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ASTM F 748 : 2016

Current
Current

The latest, up-to-date edition.

Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

04-01-2016

1.1This 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.

1.2These 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.

1.3The 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.

1.4The 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.

1.5The 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.

1.6This 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.

Committee
F 04
DocumentType
Standard Practice
Pages
7
PublisherName
American Society for Testing and Materials
Status
Current
Supersedes

ASTM F 1904 : 1998 : R2003 Standard Practice for Testing the Biological Responses to Particles In Vivo
ASTM E 1262 : 1988 : R2003 Standard Guide for Performance of the Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay
ASTM F 1983 : 1999 : R2008 Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications
ASTM F 1877 : 2005 Standard Practice for Characterization of Particles
ASTM F 1439 : 2003 Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
ASTM F 1027 : 1986 : R2012 Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices
ASTM F 1983 : 1999 : R2003 Standard Practice for Assessment of Compatibiltiy of Absorbable/Resorbable Biomaterials for Implant Applications
ASTM F 1984 : 1999 : R2008 Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
ASTM F 2065 : 2000 : EDT 1 Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials
ASTM F 1983 : 2023 Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
ASTM F 2382 : 2004 : R2010 Standard Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT)
ASTM F 1904 : 1998 : EDT 1 Standard Practice for Testing the Biological Responses to Particles In Vivo
ASTM F 2382 : 2004 : EDT 1 Standard Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT)
ASTM F 763 : 2022 Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
ASTM F 2148 : 2006 : REV A Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)
ASTM F 1903 : 2010 Standard Practice for Testing For Biological Responses to Particles <i>In Vitro</i>
ASTM E 1262 : 1988 : R1996 Standard Guide for Performance of the Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay
ASTM F 763 : 2004 : R2016 Standard Practice for Short-Term Screening of Implant Materials
ASTM F 1904 : 2023 Standard Guide for Testing the Biological Responses to Medical Device Particulate Debris and Degradation Products <emph type="ital">in vivo</emph>
ASTM F 2382 : 2017 Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)
ASTM F 2148 : 2013 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)
ASTM F 1439 : 2003 : R2008 Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
ASTM F 1904 : 2014 Standard Practice for Testing the Biological Responses to Particles <emph type="bdit" >in vivo</emph>
ASTM F 2065 : 2000 : R2010 Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials (Withdrawn 2016)
ASTM F 2148 : 2007 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)
ASTM F 1027 : 1986 : R1995 : EDT 1 Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices
ASTM F 2148 : 2018 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)
ASTM F 2148 : 2007 : R2012 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)
ASTM F 2148 : 2007 : EDT 1 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)
ASTM F 1984 : 1999 : R2018 Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
ASTM F 1439 : 2003 : R2018 Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
ASTM E 1262 : 1988 : R2013 Standard Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay
ASTM E 1262 : 1988 : R2018 Standard Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay
ASTM F 756 : 2008 Standard Practice for Assessment of Hemolytic Properties of Materials
ASTM F 1408 : 1997 Standard Practice for Subcutaneous Screening Test for Implant Materials
ASTM F 1408 : 1997 : R2008 Standard Practice for Subcutaneous Screening Test for Implant Materials
ASTM F 1984 : 1999 Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
ASTM F 1904 : 1998 : R2008 Standard Practice for Testing the Biological Responses to Particles <i>in vivo</i>
ASTM F 2148 : 2001 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)
ASTM F 1903 : 1998 Standard Practice for Testing for Biological Responses to Particles In Vitro
ASTM F 1408 : 1997 : R2002 : EDT 1 Standard Practice for Subcutaneous Screening Test for Implant Materials
ASTM F 1984 : 1999 : R2003 Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
ASTM F 2147 : 2001 : R2016 Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens
ASTM F 981 : 2004 : R2016 Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Insertion into Bone
ASTM F 763 : 1999 Standard Practice for Short-Term Screening of Implant Materials
ASTM F 2065 : 2000 : R2006 Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials
ASTM F 1439 : 2002 Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
ASTM F 2382 : 2004 Standard Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT)
ASTM F 1903 : 2018 Standard Practice for Testing for Cellular Responses to Particles <emph type="bdit" >in vitro</emph>
ASTM F 2147 : 2001 Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens
ASTM F 1877 : 2016 Standard Practice for Characterization of Particles
ASTM F 1877 : 1998 Standard Practice for Characterization of Particles
ASTM F 1027 : 1986 : R2017 Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices (Withdrawn 2023)
ASTM F 1983 : 2014 Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
ASTM F 1027 : 1986 : R2007 Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices
ASTM F 1877 : 2005 : R2010 Standard Practice for Characterization of Particles
ASTM F 1877 : 2005 : EDT 1 Standard Practice for Characterization of Particles
ASTM F 2382 : 2017 : EDT 1 Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)
ASTM F 1984 : 1999 : R2013 Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
ASTM F 1027 : 1986 : R2002 Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices
ASTM E 1262 : 1988 : R2008 Standard Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay
ASTM F 2147 : 2001 : R2006 Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens
ASTM F 1439 : 1992 : R1996 Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
ASTM F 1439 : 2003 : R2013 Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
ASTM F 2147 : 2001 : R2010 Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens
ASTM F 1983 : 1999 Standard Practice for Assessment of Compatibiltiy of Absorbable/Resorbable Biomaterials for Implant Applications
ASTM F 1408 : 1997 : R2013 Standard Practice for Subcutaneous Screening Test for Implant Materials
ASTM F 981 : 2023 Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
ASTM F 2382 : 2018 Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)

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