Tiêu chuẩn quốc tế

Số hiệu

Standard Number

ASTM F2079-09(2017)
Năm ban hành 2017

Publication date

Tình trạng A - Còn hiệu lực

Status

Tên tiếng Anh

Title in English

Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents
Chỉ số phân loại Quốc tế (ICS)

By field

11.040 - Thiết bị y tế
11.040.20 - Thiết bị truyền máu, tiêm truyền và tiêm
Số trang

Page

3
Giá:

Price

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Scope of standard

1.1 The purpose of this test method is to quantify the percentage by which the diameter of a stent decreases from its expanded diameter while still on the delivery balloon to its relaxed diameter after deflating the balloon. This test method is appropriate for stents manufactured from a material that is plastically deformed when the stent's diameter is increased from its predeployed size to its postdeployed size by mechanical means. This test method may be performed in air at room temperature unless there is a known temperature dependence of the material, in which case, the temperature at which the test is conducted shall be stated in the report. 1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this 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 and health 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.