考拉熊 发表于 2013-7-17 09:10

学习学习 之前没有接触过 受教了

dyxbaggio 发表于 2013-7-22 15:41

学习支持一下

kennykkou 发表于 2013-7-23 08:22

FDA 510K 申請中LED照護燈須符合以下清潔消毒嗎?
- AAMI TIR12: Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
- AAMI TIR30: A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
- ASTM E1837-96: Standard test method to determine efficacy of disinfection processes for reusable medical devices (simulated use test)
- ASTM E-2314-03: Standard test method for determining the effectiveness of cleaning processes for reusable medical instruments using a microbiological method (simulated-use test)

jjlamshushushu 发表于 2013-7-23 08:35

灌水帖好多哦

wildorange 发表于 2013-9-2 10:00

呵呵，其实大部分工作只是凭经验做，没有文件化，没有评审，没有验证，没有记录。
所以就啥都没有:lol

fyh0812 发表于 2013-9-4 16:31

好贴 不错不错
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