ASTM F2695 - 12(2020)

    Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications

    Active Standard ASTM F2695 | Developed by Subcommittee: F04.11

    Book of Standards Volume: 13.02


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    Abstract

    This specification covers ultra-high molecular weight polyethylene (UHMWPE) powder blended with alphatocopherol (vitamin E) intended for use in surgical implants. The requirements apply to alphatocopherol-containing UHMWPE in two forms. One is virgin polymer powder blended with alpha-tocopherol prior to consolidation. The second is any form fabricated from this blended, alpha-tocopherol-containing powder from which a finished product is subsequently produced. This specification does not apply to finished or semi-finished products that are doped with vitamin E after consolidation, nor to the packaged and sterilized finished implant, nor to UHMWPE materials extensively crosslinked by gamma and electron beam sources of ionizing radiation. Required material characteristics including composition, foreign matter, morphology, and mechanical characteristics are addressed by this specification.

    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.

    1. Scope

    1.1 This specification covers ultra-high molecular weight polyethylene (UHMWPE) powder blended with alpha-tocopherol (Vitamin E) intended for use in surgical implants.

    1.2 The requirements of this specification apply to alpha-tocopherol-containing UHMWPE in two forms. One is virgin polymer powder blended with alpha-tocopherol prior to consolidation (Section 4). The second is any form fabricated from this blended, alpha-tocopherol-containing powder from which a finished product is subsequently produced (Section 5). This specification does not apply to finished or semi-finished products that are doped with Vitamin E after consolidation.

    1.3 Aside from blending with alpha-tocopherol, the provisions of Specifications F648 and D4020 apply. Special requirements detailed in this specification are added to describe powders containing alpha-tocopherol that will be used in surgical implants. This specification addresses material characteristics and does not apply to the packaged and sterilized finished implant. This specification also does not apply to UHMWPE materials extensively crosslinked by gamma and electron beam sources of ionizing radiation.

    1.4 The following precautionary caveat pertains only to the fabricated forms portion, Section 5, of this specification. This standard 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

    1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.


    2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    ISO Standards

    ISO 3451–1 PlasticsDetermination of Ash, Part 1: General Methods Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.

    ASTM Standards

    D648 Test Method for Deflection Temperature of Plastics Under Flexural Load in the Edgewise Position

    D790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials

    D1898 Practice for Sampling of Plastics

    D4020 Specification for Ultra-High-Molecular-Weight Polyethylene Molding and Extrusion Materials

    F619 Practice for Extraction of Materials Used in Medical Devices

    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

    F749 Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit

    F756 Practice for Assessment of Hemolytic Properties of Materials

    F763 Practice for Short-Term Screening of Implant Materials

    F813 Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices

    F895 Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity

    F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Insertion into Bone


    ICS Code

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

    UNSPSC Code

    UNSPSC Code 42295500(Surgical implants and expanders and extenders and surgical wires and related products)


    Referencing This Standard
    Link Here
    Link to Active (This link will always route to the current Active version of the standard.)

    DOI: 10.1520/F2695-12R20

    Citation Format

    ASTM F2695-12(2020), Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications, ASTM International, West Conshohocken, PA, 2020, www.astm.org

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