Implants for surgery — Measurements of open-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods
外科植入物——测量开路电位以评估金属植入材料和医疗设备在较长时间内的腐蚀行为
发布日期:
2004-07-13
ISO 16429:2004规定了一种测试方法,用于在与体液相关的测试环境中,使用标准腐蚀测试电池研究植入材料和外科植入装置的电化学腐蚀性能,在延长的时间段内测量植入材料和植入装置的开路电位。
这种监测开路电位的方法也可以与机械静态或动态负载试验相结合。
ISO 16429:2004尤其适用于形成具有防腐保护性能的钝化层的金属材料,这是外科植入材料的典型情况。
本试验方法适用于单一金属材料或合金的研究。
它不适用于不同的材料组合,在测量和解释结果时需要特别考虑。
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.