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ASTM F 451 : 2021

Current

Current

The latest, up-to-date edition.

Standard Specification for Acrylic Bone Cement

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

08-04-2021

€61.92
Excluding VAT

Committee
F 04
DocumentType
Standard
Pages
16
PublisherName
American Society for Testing and Materials
Status
Current
Supersedes

1.1This specification covers self-curing resins used primarily for the fixation of internal orthopedic prostheses. The mixture may be used in either the pre-dough or dough stage in accordance with the manufacturer’s recommendations.

1.2Units of pre-measured powder and liquid are supplied in a form suitable for mixing. The mixture then sets in place.

1.3While a variety of copolymers and comonomers may be incorporated, the composition of the set cement shall contain poly(methacrylic acid esters) as its main ingredient.

1.4This specification covers compositional, physical performance, and biocompatibility as well as packaging requirements. The biocompatibility of acrylic bone cement as it has been traditionally formulated and used has been reported in the literature (1, 2).2

1.5The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.7This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ASTM F 1672 : 2014 : R2019 Standard Specification for Resurfacing Patellar Prosthesis (Withdrawn 2023)
ASTM F 2118 : 2014 : R2020 Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials
ASTM F 2083 : 2021 Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
ASTM F 2027 : 2016 Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
ASTM F 2887 : 2017 Standard Specification for Total Elbow Prostheses
ASTM F 3087 : 2015 Standard Specification for Acrylic Molding Resins for Medical Implant Applications
ASTM F 2665 : 2021 Standard Specification for Total Ankle Replacement Prosthesis

ASTM F 763 : 2022 Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
ASTM F 763 : 2004 : R2016 Standard Practice for Short-Term Screening of Implant Materials
ASTM E 275 : 2008 : R2013 Standard Practice for Describing and Measuring Performance of Ultraviolet and Visible Spectrophotometers
ASTM E 275 : 2008 : R2022 Standard Practice for Describing and Measuring Performance of Ultraviolet and Visible Spectrophotometers
ASTM E 169 : 2016 : R2022 Standard Practices for General Techniques of Ultraviolet-Visible Quantitative Analysis
ASTM F 756 : 2008 Standard Practice for Assessment of Hemolytic Properties of Materials
ASTM D 5630 : 2013 Standard Test Method for Ash Content in Plastics (Withdrawn 2022)
ASTM D 638 : 2014 Standard Test Method for Tensile Properties of Plastics
ASTM D 3835 : 2016 Standard Test Method for Determination of Properties of Polymeric Materials by Means of a Capillary Rheometer
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 D 695 : 2015 Standard Test Method for Compressive Properties of Rigid Plastics
ASTM D 3835 : 2024 Standard Test Method for Determination of Properties of Polymeric Materials by Means of a Capillary Rheometer
ASTM E 169 : 2016 Standard Practices for General Techniques of Ultraviolet-Visible Quantitative Analysis
ASTM D 5630 : 2022 Standard Test Method for Ash Content in Plastics
ASTM D 695 : 2023 Standard Test Method for Compressive Properties of Rigid Plastics
ASTM F 981 : 2023 Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
ASTM D 638 : 2022 Standard Test Method for Tensile Properties of Plastics

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