1. Scope

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 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.

ASTM Standards

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

Keywords

plastic surgical devices/applications; polyethylene (PE) plastics/surgical implant applications; polymers-surgical applicant?? ?? ?? ?? ; Plastic surgical devices/applications--specifications; Polyethylene (PE) surgical implant applications--specifications; Polymers (surgical applications)--specifications; Surgical implants--specifications

ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

DOI: 10.1520/F0755-99E01

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