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 con-
formément aux normes complémentaires
suivantes : CAN/CSA-C22.2 No. 601.1-M90
(R2005) (comprend les différences nation-
ales 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
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
Ameliyat lambası
Kalite standartlarına uygunluk
MAQUET SA kalite sistemi sertifikası
LNE/G-MED, ameliyat lambaları tasarım,
üretim, satış, tesisat ve satış sonrası servis
için MAQUET SA tarafından geliştirilen kalite
sisteminin uluslararası standartların gerekle-
rine uygun olduğunu teyid eder :
- ISO 9001 versiyon 2000
- NF EN ISO 13485 versiyon 2004
PRISMALIX ameliyat lambası aşağıdaki stan-
dartlara uygun olarak tasarlanmıştır :
• 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
Bu ürün aşağıdaki tamamlayıcı standartla-
ra uygun olarak kontrollere tabi tutulmuştur
: CAN/CSA-C22.2 No. 601.1-M90 (R2005)
(Kanada için ulusal farklılıklar içerir), EN
60601-1:1990 + A1:1993 + A2:1995 +
A13:1996, UL 60601-1, 1inci baskı, 2006-
04-26 (ABD için ulusal farklılıklar içerir).
CE İşareti
Tıbbî tertibatlarla ilgili 14 Haziran 1993 tarihli
93/42/CEE direktifinin gereklerine uygunluk di-
rektifin Ek VII' sine göre değerlendirilmiştir.
PRISMALIX ameliyat lambaları ürün yelpa-
zesi 93/42/CEE direktifinin Ek IX' una göre
Sınıf I' e aittir.
Ürünlerimizin tüm özelliklerini
garanti etmek için, çevre veya
kullanım değişikliği durumun-
da MAQUET SA' ya durumu
bildirmek gerekmektedir.
Notice d'utilisation / User manual / Kullanma talimatı
Surgical light
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