YY/T 1295-2015 in English

本标准规定了应用鲎试验评价的纳米材料，用于细胞的体外生物学试验系统的术语、定义和试验方法等要求。
本标准适用于能够被水性介质（例如：水、血清或反应介质）分散或浸提的纳米材料，包括组合在医疗器械中的纳米材料。

Scope

This standard describes the application of the Limulus test to evaluate nanomaterials and in vitro biological test systems for cells. This standard applies to nanomaterials that can be dispersed or leached by an aqueous medium (such as water, serum or reaction medium), allowing the nanomaterials to be incubated with this medium at 37°C for an appropriate period of time. This standard is limited to samples tested in vitro. This method may also be applied to nanomaterials for parenteral administration to animals.