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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.
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.
E1202 Guide for Development of Micronucleus Assay Standards
E1262 Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay
E1263 Guide for Conduct of Micronucleus Assays in Mammalian Bone Marrow Erythrocytes
E1280 Guide for Performing the Mouse Lymphoma Assay for Mammalian Cell Mutagenicity
E1397 Practice for In Vitro Rat Hepatocyte DNA Repair Assay
E1398 Practice for In Vivo Rat Hepatocyte DNA Repair 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
F1905 Practice For Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity
F1906 Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte Proliferation, and Cell Migration
F1983 Practice for Assessment of Compatibility of Absorbable/Resorbable 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)
F2151 Practice for Assessment of White Blood Cell Morphology After Contact with Materials
F2382 Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT)
Other Referenced DocumentsImmunotoxicityTestin
ICS Number Code 07.080 (Biology. Botany. Zoology)
UNSPSC Code 60104000(Biotechnology and bio chemistry and genetics and microbiology and related materials)