Laser Surgical Unit diomax
®
Revision 6
13
3
Safety Notes
3.1
General Specifications
The following standards, laws, directives and regulations were observed in the design and
manufacture of this product:
Standard
Title
MPG (MDA)
Medical Devices Act
93/42/EEC (MDD)
EU Directive 93/42/EEC concerning medical devices
IEC 60825-1:2003-10
Safety of laser products – Part 1: Equipment classification and
requirements
IEC 60601-1:1996-03
Medical electrical equipment – General requirements
IEC 60601-1-1:2002-08
Medical electrical equipment – General requirements for safety
IEC 60601-1-2: 2016-05
Medical electrical equipment – Electromagnetic disturbances –
Requirements and tests
IEC 60601-2-22:1996-12
Medical electrical equipment – Particular requirements for the
safety of diagnostic and therapeutic laser equipment
IEC 60601-1-4:2001-04
4. Collateral standard: Programmable electrical medical systems
IEC 60601-1-6:2010-10
Usability
IEC 62304:2007-03
Medical device software – Software life-cycle processes
IEC 62353:2008-08
Medical electrical equipment – Recurrent test and test after repair
of medical electrical equipment
IEC 15223-1:2012-10
Medical devices – Symbols to be used with medical device labels,
labelling and information to be supplied – Part 1: General
requirements
BGI 832
Operation of laser devices – (Application of the accident prevention
regulation concerning laser radiation (BGV B2))
NOTICE
Comply with national safety regulations!
MPG and BGV are applicable law in Germany. Compliance with all national laws, regulations
and rules is likewise required!
