IFC GLOBAL TEKNİK KONTROL SERTİFİKASYON ANONİM ŞİRKETİ

1.1

Non-Active Medical Devices

1.1.A

General non-active, non-implantable medical devices

1.1.B

Non-active implants

1.1.C

Devices for wound care

1.1.D

Non-active dental devices and accessories

1.2

Active Medical Devices (Non-Implantable)

1.2.A

General active medical devices

1.2.B

Devices for imaging

1.2.C

Monitoring devices

1.2.D

Devices for radiation therapy and thermo therapy

1.4

In Vitro Diagnostic Medical Devices (IVD)

1.4.A

Reagents and reagent products, calibrators and control materials for: Clinical Chemistry Immunochemistry (Immunology) Haematology/Haemostasis/Immunohematology Microbiology Infectious Immunology Histology/Cytology Genetic Testing

1.4.B

In Vitro Diagnostic Instruments and software

1.5

Sterilization Method for Medical Devices

1.5.A

Ethylene oxide gas sterilization (EOG)

1.5.B

Moist heat

1.5.C

Aseptic processing

1.5.D

Radiation sterilization (e.g. gamma, x-ray, electron beam)

1.5.F

Thermic sterilization with dry heat

1.6

Devices Incorporating / Utilizing Specific Substances / Technologies

1.6.A

Medical devices incorporating medicinal substances

1.6.D

Medical devices utilizing micromechanics

1.6.E

Medical devices utilizing nanomaterials

1.6.F

Medical devices utilizing biological active coatings and/or materials or being wholly or mainly absorbed

1.6.G

Medical devices incorporating or utilizing specific substances/technologies/elements, other than specified above.

1.7

Parts or Services

1.7.A

Raw materials

1.7.B

Components

1.7.C

Subassemblies

1.7.D

Calibration services

1.7.E

Distribution services

1.7.F

Maintenance services

1.7.G

Transportation services

1.7.H

Other services

Corporate Head Office

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