New guidance on parametric release for ethylene oxide sterilization

EN ISO 11135 - Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices – specifies requirements, and provides guidance, for development, validation and routine control of ethylene oxide (EO) sterilization processes....

Guidance issued on process control for sterilization using ionizing radiation

A new technical specification has been issued as Part 4 to the ISO 11137 series of standards for radiation sterilization using gamma, electron beam or x-ray irradiation. This new part of the series provides guidance on process control. Follow this link for more information....

Industrial Sterilization Process Optimization and Modality Changes

Following a unique collaboration between medical industry leaders, AAMI has published a collection of articles showcasing the best practices and alternative strategies for medical device and packaging sterilization. Shared as an 88-page free resource through AAMI’s Biomedical Instrumentation & Technology, the publication offers 11 articles...