Tiêu chuẩn quốc tế
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Số hiệu
Standard Number
ASTM F2695-12
Năm ban hành 2012
Publication date
Tình trạng
W - Hết hiệu lực
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Tên tiếng Anh
Title in English Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
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Chỉ số phân loại Quốc tế (ICS)
By field
11.040.40 - Mô cấy dùng cho mổ xẻ, lắp bộ phận giả và chỉnh hình
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Số trang
Page 4
Giá:
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Phạm vi áp dụng
Scope of standard 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-con 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. |