NA 063

DIN Standards Committee Medicine

DIN EN ISO 11139 [CURRENT] references following documents:

Document number Edition Title
DIN CEN ISO/TS 13004; DIN SPEC 13223:2014-10 2014-10 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDₘₐₓSD (ISO/TS 13004:2013); German version CEN ISO/TS 13004:2014 More 
DIN CEN ISO/TS 16775; DIN SPEC 58997:2014-10 2014-10 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2014); German version CEN ISO/TS 16775:2014 More 
DIN EN ISO 11137-2 2015-11 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013); German version EN ISO 11137-2:2015 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 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 11138-5 2017-07 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017); German version EN ISO 11138-5:2017 More 
DIN EN ISO 11140-1 2015-03 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014); German version EN ISO 11140-1:2014 More 
DIN EN ISO 11140-4 2007-07 Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration (ISO 11140-4:2007); German version EN ISO 11140-4:2007 More 
DIN EN ISO 13408-1 2015-12 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013); German version EN ISO 13408-1:2015 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