Specifies general criteria to be applied in the determination of bacterial endotoxins (pyrogens) onmedical devices, components, or raw materials. Bacterial endotoxin methodologies coveredinclude both qualitative (limit) methods and quantitative (end-point) methods using Limulusamebocyte lysate methodology. Determination of pyrogens other than bacterial endotoxins is notcovered and acceptable levels for bacterial endotoxins are not covered.
Product Details
- Published:
- 09/01/2002
- ANSI:
- ANSI Approved
- Number of Pages:
- 34
- File Size:
- 1 file , 230 KB
- Part of:
- AAMI STBK10-3
- Note:
- This product is unavailable in Russia, Ukraine, Belarus
