Tiêu chuẩn quốc tế

Số hiệu

Standard Number

ASTM F1672-14(2019)
Năm ban hành 2019

Publication date

Tình trạng A - Còn hiệu lực

Status

Tên tiếng Anh

Title in English

Standard Specification for Resurfacing Patellar Prosthesis
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

5
Giá:

Price

Liên hệ / Contact us
Phạm vi áp dụng

Scope of standard

1.1 This specification covers patellar resurfacing devices used to provide a functioning articulation between the patella and the femur. 1.2 This specification is intended to provide basic descriptions of material and device geometry. Additionally, those characteristics determined to be important to in-vivo performance of the device are defined. 1.3 This specification does not cover the details for quality assurance, design control, and production control contained in 21 CFR 820 and ISO 9001. Note 1: Devices for custom applications are not covered by this specification. 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.