ISO 10993-12:2012对ISO 10993的一个或多个部分规定了要求，并就生物系统中的医疗器械检测参考材料的准备和选择进行了指导。具体而言，ISO 10993 -12:2012解决了以下问题: 测试样品选择; 从设备中选择代表部分; 测试样品制备; 实验对照; 参考资料的选择和要求; 提取物的制备。 ISO 10993-12:2012不适用于活细胞，但可与包含活细胞的组合产品的材料或器件成分相关

ISO 10993-12:2012 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of ISO 10993. Specifically, ISO 10993-12:2012 addresses the following: test sample selection; selection of representative portions from a device; test sample preparation; experimental controls; selection of, and requirements for, reference materials; preparation of extracts. ISO 10993-12:2012 is not applicable to live cells, but can be relevant to the material or device components of combination products containing live cells.