AIMDD
EN ISO 13408-1
Aseptic processing of health care products - Part 1: General requirements
EN ISO 13408-2
Aseptic processing of health care products - Part 2: Filtration
EN ISO 13408-3
Aseptic processing of health care products - Part 3: Lyophilization
EN ISO 13408-6
Aseptic processing of health care products - Part 6: Isolator systems
EN ISO 13485
Medical devices - Quality management systems - Requirements for regulatory purposes
EN ISO 14971
Medical devices - Application of risk management to medical devices
EN 556-1
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
EN 556-2
terilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
EN ISO 11135-1
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices