Standards Development

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Swell Ratio Testing Standard Now Available

ASTM has now published F2214-02, "Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)." This new standard is currently available for download at the ASTM website.

Revision of Accelerated Aging Standard Now Available

In February, ASTM published a revision to F2003-02, "Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air." This standard is now available for download at the ASTM website.

Update on Accelerated Aging and Swell Ratio ASTM Standards

The task groups related to UHMWPE convened in Miami on Nov. 7, 2002. Click here to download the meeting minutes for the UHMWPE Characterization task group. The Standard Guide for Accelerated Aging of UHMWPE (ASTM F2003) has undergone a major revision, which was formally approved by ASTM at the November meeting. A new standard, related to measuring the Swell Ratio of UHMWPE, was also approved. The new Swell Ratio standard, as well as the revised Accelerated Aging standard (ASTM F2003-03), will be published next year. These two new documents should be first available from the ASTM website in the Spring.

ISO Update on UHMWPE Standards

The UHMWPE task force was convened at the ISO TC 150 meeting in Alexandria on Sept. 11, 2002. Click here to download the progress report from the task force meeting, which describes the latest developments in the evolution of ISO Standards for medical grade UHMWPE.

1900 Resin Discontinued by Basell: Will Type 3 Resin Remain in ASTM F-648?

At the May 2002 ASTM meeting for F-648, on Powder and Consolidated Forms for Medical Grade UHMWPE, standards developers discussed whether Type 3 resin, which was based on 1900 resin, should remain in the standard after it was discontinued earlier this spring. On January 10, 2002, Basell (formerly Montell) announced that it had sold its UHMWPE technology to Polialden, as detailed in their press release. Basell has subsequently dismantled it's USA UHMWPE plant. At the ASTM meeting, representatives from two orthopedic companies disclosed that they had sufficient stockpiles of 1900 resin to continue producing orthopedic products for the next few years. Consequently, it was decided to keep Type 3 resins in ASTM F-648, at least for the time being.

Update: Small Punch Testing Standard Available as ASTM F2183-02

The Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants (ASTM F2183-02) was approved by ASTM in May and is currently available for downloading at the ASTM website. The standard will also be published this summer in the 2002 Annual Book of Standards, Volume 13.01. For more information about the background and development of the small punch test method, click here to download a related book chapter.

Tensile and Impact Data for Contemporary UHMWPE Resins

The ASTM working group on UHMWPE conducted a survey of density, tensile, and impact behavior of contemporary Type 1 and Type 2 UHMWPE resins. Physical and mechanical property data for 680 individual lots of ram extruded and compression molded GUR 1020 & 1050 resins were analyzed. Click here to download a PDF version of the report summarizing the data.

Update on UHMWPE Standards Development at ISO

Following the UHMWPE Working Group meetings held in September at the ISO group in Canberra, Australia, action items have been proposed for further development of the morphology index standard (to be included in ISO 5834-2) and the accelerated aging standard (5834-3). Interlaboratory studies related to these draft standards are currently in the planning stages. The oxidation index standard (5834-4) was discussed at the meeting and will be voted upon later this year. Click here for more details.

NIST Mechanical Property Data for Reference UHMWPE Published at SFB

The National Institutes of Standards and Technology has completed characterization of a new UHMWPE reference material (No. 8456) which has been made publicly available to members of the orthopedic community for use in their experiments. NIST presented the results of their characterization at the Society for Biomaterials Meeting.