AIMDD Horizontal Standards


EN 1041

Information supplied by the manufacturer of medical devices

Read More


EN ISO 13408-1

Aseptic processing of health care products - Part 1: General requirements

Read More


EN ISO 13408-2

Aseptic processing of health care products - Part 2: Filtration

Read More


EN ISO 13408-3

Aseptic processing of health care products - Part 3: Lyophilization

Read More


EN ISO 13408-6

Aseptic processing of health care products - Part 6: Isolator systems

Read More


EN ISO 13485

Medical devices - Quality management systems - Requirements for regulatory purposes

Read More


EN ISO 14971

Medical devices - Application of risk management to medical devices

Read More


EN 556-1

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices

Read More


EN 556-2

terilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices

Read More


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

Read More