ASTM F 981 : 2004 : R2016
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Insertion into Bone
Hardcopy , PDF
20-10-2023
English
08-06-2016
CONTAINED IN VOL. 13.01, 2016 Describes a series of experimental protocols for biological assays of tissue reaction to non-porous non-absorbable biomaterials for surgical implants.
Committee |
F 04
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DevelopmentNote |
Supersedes ASTM F 361 (12/2001)
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DocumentType |
Standard Practice
|
Pages |
5
|
ProductNote |
Reconfirmed 2016
|
PublisherName |
American Society for Testing and Materials
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Status |
Superseded
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SupersededBy | |
Supersedes |
1.1This practice provides a series of experimental protocols for biological assays of tissue reaction to nonabsorbable biomaterials for surgical implants. It assesses the effects of the material on animal tissue in which it is implanted. The experimental protocol is not designed to provide a comprehensive assessment of the systemic toxicity, immune response, carcinogenicity, teratogenicity, or mutagenicity of the material since other standards deal with these issues. It applies only to materials with projected applications in humans where the materials will reside in bone or soft tissue in excess of 30 days and will remain unabsorbed. It is recommended that short-term assays, according to Practice F763, first be performed. Applications in other organ systems or tissues may be inappropriate and are therefore excluded. Control materials will consist of any one of the metal alloys in Specifications F67, F75, F90, F136, F138, or F562, high purity dense aluminum oxide as described in Specification F603, ultra high molecular weight polyethylene as stated in Specification F648 or USP polyethylene negative control.
1.2This practice is a combination of Practice F361 and Practice F469. The purpose, basic procedure, and method of evaluation of each type of material are similar; therefore, they have been combined.
1.3The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4This 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.
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ASTM F 2347 : 2015 | Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications |
ASTM F 688 : 2019 | Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035) |
ASTM F 2066 : 2023 | Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150) |
ASTM F 2068 : 2015 | Standard Specification for Femoral Prostheses—Metallic Implants (Withdrawn 2023) |
ASTM F 90 : 2023 | Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605) |
ASTM F 1983 : 2023 | Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications |
ASTM F 1538 : 2003 : R2017 | Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation |
ASTM F 641 : 2009 : R2023 | Standard Specification for Implantable Epoxy Electronic Encapsulants |
ASTM F 799 : 2019 | Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539) |
ASTM F 1672 : 2014 : R2019 | Standard Specification for Resurfacing Patellar Prosthesis (Withdrawn 2023) |
ASTM F 1580 : 2018 | Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants |
ASTM F 603 : 2012 : R2020 | Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application |
ASTM F 1357 : 2023 | Standard Specification for Articulating Total Wrist Implants |
ASTM F 2721 : 2009 : R2023 | Standard Guide for Preclinical <emph type="ital">in vivo</emph> Evaluation in Critical-Size Segmental Bone Defects |
ASTM F 881 : 1994 : R2022 | Standard Specification for Silicone Elastomer Facial Implants |
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ASTM F 2759 : 2019 | Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices |
ASTM F 1185 : 2023 | Standard Specification for Composition of Medical-Grade Hydroxylapatite for Surgical Implants |
ASTM F 755 : 2019 | Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants |
ASTM F 2212 : 2020 | Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) |
ASTM F 561 : 2019 | Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids |
ASTM F 3089 : 2023 | Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions |
ASTM F 1781 : 2021 | Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants |
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ASTM F 748 : 2016 | Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices |
ASTM F 560 : 2022 | Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400) |
ASTM F 2224 : 2009 : R2020 | Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants |
ASTM F 2091 : 2015 | Standard Specification for Acetabular Prostheses (Withdrawn 2023) |
ASTM F 2565 : 2021 | Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications |
ASTM F 138 : 2019 | Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673) |
ASTM F 2665 : 2021 | Standard Specification for Total Ankle Replacement Prosthesis |
ASTM F 2884 : 2021 | Standard Guide for Pre-clinical <emph type="bdit">in vivo</emph> Evaluation of Spinal Fusion |
ASTM F 2695 : 2012 : R2020 | Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications |
ASTM F 1088 : 2023 | Standard Specification for Medical-Grade Beta-Tricalcium Phosphate Raw Material for Implantable Medical Devices |
ASTM F 1408 : 2020 : REV A | Standard Practice for Subcutaneous Screening Test for Implant Materials |
ASTM F 2103 : 2018 | Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications |
ASTM F 2083 : 2021 | Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023) |
ASTM F 2529 : 2013 : R2021 | Standard Guide for <emph type="ital"> in vivo</emph> Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM) |
ASTM F 2064 : 2017 | Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications |
ASTM F 451 : 2021 | Standard Specification for Acrylic Bone Cement |
ASTM F 1378 : 2018 : EDT 1 | Standard Specification for Shoulder Prostheses |
ASTM F 3515 : 2021 | Standard Guide for Characterization and Testing of Porcine Fibrinogen as a Starting Material for Use in Biomedical and Tissue-Engineered Medical Product Applications |
ASTM F 86 : 2013 : REDLINE | Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants |
ASTM F 562 : 2022 | Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035) |
ASTM F 75 : 2023 | Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075) |
ASTM F 763 : 2022 | Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials |
ASTM F 75 : 2018 | Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075) |
ASTM F 562 : 2013 | Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035) |
ASTM F 763 : 2004 : R2016 | Standard Practice for Short-Term Screening of Implant Materials |
ASTM F 90 : 2014 : REDLINE | Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605) |
ASTM F 86 : 2013 | Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants |
ASTM F 136 : 2013 : REDLINE | Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) |
ASTM F 469 : 1978 | Practice for Assessment of Compatibility of Nonporous Polymeric Materials for Surgical Implants with Regard to Effect of Materials on Tissue (Withdrawn 1987) |
ASTM F 136 : 1998 | Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications |
ASTM F 648 : 2014 | Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants |
ASTM F 763 : 1999 | Standard Practice for Short-Term Screening of Implant Materials |
ASTM F 90 : 2023 | Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605) |
ASTM F 648 : 2021 | Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants |
ASTM F 86 : 2021 | Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants |
ASTM F 136 : 2013 | Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) |
ASTM F 562 : 2013 : REDLINE | Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035) |
ASTM F 136 : 2013 : R2021 : EDT 1 | Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) |
ASTM F 648 : 2014 : REDLINE | Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants |
ASTM F 90 : 2014 | Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605) |
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