Tiêu chuẩn quốc tế

Số hiệu

Standard Number

ASTM F1801-20
Năm ban hành 2020

Publication date

Tình trạng A - Còn hiệu lực

Status

Tên tiếng Anh

Title in English

Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials
Chỉ số phân loại Quốc tế (ICS)

By field

11.040 - Thiết bị y tế
11.040.40 - Mô cấy dùng cho mổ xẻ, lắp bộ phận giả và chỉnh hình
Số trang

Page

7
Giá:

Price

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Scope of standard

1.1 This practice covers the procedure for performing corrosion fatigue tests to obtain S-N (3.2.1) fatigue curves or statistically derived fatigue strength values, or both, for metallic implant materials. This practice describes the testing of axially loaded fatigue specimens subjected to a constant amplitude, periodic forcing function in saline solution at 37°C and in air at room temperature. The environmental test method for implant materials may be adapted to other modes of fatigue loading such as bending or torsion. While this practice is not intended to apply to fatigue tests on implantable components or devices, it does provide guidelines for fatigue tests with standard specimens in an environment related to physiological conditions. 1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard. 1.3 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. 1.4 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.