ASTM-F2665 2021(Redline)

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F2665-21 Standard Specification for Total Ankle Replacement Prosthesis (Redline)

Published By	Publication Date	Number of Pages
ASTM	2021	12

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Categories: 11.180.10 - Aids and adaptation for moving, ASTM

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Description

ASTM F2665-21

Redline Standard: Standard Specification for Total Ankle Replacement Prosthesis

ASTM F2665

Scope

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)2 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 the 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.6 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.

Keywords

ankle; ankle constraint; ankle prosthesis; ankle wear; arthroplasty; contact area; contact pressure; fatigue; particles; surface roughness; total ankle replacement (TAR); UHMWPE;

ICS Code

ICS Number Code 11.180.10 (Aids and adaptations for moving)

DOI: 10.1520/F2665-21

Additional information

Standard Title	F2665-21 Standard Specification for Total Ankle Replacement Prosthesis (Redline)
Published Code	ASTM
Publication Date	2021
Pages Count	12
ICS Codes	11.180.10 - Aids and adaptation for moving

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ASTM-F2665 2021(Redline)

ASTM F2665-21

Redline Standard: Standard Specification for Total Ankle Replacement Prosthesis

ASTM F2665

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