Publicidad
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Indicaciones de seguridad
3.1
Disposiciones generales
Norma
MPG (MDA)
93/42/EEC (MDD)
IEC 60825-1:2008-05
IEC 60601-1:2007-07
IEC 60601-1-1:2002-08
IEC 60601-1-2:2007-12
IEC 60601-2-22:1996-12
IEC 60601-1-4:2001-04
IEC 60601-1-6:2010-10
IEC 62304:2007-03
IEC 62353:2008-08
IEC 15223-1:2012-10
BGI 832
¡Observe las directivas nacionales de seguridad!
La MPG y la BGV rigen en Alemania. También deben observarse las leyes, directivas y
disposiciones nacionales.
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Titulo
Medical Devices Act
EU Directive 93/42/EEC concerning medical devices
Safety of laser products – Equipment classification and requirements
Medical electrical equipment – General requirements
Safety requirements for medical electrical systems
Medical electrical equipment – Electromagnetic compatibility –
Requirements and tests
Medical electrical equipment – Particular requirements for the safety
of diagnostic and therapeutic laser equipment
4. Collateral standard: Programmable electrical medical systems
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 equipment (Application of the accident prevention
directive "Laser radiation" (BGV B2))
Instrucciones de uso
Sistema láser de CO
MCO 25 plus
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Revision 5.5
Publicidad
