血管支架和支架系統檢測

血管支架和支架系統檢測項目報價？??解決方案？??檢測周期？??樣品要求？

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GB/T 25304-2010非血管自擴張金屬支架專用要求

本標準規(guī)定了用于擴張非血管腔體狹窄的自擴張金屬支架及其輸送系統的術語和定義、預期性能、設計屬性、材料、臨床前評估、制造、滅菌、包裝和制造商提供的信息。本標準適用于介入治療用非血管自擴張金屬支架，包括食道支架、膽道支架、氣管支架及其相應的輸送系統。本標準不適用于球囊擴張支架、球囊擴張支架建議參照YY/T 0663。

YY/T 0500-2021心血管植入物 血管假體 管狀血管移植物和血管補片

本標準規(guī)定了評估血管假體的要求以及術語、設計屬性和制造商提供信息相關的要求。本標準適用于采用直視外科手術植入(而非射線或其他非直接成像技術，如CT或核磁共振)，預期用于血管系統節(jié)段間的置換、形成旁路或分流的無菌管狀血管移植物，以及用于修補和重建血管系統的血管補片。本標準適用于采用合成編織型材料以及合成非編織型材料制成的血管假體。本標準適用于全部或部分采用非活性生物源性材料制成的血管假體，包括組織工程血管假體，但本標準未包含生物源性材料的采購、獲取、制造以及所有試驗要求。本標準適用于復合、涂層、組合和外部強化的血管假體。本標準不適用于采用經導管輸送和非直視外科植入的血管內假體。本標準包括移植物材料適當試驗方法開發(fā)相關的信息。本標準不適用于由管狀血管移植物和瓣膜組成的帶瓣管道及其瓣膜部分，可用于對其中管狀血管移植物部分進行評價，但本標準未描述該類器械的特定要求和試驗方法。本標準不適用于心臟和心包補片、血管支架、輔件器械(如吻合器械、縫合器、隧道器和縫線)和墊片。本標準不適用于細胞接種相關的要求。本標準未包含藥物洗脫或藥物涂層血管假體的藥理學內容。本標準未包含可吸收血管假體的降解、組織長入和(或)組織替換及其他與時間有關方面的內容。

YY/T 0567.7-2016醫(yī)療保健產品的無菌加工 第7部分:醫(yī)療器械及組合型產品的替代加工

本標準規(guī)定了對于不能進行終滅菌，而且不適用于YY/T 0567.1-2013模擬生產方法的醫(yī)療器械及組合產品中，無菌加工性能確認的模擬生產替代方法的要求，并提供指導。本標準適用于在開發(fā)無菌加工期間，當加工中不允許直接使用培養(yǎng)基替代產品，或者培養(yǎng)基不能替代實際的無菌加工時，使用風險評定來設計醫(yī)療器械及組合產品的模擬生產研究。

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

YY/T 0663的本部分在現有醫(yī)學知識的基礎上規(guī)定了血管支架的各種要求。關于安全性，本部分在預期性能、設計屬性、材料、設計評價、制造、滅菌、包裝及制造商提供信息方面都有要求。本部分的適用范圍包括用于治療血管病變或血管狹窄以及其他血管畸形的血管支架。這些器械可以是具有或不具有表面改性的支架，例如藥物和/或其他涂層。本部分適用于作為血管支架釋放組成部分的輸送系統。本部分不包括用于血管支架植入之前的程序和器械，如球囊血管成形術器械。本部分不包括生物可吸收及聚合物支架和涂層的降解以及其他時間依從性方面的內容。除滅菌以外，本部分不包括動物組織產品評價方面的要求。

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

本文件規(guī)定了支架系統（血管支架和輸送系統）的通用要求、預期性能、設計屬性、材料、設計評價、上市后監(jiān)管、生產、滅菌、包裝的要求。本文件適用于治療血管狹窄或其他血管異常或病變的血管支架（含可吸收性血管支架）。本文件適用于與血管內假體聯用以完成對病變治療的支架，包括橋接支架（例如，開窗型血管內假體釋放后在腎動脈內放置的支架），但并未描述聯用時的測試方法。本文件適用于具有表面改性（例如，藥物和/或其他涂層）的血管支架。本文件適用于支架系統內所含的球囊。本文件包括用于局部治療血管成形術后夾層的定位器械、彈簧圈支撐器械以及血流導向裝置，但并未對這些器械的要求和測試進行全面描述。本文件適用于藥物洗脫支架，但并未對這些器械的藥物洗脫特性進行全面描述。本文件適用于可吸收支架和可吸收涂層支架，但并未對這些器械的可吸收特性進行全面描述。本文件適用于涂層支架和涂層支架系統，但并未對涂層特性進行全面描述。本文件不適用于血管支架置入之前的程序和器械，如球囊血管成形術器械。本文件不適用于有關血管支架制造用活性組織和非活性生物材料的要求和評價。

YY/T 0693-2008血管支架尺寸特性的表征

本標準包含了與臨床性能有效性相關的血管假體尺寸屬性的識別及推薦的檢測方法。本標準還包括支架放置過程中輸送系統的包裝和特殊標識。本標準不包括作為血管成形術導管的要求見標準YY 0285.1和YY 0285.4。

YY/T 0695-2008小型植入器械腐蝕敏感性的循環(huán)動電位極化標準測試方法

本測試方法利用循環(huán)(正向和反向)動電位極化評價小型金屬植入醫(yī)療器械或其部件的腐蝕敏感性。可以用本測試方法評價的器械包括但不僅限于以下產品：血管支架、尿道支架、濾器、血管內移植物的支撐部件、心臟封堵器、動脈瘤夾及結扎夾、U型釘等。

YY/T 0807-2010預裝在輸送系統上的球囊擴張血管支架穩(wěn)固性能標準測試方法

本標準為已經預裝、尚未釋放的球囊擴張支架輸送系統的支架在輸送系統上的穩(wěn)固性能的測試前處理、測試和測試終點的設計和開發(fā)提供指導。本標準旨在協助研究者對已經預裝、無鞘的球囊擴張支架輸送系統進行設計、研究和體外表征。本標準適用于實驗室確定移動或移除預裝在輸送系統上的球囊擴張血管支架所需的剪切力。本標準提供了在測試支架穩(wěn)固性能時需要考慮的一些選項。這些選項包括測試前處理，可能的支架穩(wěn)固性能測試及相關的測試終點。

YY/T 0808-2010血管支架體外脈動耐久性標準測試方法

本測試方法通過施加流體脈動負載使得血管支架處于與體內環(huán)境類似的直徑膨脹水平來評價血管支架的耐久性能。該方法適用于已經在模擬血管(模擬血管彈性)中擴張的支架測試樣品。典型的耐久測試期相當于10年時間(按照每分鐘72次心跳計算)或至少3億8千萬次心動周期。本方法適用于金屬或合金的球囊擴張支架或自擴張支架。雖然這個測試方法也可用于涂層支架、聚合物支架或降解支架產品,但并不特別針對這些支架所特有的屬性。本方法并不推薦用于治療動脈瘤或外周血管損傷或提供血管通路的覆膜支架或其他導管產品。但其中的一些信息也許可以用在這些產品的評價上。本方法適用于由于典型的周期性血管直徑膨脹導致的支架失效,但不涉及動態(tài)彎曲、扭轉、拉伸、擠壓或磨損等導致支架失效的模式。本方法不涉及彎曲血管模型的測試條件。本方法不涉及支架重疊測試條件。本標準并非試圖對所涉及的所有安全問題進行闡述,即便需要,也應結合其使用。確立適當的安全健康的操作規(guī)范,以及在應用前明確管理權限,是本標準用戶自身的責任。

YY/T 0858-2011球囊擴張血管支架和支架系統.三點彎曲試驗方法

本標準為采用三點彎曲試驗定量表征球囊擴張支架和支架系統的柔順性提供指導。本標準用于表征已釋放支架的柔順性和未釋放支架系統中支架和球囊區(qū)域的柔順性。 本標準不適用于支架跨距與外徑比小于4：l的樣品，該類樣品可采用其他方法評估。 本標準未提供用于表征自擴張支架、自擴張支架系統、內置支架(支架－人工血管)或內置支架系統彎曲柔順性的步驟。然而，本標準中某些內容可能對開發(fā)這些產品的三點彎曲表征方法提供有益幫助。盡管本標準是建立在血管支架和支架系統之上，但對于非血管球囊擴張支架和支架系統彎曲柔順性的表征，本標準也可提供一定參考。 本標準采用單位制。括號中的數值是英寸－磅單位制下的相應數值，僅供參考。

YY/T 0859-2011均勻徑向載荷下金屬血管支架有限元分析方法指南

本標準規(guī)定了金屬血管支架有限元建模與分析中的一般要求，這種有限元分析方法用于評估均勻徑向載荷下金屬血管支架設計的性能。本標準提出了評估金屬血管支架承受均勻徑向載荷和脈沖載荷這些典型行為的推薦性準則。本標準還提出了用于確認和驗證有限元模型的推薦性程序，這些程序方法同樣可以用來評估模型本身和分析結果。后本標準列出了此類力學仿真工程報告中應包含的具體內容。本標準僅適用于以下種類金屬支架的有限元結構分析：塑性形變金屬支架、自擴張金屬支架、覆膜支架中產生塑性形變的金屬部分、自擴張覆膜支架的金屬部分。本標準中介紹的技術主要針對彈塑性材料（如不銹鋼）和超彈性材料（如鎳鈦合金）。本標準不涉及與支架形狀記憶性能有關的特定內容。本標準不涉及可能隨時間變化的條件或者與血管重建相關的載荷變化條件。本標準僅適用于均勻徑向載荷條件。本標準不提供在疲勞壽命方面有限元分析的指導。本標準不包括對有限元方法及其理論依據和計算公式的完整描述。本標準中采用單位制，括號內的數值僅作參考。

YY/T 1553-2017心血管植入物 心臟封堵器

本標準的適用范圍包括經導管植入的用于治療心臟缺損等病變的心臟封堵器，主要包括房間隔缺損封堵器、室間隔缺損封堵器、動脈導管未閉封堵器及卵圓孔未閉封堵器。本標準在基于當前醫(yī)學知識水平的前提下規(guī)定了對心臟封堵器的要求。關于安全性，本標準在預期性能、設計屬性、材料、設計評價、制造、滅菌包裝及制造商提供信息方面提出了要求。本標準適用于作為心臟封堵器釋放組成部分的輸送系統。本標準不包括生物可吸收及聚合物產品和涂層的降解以及其他時間依從性方面的內容。本標準不包括用于心臟封堵器系統植入前的程序和器械，如J型導絲及測量球囊等。本標準不包括用于左心耳封堵的器械。除滅菌以外，本標準不包括動物組織產品評價方面的要求。YY/T 0640-2016規(guī)定了無源外科植入物性能的通用要求，本標準可視為對YY/T 0640-2016的補充。

YY/T 1660-2019球囊擴張和自擴張血管支架的徑向載荷測試方法

本標準規(guī)定了開發(fā)測量球囊擴張血管支架徑向強度或塌陷壓力及自擴張血管支架慢性外展力的體外試驗方法的指導原則。本標準適用于管狀結構的球囊擴張和自擴張支架。本標準適用于裸支架和覆膜支架，但不適用于分叉支架及非圓截面的支架或錐形支架。

ASTM F2394-2007安裝在傳輸系統上的氣球狀可擴展血管支架穩(wěn)當性測量的標準指南

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)測量輸送系統安裝的球囊擴張式血管支架穩(wěn)固性的標準指南

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)安裝在輸送系統上的球囊擴張血管支架的安全性測量指南

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)球囊可膨脹血管支架和支架系統的三點彎曲標準指南

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涂料藥物洗脫血管支架系統檢查和急性顆粒表征的標準指南

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)涂層藥物洗脫血管支架系統的涂層檢驗和急性顆粒特性的標準指南

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......