ASTM F748-04

ASTM F748-04 - 1.5.2004

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 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.

1.5 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.

2. Referenced Documents

F719-20e1	Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation (Includes all amendments and changes 11/2/2020).
F619-20	Standard Practice for Extraction of Materials Used in Medical Devices
E1262-88(2018)	Standard Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay
F895-11(2016)	Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
F981-23	Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
F2382-18	Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)
F2148-18	Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)
F2147-01(2016)	Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens
F2065-00e1	Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials
F1984-99(2018)	Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
F1983-23	Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
F1904-23	Standard Guide for Testing the Biological Responses to Medical Device Particulate Debris and Degradation Products in vivo
F1903-18	Standard Practice for Testing for Cellular Responses to Particles in vitro
Immunotoxicity Testing Guidance-FDA
F1439-03(2018)	Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
F1408-20a	Standard Practice for Subcutaneous Screening Test for Implant Materials (Includes all amendments and changes 9/1/2020).
F1027-86(1995)e1	Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices
F813-20	Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
F763-22	Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
F756-17	Standard Practice for Assessment of Hemolytic Properties of Materials
F750-20	Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse
F749-20	Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
F720-17	Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
F1877-16	Standard Practice for Characterization of Particles
General Program Memorandum #G95-1 FDA Available from CDRH, 5600 Fishers Ln., Rockville, MD 20857.
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, http://www.ansi.org.
	Biological Testing of Medical and Dental Materials and Devices--Part 1: Evaluation and Testing within a Risk Management Process