Table des Matières
Publicité
Mode d'emploi
Appareil chirurgical laser Limax
3
Consignes de sécurité
3.1
Prescriptions d'ordre général
Les normes, lois, directives et règlements suivants ont été pris en compte au moment de la
conception et de la fabrication du présent appareil :
Norme
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
INDICATION
Respecter les directives nationales en matière de sécurité !
Les normes MPG et BGV s'appliquent en Allemagne. Les autres lois, directives et ordonnances
nationales s'appliquent également!
V. 2.0
®
60
Titre
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
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