Norsk akkreditering

Akkrediteringsomfang for

PROD 021

DNV GL Presafe AS

Postboks 116
1300 Sandvika

Telefon: 67 57 88 00
E-post: malin.wittgren@dnvgl.com
Hjemmeside: http://www.presafe.com
Sertifiseringsorganet tilfredsstiller kravene i
NS-EN ISO/IEC 17065




Akkrediteringen omfatter:
Den administrative/geografiske enheten:
DNV GL Nemko Presafe AS Veritasveien 3
1363 Høvik




er akkreditert for sertifisering av produkter i henhold til følgende normative dokumenter:
Produkter/Normativt dok.
Kompetanseområde/Tilhørende tekst
Sert. system ISO Guide 67
Merknader
Produkter/Normativt dok.
Direktiv 2014/34/EU, equipment and protective systems intended for use in potentially explosive atmospheres (ATEX)
Kompetanseområde/Tilhørende tekst
Module B: EU Type examination
Sert. system ISO Guide 67
Merknader
Produkter/Normativt dok.
Direktiv 2014/34/EU, equipment and protective systems intended for use in potentially explosive atmospheres (ATEX)
Kompetanseområde/Tilhørende tekst
Module C1: Conformity to type based on internal production control plus supervised product testing
Sert. system ISO Guide 67
Merknader
Produkter/Normativt dok.
Direktiv 2014/34/EU, equipment and protective systems intended for use in potentially explosive atmospheres (ATEX)
Kompetanseområde/Tilhørende tekst
Module D: Conformity to type based on quality assurance of the production process
Sert. system ISO Guide 67
Merknader
Produkter/Normativt dok.
Direktiv 2014/34/EU, equipment and protective systems intended for use in potentially explosive atmospheres (ATEX)
Kompetanseområde/Tilhørende tekst
Module E: Conformity to type based on product quality assurance
Sert. system ISO Guide 67
Merknader
Produkter/Normativt dok.
Direktiv 2014/34/EU, equipment and protective systems intended for use in potentially explosive atmospheres (ATEX)
Kompetanseområde/Tilhørende tekst
Module F: Conformity to type based on product verification
Sert. system ISO Guide 67
Merknader
Produkter/Normativt dok.
Direktiv 2014/34/EU, equipment and protective systems intended for use in potentially explosive atmospheres (ATEX)
Kompetanseområde/Tilhørende tekst
Module G: Conformity based on unit verification
Sert. system ISO Guide 67
Merknader
Produkter/Normativt dok.
Direktiv 93/42/EEC, medical devices
Kompetanseområde/Tilhørende tekst
MDS 7010 Medical devices incorporating software/utilizing software/controlled by software
Sert. system ISO Guide 67
Merknader
Harmonized standard under directive 93/42/EC, 2003/32/EC and 2007/0047/EC Class I, IIa, IIb and III
Produkter/Normativt dok.
Direktiv 93/42/EEC, medical devices
Kompetanseområde/Tilhørende tekst
MD 0100 General non-active non-implantable medical devices. Annex II / Annex V.
Sert. system ISO Guide 67
Merknader
Harmonized standard under directive 93/42/EC, 2003/32/EC and 2007/0047/EC - Class I, IIa, IIb and III
Produkter/Normativt dok.
Direktiv 93/42/EEC, medical devices
Kompetanseområde/Tilhørende tekst
MD 0102 Non-active devices for injection, infusion, transfusion and intensive care. Annex II / Annex V.
Sert. system ISO Guide 67
Merknader
Harmonized standard under directive 93/42/EC, 2003/32/EC and 2007/0047/EC - Class I, IIa, IIb and III
Produkter/Normativt dok.
Direktiv 93/42/EEC, medical devices
Kompetanseområde/Tilhørende tekst
MD 0200 Non-active implants. Annex II / Annex V.
Sert. system ISO Guide 67
Merknader
Harmonized standard under directive 93/42/EC, 2003/32/EC and 2007/0047/EC - Class I, IIa, IIb and III
Produkter/Normativt dok.
Direktiv 93/42/EEC, medical devices
Kompetanseområde/Tilhørende tekst
MD 0300 Devices for wound care. Annex II / Annex V.
Sert. system ISO Guide 67
Merknader
Harmonized standard under directive 93/42/EC, 2003/32/EC and 2007/0047/EC - Class I, IIa, IIb and III
Produkter/Normativt dok.
Direktiv 93/42/EEC, medical devices
Kompetanseområde/Tilhørende tekst
MD 0400 Non-active dental devices and accessories. Annex II / Annex V.
Sert. system ISO Guide 67
Merknader
Harmonized standard under directive 93/42/EC, 2003/32/EC and 2007/0047/EC - Class I, IIa, IIb and III
Produkter/Normativt dok.
Direktiv 93/42/EEC, medical devices
Kompetanseområde/Tilhørende tekst
MD 1100 General active medical devices. Annex II / Annex V.
Sert. system ISO Guide 67
Merknader
Harmonized standard under directive 93/42/EC, 2003/32/EC and 2007/0047/EC - Class I, IIa, IIb and III
Produkter/Normativt dok.
Direktiv 93/42/EEC, medical devices
Kompetanseområde/Tilhørende tekst
MD 1200 Devices for imaging. Annex II / Annex V.
Sert. system ISO Guide 67
Merknader
Harmonized standard under directive 93/42/EC, 2003/32/EC and 2007/0047/EC - Class I, IIa, IIb and III
Produkter/Normativt dok.
Direktiv 93/42/EEC, medical devices
Kompetanseområde/Tilhørende tekst
MD 1300 Monitoring devices. Annex II / Annex V.
Sert. system ISO Guide 67
Merknader
Harmonized standard under directive 93/42/EC, 2003/32/EC and 2007/0047/EC - Class I, IIa, IIb and III
Produkter/Normativt dok.
Direktiv 93/42/EEC, medical devices
Kompetanseområde/Tilhørende tekst
MD 1400 Devices for radiation therapy and thermo therapy. Annex II / Annex V.
Sert. system ISO Guide 67
Merknader
Harmonized standard under directive 93/42/EC, 2003/32/EC and 2007/0047/EC - Class I, IIa, IIb and III
Produkter/Normativt dok.
Direktiv 93/42/EEC, medical devices
Kompetanseområde/Tilhørende tekst
MDS 7002 Medical devices utilising tissues of animal origin, including regulation 722/2012
Sert. system ISO Guide 67
Merknader
Harmonized standard under directive 93/42/EC, 2003/32/EC and 2007/0047/EC - Class III
Produkter/Normativt dok.
Direktiv 93/42/EEC, medical devices
Kompetanseområde/Tilhørende tekst
MDS 7001 Medical devices incorporating medicinal substances according to 2001/83/EC
Sert. system ISO Guide 67
Merknader
Harmonized standard under directive 93/42/EC, 2003/32/EC and 2007/0047/EC - Class III
Produkter/Normativt dok.
Direktiv 93/42/EEC, medical devices
Kompetanseområde/Tilhørende tekst
MDS 7003 Medical devices incorporating derivates of human blood, according to directive 2000/70/EC, amended by directive 2001/104/EC
Sert. system ISO Guide 67
Merknader
Harmonized standard under directive 93/42/EC, 2003/32/EC and 2007/0047/EC - Class III
Produkter/Normativt dok.
Direktiv 93/42/EEC, medical devices
Kompetanseområde/Tilhørende tekst
MDS 7004 Medical devices refering the directive 2006/42/EC on machinery
Sert. system ISO Guide 67
Merknader
Harmonized standard under directive 93/42/EC, 2003/32/EC and 2007/0047/EC - Class I, IIa, IIb, II
Produkter/Normativt dok.
Direktiv 93/42/EEC, medical devices
Kompetanseområde/Tilhørende tekst
MDS 7006 Medical devices in sterile conditions
Sert. system ISO Guide 67
Merknader
Harmonized standard under directive 93/42/EC, 2003/32/EC and 2007/0047/EC - Class I, IIa, IIb, II
Produkter/Normativt dok.
Direktiv 93/42/EEC, medical devices
Kompetanseområde/Tilhørende tekst
MDS 7007 Medical devices utilizing micromechanics
Sert. system ISO Guide 67
Merknader
armonized standard under directive 93/42/EC, 2003/32/EC and 2007/0047/EC - Class I, IIa, IIb, II
Produkter/Normativt dok.
Direktiv 93/42/EEC, medical devices
Kompetanseområde/Tilhørende tekst
MDS 7008 Medical devices utilizing nano materials
Sert. system ISO Guide 67
Merknader
Harmonized standard under directive 93/42/EC, 2003/32/EC and 2007/0047/EC - Class I, IIa, IIb, II
Produkter/Normativt dok.
Direktiv 93/42/EEC, medical devices
Kompetanseområde/Tilhørende tekst
MDS 7009 Medical devices utilising biological active coatings and/or materials that are holy or mainly absorbed
Sert. system ISO Guide 67
Merknader
Harmonized standard under directive 93/42/EC, 2003/32/EC and 2007/0047/EC - Class I, IIa, IIb, II