内毒素干扰试验 样品批次问题( FDA工业指南)

秋e56c1128

USP Guidance for Industry: Pyrogen and Endotoxins Testinguestions and Answers  JUNE 2012
11. What are the endotoxins limits for medical devices?
医疗器械的内毒素限度是什么？有如下描述：大侠们怎么理解：样品至少3批次进行干扰试验问题
是需要3个不同的批次，还是1个批次做3次也是可以的？
When a manufacturer of medical devices plans to use LAL testing that deviates signi?cantly from this guidance or
recognized standard, a premarket noti?cation (510(k)) under section 510(k) of the Federal Food, Drug, and Cosmetic Act

(the Act) or a premarket approval application (PMA) supplement under section 515 of the Act should be submitted.
Signi?cant deviations include, but are not necessarily limited to: higher endotoxin concentration release criteria, sampling
from fewer than three (3) lots for inhibition/enhancement testing, lesser sensitivity to endotoxins, and a device rinsing
protocol resulting in greater dilution of endotoxins than that recommended in this guidance.

3075589379

lots一般就是指批次。这里说的是变动情况，3批次也更符合逻辑。

小金库

谢谢分享。