ASTM F748 - 16

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

    Active Standard ASTM F748 | Developed by Subcommittee: F04.16

    Book of Standards Volume: 13.01

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    Significance and Use

    4.1 The objective of this practice is to recommend appropriate biological endpoint assessments (which may or may not require 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.

    4.2 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 assessment 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 assessment may not be necessary or reasonable for a specific material or application.

    1. 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.

    2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    ASTM Standards

    E1262 Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay

    F619 Practice for Extraction of Medical Plastics

    F719 Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation

    F720 Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test

    F749 Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit

    F750 Practice for Evaluating Material Extracts by Systemic Injection in the Mouse

    F756 Practice for Assessment of Hemolytic Properties of Materials

    F763 Practice for Short-Term Screening of Implant Materials

    F813 Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices

    F895 Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity

    F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone

    F1027 Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices

    F1408 Practice for Subcutaneous Screening Test for Implant Materials

    F1439 Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials

    F1877 Practice for Characterization of Particles

    F1903 Practice for Testing For Biological Responses to Particles In Vitro

    F1904 Practice for Testing the Biological Responses to Particles in vivo

    F1983 Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications

    F1984 Practice for Testing for Whole Complement Activation in Serum by Solid Materials

    F2065 Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials

    F2147 Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens

    F2148 Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)

    F2382 Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT)

    Other Referenced Documents

    General Program Memorandum #G95-1 FDA Available fr

    Immunotoxicity Testing Guidance-FDA

    ISO/AAMI/ANSI 10993-1 Biological Testing of Medical and Dental Materials and Devices--Part 1: Evaluation and Testing within a Risk Management Process Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036,

    ICS Code

    ICS Number Code 07.080 (Biology. Botany. Zoology)

    UNSPSC Code

    UNSPSC Code 60104000(Biotechnology and bio chemistry and genetics and microbiology and related materials)

    Referencing This Standard
    Link Here
    Link to Active (This link will always route to the current Active version of the standard.)

    DOI: 10.1520/F0748-16

    Citation Format

    ASTM F748-16, Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices, ASTM International, West Conshohocken, PA, 2016,

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