Tiêu chuẩn quốc tế

Số hiệu

Standard Number

ASTM F983-86(2018)
Năm ban hành 2018

Publication date

Tình trạng A - Còn hiệu lực

Status

Tên tiếng Anh

Title in English

Standard Practice for Permanent Marking of Orthopaedic Implant Components
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

2
Giá:

Price

Liên hệ / Contact us
Phạm vi áp dụng

Scope of standard

1.1 It is common practice for orthopaedic implant manufacturers to apply permanent identification to implant components. In this regard, Practice F86 describes recommended locations and methods of marking for metallic implants. 1.2 The purpose of this practice is to (1) recommend that orthopaedic implants be permanently marked, and (2) recommend practical amounts of information that should be included in the marking. It is recognized, however, that marking is not practical in some cases (see 4.1). 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.