AAMI ST108-2023 Water for the processing of medical devices 医疗器械加工用水.pdf

- a aN m h i γ ． 比 α n n0 缸 n u 征 阳 , ， 川 d ， d ANSI/AAMI ST108:2023 Water for the processing of medica l devices AAM~ AdvancmQ Safetv in Health TechnoloQY American National Standard A NSl/AAMI ST108:2023 Water for the processing of medical devices Approved 30 June 2023 by AAM I Approved 4 Au gust 2023 by Ameri臼n Nati。nal Standards lnstitu恤， Inc. Abs tract: This standard cove陌the sel ecti。n and maintenan四。f effedive water quality suitable fo r processing medical devices. It provides guidelines fo r selecting the water quality necessary for the processing of categories of medical devi饵s and addresses water treatment equipment, water distribution and storage, quality c。ntrol procedures fo r mon阳ring water quality, strategies fo r bacterial c。ntr。· I , and environmental and pers。nnel considerations Keywords：臼rbon 白l ters, dei。nization, disinfecti。n, distillation, medical devices, pasteurization, processing, reverse 。sm。sis, rinsing, sediment filters, steam pu时ty, sterilization . ultrafiltration, water filtrati。n, water quality , washing, water softening, water quali 句， water treatment AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those substanti ally concerned with its scope and provisions. The existence of an AAM I standard does not in any respect preclude anyone, whether they h