Scopes of accreditation ISO 13485 - Medical Devices Quality Management Systems
Main Technical Areas as per IAF MD 8
Main Technical Areas (as per IAF MD 8)
Description
Technical Areas
A 1.1
Non-Active Medical Devices
General non-active, nonimplantable medical devices
Non-active implants Devices for wound care Non-active dental devices and accessories
Non-active medical devices other than specified above
A 1.2
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
A 1.4
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
A 1.5
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
A 1.6
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
