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3
Safety Notices & Instructions
3.1
General Regulations
The following standards, laws, directives and regulations were observed in the design and
manufacture of this product:
Standard
MPG (MDA)
93/42/EEC (MDD)
IEC 60825-1:1993 + A1:1997 + A2:2001
DIN EN 60825-1:1994 + A1:2002 + A2:2001
EN 60601-1:1990 + A1:1993 + A2:1995
IEC 601-1:1988 + A1:1991 + A2:1995
EN 60601-1-1:2001
IEC 60601-1-1:2000
EN 60601-2-2:2007
IEC 60601-2-2:2006
EN 60601-2-22:1996
IEC 601-2-22:1995
IEC 60601-1-4:1996 + A1:1999
EN 60601-1-6:2010
IEC 60601-1-6:2010
EN 62304:2006
IEC 62304:2006
EN 62353:2008
IEC 62353:2007
EN ISO 15223-1:2012
ISO 15223-1:2012
BGI 832
NOTICE
Observe national safety regulations!
MPG (Medical Devices Act) and BGV (accident prevention rules) specifically refer to
regulations in force in Germany. Be sure to observe your relevant national / local regulations
(laws, directives, rules, etc.) as well!
14
Title
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))
Instructions for Use
Surgical Laser Unit Limax
®
60
V. 1.0
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