Akkreditert sertifisering etter ovennevnte standard er begrenset til følgende bransjer:
Kode
Betegnelse av bransjene som akkrediteringen omfatter
1_1_1 Non-Activ
General non-active, nonimplantable medical devices
1_1_2 Non-Activ
Non-active implants
1_1_3 Non-Activ
Devices for wound care
1_1_4 Non-Activ
Non-active dental devices and accessories
1_1_5 Non-Activ
Non-active medical devices other than specified above
1_2_1 Active Me
General active medical devices
1_2_2 Active Me
Devices for imaging
1_2_3 Active Me
Monitoring devices
1_2_4 Active Me
Devices for radiation therapy and thermo therapy
1_2_5 Active Me
Active (non-implantable) medical devices other than specified above
1_4_1 In Vitro
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
In Vitro Diagnostic Instruments and software
1_4_3 In Vitro
IVD medical devices other than specified above
1_5_1 Steriliza
Ethylene oxide gas sterilization (EOG)
1_5_2 Steriliza
Moist heat
1_5_3 Steriliza
Aseptic processing
1_5_4 Steriliza
Radiation sterilization (e.g.gamma, x-ray, electron beam)
1_5_5 Steriliza
Low temperature steam and formaldehyde sterilization
1_5_6 Steriliza
Thermic sterilization with dry heat
1_5_7 Steriliza
Sterilization with hydrogen peroxide.
1_5_8 Steriliza
Sterilization method other than specified above
1_6_1 Dev Incor
Medical devices incorporating medicinal substances
1_6_2 Dev Incor
Medical devices utilizing tissues of animal origin
1_6_3 Dev Incor
Medical devices incorporating derivates of human blood
1_6_4 Dev Incor
Medical devices utilizing micromechanics
1_6_5 Dev Incor
Medical devices utilizing nanomaterials
1_6_6 Dev Incor
Medical devices utilizing biological active coatings and/or materials or being wholly or mainly absorbed
1_6_7 Dev Incor
Medical devices incorporating or utilizing specific substances/technologies/elements, other than specified above.
1_7_1 Parts or
Raw materials
1_7_2 Parts or
Components
1_7_3 Parts or
Subassemblies
1_7_4 Parts or
Calibration services
1_7_5 Parts or
Distribution services
1_7_6 Parts or
Maintenance services
1_7_7 Parts or
Transportation services
1_7_8 Parts or
Other services