
Process Development And Performance Qualification For Ethylene Oxide Sterilization - Microbiological Aspects
出版:Association for Advancement of Medical Instrumentation

专家解读视频
Gives additional guidance to augment ANSI/AAMI/ISO 11135:1994, Medical devices - Validation and routine control of ethylene oxide sterilization (AAMI 1994) for medical device manufacturers, including those that use contract sterilization facilities or contract sterilization operations.
Formerly it was AAMI ST27 (It is an updated material from ANSI/AAMI ST27:1988 (05/2001)
ISO 11135:1994 - Identical