Declaration Of Conformity Of The Manufacturer - Tecno-gaz ORION Serie Manual De Uso

TECNO-GAZ
9
The company:
TECNO-GAZ S.P.A. Strada Cavalli n. 4 - CAP 43038 - Sala Baganza – Parma – ITALY
Declares under its own responsibility that the Product (Medical lighting device for surgical and
diagnosis use):
made by TECNO-GAZ S.P.A., complies with Annex VII of Directive 93/42/EEC dated 14/05/1993,
and subsequent amendments (including Directive 2007/47/EC dated 05/09/2007) and the following
standards:

IEC 60601-1 (Part 1: General requirements for basic safety and essential performance)
(Part 2: Particular requirements for basic safety and essential performance of surgical

IEC 60601-2-41
luminaires and luminaires for diagnosis)
(Part 1: General requirements for basic safety and essential performance – Collateral

IEC 60601-1-2
standard: Electromagnetic compatibility – Requierements and tests)
Classification with reference to article 9 and Annex IX of Directives 93/42/EEC and 2007/47/EC
DURATION:
DESCRIPTION:
CLASS:
Name: Paolo Bertozzi
Position: Managing Director
Sala Baganza, 19-04-2012
Operation and
maintenance manual

Declaration of Conformity of the Manufacturer

Short term (Par.1 "Definitions", art.1, sub-section 1.1, annex IX)
Non-invasive medical device (Par.1 "Definitions", art.1, sub-section 1.2, annex IX)
Active medical device (Par.1 "Definitions", art.1, sub-section 1.4, annex IX)
I (Par.3 "Classification", art.1, sub-section 1.1 Rule 1, annex IX)
MU_025
Rev.2
ORION 60-80
APPLICARE
ETICHETTA
04/02/16
EN
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