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MO-7.5.2-10
rev. 4 del 11/03/2011
TLR s.r.l. u.
Touch Life Rehab
www.lasertlr.com
Registered Offices:
via Amighetti n.2/a
24125 Bergamo Italy
VAT (I) 03245230165
tel. 035 4523869 - fax 035 2922884
Declaration of Conformity
For the AG6-model medical device (vers. Doc-Laser)
Touch Life Rehab s.r.l.u, with registered offices at Via Alessio Amighetti 2/A – 24125 –
Bergamo, Italy hereby declares that the DOCLASERversion of the AG6-model medical
device was manufactured in accordance with the following standards:
IEC-EN-60601-1 Medical Electrical Equipment - Part 1: General requirements for safety (ed. III) (2007)
IEC-EN-60601-1-2 Medical Electrical Equipment - Part 1: General requirements for safety 2. Collateral standard.
Electromagnetic compatibility. Requirements and tests
IEC-EN-60601-1-4 Medical Electrical Equipment - Part 1-4: General requirements for safety 4. Collateral standard.
Programmable electrical medical systems (ed. I) (1997)
IEC-EN-60601-2-22 Medical Electrical Equipment - Part 2: Particular requirements for the safety of diagnostic and
therapeutic laser equipment (ed. II) (1997)
IEC-EN-60825-1 Safety of laser equipment: Part 1: Equipment classification, requirements and user’s guide (ed. IV)
(2004)
IEC-EN-61000-3-2 Electromagnetic compatibility (EMC). Limits for harmonic current emissions (ed. IV) (2007)
IEC-EN-61000-3-3 Limitation of variations of voltage, voltage fluctuation and flicker (ed. II) (2009)
IEC-EN-61000-4-2 Electrostatic discharge immunity test (2010)
IEC-EN-61000-4-3 Radiated, radio-frequency, electromagnetic field immunity test (ed. III) (2007)
IEC-EN-61000-4-4 Electrical fast transient/burst immunity test (ed. II) (2008)
IEC-EN-61000-4-5 Surge immunity test (ed. II) (2007)
IEC-EN-61000-4-6 Immunity to conducted disturbances induced by radio-frequency fields (2010)
IEC-EN-61000-4-8 Power frequency magnetic field immunity test (ed. I) (2001)
IEC-EN-61000-4-11 Voltage dips, short interruptions and voltage variation immunity tests (ed. II) (2006)
IEC-EN-17050-1 Conformity assessment. Supplier’s declaration of conformity. Part 1 – General requirements (2010)
The device bears the marking
0068
in accordance with Directive 93/42 EEC relating to medical devices, and it is compliant with the
essential requisites indicated in appendix I of the same regulation.
The device belongs to Class II b according to appendix IX of this directive.
It is moreover herby declared that the device was designed, manufactured and checked according
to the provisions of the complete Quality Assurance System of the company, verified and certified
on the basis of the indications in Appendix II of the aforementioned Directive 93/42 EEC.
Conformity with the Quality Assurance System was checked and approved by the ISTITUTO DI
RICERCHE E COLLAUDI M. Masini .
Bergamo, 11 March 2011
Technical Manager
Ing. Palo Milanesi