Code
Description of the scopes which are included in the accreditation
1_1_1 Non-Active Medical Devices
General non-active, nonimplantable medical devices
1_1_2 Non-Active Medical Devices
Non-active implants
1_1_3 Non-Active Medical Devices
Devices for wound care
1_1_4 Non-Active Medical Devices
Non-active dental devices and accessories
1_1_5 Non-Active Medical Devices
Non-active medical devices other than specified above
1_2_1 Active Medical Devices (Non-Implantable)
General active medical devices
1_2_2 Active Medical Devices (Non-Implantable)
Devices for imaging
1_2_3 Active Medical Devices (Non-Implantable)
Monitoring devices
1_2_4 Active Medical Devices (Non-Implantable)
Devices for radiation therapy and thermo therapy
1_2_5 Active Medical Devices (Non-Implantable)
Active (non-implantable) medical devices other than specified above
1_4_1 In Vitro Diagnostic Medical Devices (IVD)
Reagents and reagent products,
calibrators and control materials
for:
Clinical Chemistry
Immunochemistry
(Immunology)
Haematology/Haemostasis/Im
munohematology
Microbiology
Infectious Immunology
Histology/Cytology
Genetic Testing
1_4_2 In Vitro Diagnostic Medical Devices (IVD)
In Vitro Diagnostic Instruments and software
1_4_3 In Vitro Diagnostic Medical Devices (IVD)
IVD medical devices other than specified above
1_5_1 Sterilization Method for Medical Devices
Ethylene oxide gas sterilization (EOG)
1_5_2 Sterilization Method for Medical Devices
Moist heat
1_5_3 Sterilization Method for Medical Devices
Aseptic processing
1_5_4 Sterilization Method for Medical Devices
Radiation sterilization (e.g. gamma, x-ray, electron beam)
1_5_5 Sterilization Method for Medical Devices
Low temperature steam and formaldehyde sterilization
1_5_6 Sterilization Method for Medical Devices
Thermic sterilization with dry heat
1_5_7 Sterilization Method for Medical Devices
Sterilization with hydrogen peroxide.
1_5_8 Sterilization Method for Medical Devices
Sterilization method other than specified above
1_6_1 Dev Incorporating Specific Substances
Medical devices incorporating medicinal substances
1_6_2 Dev Incorporating Specific Substances
Medical devices utilizing tissues of animal origin
1_6_3 Dev Incorporating Specific Substances
Medical devices incorporating derivates of human blood
1_6_4 Dev Incorporating Specific Substances
Medical devices utilizing micromechanics
1_6_5 Dev Incorporating Specific Substances
Medical devices utilizing nanomaterials
1_6_6 Dev Incorporating Specific Substances
Medical devices utilizing biological active coatings and/or materials or being wholly or mainly absorbed
1_6_7 Dev Incorporating Specific Substances
Medical devices incorporating or utilizing specific substances/technologies/elements, other than specified above.
1_7_1 Parts or Services
Raw materials
1_7_2 Parts or Services
Components
1_7_3 Parts or Services
Subassemblies
1_7_4 Parts or Services
Calibration services
1_7_5 Parts or Services
Distribution services
1_7_6 Parts or Services
Maintenance services
1_7_7 Parts or Services
Transportation services
1_7_8 Parts or Services
Other services