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ASTM F 755 : 2019

Current
Current

The latest, up-to-date edition.

Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2020

1.1This specification covers the properties and test methods for porous high-density-polyethylene (HDPE) and porous ultra-high-molecular-weight-polyethylene (UHMWPE) intended for use in surgical implants. The porous polyethylene may be used as a free-standing product or as a coating on a substrate in non-loaded applications.

1.2Materials covered by this standard can have a broad range of mechanical and morphological properties depending on the starting material and fabrication processes. Therefore no attempt has been made to standardize the properties, and the requirements for a specific application are not within the scope of this standard.

1.3Evaluation of the tissue response to a porous polyethylene must be completed. Guidance in establishing biocompatibility may be found in the list of references.

1.4Clinical experience and animal studies have shown that tissue will grow into the open pores of porous polyethylene. The tissue ingrowth into the pores may facilitate the establishment of implant fixation.

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.

Committee
F 04
DocumentType
Standard
Pages
4
PublisherName
American Society for Testing and Materials
Status
Current
Supersedes

ASTM D 883 : 2023 Standard Terminology Relating to Plastics
ASTM D 2238 : 2022 Standard Test Methods for Absorbance of Polyethylene Due to Methyl Groups at 1378 cm<sup>−1</sup>
ASTM D 1238 : 2023 Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
ASTM D 1238 : 2023 : REV A Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
ASTM D 883 : 2024 Standard Terminology Relating to Plastics
ASTM D 1621 : 2016 : R2023 Standard Test Method for Compressive Properties of Rigid Cellular Plastics
ASTM D 883 : 2022 Standard Terminology Relating to Plastics
ASTM D 883 : 2020 : REV B Standard Terminology Relating to Plastics
ASTM D 1621 : 2016 Standard Test Method for Compressive Properties of Rigid Cellular Plastics
ASTM D 2238 : 1992 : R2012 : EDT 1 Standard Test Methods for Absorbance of Polyethylene Due to Methyl Groups at 1378 cm<sup>−1</sup> (Withdrawn 2021)
ASTM D 638 : 2014 Standard Test Method for Tensile Properties of Plastics
ASTM F 648 : 2014 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
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 648 : 2021 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
ASTM D 1623 : 2017 Standard Test Method for Tensile and Tensile Adhesion Properties of Rigid Cellular Plastics
ASTM D 1623 : 2017 : R2023 Standard Test Method for Tensile and Tensile Adhesion Properties of Rigid Cellular Plastics
ASTM D 1238 : 2020 Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
ASTM E 562 : 1999 Standard Test Method for Determining Volume Fraction by Systematic Manual Point Count
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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