ANSI/AAMI/ISO 11135:2014/A1:2018 | 1 Jan 2018 | BSI Knowledge
Standard
ANSI/AAMI/ISO 11135:2014/A1:2018
Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices. Amendment 1: Revision of Annex E, Single batch release