Specifies general criteria to be applied in the determination of bacterial endotoxins (pyrogens) onmedicaldevices,components,orrawmaterials.Bacterialendotoxinmethodologiescoveredincludebothqualitative(limit)methodsandquantitative(end-point)methodsusingLimulusamebocyte lysate methodology. Determination of pyrogens other than bacterial endotoxins is notcovered and acceptable levels for bacterial endotoxins are not covered.
- 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
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