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This specification covers the raw material and final product requirements, and the associated test methods for the selection of porous high density and ultra high molecular weight polyethylenes 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 nonloaded applications. Physical properties such as pore size and volume, as well as tensile, compressive, flexural, and shear properties shall be determined, but will be specified in the particular device to which its end use shall be applied.
This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.
Significance and Use
1.1 This specification covers the properties and test methods for porous high density and ultra high molecular weight polyethylenes 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 nonloaded applications.
1.2 Evaluation of tissue response to a porous polyethylene must be completed. Guidance in establishing biocompatibility may be found in the list of references.
1.3 Clinical experience and animal studies have shown that tissue will grow into the open pores of porous polyethylene. The tissue ingrowth into the pores may allow for the establishment of implant fixation.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 This section 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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
D638 Test Method for Tensile Properties of Plastics
D732 Test Method for Shear Strength of Plastics by Punch Tool
D790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
D883 Terminology Relating to Plastics
D1238 Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
D1505 Test Method for Density of Plastics by the Density-Gradient Technique
D1621 Test Method for Compressive Properties of Rigid Cellular Plastics
D1623 Test Method for Tensile and Tensile Adhesion Properties of Rigid Cellular Plastics
D1898 Practice for Sampling of Plastics
D2238 Test Methods for Absorbance of Polyethylene Due to Methyl Groups at 1378 cm-1
D2873 Test Method for Interior Porosity of Poly(Vinyl Chloride) (PVC) Resins by Mercury Intrusion Porosimetry
E562 Test Method for Determining Volume Fraction by Systematic Manual Point Count
F316 Test Methods for Pore Size Characteristics of Membrane Filters by Bubble Point and Mean Flow Pore Test
F648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F763 Practice for Short-Term Screening of Implant Materials
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
UNSPSC Code 42295500(Surgical implants and expanders and extenders and surgical wires and related products); 13111016(Polyethylene)