This site summarizes standards activities for UHMWPE at the American Society for Testing and Materials (ASTM) and the International Organization for Standardization (ISO).

CURRENT ASTM STANDARDS FOR MEDICAL GRADE UHMWPE

ASTM D4020: Standard Specification for Ultra-High-Molecular-Weight Polyethylene Molding and Extrusion Materials This specification provides for the determination of the dilute solution viscosity and Izod impact strength of UHMW-PE. Those polyethylenes with a relative viscosity of greater of 1.44 at a solution concentration of 0.02% in decalin are considered UHMW-PE resins.

ASTM F648-00: Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants This specification defines material characteristics for UHMW-PE used for the application of surgical implants. The standard is written in two parts: powder and fabricated form, the latter used for the fabricated device. The specification does not apply to packaging and sterilization of the final product.

ASTM F2003-00: Standard Guide for Accelerated Aging of UHMWPE This guide outlines two procedures for accelerated aging to evaluate the oxidative stability of UHMWPE. The procedures have been validated based on certain components that were gamma irradiated in air and subsequently shelf-aged in air. However, the procedures do not replicate natural aging of UHMWPE irradiated in an inert environment. This guide is currently under consideration for revision by ASTM.

ASTM F2102-01: Standard Guide for Evaluating the Extent of Oxidation in Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants This guide outlines a procedure for quantifying the oxidation of UHMWPE using Fourier Transform Infrared Spectroscopy. The standard definition of an oxidation index for UHMWPE is provided in this standard.

ASTM F2183-02: Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants This standard describes a method for evaluating the mechanical behavior of UHMWPE using miniature disk specimens 0.5 mm in thickness and 6.4 mm in diameter. Because of the miniature specimen size, it is useful for testing fabricated components as well as retrieved implants after revision surgery. Click here to review a recent book chapter about the small punch test for UHMWPE.

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CURRENT ISO STANDARDS FOR MEDICAL GRADE UHMWPE

ISO 11542.1/.2 Plastics – Ultra-high-molecular weight polyethylene (PE-UHMW) moulding and extrusion materials – Part 1: Designation system and basis for specifications / Part 2: Preparation of test specimens and determination of properties These specifications establish a designation system, test specimen preparation methods and testing methods for polyethylenes with a MFR (melt flow rate) of less than 0.1 g/10 min. measured at 190 °C and 21.6 kg load. The designation is based primarily on the following parameters: density, viscosity number and elongational stress.

ISO 5834.1/.2 – Implants for surgery – Ultra-high molecular weight polyethylene – Part 1: Powder form/Part 2: Moulded forms These specifications provide the requirements and corresponding test methods for powder and molded forms of UHMW-PE used in the manufacture of surgical implants.

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ASTM Working Groups for UHMWPE under Committee F04

F04.22.10 Hip Wear (Chaired by D. O'Connor) Responsible for ASTM Standard F 1714, "Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices."

F04.22.11 Knee Wear (Chaired by D. O’Connor) Responsible for ASTM Standard F 1715, “Guide for Gravimetric Wear Assessment of Prosthetic Knee Designs in Simulator Devices.”

F04.11.08 UHMWPE (Chaired by R. Gsell) Responsible for ASTM Standard F 648, “Specification of Ultra-High Molecular Weight Powder and Fabricated Forms for Surgical Implants.”

F04.15.12 UHMWPE Test Methods (Chaired by S. Kurtz) Responsible for ASTM Standard F 2003, “Guide for Accelerated Aging of UHMWPE.” Also responsible for developing new ASTM Standard for measuring the oxidation index of UHMWPE.

F04.22.11 UHMWPE Crosslink Density (Chaired by S. Spiegelberg) Responsible for developing new ASTM Standard for measuring the crosslinked density of UHMWPE.

ISO Task Forces for UHMWPE under ISO/TC 150/SC 1

UHMWPE Task Force (Leader, S. Kurtz) Responsible for developing ISO 5834-2, “Implants for Surgery—Ultra-High Molecular Weight Polyethylene—Part 2: Moulded Forms;” ISO 5834-3, “Implants for Surgery—Ultra-High Molecular Weight Polyethylene—Part 3: Accelerated Aging Methods;” and ISO 5834-2, “Implants for Surgery—Ultra-High Molecular Weight Polyethylene—Part 4: Oxidation Index Measurement Method.”