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FDA 510K 申請中LED照護燈須符合以下清潔消毒嗎?
4 c. P+ a7 S L2 p" L5 I8 W5 a) K- AAMI TIR12: Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers" h1 k0 N3 }) b0 H6 }3 P W
- AAMI TIR30: A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices& ?' U" N$ h% k+ e
- ASTM E1837-96: Standard test method to determine efficacy of disinfection processes for reusable medical devices (simulated use test)
! U( q' c' q1 p$ q! E' H- 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)0 t+ J$ |& T* J& ~8 Z6 q( |6 S' o
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发表于 2013-7-17 09:10
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