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Development of a Standard Guide for UHMWPE Implant Components at ASTM
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At the May 2008 ASTM meeting for F04, a new task force convened to develop an "umbrella" type document listing all of the recommended preclinical testing that should be performed for UHMWPE implants components by manufacturers. The scope includes conventional and highly crosslinked UHMWPE, with and without Vitamin E. This standard is expected to provide guidance for UHMWPE testing to manufacturers of hip, knee, upper extremity, and spinal implants. The intent of this proposed standard is to provide the basis for a future FDA guidance document for UHMWPE. Participation in this task force continues to be open to all. To join the task force and participate in the standard development process, please contact the Task Force Chair,
Prof. Warren Haggard, U. of Memphis or the Vice Chair,
David Schroeder, from Biomet. The next face-to-face meeting of the task force, to discuss the initial ballot results, is expected to take place at next ASTM meeting in November 2008. |
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New Task Force Established to Develop a Standard Guide for UHMWPE Implant Components at ASTM
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At the November 2007 ASTM meeting for F04, a new task force was created to develop an "umbrella" type document listing all of the recommended preclinical testing that should be performed for UHMWPE implants components by manufacturers. The scope will include conventional and highly crosslinked UHMWPE, with and without Vitamin E. This standard is expected to provide guidance for UHMWPE testing to manufacturers of hip, knee, upper extremity, and spinal implants. The intent of this proposed standard is to provide the basis for a future FDA guidance document for UHMWPE. Development of the standard will begin immediately via email, with the goal of providing a standard for ballot as soon as possible. Participation in this task force is open to all. To join the task force and participate in the early standard development process, please contact the Task Force Chair, Prof. Warren Haggard, U. of Memphis (whaggrd1@memphis.edu) or the Vice Chair, David Schroeder, from Biomet (Dave.Schroeder@biomet.com). The first face-to-face meeting of the task force, ideally to discuss the initial ballot results, is expected to take place at next ASTM meeting in May 2008. |
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Specification for Vitamin E-Blended UHMWPE To Be Published by ASTM; Task Force Disbanded
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At the November 2007 ASTM meeting for F04, it was announced that the new draft standard, "Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications," had successfully traversed sub-committee and main committee ballots and has been approved for publication. This specification covers Vitamin E-blended UHMWPE resin and fabricated forms of blended UHMWPE resin. The reference number (i.e., designation) for this standard is not yet available, but please check the ASTM site regularly for updates. Because no further revisions to this specification are planned in the near future, the task force voted unanimously to disband until further notice. No additional standards work on Vitamin E-blended UHMWPE is expected to take place at ASTM in 2008. |
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New Task Forces Created by ASTM for Vitamin E in Medical Grade UHMWPE
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The formation of two new task forces related to Vitamin E in Medical Grade UHMWPE were announced at the November 2006 F04 ASTM Meeting in Atlanta. One task force will be dedicated to creating a material specification for medical grade UHMWPE materials blended with commercially available Vit E-containing resin. A second task force will be convened to standardize test methods for characterizing Vitamin E levels in blended and doped UHMWPE materials. Both task forces will be convene for the first time at the ASTM meeting on Thursday, May 24, 2007 at the Waterside Convention Center; Norfolk, VA US. See the ASTM website for more details about the upcoming F04 meeting. Contact Steve Kurtz, Chair, for more details about the Vitamin E Material Specification Task Force; and Ray Gsell, Chair, for more information about standards for characterizing Vitamin E materials. |
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Specification for Highly Crosslinked UHMWPE Published by ASTM; Previous Task Forces Disbanded
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At the November 2006 ASTM meeting for F04, it was announced that the new standard, "ASTM F2565-06 Standard Guide for Extensively Irradiation Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications," has now been published by ASTM. This guide covers the test methods recommended for characterization of highly crosslinked UHMWPEs. This standard is now available for download from the ASTM website. Because no further updates to this specification are planned in the near future, the task force voted unanimously to disband until further notice. The task force dedicated to developing a shelf life standard for UHMWPE also voted to disband due to lack of interest in developing standards related to this topic. Consequently, no further work on crosslinked materials or shelf life testing will take place at ASTM in 2007. |
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Specification for Highly Crosslinked UHMWPE Approved by ASTM
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A new standard, "Standard Guide for Extensively Irradiation Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications," has successfully traversed Main and Subcommittee Ballot approval by ASTM. This guide covers the test methods recommended for characterization of highly crosslinked UHMWPEs. As this standard has been recently approved (as of May 2006), no designation number is currently available and it is not yet available for download on the ASTM website. |
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Updated Oxidation Index Test Method Published by ASTM
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ASTM has now published F2381-06, "Standard Guide for Evaluating the Extent of Oxidation in Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants." This updated method has incorporated additional details regarding the limits of integration for the carbonyl region of the FTIR spectrum. The standard is currently available to download from the ASTM website. At the May 2006 ASTM meeting, ongoing development of the standard was discussed to include protocols for measuring oxidation in retrieved components. |
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Conference on Degradation, Stabilization, and Crosslinking of UHMWPE
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Orthopedic surgeons and researchers at the Univerisity of Turin, Italy, will be convening a new, one-day symposium about UHMWPE on Friday, March 18, 2005. The meeting will be held at the Museo dell'Automobile "Carlo Biscaretti di Medicina del Lavoro Ruffia", Corso Unità d'Italia, 40 - Torino. The meeting, directed primarily towards clinicians and researchers, is being organized (in part) to discuss advances in the stabilization of polyethylene using Vitamin E. Click here to download the meeting agenda. For further details, please visit the conference website or contact Prof. Luigi Costa. |
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Trans-Vinylene FTIR Test Method Published by ASTM
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ASTM has now published F2381-04, "Standard Test Method for Evaluating the Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene." This new method can be used to infer the dose of radiation used to crosslink UHMWPE. The standard is currently available to download from the ASTM website. At the November 2004 meeting in Washington DC, further clarifications on the round robin protocol were made. The purpose of the round robin will be to quantify the repeatability and reproducibility of this new test method. |
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ISO Publishes Resin, Oxidation Index, and Morphology Standards
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At the September 2004 ISO TC 150 Meeting in Vancouver, Canada, it was announced that several parts of the ISO standards related to UHMWPE had now advanced to the publication stage. The resin standard (ISO 5834 Part 1), oxidation index (Part 4), and morphology index (Part 5) test methods are all expected to be published by ISO this fall. Parts 1 and Parts 5 of ISO 5834 are similar to ASTM Standard F648, whereas the oxidation index standard (Part 4) is the same method as ASTM F2102. |
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Accelerated Aging Test Method and Consolidated Form Specification Now Final Draft ISO Standards
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The ISO accelerated aging standard (5834 Part 3) and the updated specification for consolidated forms (Part 2) will be circulated this fall as final draft ISO standards (FDIS). The ISO aging standard is the same method as ASTM F2003, whereas the consolidated form standard (Part 2) is similar to ASTM F648. |
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Trans-Vinylene FTIR Test Method Approved at ASTM
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In April 2004, ASTM approved F2381-04, "Standard Test Method for Evaluating the Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene." This new method can be used to infer the dose of radiation used to crosslink UHMWPE. The standard will be available for download from the ASTM website (www.astm.org) in the near future. A round robin has been initiated to quantify the repeatability and reproducibility of this new test method. |
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Resin, Aging, and Morphology Test Methods Passed as Draft International Standards
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During the latest ballot, the ISO TC 150 elevated parts 1, 3, and 5 of ISO 5834 to the status of "Draft International Standards (DIS)." These parts of the ISO standard pertain to medical grade UHMWPE resin, accelerated aging, and morphology index. The draft ISO standards are expected to be finalized in 2004. Parts 1 and 5 of the ISO 5834 standard incorporate the specification and morphology test methods contained in ASTM F648. The accelerated aging ISO document (Part 3 of ISO 5834) incorporates the test method from ASTM F2003. |
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Miniature Specimen Izod Round Robin
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The UHMWPE task force for ASTM F648 is conducting a round robin to evaluate miniature specimens that can be used with 1" diameter rod stock. The existing standard IZOD impact specimen is too large to be used under such circumstances. Starting in May 2003, seven centers agreed to participate in the testing of miniature and standard-sized IZOD specimens fabricated from Type 1, Type 2, and Type 3 resin. As of the November 2003 ASTM meeting in Tampa, all of the participating centers had completed testing. Analysis of the round robin results is anticipated by the next ASTM meeting in March 2004. |
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Oxidation Index Method Passed as Draft International Standard
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During September 2003, at the ISO TC 150 meeting in Izmir, Turkey, the oxidation index standard was elevated to the status of "Draft International Standard (DIS)." The standard will be designated ISO 5834-4, "Ultra-high molecular weight polyethylene. Part 4: Procedure for Measuring the Extent of Oxidation in UHMWPE." The draft ISO standard will be finalized in 2004. This standard incorporates the oxidation index method described in ASTM F2102. |
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Morphology Index Round Robin Completed
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The task forces for medical grade UHMWPE at ASTM (F648) and ISO (5834-5) embarked last year on a round robin to evaluate the repeatability and reproducibility of a standard method for quantifying the morphology index of UHMWPE. The morphology index method is currently part of ASTM F648-00, and is being considered for adoption into ISO 5834-5. Six centers participated in this international study, which was completed in May 2003. The results for the round robin testing are summarized in the PDF report, which is available here for download. |
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Swell Ratio Testing Standard Now Available
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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. |
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Revision of Accelerated Aging Standard Now Available
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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. |
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Update on Accelerated Aging and Swell Ratio ASTM Standards
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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. |
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ISO Update on UHMWPE Standards
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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. |
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1900 Resin Discontinued by Basell: Will Type 3 Resin Remain in ASTM F-648?
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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. |
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Update: Small Punch Testing Standard Available as ASTM F2183-02
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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. |
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Tensile and Impact Data for Contemporary UHMWPE Resins
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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. |
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Update on UHMWPE Standards Development at ISO
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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. |
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NIST Mechanical Property Data for Reference UHMWPE Published at SFB
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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. |
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