extracts. Rationale and comments on current
malian Bone Marrow Erythrocytes
state of the art are included for all test procedures described.
E1280 Guide for Performing the Mouse Lymphoma Assay
1.3 The biocompatibility of materials used in single or
for Mammalian Cell Mutagenicity
multicomponent medical devices for human use depends to a
E1397 Practice for In Vitro Rat Hepatocyte DNA Repair
largedegreeontheparticularnatureoftheend-useapplication.
Assay
Biological reactions that are detrimental to the success of a
E1398 Practice for In Vivo Rat Hepatocyte DNA Repair
materialinonedeviceapplicationmayhavelittleornobearing
Assay
on the successful use of the material for a different application.
F619 Practice for Extraction of Medical Plastics
It is, therefore, not possible to specify a set of biocompatibility
F719 Practice for Testing Biomaterials in Rabbits for Pri-
test methods which will be necessary and sufficient to establish
mary Skin Irritation
biocompatibility for all materials and applications.
F720 Practice for Testing Guinea Pigs for Contact Aller-
1.4 The evaluation of tissue engineered medical products
gens: Guinea Pig Maximization Test
(TEMPs) may, in some cases, involve different or additional
F749 Practice for Evaluating Material Extracts by Intracu-
testing beyond those suggested for non-tissue-based materials
taneous Injection in the Rabbit
anddevices.Whereappropriate,thesedifferencesarediscussed
F750 Practice for Evaluating Material Extracts by Systemic
in this practice and additional tests described.
Injection in the Mouse
1.5 Theethicaluseofresearchanimalsplacestheobligation
F756 Practice for Assessment of Hemolytic Properties of
on the individual investigator to determine the most efficient
Materials
methods for performing the necessary testing without undue
F763 Practice for Short-Term Screening of Implant Materi-
als
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
Surgical Materials and Devices and is direct responsibility of Subcommittee F04.16
2
on Biocompatibility Test Methods. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Dec. 1, 2006. Published January 2007. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 1982. Last previous edition approved in 2004 as F748 – 04. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F0748-06. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F748–06
F813 Practice f
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5.1 An acute toxicity test is conducted to obtain information concerning the immediate effects on test organisms of a short-term exposure to a test material under specific experimental conditions. An acute toxicity test does not provide information about whether delayed effects will occur, although a post-exposure observation period, with appropriate feeding, if necessary, might provide such information. Bioavailability of the test substance may also differ between real-world exposures and laboratory exposures due to site-specific water quality conditions (see Guides E1192, E1563, and E2455).  
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SCOPE
1.1 This guide (1)2 describes procedures for obtaining laboratory data concerning the adverse effects (for example, lethality and immobility) of a test material added to dilution water, but not to food, on certain species of freshwater and saltwater fishes, macroinvertebrates, and amphibians, usually during 2 to 4-day exposures, depending on the species. These procedures will probably be useful for conducting acute toxicity tests with many other aquatic species, although modifications might be necessary.  
1.2 Other modifications of these procedures might be justified by special needs or circumstances such as meeting specific study goals, regulatory needs, or to accommodate specific test organism life stages. Although using appropriate procedures is more important than following prescribed procedures, results of tests conducted using unusual or novel procedures are not likely to be comparable to results of many other tests. Comparison of results obtained using modified and unmodified versions of these procedures might provide useful information concerning new concepts and procedures for conducting acute tests.  
1.3 This guide describes tests using three basic exposure techniques: static, renewal, and flow-through. Selection of the technique to use in a specific situation will depend on the needs of the investigator and on available resources. Tests using the static technique provide the most easily obtained measure of acute toxicity, but conditions often change substantially during static tests; therefore, static tests should not last longer than 96 h, and test organisms should not be fed during such tests unless the test organisms are severely stressed without feeding over 48 h. Static tests should probably not be conducted on materials that have a high oxygen demand, are highly volatile, are rapidly transformed biologically or chemically in aqueous solution, or are removed from test solutions in substantial quantities by the test chambers or organisms during the test. Because the pH and concentrations of dissolved oxygen and test material are maintained at desired levels and degradation and metabolic products are removed, tests using ren...

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ASTM
ASTM E1242-23(Practice)
Standard Practice for Using Octanol-Water Partition Coefficient to Estimate Median Lethal Concentrations for Fish Due to Narcosis

SIGNIFICANCE AND USE
5.1 This procedure can be used to limit the need for screening tests prior to performing a test for estimating the LC50 of a non-reactive and non-electrolytic chemical to the fathead minnow. By eliminating the screening test, fewer fish need be tested. The time used for preparing and performing the screening test can also be saved. The value obtained in this procedure can be used as the preliminary estimate of the LC50 in a full-scale test.  
5.2 Estimates can be used to set testing priority of groups of non-reactive and non-electrolytic chemicals.  
5.3 If the estimated value is more than 0.3 times the experimental value, the mechanism of action is probably narcosis. If less, the effect concentration is considered to reflect a different mechanism of action.  
5.4 This practice estimates a maximum LC50, that is, non-reactive and non-electrolytic chemicals are at least as toxic as the practice predicts, but may have a lower LC50 if acting by a more specific mechanism. Data on a chemical indicating a lower toxicity than predicted should be considered suspect or an artifact because of limited solubility of the test material.
SCOPE
1.1 This practice covers a procedure for estimating the fathead minnow (Pimephales promelas) 96-h LC50 of nonreactive (that is, covalently bonded without unsaturated residues) and nonelectrolytic (that is, require vigorous reagents to facilitate substitution, addition, replacement reactions and are non-ionic, non-dissociating in aqueous solutions) organic chemicals acting solely by narcosis, also referred to as Meyer-Overton toxicity relationship.2  
1.2 This procedure is accurate for organic chemicals that are toxic due to narcosis and are non-reactive and non-electrolytic. Examples of appropriate chemicals are: alcohols, ketones, ethers, simple halogenated aliphatics, aromatics, and aliphatic substituted aromatics. It is not appropriate for chemicals whose structures include a potential toxiphore (that structural component of a chemical molecule that has been identified to show mammalian toxicity, for example CN is known to be reponsible for inactivation of enzymes, NO2 for decoupling of oxidative phosphorylation, both leading to mammalian toxicity). Examples of chemicals inappropriate for this practice are: carbamates, organophosphates, phenols, beta-gamma unsaturated alcohols, electrophiles, and quaternary ammonium salts.  
1.3 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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