ISO 10993-12:20 07规定了根据ISO 10993系列的一个或多个部分制备样品和选择生物系统中医疗器械测试参考材料时应遵循的程序的要求并给出了指导。具体而言，ISO 10993-12:20 07地址: 测试样品选择；从装置中选择代表性部分；供试品制备；实验对照；标准物质的选择和要求；提取物的制备。 ISO 10993-12:20 07不适用于含有活细胞的材料或器械。

ISO 10993-12:2007 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 the ISO 10993 series. Specifically ISO 10993-12:2007 addresses:

1. test sample selection;
2. selection of representative portions from a device;
3. test sample preparation;
4. experimental controls;
5. selection of and requirements for reference materials;
6. preparation of extracts.

ISO 10993-12:2007 is not applicable to materials or devices containing live cells.