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ASTM F 748 : 2016 : REDLINE

Current
Current

The latest, up-to-date edition.

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

Published date

04-01-2016

CONTAINED IN VOL. 13.01, 2016 Outlines generic biological test methods for devices and materials according to end-use applications.

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
Redline
Pages
8
PublisherName
American Society for Testing and Materials
Status
Current

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ASTM F 1027 : 1986 : R1995 : EDT 1 Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices
CSA ISO 10993-6 : 1997(R2009) BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION
CSA Z323.3.1 : 1982 ELECTRICAL AIDS FOR PHYSICALLY DISABLED PERSONS
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ASTM F 2042 : 2000 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication
BS EN 30993-6:1995 Biological evaluation of medical devices Tests for local effects after implantation
EN ISO 10993-6:2016 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
ASTM F 750 : 1987 : R2012 Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse
ASTM F 749 : 2013 : REDLINE Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
ASTM F 1441 : 2003 Standard Specification for Soft-Tissue Expander Devices
ASTM F 1984 : 1999 : R2008 Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
ASTM F 750 : 1987 : R2007 Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse
ASTM F 604 : 1994 Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001)
ASTM F 1027 : 1986 : R2012 Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices
ASTM F 3087 : 2015 Standard Specification for Acrylic Molding Resins for Medical Implant Applications
ASTM F 750 : 1987 : R2002 Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse
ASTM F 2065 : 2000 : EDT 1 Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials
ASTM F 1855 : 2000 : R2011 Standard Specification for Polyoxymethylene (Acetal) for Medical Applications
ASTM F 2091 : 2015 : REDLINE Standard Specification for Acetabular Prostheses
ASTM F 1441 : 2003 : R2009 Standard Specification for Soft-Tissue Expander Devices
ASTM F 1538 : 2003 : R2017 Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation
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ASTM F 703 : 2018 Standard Specification for Implantable Breast Prostheses
ASTM F 982 : 1986 : R2008 Standard Specification for Disclosure of Characteristics of Surgically Implanted Clamps for Carotid Occlusion (Withdrawn 2017)
ASTM F 756 : 2017 : REDLINE Standard Practice for Assessment of Hemolytic Properties of Materials
ASTM F 1581 : 2008 : EDT 1 Standard Specification for Composition of Anorganic Bone for Surgical Implants
ASTM F 755 : 1999 : R2011 Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
ASTM F 1538 : 2003 : EDT 1 Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation
ASTM F 2051 : 2000 : R2006 Standard Specification for Implantable Saline Filled Breast Prosthesis
ASTM F 619 : 2014 : REDLINE Standard Practice for Extraction of Medical Plastics
ASTM F 1441 : 2003 : R2014 Standard Specification for Soft-Tissue Expander Devices
ASTM F 639 : 2009 Standard Specification for Polyethylene Plastics for Medical Applications
ASTM F 2083 : 2012 : REDLINE Standard Specification for Knee Replacement Prosthesis
ASTM F 2847 : 2017 : REDLINE Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments
DIN EN ISO 10993-6:2009-08 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016)
ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
DIN EN ISO 10993-6:2017-09 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016)

ASTM F 1877 : 2016 : REDLINE Standard Practice for Characterization of Particles
ASTM F 756 : 2017 : REDLINE Standard Practice for Assessment of Hemolytic Properties of Materials
ASTM F 1983 : 2014 : REDLINE Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
ASTM F 749 : 2013 : REDLINE Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
ASTM F 1903 : 2010-07 PRACTICE FOR TESTING FOR BIOLOGICAL RESPONSES TO PARTICLES IN VITRO
ASTM F 1408 : 1997 Standard Practice for Subcutaneous Screening Test for Implant Materials
ASTM F 619 : 2014 : REDLINE Standard Practice for Extraction of Medical Plastics
ASTM F 720 : 2017 : REDLINE Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ASTM F 1904 : 2014 : REDLINE Standard Practice for Testing the Biological Responses to Particles <emph type="bdit" >in vivo</emph>

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