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 concep-
tion, la réalisation, la vente, l'installation et le
service après-vente d'éclairages opératoires
est conforme aux exigences des normes inter-
nationales :
- ISO 9001 version 2000
- NF EN ISO 13485 version 2004
L'éclairage opératoire PRISMALIX a été conçu
pour répondre aux normes suivantes:
• 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 confor-
mément aux normes complémentaires suivan-
tes : CAN/CSA-C22.2 No. 601.1-M90 (R2005)
(comprend les différences nationales pour
le Canada), EN 60601-1:1990 + A1:1993 +
A2:1995 + A13:1996, UL 60601-1, 1ère édition,
2006-04-26 (comprend les différences nationa-
les pour les Etats-Unis).
Marquage CE
La conformité aux exigences de la Directive
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 produits, il est nécessaire
de prévenir MAQUET SA en cas de
changement d'environ-nement ou
d'utilisation.
4
Quality compliance
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
following additional standards: 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
of our products, it is necessary to
contact MAQUET SA in case of use
or environment change.
0113103
Éclairage opératoire
Lampada chirurgica
Conformità alle normative
Certificazione del sistema di qualità di MA-
QUET SA
LNE/G-MED certifica che il sistema di qualità
messo a punto da MAQUET SA per le attività
di progettazione, produzione, vendita, instal-
lazione e assistenza post-vendita di lampade
operatorie è conforme ai requisiti delle norma-
tive internazionali:
-
ISO 9001 versione 2000
-
NF EN ISO 13485 versione 2004
La lampada operatoria PRISMALIX è stata pro-
gettata in conformità alle normative seguenti :
• 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
Questo prodotto è stato realizzato in con-
formità ai seguenti standard addiziona-
li: CAN/CSA-C22.2 No. 601.1-M90 (R2005)
(include le National Differences for Canada),
EN 60601-1:1990 + A1:1993 + A2:1995 +
A13:1996, UL 60601-1, 1st Edition, 2006-04-26
(include le National Differences for USA).
Etichettatura CE
La conformità alle esigenze della Diretti-
va 93/42/CEE del 14 giugno 1993 relativa ai
dispositivi medicali è stata valutata secondo
l'Annesso VII della Direttiva. La gamma di illu-
minazione operatoria PRISMALIX appartiene
alla Classe I secondo l'Annesso IX della Diret-
tiva 93/42/CEE.
Per garantire la qualità dei nostri
prodotti, si consiglia all'utente di
contattare MAQUET SA qualora
desideri modificare l'ambiente di
utilizzo o la destinazione d'uso del
prodotto.
Notice d'utilisation / User manual / Manuale d'utilizzo
Surgical light
Publicité
