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QUALITY STANDARDS COMPLIANCE
Certification of MAQUET SA quality system
LNE/G-MED certifies that the quality system developed by
MAQUET SA for design, implementation, sales, installation and
after-sales service of surgical lights complies with the require-
ments of the following international standards:
• ISO 9001:2000
• NF EN ISO 13485:2004
Reference standards
The G8 Evolution surgical light was designed to comply with
the following 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
CE Marking/Intended use
Compliance with the requirements of Directive 93/42/EEC re-
lating to medical devices has been assessed and approved by
LNE/G-MED. The G8 Evolution surgical light is a class I device
in accordance with Annex IX of Directive 93/42/EEC.
The range includes single, double or triple ceiling-mounted
configurations, with or without a pre-installed video system
(HANAUVISION). Possible options include a double fork, flat
screen support and separate camera support.
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CONFORMIDAD CON LAS NORMAS DE CALIDAD
Certificación del sistema de calidad de MAQUET SA
El LNE/G-MED certifica que el sistema de calidad desarrollado
por MAQUET SA para el diseño, la realización, la venta, la
instalación y el servicio postventa de lámparas de quirófano
cumple los requisitos de las normas internacionales:
• ISO 9001 versión 2000
• NF EN ISO 13485 versión 2004
Normas de referencia
La lámpara de quirófano BLUE 30/80 se ha diseñado para res-
ponder a las normas siguientes:
• EN ISO 14971:2000
• EN ISO 14971:2000/A1:2003
• EN 60601-1:1990
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
• EN 60601-1-4:1996
Amendment A1:1999 to EN 60601-1-4:1996
• EN 60601-1-6:2004
• EN 60601-2-41:2000
Marca CE/utilización prevista
La conformidad con las exigencias de la Directiva 93/42/CEE
del 14 juno 1993 relativa a los dispositivos médicos ha sido
evaluada según el anexo VII de la Directiva. Esta gama de
lámparas operatorias pertenece a la clase I con arreglo al
anexo IX de la Directiva 93/42/CEE.
La gama está compuesta de configuraciones de techo sim-
ples, dobles, o triples, pre-equipadas o no con vídeo (HANAU-
VISION). Opciones posibles: horquilla doble, soporte pantalla
plana, soporte cámara separado.
0138101
Surgical light
Lámpara de quirófano
Medical devices - Application of risk
management to medical devices
(ISO 14971:2000)
Medical electrical equipment - Part
1: General requirements for safety
Medical electrical equipment
- Part 1-2: General requirements
for safety - Collateral standard:
Electromagnetic compatibility -
Requirements and tests
Medical electrical equipment - Part
1-4: General requirements for safety
- Collateral standard: Programmable
electrical medical systems
Medical electrical equipment - Part
1-6: General requirements for safety
- Collateral standard: Usability
Medical electrical equipment - Part
2-41: Particular requirements for
the safety of surgical luminaires and
luminaires for diagnosis
User's manual / Manual de utilización
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