MDD Sterility
EN ISO 11140-3
Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
EN ISO 11607-1
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
EN ISO 11607-2
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
EN ISO 11737-1
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
EN ISO 11737-2
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
EN 13624
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants
EN 13727
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity
EN 14180
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
EN 14348
hemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants
EN 14561
Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of bactericidal activity for instruments