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Subcommittee F04.16 on B…
Subcommittee F04.16 on Biocompatibility Test Methods
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Matching Standards Under the Jurisdiction of F04.16 by Status
Active
25 matching standards
F1983-23 Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
F619-20(2025) Standard Practice for Extraction of Materials Used in Medical Devices
-See also WK95109 proposed Reapproval
F719-20(2025) Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation
-See also WK95110 proposed Reapproval
F720-24 Standard Test Method for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
F748-25 Standard Practice for Selecting Biological Test Methods for Materials and Devices
-See also WK76724 proposed Revision
F749-20 Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
F750-20 Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse
F756-17(2025) Standard Practice for Assessment of Hemolytic Properties of Materials
-See also WK95108 proposed Reapproval
F763-22 Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
F813-20 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
F895-25 Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
-See also WK76726 proposed Revision
F981-23 Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
F1408-20a Standard Practice for Subcutaneous Screening Test for Implant Materials
F1904-23 Standard Guide for Testing the Biological Responses to Medical Device Particulate Debris and Degradation Products
in vivo
F2147-01(2025) Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens
-See also WK92588 proposed Reapproval
F1903-18 Standard Practice for Testing for Cellular Responses to Particles
in vitro
-See also
WK91753
proposed Revision
F2148-18 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)
-See also
WK91064
proposed Revision
F2901-19 Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
-See also
WK96106
proposed Revision
E1262-24 Standard Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay
F1439-24 Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
F1877-24 Standard Practice for Characterization of Particles
F1984-25 Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
-See also WK90775 proposed Revision
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
F2888-19 Standard Practice for Platelet Leukocyte Count—An
In-Vitro
Measure for Hemocompatibility Assessment of Cardiovascular Materials
F2382-24 Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)
Proposed New
0 matching standards
Withdrawn, Replaced
15 matching standards
F2151-01 Standard Practice for Assessment of White Blood Cell Morphology After Contact with Materials (Withdrawn 2007)
F2065-00(2010) Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials (Withdrawn 2016)
E1202-87(2008) Standard Guide for Development of Micronucleus Assay Standards (Withdrawn 2013)
E1263 Standard Guide for Conduct of Micronucleus Assays in Mammalian Bone Marrow Erythrocytes (Withdrawn 2015)
E1263-97(2008) Standard Guide for Conduct of Micronucleus Assays in Mammalian Bone Marrow Erythrocytes (Withdrawn 2015)
E1280 Standard Guide for Performing the Mouse Lymphoma Assay for Mammalian Cell Mutagenicity (Withdrawn 2015)
E1398-91(2008) Standard Practice for
In Vivo
Rat Hepatocyte DNA Repair Assay (Withdrawn 2014)
F1027-86(2017) Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices (Withdrawn 2023)
F2065 Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials (Withdrawn 2016)
F2567-06(2010) Standard Practice for Testing for Classical Pathway Complement Activation in Serum by Solid Materials (Withdrawn 2016)
E1280-97(2008) Standard Guide for Performing the Mouse Lymphoma Assay for Mammalian Cell Mutagenicity (Withdrawn 2015)
E1397-91(2008) Standard Practice for
In Vitro
Rat Hepatocyte DNA Repair Assay (Withdrawn 2014)
F1905-98(2003) Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity (Withdrawn 2011)
F1906-98(2003) Standard Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte, Proliferation, and Cell Migration (Withdrawn 2011)
F2567 Standard Practice for Testing for Classical Pathway Complement Activation in Serum by Solid Materials (Withdrawn 2016)
