YY/T 1295-2015
Biological evaluation of medical devices.Nanomaterial: Endotoxin test (English Version)
- Standard No.
- YY/T 1295-2015
- Language
- Chinese, Available in English version
- Release Date
- 2015
- Published By
- Professional Standard - Medicine
- Latest
- YY/T 1295-2015
- 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.
YY/T 1295-2015 history
- 2015 YY/T 1295-2015 Biological evaluation of medical devices.Nanomaterial: Endotoxin test
