NA 176

DIN Standards Committee Health Technologies

DIN EN 556-2 [CURRENT] references following documents:

Document number Edition Title
EN ISO 11135 2014-07 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014) More 
EN ISO 11137-1 2015-06 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) More 
EN ISO 13408-5 2011-06 Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006) More 
EN ISO 14937 2009-10 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009) More 
EN ISO 20857 2013-04 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010) More 
EN ISO 11137-2 2015-06 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013) More 
EN ISO 13408-3 2011-06 Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006) More 
EN ISO 13408-4 2011-06 Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005) More 
ISO 13408-7 2012-08 Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products More