ISO 7198:2016 specifies requirements for the evaluation of vascular prostheses and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge.

This International Standard is an update of ISO 7198:1998, necessary given the introduction of new standards for endovascular prostheses, vascular stents and vascular device-drug combination products.

This International Standard is an update of ISO 7198:1998, necessary given the introduction of new standards for endovascular prostheses, vascular stents and vascular device-drug combination products.

官方高清原版 可编辑iso 7198-2016 星级： 62 页 iso内审-iso内审 星级： 7 页 iso组织及iso标准简介 星级： 31 页 iso组织及iso标准简介 星级： 31 页 菲林iso vs.数码iso 星级： 3 页 惠州iso咨询 东莞iso咨询 ...

本标准规定了人工血管各项机械力学性能的名称。 而且在本标准中还列出了部分制造者对人工血 管几何形状和机械力学性能的测试测量方法。 本标准还提到了人工血管的灭菌方法，并对产品的包装 和标志做出了规定。 在本标准中还列出了关于人工血管一些常用术语的定义。 1．2本标准并没有全部列出人工血管所有的性能指标或几何形状，但本标准所列出的对样品的检测方 法，可以验证制造者所提供的标示性能指标是否在可以接受的范围内。 不过，并不能因此而认为在本标 准 …

英文原版：ISO 7198:2016 specifies requirements for the evaluation of vascular prostheses and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro test methods is included in an informative annex to ISO 7198:2016.

ISO 7198:2016 specifies requirements for the evaluation of vascular prostheses and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro test methods is included in an informative annex to ISO 7198:2016.

2016年8月2日 · Specifies requirements for the evaluation of vascular prostheses and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro test methods is included in an informative annex to this International Standard.

国际标准化组织（ISO）制定的《ISO 7198心血管植入物和体外系统-血管假体-管状血管移植物和血管补片》标准中，对血管假体的评估要求以及提供的命名、设计特点和信息提出了要求。 由制造商根据现有的医学知识进行解释。 关于体外测试方法开发的指南包含在该标准的附件中。 该标准被视为“ISO 14630 非活动手术植入物 - 一般要求”标准的补充，该标准规定了非活动手术植入物性能的一般要求。 本标准适用于通过直接成像手术技术放置的无菌管状血管移植物，而不是荧 …

update of ISO 7198:1998, necessary given the introducti on of new standards for endovascular prostheses and vascular device-drug combination products. This standard covers vascular prostheses implanted using direct visualization surgical techniques as opposed