Rhima DEKO 190iX - Declaration of Conformity; Compliance with European Directives and Standards

8 DECLARATION OF CONFORMITY
Manufacturer: FRANKE MEDICAL OY
Address: Vartiokuja 1, 76850 Naarajärvi, FINLAND
Hereby declares that: Deko 190 LC complies with the following Directives:
- Medical Device Directive (93/42/EEC)
- The Restriction of Hazardous Substances Directive (RoHs 2011/65/EU)
and that the following harmonized standards have been applied:
- EN 61010-1 Safety requirements for electrical equipment for measurement,
control, and laboratory use
General requirements
- IEC 61010-2-040 Particular requirements for ward disinfectors used in medical,
pharmaceutical, veterinary and laboratory fields.
- EN 61326-1 Electrical equipment for measurement, control and laboratory use.
EMC requirements.
- EN ISO 13485 Medical devices. Quality management systems. Requirements for
regulatory purposes (ISO 13485:2003)
- EN ISO 15883-1 Washer-disinfectors, Part1: General requirements, definitions and tests
- EN ISO 15883-3 Washer-disinfectors, Part3: Requirements and tests for washer-disinfectors
employing thermal disinfection for human waste containers.
This product complies with the essential requirements of the applicable
European laws and Directives with respect to safety, health, environment
and consumer protection. Design, manufacture and final inspection in
Franke Medical Oy are evaluated by VTT which Notified Body is no. 0537
under the Council Directive 93/42/EEC.
(Signature)
Antero Asikainen, Managing Director
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