Tiêu chuẩn quốc tế
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Số hiệu
Standard Number
ASTM F2665-09
Năm ban hành 2009
Publication date
Tình trạng
W - Hết hiệu lực
Status |
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Tên tiếng Anh
Title in English Standard Specification for Total Ankle Replacement Prosthesis
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Chỉ số phân loại Quốc tế (ICS)
By field |
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Số trang
Page 7
Giá:
Price Liên hệ / Contact us
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Phạm vi áp dụng
Scope of standard 1.1 This specification covers total ankle replacement (TAR) prostheses used to provide functioning articulation by employing talar and tibial components that allow for a minimum of 15° of dorsiflexion and 15 to 25° (1) of plantar flexion, as determined by non-clinical testing. 1.2 Included within the scope of this specification are ankle components for primary and revision surgery with modular and non-modular designs, bearing components with fixed or mobile bearing designs, and components for cemented and/or cementless use. 1.3 This specification is intended to provide basic descriptions of material and prosthesis geometry. In addition, those characteristics determined to be important to in vivo performance of the prosthesis are defined. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 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.
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