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20. EC-Declaration Of Conformity
EC DECLARATION OF CONFIRMITY
Hereby, we
Gharieni Group GmbH
Gutenbergstr. 40
D-47443 Moers
declare that the design and construction of the appliance listed below complies with the relevant
essential health and safety requirements of the EU,
(Type or model, name)
SPL med 4 / SPL med 5
2019
Relevant EU directives and harmonized standards used:
2006/42/EC
Safety of Machinery
2014/30/EU
Electromagnetic compatibility
2011/65/EU
RoHS Directive
93/42/EEC
MDD (Medical Device Directive)
ISO 12100:2010
Fundamentals of machine safety
EN 60204-1:2006
Safety of machinery
— electrical equipment of machinery
EN 1005-3:2002+A1:2008
Recommended limits of force for machine operation
EN 349:1993+A1:2008
Avoidance of bruising
EN 614-1:2006+A1:2009
Fundamentals of ergonomics
EN ISO 13849-1:2015
Safety-related parts of controllers
EN ISO 14118:2018
Avoidance of unexpected start-up
EN ISO 14120:2015
Separating protection devices
EN 50581:2012
RoHS Directive
DIN EN 60601-1
Medical electrical appliances; Part 1: general requirements for
safety including essential performance features
DIN EN 55014-1:2012-05
Electromagnetic compatibility - requirements for household
appliances, power tools and similar electrical equipment
–
part 1: emitted interference
DIN EN 55014-2:2016-01
Electromagnetic compatibility - requirements for household
appliances, power tools and similar electrical equipment
–
part 2: interference immunity
EN 61000-3-2:2014
Electromagnetic compatibility - part 3-2: limit values
– for harmonic
currents
EN 61000-3-3:2014-03
Electromagnetic compatibility - part 3- 3: limit values
–
limitation of voltage changes
Yavuz Gündogar
Gutenbergstr. 40
D-47443 Moers
Responsible for documentation
CEO: Sammy Gharieni,
Manufacturer`s signature
Moers, 04/16/.2019
Place and date
