GSO ISO/TS 10993-19:2016

Biological evaluation of medical devices -- Part 19: Physico-chemical, morphological and topographical characterization of materials


 

 

非常抱歉,我们暂时无法提供预览,您可以试试: 免费下载 GSO ISO/TS 10993-19:2016 前三页,或者稍后再访问。

您也可以尝试购买此标准,
点击右侧 “立即购买” 按钮开始采购(由第三方提供)。

 

标准号
GSO ISO/TS 10993-19:2016
发布
2016年
发布单位
GSO
当前最新
GSO ISO/TS 10993-19:2016
 
 
适用范围
This Technical Specification provides a compilation of parameters and test methods that can be useful for the identification and evaluation of the physico-chemical, morphological and topographical (PMT) properties of materials in finished medical devices. Such an assessment is limited to those properties that are relevant to biological evaluation and the medical device’s intended use (clinical application and duration of use) even if such properties overlap with clinical effectiveness. This part of ISO 10993 does not address the identification or quantification of degradation products, which are covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15. Chemical characterization of materials is covered by ISO 10993-18. The ISO 10993 series of International Standards is not applicable when the material or device does not contact the body directly or indirectly (see ISO 10993-1:2003, 4.2).

GSO ISO/TS 10993-19:2016相似标准





Copyright ©2007-2022 ANTPEDIA, All Rights Reserved
京ICP备07018254号 京公网安备1101085018 电信与信息服务业务经营许可证:京ICP证110310号