ASTM F2695-12
Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
- Standard No.
- ASTM F2695-12
- Release Date
- 2012
- Published By
- American Society for Testing and Materials (ASTM)
- Status
- Replace By
- ASTM F2695-12(2020)
- Latest
- ASTM F2695-12(2020)
- 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 and health practices and determine the applicability of regulatory limitations prior to use.
ASTM F2695-12 Referenced Document
- ASTM D1898
- ASTM D4020 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Molding and Extrusion Materials
- ASTM D648 Standard Test Method for Deflection Temperature of Plastics Under Flexural Load in the Edgewise Position*， 2024-04-19 Update
- ASTM D790 Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials*， 2024-04-19 Update
- ASTM F619 Standard Practice for Extraction of Medical Plastics
- ASTM F648 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
- ASTM F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
- ASTM F749 Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
- ASTM F756 Standard Practice for Assessment of Hemolytic Properties of Materials
- ASTM F763 Standard Practice for Short-Term Screening of Implant Materials
- ASTM F813 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
- ASTM F895 Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
- ASTM F981 Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
- ISO 10993 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
ASTM F2695-12 history
- 2020 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
- 2012 ASTM F2695-12 Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
- 2007 ASTM F2695-07 Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
