|
|
FDA 510K 申請中LED照護燈須符合以下清潔消毒嗎?
1 t4 o0 p7 {5 }: \. F- AAMI TIR12: Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
& z& S; ~$ S' \/ F$ A) V3 b! {- AAMI TIR30: A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
, |8 y) [9 _* _8 j; n9 n6 n- ASTM E1837-96: Standard test method to determine efficacy of disinfection processes for reusable medical devices (simulated use test)
. t& u' k7 N+ X& R) n+ b- 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)
& b7 [$ U$ J& S" ~ |
|
|关于安规|小黑屋|安规QQ群|Archiver|手机版|安规网
( 粤ICP13023453-10 ) 
窥视卡
雷达卡
发表于 2013-7-17 09:10
显身卡