ANSI/AAMI/ISO 5840-3-2013

Cardiovascular implants - Cardiac valve prostheses - Part 3:Heart valve substitutes implanted by transcatheter techniques

ANSI/AAMI/ISO 5840-3-2013 发布历史

Outlines an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management. The selection of appropriate verification/validation tests and methods are to be derived from the risk assessment. The tests may include those to assess the physical, chemical, biological and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.

ANSI/AAMI/ISO 5840-3-2013由US-AAMI 发布于 2012-11-23。

ANSI/AAMI/ISO 5840-3-2013的历代版本如下：

• 2012年 ANSI/AAMI/ISO 5840-3-2012 心血管植入物.心脏瓣膜修复术.第3部分:微创技术植入的心脏瓣膜替代品
• 2012年11月23日 ANSI/AAMI/ISO 5840-3-2013

非常抱歉，我们暂时无法提供预览，您可以试试： 免费下载 ANSI/AAMI/ISO 5840-3-2013 前三页，或者稍后再访问。

注意： 点击下载后，生成下载文件时间比较长，请耐心等待......

标准号

ANSI/AAMI/ISO 5840-3-2013

发布日期

2012年11月23日

实施日期

废止日期

无

发布单位

US-AAMI

适用范围

Outlines an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management. The selection of appropriate verification/validation tests and methods are to be derived from the risk assessment. The tests may include those to assess the physical, chemical, biological and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.

ANSI/AAMI/ISO 5840-3-2013系列标准