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FDA 510K 申請中LED照護燈須符合以下清潔消毒嗎?* k2 ^* B% D6 d$ S
- AAMI TIR12: Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers" z8 C+ J0 G K9 h9 }
- AAMI TIR30: A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices0 e2 V: w. n- X5 G c
- ASTM E1837-96: Standard test method to determine efficacy of disinfection processes for reusable medical devices (simulated use test)' `. m# j# [3 A! |# ]8 r) | `
- 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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