Operative Manual
MO079-IT
15/06/12
Rev.0
Pag. 4 di 16
1.4
Declaration of Conformity of the Manufacturer
The company:
RIMSA P. LONGONI S.r.l. Via Monterosa, 18/20/22 - 20831 SEREGNO (MB) - ITALY
Declares under its own responsibility that the Product (Medical lighting device for surgical and diagnosis use):
made by RIMSA P.LONGONI S.r.l., 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)
IEC 60601-2-41
(Part 2: Particular requirements for basic safety and essential performance of surgical luminaires
and luminaires for diagnosis)
IEC 60601-1-2
(Part 1: General requirements for basic safety and essential performance – Collateral 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:
Short term (Par.1 “Definitions”, art.1, sub-section 1.1, annex IX)
DESCRIPTION:
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)
CLASS:
I (Par.3 “Classification”, art.1, sub-section 1.1 Rule 1, annex IX)
Reference to technical file Code RIM-FT019.
The conformity assessment is developed with reference to article 11 of Directive 93/42/EEC and 2007/47/EC.
The RIMSA Quality System complies with UNI EN ISO 9001 and UNI CEI EN ISO 13485 standards and is
certified by CSQ (CSQ certificate no. 9120.RMS1 and 9124.RMS2).
The Medical Device to illuminate the body of the patient locally is supplied in
NOT STERILIZED
form.
Name: Paolo Longoni
Position: Managing Director
PRIMALED/ PRIMALED-FLEX
APPLICARE
ETICHETTA
