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ASTM F2394-07(2017)
Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System- 발행일 : 2017-09-01
- 발행기관 : ASTM
상세정보
| 분야 | 13.01 : 의료기, 외과용 도구 및 장비 |
|---|---|
| 적용범위 | 1.1 This guide provides guidance for the design and development of pre-test treatments, tests, and test endpoints to measure stent securement of pre-mounted, unsheathed, balloon-expandable stent delivery systems. This guide is intended to aid investigators in the design, development, and in vitro characterization of pre-mounted, unsheathed, balloon-expandable stent delivery systems. 1.2 This guide covers the laboratory determination of the shear force required to displace or dislodge a balloon-expandable endovascular stent mounted on a delivery system. The guide proposes a set of options to consider when testing stent securement. The options cover pre-test treatments, possible stent securement tests, and relevant test endpoints. An example test apparatus is given in 7.1. 1.3 This guide covers in vitro bench testing characterization only. Measured levels of securement and product design/process differentiation may be particularly influenced by selections of pre-test treatments, securement test type (for example, stent gripping method), and test endpoint. In vivo characteristics may also differ from in vitro results. 1.4 This guide does not cover all possible pre-test treatments, stent securement tests, or test endpoints. It is intended to provide a starting point from which to select and investigate securement test options. 1.5 This guide does not specify a method for mounting the stent onto the delivery system. 1.6 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. 1.7 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 requirements prior to use. 1.8 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. |
| 국제분류(ICS)코드 | 11.040.20 : 수혈. 주입. 주사장비 |
| 페이지수 | 13 |
| Edition | 07(2017) |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ASTM F2394-07(2022)상세보기 | Standard Guide for Measuring Securement of Balloon-Expandable Vascular Stent Mounted on Delivery System | 2022-10-01 | 표준 |
| 2 | ASTM F2394-07(2017)상세보기 | Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System | 2017-09-01 | 구판 |
| 3 | ASTM F2394-07(2013)상세보기 | Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System | 2013-03-01 | 구판 |
| 4 | ASTM F2394-07상세보기 | Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System | 2007-07-15 | 구판 |
| 5 | ASTM F2394-04상세보기 | Standard Guide for Measuring Securement of Balloon Expandable Stent Mounted on Delivery System | 2004-05-01 | 구판 |
관련상품
- 관련상품이 존재하지 않습니다.
다른 사람이 함께 구입한 상품
- ASTM F2514-08(2014) - Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading
- ASTM F2743-11(2018) - Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems
- ASTM F3067-14(2021) - Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents
- ASTM F2630-14 REDLINE - Standard Guide for Self-Closing/Self-Latching General-Purpose Gates
- ASTM F2606-08(2021) - Standard Guide for Three-Point Bending of Balloon-Expandable Vascular Stents and Stent Systems
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- KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스
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