NA 027

DIN Standards Committee Optics and Precision Mechanics

DIN EN ISO 22442-1 [CURRENT] references following documents:

Document number Edition Title
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 11137-1 2020-04 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 + Amd.2:2018); German version EN ISO 11137-1:2015 + A2:2019 More 
DIN EN ISO 11137-3 2017-11 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017); German version EN ISO 11137-3:2017 More 
DIN EN ISO 11737-2 2020-07 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019); German version EN ISO 11737-2:2020 More 
DIN EN ISO 13408-2 2018-06 Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018); German version EN ISO 13408-2:2018 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 
DIN EN ISO 14937 2010-03 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); German version EN ISO 14937:2009 More