Norsk akkreditering

Akkrediteringsomfang for

PROD 021

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 17065




Akkrediteringen omfatter:
Den administrative/geografiske enheten:
DNV PRODUCT ASSURANCE AS
Veritasveien 3
1363 Høvik




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