MDD Horizontal Standards
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
EN 14562
Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments
EN 14563
Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments
EN ISO 14937
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