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Biocompatibility Test Methods

ASTM is one of the leading standards developers for medical devices. With 24 categories, addressing everything from surgical implements to automated analysis, ASTM medical device standards cover a truly wide range. With how much research and training goes into the medical industry, standardization plays a key role in productively actualizing that effort. Organized below for your convenience by usage, industry, and theme are over 300 standards. This list includes standards related to Biocompatibility Test Methods.

ASTM F619-20

Standard Practice for Extraction of Materials Used in Medical Devices

1.1 This practice covers methods of extraction of medical plastics and may be applicable to other materials. This practice identifies a method for obtaining extract liquid for use in determining the biological response in preclinical testing. Further testing of the extract liquid is specified in other ASTM standards. The extract may undergo chemical analysis as part of the preclinical evaluation of the biological response, and the material after extraction may also be examined. 1.2 This practice may be used for, but is not limited to, the following areas: partial evaluation of raw materials, auditing materials within the manufacturing process, and testing final products. This practice may also be used as a reference method for the measurement of extractables in plastics used in medical devices. In general, it is the responsibility of the user of the standard to determine if the methods described in this standard are appropriate for the materials in their device. 1.3 This practice was initially developed for extraction of medical plastics not intended to undergo degradation or absorption during normal medical device usage. When applied to the extraction of absorbable materials, additional considerations may be necessary in the selection of extraction procedures and fluids. 1.4 For assessment of compatibility of the Single-use System material with the cell culture medium or the manufacturing processes used for cell-based therapeutics, vaccines, cell-based diagnostics, or other biopharmaceutical products, the user should refer to Guide E3231 . 1.5 The values stated in SI units are to be regarded as standard. The values given in parentheses are mathematical conversions to inch-pound units that are provided for information only and are not considered standard. 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.7 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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ASTM F1904-14

Standard Practice for Testing the Biological Responses to Particles in vivo

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.

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ASTM F1983-14

Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications

1.1 This practice provides experimental protocols for biological assays of tissue reactions to absorbable biomaterials for implant applications. This practice applies only to absorbable materials with projected clinical applications in which the materials will reside in bone or soft tissue longer than 30 days and less than three years. Other standards with designated implantation times are available to address shorter time periods. Careful consideration should be given to the appropriateness of this practice for slowly degrading materials that will remain for longer than three years. It is anticipated that the tissue response to degrading biomaterials will be different from the response to nonabsorbable materials. In many cases, a chronic inflammatory response may be observed during the degradation phase, but the local histology should return to normal after absorption; therefore, the minimal tissue response usually equated with biocompatibility may require long implantations. 1.2 The time period for implant absorption will vary depending on chemical composition implant size, implant location, and test subject species; therefore, the implantation times for examination of tissue response will be linked to the rate of absorption. No single implantation time is indicated in this practice.

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ASTM E1262-88(2018)

Standard Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay

1.1 This guide highlights some of the more relevant biological concepts as they are currently understood, and summarizes the critical technical aspects for acceptable bioassay performances as they currently are perceived and practiced. The Chinese hamster ovary cell/hypoxanthine guanine phosphoribosyl transferase (CHO/HGPRT) assay ( 1 ) 2 has been widely applied to the toxicological evaluation of industrial and environmental chemicals. 1.2 This guide concentrates on the practical aspects of cell culture, mutagenesis procedures, data analysis, quality control, and testing strategy. The suggested approach represents a consensus of the panel members for the performance of the assay. It is to be understood, however, that these are merely general guidelines and are not to be followed without the use of sound scientific judgement. Users of the assay should evaluate their approach based on the properties of the substances to be tested and the questions to be answered. 1.3 Deviation from the guidelines based on sound scientific judgement should by no means invalidate the results obtained. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 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. 1.6 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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ASTM F720-17

Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test

1.1 This practice is intended to determine the potential for a substance, or material extract, to elicit contact dermal allergenicity. 1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 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, health and environmental practices and determine the applicability of regulatory limitations prior to use. 1.4 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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ASTM F749-20

Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit

1.1 This practice is an intracutaneous reactivity test used to assess the potential of the material under test to produce irritation following intradermal injections of extracts of the material. 1.2 The liquids injected into the rabbits are those obtained by Practice F619 where the extraction vehicles are saline, vegetable oil, or other liquids simulating human body fluids. 1.3 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 may provide guidance for the selection of appropriate methods for testing materials for a specific application. 1.4 The values stated in SI units, including units officially accepted for use with the SI, are to be regarded as standard. No other systems of measurement are included in this standard. 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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ASTM F756-17

Standard Practice for Assessment of Hemolytic Properties of Materials

1.1 This practice provides a protocol for the assessment of hemolytic properties of materials used in the fabrication of medical devices that will contact blood. 1.2 This practice is intended to evaluate the acute in vitro hemolytic properties of materials intended for use in contact with blood. 1.3 This practice consists of a protocol for a hemolysis test under static conditions with either an extract of the material or direct contact of the material with blood. It is recommended that both tests (extract and direct contact) be performed unless the material application or contact time justifies the exclusion of one of the tests. 1.4 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 may provide guidance for the selection of appropriate methods for testing materials for a specific application. Test Method E2524 provides a protocol using reduced test volumes to assess the hemolytic properties of blood-contacting nanoparticulate materials; this may include nanoparticles that become unbound from material surfaces. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 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. 1.7 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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ASTM F1408-20a

Standard Practice for Subcutaneous Screening Test for Implant Materials

1.1 This practice covers a short-term testing method to screen the subcutaneous tissue reaction to implant candidate materials in small laboratory animals. The material may be dense or porous. This method may not work for absorbable materials, depending on the absorption kinetics. The tissue reactions will be evaluated in comparison to those evoked by control materials that are accepted as clinical implant materials. 1.2 This practice, along with other appropriate biological tests (including other ASTM test methods), may be used to assess the biocompatibility of candidate materials for use in the fabrication of devices for clinical application. It may also be applied to evaluate the effect of special surface textures and preparations of known materials. 1.3 This practice does not provide a comprehensive assessment of the systemic toxicity, carcinogenicity, teratogenicity, or mutagenicity of the material. Additional information may be needed on the material in its final finished form, such as implantation assessment at the clinically relevant location. 1.4 The values stated in SI units, including units officially accepted for use with SI, are to be regarded as standard. No other systems of measurement are included in this standard. 1.5 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. 1.6 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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ASTM F1439-03(2018)

Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials

1.1 This guide is intended to assist the biomaterials testing laboratory in the conduct and evaluation of tumorigenicity tests to evaluate the potential for new materials to evoke a neoplastic response. The procedure is generally reserved only for those materials which have not previously been used for human implantation for a significant period of time. 1.2 Assessment of tumorigenicity is one of several procedures employed in determining the biological response to a material as recommended in Practice F748 . It is assumed that the investigator has already determined that this type of testing is necessary for a particular material before consulting this guide. The recommendations of Practice F748 should be considered before a study is commenced. 1.3 Whenever possible, it is recommended that a battery of genotoxicity procedures be initiated and proposed as an alternative to an in-vivo tumorigenicity bioassay. Genotoxicity assays may also be considered as initial screening procedures due to the sensitivity of the assays, the significant reduction in time to gain valuable data, and the desire to reduce the use of animals for testing. Genotoxicity assays that may be considered are outlined in Guides E1262 , E1263 , E1280 , and E2186 , and Practices E1397 and E1398 . Additionally, other genotoxicity testing which might be considered (but which do not yet have ASTM test methods) include Salmonella/Mammalian-Microsomal Plate Incorporation Mutagenicity Assay, In Vivo Cytogenetics Bone Marrow Chromosomal Damage Assay, BALB/3T3 Morphological Transformation of Mouse Embryo Cells, and the Mouse Micronucleus Assay. The investigator is advised to consider carefully the appropriateness of a particular method for his application after a review of the published literature. 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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ASTM F1984-99(2018)

Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials

1.1 This practice provides a protocol for rapid, in vitro screening for whole complement activating properties of solid materials used in the fabrication of medical devices that will contact blood. 1.2 This practice is intended to evaluate the acute in vitro whole complement activating properties of solid materials intended for use in contact with blood. For this practice, the words serum and complement are used interchangeably (most biological supply houses use these words synonymously in reference to serum used as a source of complement). 1.3 This practice consists of two procedural parts. Procedure A describes exposure of solid materials to a standard lot of human serum, using a 0.1-mL serum/13 x 100-mm disposable test tube. Cellulose acetate powders and fibers are used as examples of test materials. Procedure B describes assaying the exposed serum for significant functional whole complement depletion as compared to control samples. 1.4 This practice does not address function, elaboration, or depletion of individual complement components, nor does it address the use of plasma as a source of complement. 1.5 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 may provide guidance for the selection of appropriate methods for testing materials for other aspects of biocompatibility. 1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.7 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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ASTM F2148-18

Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)

1.1 This practice provides a methodology to use a combination of in vivio and in situ procedures for the evaluation of delayed contact hypersensitivity reactions. 1.2 This practice is intended to provide an alternative to the use of guinea pigs for evaluation of the ability of a device material to stimulate delayed contact hypersensitivity reactions. This alternative is particularly applicable for materials used in devices that contact only intact skin. However, the guinea pig maximization test is still the recommended method when assessing the delayed hypersensitivity response to metals or when testing substances that do not penetrate the skin but are used in devices that contact deep tissues or breached surfaces. This practice may be used for testing metals, with the exception of nickel-containing metals, unless the unique physicochemical properties of the materials may interfere with the ability of LLNA to detect sensitizing substances. 1.3 This practice consists of a protocol for assessing an increase in lymphocyte proliferation in the lymph nodes draining the site of test article administration on the ears of mice. 1.4 The LLNA has been validated only for low-molecular-weight chemicals that can penetrate the skin. The absorbed chemical or metabolite must bind to macromolecules, such as proteins, to form immunogenic conjugates. 1.5 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 may provide guidance for the selection of appropriate methods for testing materials for a specific application. 1.6 Identification of a supplier of materials or reagents is for the convenience of the user and does not imply a single source. Appropriate materials and reagents may be obtained from many commercial supply houses. 1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.8 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. 1.9 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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ASTM F2888-19

Standard Practice for Platelet Leukocyte Count—An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials

1.1 This practice assists in the evaluation of cardiovascular device materials for their ability to induce thrombus formation. Thrombus formation is assessed by means of a reduction in human platelets and leukocytes when consumed by thrombus after activation on the material surface. This assay may be part of the hemocompatibility evaluation for devices and materials contacting human blood, as in accordance with ANSI/AAMI/ISO 10993 4. See also Test Method F2382 . 1.2 All safety policies and practices shall be observed during the performance of this practice. All human blood and any materials that had contact with human blood shall be bagged in a biohazard bag, properly labeled with the contents, and disposed of by appropriate means. 1.3 The human blood should be handled at Biosafety Level 2 (BSL-2) as recommended in the Centers for Disease Control/National Institutes of Health publication, Biosafety in Microbiological and Biomedical Laboratories (BMBL). The human blood donor must have tested negative for Hepatitis B (HBV) and Human Immunodeficiency (HIV) viruses. The blood should be treated like any patient blood and handled/manipulated using standard precautions. Note 1: The results of this in-vitro test may not correspond to actual human response. 1.4 The values stated in SI (International System of Units) units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 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. Some specific hazards statements are given in Section 8 on Hazards. 1.6 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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ASTM F2901-19

Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices

1.1 Medical devices may cause adverse effects on the structure and/or function of the nervous system. In this guide, these adverse effects are defined as neurotoxicity. This guide provides background information and recommendations on methods for neurotoxicity testing. This guide should be used with Practice F748 , and may be helpful where neurotoxicity testing is needed to evaluate medical devices that contact central and/or peripheral nervous system tissue or cerebral spinal fluid (CSF). Note 1: The results of these in vitro and in vivo tests may not correspond to actual human response. 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 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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ASTM F719-20e1

Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation

1.1 This practice covers a procedure by which the irritancy of a material may be assessed through contact with abraded and intact skin of rabbits. 1.2 The results of this practice depend upon the effectiveness with which contact between the skin and the test material is established and maintained. Because of the operator technique included in performing this test, it is important that the test be performed by personnel with appropriate training. 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 may involve hazardous materials, operations, and equipment. 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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ASTM F750-20

Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse

1.1 This practice covers a nonspecific, acute toxicity test used for detecting leachables from materials used in medical devices. 1.2 The liquids injected into the mouse are those obtained by Practice F619 where the extraction vehicles are saline, vegetable oil, or other liquids simulating human body fluids. 1.3 Two procedures are outlined: Method A for intravenous injection and Method B for intraperitoneal injection. 1.4 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 may provide guidance for the selection of appropriate methods for testing materials for a specific application. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.7 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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ASTM F813-20

Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices

1.1 This practice covers a reference method of direct contact cell culture testing which may be used in evaluating the cytotoxic potential of materials for use in the construction of medical materials and devices. 1.2 This practice may be used either directly to evaluate materials or as a reference against which other cytotoxicity test methods may be compared. 1.3 This is one of a series of reference test methods for the assessment of cytotoxic potential, employing different techniques. 1.4 Assessment of cytotoxicity is one of several tests employed in determining the biological response to a material, as recommended in Practice F748 . 1.5 The L-929 cell line was chosen because it has a significant history of use in assays of this type. This is not intended to imply that its use is preferred; only that the L-929 is a well characterized, readily available, established cell line that has demonstrated reproducible results in several laboratories. 1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.7 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. 1.8 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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ASTM F1027-86(2017)

Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices

1.1 This practice describes a procedure to assess the cytotoxic potential of materials for use in the construction of medical materials and devices using human excised donor (HED) tissues and their derived primary cells taken from the orofacial region. 1.2 This practice may be used either directly to evaluate materials or as a reference against which other cytotoxicity methods may be compared. 1.3 This practice is one of a series of reference methods for assessment of cytotoxic potential, employing different techniques. 1.4 Assessment of cytotoxicity is one of several procedures employed in determining the biological response to a material, as recommended in Practice F748 . 1.5 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. 1.6 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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ASTM F895-11(2016)

Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity

1.1 This test method is appropriate for materials in a variety of shapes and for materials that are not necessarily sterile. This test method would be appropriate in situations in which the amount of material is limited. For example, small devices or powders could be placed on the agar and the presence of a zone of inhibition of cell growth could be examined. 1.1.1 This test method is not appropriate for leachables that do not diffuse through agar or agarose. 1.1.2 While the agar layer can act as a cushion to protect the cells from the specimen, there may be materials that are sufficiently heavy to compress the agar and prevent diffusion or to cause mechanical damage to the cells. This test method would not be appropriate for these materials. 1.2 The L-929 cell line was chosen because it has a significant history of use in assays of this type. This is not intended to imply that its use is preferred, only that the L-929 is an established cell line, well characterized and readily available, that has demonstrated reproducible results in several laboratories. 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.

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ASTM F748-16

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

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.

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ASTM F763-04(2016)

Standard Practice for Short-Term Screening of Implant Materials

1.1 This practice provides guidelines for short-term testing or screening of candidate materials, both porous and dense, as to the effects of the material on animal tissue in which it is implanted. This is a rapid screening procedure for determining acceptability of candidate materials. 1.2 This practice, along with other appropriate biological tests (including other appropriate ASTM tests) may be used in the biocompatibility assessment of the candidate materials for use in the fabrication of devices for clinical application. 1.3 This experimental protocol is not designed to provide a comprehensive assessment of the systemic toxicity, carcinogenicity, teratogenicity, or mutagenicity of the material since other standards deal with these issues. 1.4 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 provides guidance for the selection of appropriate methods for testing materials for a specific application. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 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.

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ASTM F981-04(2016)

Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Insertion into Bone

1.1 This practice provides a series of experimental protocols for biological assays of tissue reaction to nonabsorbable biomaterials for surgical implants. It assesses the effects of the material on animal tissue in which it is implanted. The experimental protocol is not designed to provide a comprehensive assessment of the systemic toxicity, immune response, carcinogenicity, teratogenicity, or mutagenicity of the material since other standards deal with these issues. It applies only to materials with projected applications in humans where the materials will reside in bone or soft tissue in excess of 30 days and will remain unabsorbed. It is recommended that short-term assays, according to Practice F763 , first be performed. Applications in other organ systems or tissues may be inappropriate and are therefore excluded. Control materials will consist of any one of the metal alloys in Specifications F67 , F75 , F90 , F136 , F138 , or F562 , high purity dense aluminum oxide as described in Specification F603 , ultra high molecular weight polyethylene as stated in Specification F648 or USP polyethylene negative control. 1.2 This practice is a combination of Practice F361 and Practice F469 . The purpose, basic procedure, and method of evaluation of each type of material are similar; therefore, they have been combined. 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.

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ASTM F1877-16

Standard Practice for Characterization of Particles

1.1 This practice covers a series of procedures for characterization of the morphology, number, size, and size distribution of particles. The methods utilized include sieves, optical, scanning electron microscopy (SEM), transmission electron microscopy (TEM), and electrooptical. 1.2 These methods are appropriate for particles produced by a number of different methods. These include wear test machines (Test Method F732 ), total joint simulation systems (Guides F1714 and F1715 ), abrasion testing, methods for producing particulates, such as shatter boxes or pulverizers, commercially available particles, and particles harvested from tissues in animal or clinical studies. 1.3 The debris may include metallic, polymeric, ceramic, or any combination of these. 1.4 The digestion procedures to be used and issues of sterilization of retrieved particles are not the subject of this practice. 1.5 A classification scheme for description of particle morphology is included in Appendix X3 . 1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.7 As a precautionary measure, removed debris from implant tissues should be sterilized or minimally disinfected by an appropriate means that does not adversely affect the particulate material. 1.8 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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ASTM F1903-18

Standard Practice for Testing for Cellular Responses to Particles in vitro

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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ASTM F2147-01(2016)

Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens

1.1 This practice is intended to determine the potential for a substance, or material extract, to elicit contact dermal allergenicity. 1.2 This practice is intended as an alternative to the Guinea Pig Maximization Test (GPMT), given the limitations on dosage form and tendency for false positives associated with the latter test. See Rationale and References. 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.

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ASTM F2382-18

Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)

1.1 This test method covers the screening of circulating blood-contacting device materials for their ability to induce blood coagulation via the intrinsic coagulation pathway. This assay should be part of the hemocompatibility evaluation for devices and materials contacting human blood, as per ANSI/AAMI/ISO 10993-4. 1.2 All safety policies and practices shall be observed during the performance of this test method. 1.3 All plasma and any materials that had contact with plasma will be bagged in a biohazard bag, properly labelled with the contents, and disposed of by appropriate means. The plasma should be handled at the Biosafety Level 2 as recommended in the Centers for Disease Control/National Institutes of Health Manual Biosafety in Microbiological Laboratories. 1.4 The normal pooled human plasma must have tested negative for Hepatitis B (HBV) or Human Immunodeficiency (HIV) viruses. The plasmas should be treated like any patient plasma using standard precautions. The plasma should be handled at the Biosafety Level 2 as recommended in the Centers for Disease Control/National Institutes of Health Manual Biosafety in Microbiological Laboratories. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.7 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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ASTM F2808-17

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

1.1 The Behind-the-Knee (BTK) method, using the popliteal fossa of human volunteers as a test site, simultaneously evaluates the inherent chemical irritation, and the potential for mechanical irritation of substrates and products that are designed to come into repeated or extended close contact with the skin (see validation references 1- 7 ). 2 This is a bilateral test comparing a test material to a reference material with a known safety profile. 1.2 This test method shall be used by qualified health care professionals experienced in good clinical practice (GCP) procedures. 1.3 This test method can be performed using human subjects on either intact or compromised skin. Testing should be performed on intact skin for test substrates or products expected to have contact with normal, intact skin, or for direct comparison to products with a known skin irritation profile. Testing can be performed on compromised skin for test substrates or products that may commonly come into contact with damaged skin (for example, skin with diaper rash, or chapped skin) or skin that is expected to be hydrated. 1.4 Visual scoring of erythema and dryness is performed by a trained skin grader on a pre-defined scale. 1.5 Prior to use in this test, materials shall undergo overall favorable biocompatibility testing consistent with the approach outlined in protocol Practice F748 or ISO 10993-1:2009. As a part of this series of testing, irritation per Practice F719 or ISO 10993-10 shall be conducted. 1.6 The values stated in inch-pound units are to be regarded as standard. No other units of measurement are included in this standard. 1.7 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. 1.8 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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