NA 176

DIN Standards Committee Health Technologies

DIN ISO 11040-4 [CURRENT] references following documents:

Document number Edition Title
ISO 11137-1 AMD 1 2013-07 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices; Amendment 1 More 
ISO 11137-2 2013-06 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose More 
ISO 11140-1 2014-11 Sterilization of health care products - Chemical indicators - Part 1: General requirements More 
ISO 11140-3 2007-03 Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test More 
ISO 11140-3 Technical Corrigendum 1 2007-11 Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test; Technical Corrigendum 1 More 
ISO 11140-4 2007-03 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 More 
ISO 11140-5 2007-03 Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests More 
ISO 14937 2009-10 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 More 
ISO 2039-2 1987-07 Plastics; Determination of hardness; Part 2 : Rockwell hardness More 
ISO 2859-1 1999-11 Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection More