血管支架和支架系统检测

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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、球囊扩张支架建议参照YY/T 0663。

YY/T 0500-2021心血管植入物 血管假体 管状血管移植物和血管补片

本标准规定了评估血管假体的要求以及术语、设计属性和制造商提供信息相关的要求。本标准适用于采用直视外科手术植入(而非射线或其他非直接成像技术，如CT或核磁共振)，预期用于血管系统节段间的置换、形成旁路或分流的无菌管状血管移植物，以及用于修补和重建血管系统的血管补片。本标准适用于采用合成编织型材料以及合成非编织型材料制成的血管假体。本标准适用于全部或部分采用非活性生物源性材料制成的血管假体，包括组织工程血管假体，但本标准未包含生物源性材料的采购、获取、制造以及所有试验要求。本标准适用于复合、涂层、组合和外部强化的血管假体。本标准不适用于采用经导管输送和非直视外科植入的血管内假体。本标准包括移植物材料适当试验方法开发相关的信息。本标准不适用于由管状血管移植物和瓣膜组成的带瓣管道及其瓣膜部分，可用于对其中管状血管移植物部分进行评价，但本标准未描述该类器械的特定要求和试验方法。本标准不适用于心脏和心包补片、血管支架、辅件器械(如吻合器械、缝合器、隧道器和缝线)和垫片。本标准不适用于细胞接种相关的要求。本标准未包含药物洗脱或药物涂层血管假体的药理学内容。本标准未包含可吸收血管假体的降解、组织长入和(或)组织替换及其他与时间有关方面的内容。

YY/T 0567.7-2016医疗保健产品的无菌加工 第7部分:医疗器械及组合型产品的替代加工

本标准规定了对于不能进行终灭菌，而且不适用于YY/T 0567.1-2013模拟生产方法的医疗器械及组合产品中，无菌加工性能确认的模拟生产替代方法的要求，并提供指导。本标准适用于在开发无菌加工期间，当加工中不允许直接使用培养基替代产品，或者培养基不能替代实际的无菌加工时，使用风险评定来设计医疗器械及组合产品的模拟生产研究。

YY/T 0663.2-2016心血管植入物 血管内器械 第2部分:血管支架

YY/T 0663的本部分在现有医学知识的基础上规定了血管支架的各种要求。关于安全性，本部分在预期性能、设计属性、材料、设计评价、制造、灭菌、包装及制造商提供信息方面都有要求。本部分的适用范围包括用于治疗血管病变或血管狭窄以及其他血管畸形的血管支架。这些器械可以是具有或不具有表面改性的支架，例如药物和/或其他涂层。本部分适用于作为血管支架释放组成部分的输送系统。本部分不包括用于血管支架植入之前的程序和器械，如球囊血管成形术器械。本部分不包括生物可吸收及聚合物支架和涂层的降解以及其他时间依从性方面的内容。除灭菌以外，本部分不包括动物组织产品评价方面的要求。

YY/T 0663.2-2024心血管植入器械 血管内器械 第2部分：血管支架

本文件规定了支架系统（血管支架和输送系统）的通用要求、预期性能、设计属性、材料、设计评价、上市后监管、生产、灭菌、包装的要求。本文件适用于治疗血管狭窄或其他血管异常或病变的血管支架（含可吸收性血管支架）。本文件适用于与血管内假体联用以完成对病变治疗的支架，包括桥接支架（例如，开窗型血管内假体释放后在肾动脉内放置的支架），但并未描述联用时的测试方法。本文件适用于具有表面改性（例如，药物和/或其他涂层）的血管支架。本文件适用于支架系统内所含的球囊。本文件包括用于局部治疗血管成形术后夹层的定位器械、弹簧圈支撑器械以及血流导向装置，但并未对这些器械的要求和测试进行全面描述。本文件适用于药物洗脱支架，但并未对这些器械的药物洗脱特性进行全面描述。本文件适用于可吸收支架和可吸收涂层支架，但并未对这些器械的可吸收特性进行全面描述。本文件适用于涂层支架和涂层支架系统，但并未对涂层特性进行全面描述。本文件不适用于血管支架置入之前的程序和器械，如球囊血管成形术器械。本文件不适用于有关血管支架制造用活性组织和非活性生物材料的要求和评价。

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。

YY/T 0695-2008小型植入器械腐蚀敏感性的循环动电位极化标准测试方法

本测试方法利用循环(正向和反向)动电位极化评价小型金属植入医疗器械或其部件的腐蚀敏感性。可以用本测试方法评价的器械包括但不仅限于以下产品：血管支架、尿道支架、滤器、血管内移植物的支撑部件、心脏封堵器、动脉瘤夹及结扎夹、U型钉等。

YY/T 0807-2010预装在输送系统上的球囊扩张血管支架稳固性能标准测试方法

本标准为已经预装、尚未释放的球囊扩张支架输送系统的支架在输送系统上的稳固性能的测试前处理、测试和测试终点的设计和开发提供指导。本标准旨在协助研究者对已经预装、无鞘的球囊扩张支架输送系统进行设计、研究和体外表征。本标准适用于实验室确定移动或移除预装在输送系统上的球囊扩张血管支架所需的剪切力。本标准提供了在测试支架稳固性能时需要考虑的一些选项。这些选项包括测试前处理，可能的支架稳固性能测试及相关的测试终点。

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支架。虽然这个测试方法也可用于涂层支架、聚合物支架或降解支架产品,但并不特别针对这些支架所特有的属性。本方法并不推荐用于治疗动脉瘤或外周血管损伤或提供血管通路的覆膜支架或其他导管产品。但其中的一些信息也许可以用在这些产品的评价上。本方法适用于由于典型的周期性血管直径膨胀导致的支架失效,但不涉及动态弯曲、扭转、拉伸、挤压或磨损等导致支架失效的模式。本方法不涉及弯曲血管模型的测试条件。本方法不涉及支架重叠测试条件。本标准并非试图对所涉及的所有安全问题进行阐述,即便需要,也应结合其使用。确立适当的安全健康的操作规范,以及在应用前明确管理权限,是本标准用户自身的责任。

YY/T 0858-2011球囊扩张血管支架和支架系统.三点弯曲试验方法

本标准为采用三点弯曲试验定量表征球囊扩张支架和支架系统的柔顺性提供指导。本标准用于表征已释放支架的柔顺性和未释放支架系统中支架和球囊区域的柔顺性。 本标准不适用于支架跨距与外径比小于4：l的样品，该类样品可采用其他方法评估。 本标准未提供用于表征自扩张支架、自扩张支架系统、内置支架(支架－人工血管)或内置支架系统弯曲柔顺性的步骤。然而，本标准中某些内容可能对开发这些产品的三点弯曲表征方法提供有益帮助。尽管本标准是建立在血管支架和支架系统之上，但对于非血管球囊扩张支架和支架系统弯曲柔顺性的表征，本标准也可提供一定参考。 本标准采用单位制。括号中的数值是英寸－磅单位制下的相应数值，仅供参考。

YY/T 0859-2011均匀径向载荷下金属血管支架有限元分析方法指南

本标准规定了金属血管支架有限元建模与分析中的一般要求，这种有限元分析方法用于评估均匀径向载荷下金属血管支架设计的性能。本标准提出了评估金属血管支架承受均匀径向载荷和脉冲载荷这些典型行为的推荐性准则。本标准还提出了用于确认和验证有限元模型的推荐性程序，这些程序方法同样可以用来评估模型本身和分析结果。后本标准列出了此类力学仿真工程报告中应包含的具体内容。本标准仅适用于以下种类金属支架的有限元结构分析：塑性形变金属支架、自扩张金属支架、覆膜支架中产生塑性形变的金属部分、自扩张覆膜支架的金属部分。本标准中介绍的技术主要针对弹塑性材料（如不锈钢）和超弹性材料（如镍钛合金）。本标准不涉及与支架形状记忆性能有关的特定内容。本标准不涉及可能随时间变化的条件或者与血管重建相关的载荷变化条件。本标准仅适用于均匀径向载荷条件。本标准不提供在疲劳寿命方面有限元分析的指导。本标准不包括对有限元方法及其理论依据和计算公式的完整描述。本标准中采用单位制，括号内的数值仅作参考。

YY/T 1553-2017心血管植入物 心脏封堵器

本标准的适用范围包括经导管植入的用于治疗心脏缺损等病变的心脏封堵器，主要包括房间隔缺损封堵器、室间隔缺损封堵器、动脉导管未闭封堵器及卵圆孔未闭封堵器。本标准在基于当前医学知识水平的前提下规定了对心脏封堵器的要求。关于安全性，本标准在预期性能、设计属性、材料、设计评价、制造、灭菌包装及制造商提供信息方面提出了要求。本标准适用于作为心脏封堵器释放组成部分的输送系统。本标准不包括生物可吸收及聚合物产品和涂层的降解以及其他时间依从性方面的内容。本标准不包括用于心脏封堵器系统植入前的程序和器械，如J型导丝及测量球囊等。本标准不包括用于左心耳封堵的器械。除灭菌以外，本标准不包括动物组织产品评价方面的要求。YY/T 0640-2016规定了无源外科植入物性能的通用要求，本标准可视为对YY/T 0640-2016的补充。

YY/T 1660-2019球囊扩张和自扩张血管支架的径向载荷测试方法

本标准规定了开发测量球囊扩张血管支架径向强度或塌陷压力及自扩张血管支架慢性外展力的体外试验方法的指导原则。本标准适用于管状结构的球囊扩张和自扩张支架。本标准适用于裸支架和覆膜支架，但不适用于分叉支架及非圆截面的支架或锥形支架。

ASTM F2394-2007安装在传输系统上的气球状可扩展血管支架稳当性测量的标准指南

The securement of the endovascular stent on the balloon is a critical parameter to ensure that the stent is safely delivered to or from the treatment site. This guide is intended for use by researchers and manufacturers for the development and selection of pre-test treatments, tests and test endpoints to measure stent securement (displacement distances and dislodgment forces). This guide may be used to investigate which practical combinations of in vitro tests best characterize clinical scenarios. This guide should be used with discretion in choosing securement tests and evaluating results due to the myriad possible combinations of clinical conditions, failure modes, and stent delivery system designs. This guide may be of use for developing a test for meeting parts 2 and 3 of the requirements of EN 14299, Section 7.3.4.4 on Trackability. This guide may be of use for developing a test to meet section VII-C-8 of CDRH Guidance document.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 .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.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.

ASTM F2394-2007(2017)测量输送系统安装的球囊扩张式血管支架稳固性的标准指南

4.1x00a0;The securement of the endovascular stent on the balloon is a critical parameter to ensure that the stent is safely delivered to or from the treatment site. 4.2x00a0;This guide is intended for use by researchers and manufacturers for the development and selection of pre-test treatments, tests and test endpoints to measure stent securement (displacement distances and dislodgment forces). 4.3x00a0;This guide may be used to investigate which practical combinations of in vitro tests best characterize clinical scenarios. 4.4x00a0;This guide should be used with discretion in choosing securement tests and evaluating results due to the myriad possible combinations of clinical conditions, failure modes, and stent delivery system designs. 4.5x00a0;This guide may be of use for developing a test for meeting parts 2 and 3 of the requirements of EN 14299, Section 7.3.4.4 on Trackability. 4.6x00a0;This guide may be of use for developing a test to meet section VII-C-8 of CDRH Guidance document. 1.1x00a0;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. 1.2x00a0;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. 1.3x00a0;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. 1.4x00a0;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. 1.5x00a0;This guide does not specify a method for mounting the stent onto the delivery system.

ASTM F2394-2007(2022)安装在输送系统上的球囊扩张血管支架的安全性测量指南

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 are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined. 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 appropria

ASTM F2606-2008(2021)球囊可膨胀血管支架和支架系统的三点弯曲标准指南

1.1?This guide provides guidelines for quantitatively characterizing balloon-expandable stent and stent system flexibility using three-point bending procedures. Guidelines are provided for characterizing deployed stent flexibility, and for characterizing pre-deployment stent system flexibility in the region of the stent and balloon. 1.2?This guide is not recommended for test articles that cannot be appropriately evaluated using a span length to stent outer diameter (as tested) ratio of at least 4:1. Test articles that do not meet this requirement are likely to exhibit appreciable deformation by modes other than bending. 1.3?This guide does not provide procedures for characterizing the bending flexibility of self-expanding stents, self-expanding stent systems, endoprostheses (stent-grafts), or endoprostheses systems. However, some aspects of this guide may be useful for developing appropriate three-point bending characterization procedures for these devices. While this guide was developed with vascular stents and stent systems in mind, it may be useful for characterizing the bending flexibility of balloon-expandable stents and stent systems used in non-vascular applications. 1.4?The values stated in SI units are to be regarded as the standard. The values given in parentheses are mathematical conversions to inch-pound units that are provided for information only and are not considered standard. 1.5?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.

ASTM F2743-2011涂料药物洗脱血管支架系统检查和急性颗粒表征的标准指南

The shedding of the coating from a vascular stent can alter its clinical safety and/or therapeutic benefit. Clinical performance (for example, drug elution) may be affected by particulate generation from the coated stent system and coating defects. This document provides guidance for coating inspection and acute particulate characterization of drug eluting vascular stents. Information about the potential for shedding can be gained during bench testing. The general guidelines presented here may be used for writing detailed protocols for specific products at the various stages of the product development process. Such testing may be performed during device development, design validation testing, lot-release testing, and/or stability testing although different requirements may apply at each stage. These suggested methods may represent a reasonable simulation of clinical usage. When establishing the coating inspection and acute particulate characterization testing conditions, the current clinical usage/practice (for example, post-dilation, overlapping stents) and the instructions for use (IFU), as applicable, should be considered. While methods for chronic particulate characterization and coating inspection have not been established, these suggested methods may be helpful in the development of chronic methods. Testing in accordance with recommendations in this guide will generate data that may lead to further improvements in the method and its validation, as well as possible advancements in device design and performance. See also FDA Guidance for Industry and FDA Staff and AAMI TIR42:2010.1.1 This guide describes recommended in vitro test procedures for coating inspection and acute particulate characterization of coated drug-eluting vascular (balloon-expandable and self-expanding) stent systems. 1.2 Recommended practices for coating inspection and acute particulate characterization include baseline (deployment) testing and simulated use testing. This guide describes the capture and analysis of particulates. This guide describes the inspection of the coated stent surface. This guide was developed for characterization and not intended for production release testing of coated drug-eluting vascular stent systems although some sections may be appropriate. 1.3 Chronic particulate characterization and coating inspection are not included herein. 1.4 Coating systems specifically designed to degrade or otherwise intentionally separate themselves from the permanent stent structure may not be fully addressed herein. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.

ASTM F2743-2011(2018)涂层药物洗脱血管支架系统的涂层检验和急性颗粒特性的标准指南

5.1x00a0;The shedding of the coating from a vascular stent can alter its clinical safety and/or therapeutic benefit. Clinical performance (for example, drug elution) may be affected by particulate generation from the coated stent system and coating defects. This document provides guidance for coating inspection and acute particulate characterization of drug eluting vascular stents. Information about the potential for shedding can be gained during bench testing. The general guidelines presented here may be used for writing detailed protocols for specific products at the various stages of the product development process. Such testing may be performed during device development, design validation testing, lot-release testing, and/or stability testing although different requirements may apply at each stage. These suggested methods may represent a reasonable simulation of clinical usage. When establishing the coating inspection and acute particulate characterization testing conditions, the current clinical usage/practice (for example, post-dilation, overlapping stents) and the instructions for use (IFU), as applicable, should be considered. While methods for chronic particulate characterization and coating inspection have not been established, these suggested methods may be helpful in the development of chronic methods. Testing in accordance with recommendations in this guide will generate data that may lead to further improvements in the method and its validation, as well as possible advancements in device design and performance. See also FDA Guidance for Industry and FDA Staff and AAMI8201;TIR42:2010. 1.1x00a0;This guide describes recommended in vitro test procedures for coating inspection and acute particulate characterization of coated drug-eluting vascular (balloon-expandable and self-expanding) stent systems. 1.2x00a0;Recommended practices for coating inspection and acute particulate characterization include baseline (deployment) testing and simulated use testing. This guide describes the capture and analysis of particulates. This guide describes the inspection of the coated stent surface. This guide was developed for characterization and not intended for production release testing of coated drug-eluting vascular stent systems although some sections may be appropriate. 1.3x00a0;Chronic particulate characterization and coating inspection are not included herein. 1.4x00a0;Coating systems specifically designed to degrade or otherwise intentionally separate themselves from the permanent stent structure may not be fully addressed herein. 1.5x00a0;The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6x00a0;The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard. 1.7x00a0;This international standard was developed in accordance with internationally recognized principles on stan......