NA 176

DIN Standards Committee Health Technologies

DIN EN ISO 14160 [CURRENT] references following documents:

Document number Edition Title
ISO 11737-1 2018-01 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products More 
ISO 13408-2 2018-01 Aseptic processing of health care products - Part 2: Sterilizing filtration More 
ISO 13408-3 2006-09 Aseptic processing of health care products - Part 3: Lyophilization More 
ISO 13408-4 2005-11 Aseptic processing of health care products - Part 4: Clean-in-place technologies More 
ISO 13408-5 2006-11 Aseptic processing of health care products - Part 5: Sterilization in place More 
ISO 13408-6 2021-04 Aseptic processing of health care products - Part 6: Isolator systems More 
ISO 13408-7 2012-08 Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products More 
DIN EN ISO 11135 2020-04 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 + Amd.1:2018); German version EN ISO 11135:2014 + A1:2019 More 
DIN EN ISO 11138-1 2017-07 Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017); German version EN ISO 11138-1:2017 More 
DIN EN ISO 11138-7 2019-11 Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results (ISO 11138-7:2019); German version EN ISO 11138-7:2019 More