Declaration Of Conformity Of The Manufacturer - Tecno-gaz SLIM Notice D'utilisation Et D'entretien

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, enforced in Italy by
Legislative Decree No. 46 dated 24 February 1997 and subsequent amendments (including Directive 2007/47/EC dated
05/09/2007, enforced in Italy by Legislative Decree No. 37 dated 25 January 2010) and with the following standards:
•
IEC 60601-1
•
IEC 60601-2-41
•
IEC 60601-1-2
Classification with reference to article 9 and Annex IX of Directives 93/42/EEC and 2007/47/EC
DURATION:
DESCRIPTION:
CLASS I:
•
The conformity assessment is developed with reference to article 11 of Directive 93/42/EEC and 2007/47/EC.
•
The TECNO-GAZ Quality System complies with UNI EN ISO 9001 and UNI CEI EN ISO 13485 standards and is certified
by CSQ (CSQ certificate no. 9120.TGA1 and 9124.TGA2).
Name: PAOLO BERTOZZI
Position: President
MU_023 Rev.2
9 Declaration of Conformity of the
(Part 1: General requirements for basic safety and essential performance)
(Part 1: Particular requirements for the safety of surgical luminaires and luminaires for
diagnosis)
(Part 2: General requirements for basic safety and essential performance - Collateral
Standard: Electromagnetic disturbances - Requirements and tests)
Short term (Annex IX, Par.1 "Definitions", art.1, subsection 1.1)
DESCRIPTION: Non-invasive medical device (Annex IX, Par.1 "Definitions", art.1, subsection
1.2)
DESCRIPTION: Active medical device (Annex IX, Par.1 "Definitions", art.1, subsection 1.4)
(Annex IX, Par.3 "Classification", art.3, subsection 3.3, Rule 12) and
(Annex IX Par.3 "Classification", art.1, subsection 1.1 Rule 1)
28/10/2019
OPERATION AND
MAINTENANCE MANUAL
Manufacturer
SLIM
APPLY
LABEL
EN
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