ASTM F2695-12(2025)

Kategorie - podobné normy:

Implantáty pro chirurgii, protetiku a ortotiku

Anotace textu normy ASTM F2695-12(2025) :

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.

Keywords:

alpha-tocopherol, fabricated forms, powdered form, ultra-high molecular weight polyethylene, vitamin E,, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)