非血管支架检测

GB/T 25304-2010 非血管自扩张金属支架专用要求

本标准规定了用于扩张非血管腔体狭窄的自扩张金属支架及其输送系统的术语和定义、预期性能、设计属性、材料、临床前评估、制造、灭菌、包装和制造商提供的信息。 本标准适用于介入治疗用非血管自扩张金属支架，包括食道支架、胆道支架、气管支架及其相应的输送系统。 本标准不适用于球囊扩张支架、球囊扩张支架建议

Specific requirements for non-vascular self-expanding metallic stents

BS EN ISO 25539-2:2010 心血管植入物 血管内器械 血管支架

Cardiovascular implants. Endovascular devices. Vascular stents

BS EN ISO 25539-2:2009 心血管植入物 血管内器械 血管支架

Cardiovascular implants - Endovascular devices - Vascular stents

BS EN ISO 25539-2:2008 心血管植入物.血管内器械.血管支架

Cardiovascular implants - Endovascular devices - Vascular stents

BS EN ISO 25539-2:2012 心血管植入物.血管内器械.血管支架

Cardiovascular implants. Endovascular devices. Vascular stents

YY/T 0663.2-2016 心血管植入物血管内器械第2部分:血管支架

GOST R 52732-2007 血管支架.技术要求

Vascular stents. Technical requirements

EN ISO 25539-2:2020 心血管植入血管内设备.第2部分:血管支架

This document specifies requirements for the evaluation of stent systems (vascular stents and delivery systems) and requirements with respect

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2020)

EN ISO 25539-2:2012 心血管植入血管内设备.第2部分:血管支架

1.1 This part of ISO 25539 specifies requirements for vascular stents, based upon current medical knowledge. With regard to safety, it gives

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)

KS P ISO 25539-2:2009 心血管植入物.血管内器械.第2部分:血管支架

이 표준에서는 현재의 의료지식에 근거해서 혈관 스텐트에 대한 요건을 규정한다. 또한 안전과

Cardiovascular implants-Endovascular devices-Part 2:Vascular stents

ISO 25539-2:2008 心血管植入物.血管内器械.第2部分:血管支架

1.1 This part of ISO 25539 specifies requirements for vascular stents, based upon current medical knowledge. With regard to safety, it gives

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents

ISO 25539-2:2012 心血管植入物.血管内器械.第2部分:血管支架

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents

NF S94-203-2:2013 心血管植入物.血管内器械.第2部分:血管支架

Cardiovascular implants - Endovascular devices - Part 2: vascular stents

EN ISO 25539-2:2009 心血管植入物.心血管装置.第2部分:血管支架

This part of ISO 25539 specifies requirements for vascular stents, based upon current medical knowledge. With regard to safety, it gives requirements

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents

ANSI/AAMI/ISO 25539-2:2012 心血管植入物.血管内器械.第2部分:血管支架

Specifies requirements for vascular stents, based upon current medical knowledge. Gives requirements for intended performance, design attributes

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents

ANSI/AAMI/ISO 25539-2:2012 心血管植入物.血管内器械.第2部分:血管支架

Specifies requirements for vascular stents, based upon current medical knowledge. Gives requirements for intended performance, design attributes

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents

ISO 25539-2:2020 心血管植入物 - 血管内装置 - 第2部分:血管支架

Cardiovascular implants — Endovascular devices — Part 2: Vascular stents

KS P ISO 25539-2:2020 心血管植入物 - 血管内装置 - 第2部分:血管支架

Cardiovascular implants — Endovascular devices — Part 2: Vascular stents

ANSI/AAMI/ISO 25539-2:2008 心血管植入物.血管内器械.第2部分:血管支架

1.1 This part of ISO 25539 specifies requirements for vascular stents, based upon current medical knowledge. With regard to safety, it gives

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents

GOST R ISO 25539-2-2012 心血管植入物. 血管内装置. 第2部分. 血管支架

Cardiovascular implants. Endovascular devices. Part 2. Vascular stents

YY/T 0693-2008 血管支架尺寸特性的表征

本标准包含了与临床性能有效性相关的血管假体尺寸属性的识别及推荐的检测方法。本标准还包括支架放置过程中输送系统的包装和特殊标识。 本标准不包括作为血管成形术导管的要求见标准YY 0285.1和YY 0285.4

Standard guide for characterization and presentation of the dimensional attributes of vascular stents

EN ISO 25539-2:2008 心血管植入物.血管内器械.第2部分:血管支架［代替:CEN EN 14299］

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents [Superseded: CEN EN 14299]

YY/T 1747-2021 神经血管植入物 颅内动脉支架

ASTM F2477-06 血管支架在玻璃试管内搏动耐力测试

1.1 These test methods cover the determination of the durability of a vascular stent by exposing it to physiologically relevant diametric

Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents

ASTM F2606-08(2021 球囊可膨胀血管支架和支架系统的三点弯曲标准指南

Standard Guide for Three-Point Bending of Balloon-Expandable Vascular Stents and Stent Systems

ASTM F2606-08 三点弯曲血管球囊膨胀型支架和支架装置的标准指南

This guide can be used to obtain force versus deflection or midspan bending moment versus midspan curvature curves for stents and stent systems

Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems

ASTM F2606-08(2014 三点弯曲血管球囊膨胀型支架和支架装置的标准指南

3.1x00a0;This guide can be used to obtain force versus deflection or midspan bending moment versus

Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems

YY/T 0808-2010 血管支架体外脉动耐久性标准测试方法

本测试方法通过施加流体脉动负载使得血管支架处于与体内环境类似的直径膨胀水平来评价血管支架的耐久性能。该方法适用于已经在模拟血管(模拟血管弹性)中扩张的支架测试样品。典型的耐久测试期相当于10年时间(按照每分钟72次心跳计算)或至少3亿8千万次心动周期。 本方法适用于金属或合金的球囊扩张支架或自扩张

Standard test methods for in vitro pulsatile durability testing of vascular stents

T/CSBM 0013-2021 直管型血管支架 磁共振适用性 射频致热试验方法

1 试验方法概述: 1.1 待测直管型血管支架放置在可模拟人体电属性和热属性的体模材料中。直管型血管支架所在位置应有典型的照射条件，可通过评价局部 SAR值表征该位置的照射条件。体模材料是由盐水和凝胶剂制成的盐水凝胶。温度探针应放置在直管型血管支架两个端部。体模放置在

Test Method for Measurement of Radio Frequency Induced Heating On Straight Tubular Stents During Magnetic Resonance Imaging

DIN EN ISO 25539-2:2021 心血管植入物. 心血管装置. 第2部分: 血管支架(ISO 25539-2-2020); 德文版本EN ISO 25539-2-2020

This document has been prepared to provide minimum requirements for vascular stents. The normative requirements are provided in the main body

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2020); German version EN ISO 25539-2:2020