标准摘要
[中文适用范围]： 本国际标准规定了一种测试方法，用于在长时间内测量浸入与体液相关的测试环境中的植入材料和手术植入装置的开路电位，使用标准腐蚀测试电池来研究材料的电化学腐蚀特性。 设备。 这种监测开路电位的方法还可以与机械静态或动态负载测试相结合。 本国际标准特别适用于形成具有防腐蚀保护性能的钝化层的金属材料，如典型的外科植入材料。 该测试方法旨在研究单一金属材料或合金。 它不适用于不同材料的组合，这需要在测量和解释结果时特别考虑。 [外文原描述]： ISO 16429:2004 specifies a test method for measurements over extended time periods of the open-circuit potential of implant materials and surgically implantable devices immersed in a test environment related to body fluid, using a standard corrosion test cell to study the electrochemical corrosion properties of the devices. This method of monitoring the open-circuit potential can also be combined with mechanical static or dynamic loading tests. ISO 16429:2004 is applicable in particular to metallic materials which form passive layers with protective properties against corrosion, as typical for surgical implant materials. This test method is intended for the investigation of single metallic materials or alloys. It is not applicable to dissimilar material combinations, which require particular considerations in measuring and interpreting the results.
英文名称Implants for surgery — Measurements of open-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods