Norsk akkreditering

Akkrediteringsomfang for

MSYS 018

DNV PRODUCT ASSURANCE AS

Postboks 116
1300 Sandvika

Telefon: +47 67 57 99 00
E-post: infodnvpa@dnv.com
Hjemmeside: http://www.dnv.com
Sertifiseringsorganet tilfredsstiller kravene i

NS-EN ISO/IEC 17021-1:2015



Akkrediteringen omfatter:
Den administrative/geografiske enheten:
DNV PRODUCT ASSURANCE AS
Veritasveien 1
1363 Høvik



er akkreditert for sertifisering av styringssystemer i henhold til følgende standarder:
Standard
Betegnelse
Merknad
Standard
NS-EN ISO 13485:2016
Betegnelse
Medisinsk utstyr - Systemer for kvalitetsstyring - Krav for å oppfylle regelverk
Merknad
Akkreditert sertifisering etter ovennevnte standard er begrenset til følgende bransjer:
Kode
Betegnelse av bransjene som akkrediteringen omfatter
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