AAMI TIR 74:2016 is now available? Change summary for ISO 11135:2014, Sterilization of health care products - Ethylene oxide - Requirements for the development, validation, and routine control of a sterilization process for medical devices
ANSI/AAMI/ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices is now available?
ANSI/AAMI/ISO TIR 17665-3:2014 Sterilization of health care products - Moist heat - Guidance on the designation of a medical product to a product family and processing category for steam sterilization is now available?
All three parts of ANSI/AAMI/ISO 11138:2017 are available? Sterilization of health care products - Biological indicators Parts 1, 2, and 3 for General requirements, ethylene oxide, and moist heat sterilization.
For hospital users, AAMI ST 79 has been re-issued for 2017 - Comprehensive guide to steam sterilization and sterility assurance in health care facilities.
Are your validation protocols and SOPs up-to-date ?
3M 8XL Sterilization System
Medical Device Consulting - Sterilization and Microbiology