NA 176

DIN Standards Committee Health Technologies

DIN EN ISO 13408-2 [CURRENT] references following documents:

Document number Edition Title
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 More 
ISO 11137-1 2006-04 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices More 
ISO 11139 2018-08 Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards More 
ISO 13408-5 2006-11 Aseptic processing of health care products - Part 5: Sterilization in place More 
ISO 13485 2016-03 Medical devices - Quality management systems - Requirements for regulatory purposes More 
DIN EN ISO 13408-3 2011-09 Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006); German version EN ISO 13408-3:2011 More 
DIN EN ISO 13408-4 2011-09 Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005); German version EN ISO 13408-4:2011 More 
DIN EN ISO 13408-5 2011-09 Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006); German version EN ISO 13408-5:2011 More 
DIN EN ISO 13408-7 2015-11 Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012); German version EN ISO 13408-7:2015 More 
ISO 11737-1 2018-01 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products More