Publicité
Conformité aux normes
de qualité
Certification du système qualité de
MAQUET SA
Le LNE/G-MED certifie que le système
qualité développé par MAQUET SA pour la
conception, la réalisation, la vente, l'instal-
lation et le service après-vente d'éclairages
opératoires est conforme aux exigences des
normes internationales :
- ISO 9001 version 2000
- NF EN ISO 13485 version 2004
L'éclairage opératoire PRISMALIX a été
conçu pour répondre aux normes suivan-
tes:
• EN ISo 14971:2000
Medical devices - Application of risk
management to medical devices
(ISO 14971:2000)
• EN ISO 14971:2000/A1:2003
• EN 60601-1:1990
Medical electrical equipment -
Part 1: General requirements for safety
Amendment A1:1993 to EN 60601-1:1990
Amendment A2:1995 to EN 60601-1:1990
Amendment A13:1996 to EN 60601-
1:1990
• EN 60601-1-2:2001
Medical electrical equipment -
Part 1-2: General requirements for safety
- Collateral standard: Electromagnetic
compatibility - Requirements and tests
• EN 60601-1-4:1996
Medical electrical equipment -
Part 1-4: General requirements for safety
- Collateral standard: Programmable
electrical medical systems
Amendment A1:1999 to EN 60601-1-
4:1996
• EN 60601-1-6:2004
Medical electrical equipment -
Part 1-6: General requirements for safety -
Collateral standard: Usability
• EN 60601-2-41:2000
Medical electrical equipment -
Part 2-41: Particular requirements for
the safety of surgical luminaires and
luminaires for diagnosis
Ce produit a fait l'objet de vérifications
conformément aux normes complémentaires
suivantes : CAN/CSA-C22.2 No. 601.1-M90
(R2005) (comprend les différences natio-
nales pour le Canada), EN 60601-1:1990 +
A1:1993 + A2:1995 + A13:1996, UL 60601-
1, 1ère édition, 2006-04-26 (comprend les
différences nationales pour les Etats-Unis).
Marquage CE
La conformité aux exigences de la Direc-
tive 93/42/CEE du 14 juin 1993 relative aux
dispositifs médicaux a été évaluée selon
l'Annexe VII de la Directive. La gamme
d'éclairage opératoire PRISMALIX appartient
à la Classe I selon l'Annexe IX de la Directive
93/42/CEE.
+
Afin de garantir toutes les
qualités de nos
est nécessaire de prévenir
MAQUET SA en cas de chan-
gement d'environ-nement ou
d'utilisation.
4
B
Certification of MAQUET SA quality
system
LNE/G-MED certifies that the quality system
created by Maquet SA for the design,
manufacturing, marketing, installation and
customer servicing of its surgical lights meets
the requirements of the following international
standards:
- ISO 9001:2000
- ISO 13485:2004
PRISMALIX is designed to fullfill the following
applicable standards:
• EN ISo 14971:2000
Medical devices - Application of risk
management to medical devices
(ISO 14971:2000)
• EN ISO 14971:2000/A1:2003
• EN 60601-1:1990
Medical electrical equipment -
Part 1: General requirements for safety
Amendment A1:1993 to EN 60601-1:1990
Amendment A2:1995 to EN 60601-1:1990
Amendment A13:1996 to EN 60601-
1:1990
• EN 60601-1-2:2001
Medical electrical equipment -
Part 1-2: General requirements for safety
- Collateral standard: Electromagnetic
compatibility - Requirements and tests
• EN 60601-1-4:1996
Medical electrical equipment -
Part 1-4: General requirements for safety
- Collateral standard: Programmable
electrical medical systems
Amendment A1:1999 to EN 60601-1-
4:1996
• EN 60601-1-6:2004
Medical electrical equipment -
Part 1-6: General requirements for safety -
Collateral standard: Usability
• EN 60601-2-41:2000
Medical electrical equipment -
Part 2-41: Particular requirements for
the safety of surgical luminaires and
luminaires for diagnosis
This product was investigated according
to
the
CAN/CSA-C22.2 No. 601.1-M90 (R2005)
(includes National Differences for Canada),
EN 60601-1:1990 + A1:1993 + A2:1995 +
A13:1996, UL 60601-1, 1st Edition, 2006-
04-26 (includes National Differences for
USA).
CE Marking
Compliance with the requirements of Directive
93/42/EEC dated of June 14th 1993, relating
to medical devices has been assessed in
accordance with Annex VII of this Directive.
This PRISMALIX Surgical lights range is a
class I device in accordance with Annex IX
of Directive 93/42/EEC.
+
In order to guarantee the quality
produits, il
of our products, it is necessary
to contact MAQUET SA in
case of use or environment
change.
Quality compliance
following
additional
standards:
0113103
éclairage opératoire
oerationsbelysning
Överensstämmelse med
kvalitetsnormer
Certifiering av
MAQUET SA:s kvalitetssystem.
LNE/G-MED attesterar att kvalitetssyste-
met som MAQUET SA tagit fram för utfor-
mning, tillverkning, försäljning, installation
och garantiservice av operationsbelysning
överensstämmer med kraven i följande in-
ternationella normer:
- ISO 9001 version 2000
- NF EN ISO 13485 version 2004
operationsbelysningen PRISMALIX har
utformats för att uppfylla följande normer:
• EN ISo 14971:2000
Medical devices - Application of risk
management to medical devices
(ISO 14971:2000)
• EN ISO 14971:2000/A1:2003
• EN 60601-1:1990
Medical electrical equipment -
Part 1: General requirements for safety
Amendment A1:1993 to EN 60601-1:1990
Amendment A2:1995 to EN 60601-1:1990
Amendment A13:1996 to EN 60601-
1:1990
• EN 60601-1-2:2001
Medical electrical equipment -
Part 1-2: General requirements for safety
- Collateral standard: Electromagnetic
compatibility - Requirements and tests
• EN 60601-1-4:1996
Medical electrical equipment -
Part 1-4: General requirements for safety
- Collateral standard: Programmable
electrical medical systems
Amendment A1:1999 to EN 60601-1-
4:1996
• EN 60601-1-6:2004
Medical electrical equipment -
Part 1-6: General requirements for safety -
Collateral standard: Usability
• EN 60601-2-41:2000
Medical electrical equipment -
Part 2-41: Particular requirements for
the safety of surgical luminaires and
luminaires for diagnosis
Denna produkt har varit föremål för kontrol-
ler enligt följande kompletterande normer:
CAN/CSA-C22.2 No. 601.1-M90 (R2005)
(omfattar nationella särdrag för Kanada),
EN 60601-1:1990 + A1:1993 + A2:1995 +
A13:1996, UL 2006-04-26, 1:a upplagan,
2006-04-26 (omfattar nationella särdrag för
USA).
CE-märkning
Överensstämmelse med kraven i Direktivet
93/42/CEE av 14 juni 1993 angående medi-
cintekniska utrustningar har utvärderats enligt
Direktivets Bilaga VII. Operationsbelysnings-
programmet PRISMALIX tillhör Klass I enligt
Bilaga IX av Direktivet .
+
För att garantera våra produk-
ters kvalitet är det nödvändig
att meddela MAQUET SA om
eventuella ändringar i omgi-
vningen eller användningen.
Notice d'utilisation / User manual / Bruksanvisning
Surgical light
Publicité
