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FDA 510K 申請中LED照護燈須符合以下清潔消毒嗎?8 ]; h% V3 T$ ~" a1 k* W+ ^! v
- AAMI TIR12: Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers3 F6 Z$ Y% K$ L0 K$ ?
- AAMI TIR30: A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices: C! Q W) H& F; O8 d
- ASTM E1837-96: Standard test method to determine efficacy of disinfection processes for reusable medical devices (simulated use test)
2 c; f% N+ e2 d" {" X( n- 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)
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发表于 2013-7-17 09:10
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