ISO 13485 - Medical Devices Quality Management Systems
Main Technical Areas (as per IAF MD 8)
Description (Main Technical Areas)
Technical Areas
A1.1
Non-Active Medical Devices
General non-active, non-implantable medical devices Non-active implants
Devices for wound care Non-active dental devices and accessories Non-active medical devices other than specified above
A1.2
Active Medical Devices (Non-Implantable)
General active medical devices Devices for imaging Monitoring devices
Devices for radiation therapy and thermo therapy Active (non-implantable) medical devices other than specified above
A1.3
Active Implantable Medical Devices
General active implantable medical devices Implantable medical devices other than specified above
A1.4
In Vitro Diagnostic Medical Devices (IVD)
Reagents and reagent products, calibrators and control materials for:
Clinical Chemistry
Immunochemistry (Immunology)
Haematology / Haemostasis / Immunohematology
Microbiology
Infectious Immunology
Histology/Cytology
Genetic Testing
In Vitro Diagnostic Instruments and software IVD medical devices other than specified above
A1.5
Sterilization Method for Medical Devices
Ethylene oxide gas sterilization (EOG) Moist heat Aseptic processing
Radiation sterilization (e.g. gamma, x-ray, electron beam) Sterilization method other than specified above
A1.6
Devices Incorporating / Utilizing Specific Substances/ Technologies
Medical devices incorporating medicinal substances Medical devices utilizing tissues of animal origin Medical devices incorporating derivates of human blood Medical devices utilizing micromechanics
Medical devices utilizing nanomaterials Medical devices utilizing biological active coatings and/or materials or being wholly or mainly absorbed Medical devices incorporating or utilizing specific substances/ technologies/ elements, other than specified above
