Publicidad
Instrucciones de uso
Equipo de cirugía láser Limax
3
Indicaciones de seguridad
3.1
Prescripciones generales
Se han observado las siguientes normas, leyes, directivas y reglamentos en [el diseño y] la
fabricación de este producto:
Norma
MPG (MDA)
93/42/EEC (MDD)
IEC 60825-1:1993 + A1:1997 + A2:2001
DIN EN 60825-1:1994 + A1:2002 + A2:2001
IEC 60601-1:2005 + corr.1 (2006) +
corr.2 (2007)
IEC 60601 1:1988 + A1:1991 + A2:1995
UL 60601-1:1988 + A1:1991 + A2:1995
ANSI AAMI ES 60601-1:2005
CAN/CSA-C22.2 No. 601.1-M90 (Update No. 2,
11/2003)
DIN EN 60601-1:2007-07
IEC 60601-1-1:2002-08
IEC 60601-1-2:2007
IEC 60601-2-22:1995
IEC 60601-1-4:1996 + A1:1999
IEC 60601-1-6:2010
IEC 62304:2006
IEC 62353:2007
ISO 15223-1:2012-10
BGI 832
INDICACIÓN
¡Observe las directivas de seguridad nacionales!
La ley de productos sanitarios alemana (MPG) y el reglamento de la mutua de accidentes
profesionales alemana (BGV) son aplicables en la República Federal de Alemania. iTambién
deberán observarse las leyes, las directivas y los reglamentos nacionales respectivos!
V. 2.0
®
60
Título
Medical Devices Act
EU Directive 93/42/EEC concerning medical devices
Safety of laser products – Part 1: Equipment
classification and requirements
Medical electrical equipment – Part 1: General
requirements for basic safety and essential performance
Medical electrical equipment – Part 1-1: General
requirements for safety
Medical electrical equipment – Part 1-2: General
requirements for basic safety and essential
performance – Collateral standard: Electromagnetic
compatibility – Requirements and tests
Medical electrical equipment – Part 2-22: Particular
requirements for the safety of diagnostic and
therapeutic laser equipment
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 basic safety and essential
performance – Collateral standard: Usability
Medical device software – Software life-cycle processes
Medical electrical equipment – Recurrent test and test
after repair of medical electrical equipment
Medical devices – Symbols to be used with medical
device labels, labelling and information to be supplied –
Part 1: General requirements
Operation of laser devices – (Application of the accident
prevention regulation concerning laser radiation
(BGV B2))
15
Publicidad
