NA 176

DIN Standards Committee Health Technologies

DIN ISO 11040-7 [CURRENT] references following documents:

Document number Edition Title
DIN EN ISO 11140-3 2009-09 Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007); German version EN ISO 11140-3:2009 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 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 
DIN EN ISO 15378 2018-04 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017); German version EN ISO 15378:2017 More 
ISO 11138-1 2017-03 Sterilization of health care products - Biological indicators - Part 1: General requirements More 
ISO 11138-2 2017-03 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes More 
ISO 11138-3 2017-03 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes More 
ISO 11138-4 2017-03 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes More 
ISO 11138-5 2017-03 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes More 
ISO 11138-7 2019-03 Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results More