Certified system

Certifications

Presidio medico chirurgico classe 1

Class 1 medical surgical device

CE Marking

CE Marking

⦿ Meets the 2014-35-EC Low Voltage Directive

⦿ Meets the 2014-30-EC Electromagnetic Compatibility Directive

Dlgs 46/97 attuazione direttiva 93/42/CEE

  • art 1 cm 2
    For the purposes of this decree, a medical device is understood to mean any instrument, device, system, software, substance or other product, used alone or in combination, including intended software by the manufacturer to be used specifically with the purpose? diagnostic or therapeutic and necessary for the correct functioning of the device, intended from manufacturer to be used on humans for diagnosis, prevention, control, therapy or alleviation of a disease; diagnosis, control, therapy, mitigation or compensation for an injury or handicap; study, replacement or modification anatomy or a physiological process; intervention on conception, which product does not exert the main action, in or on the human body, which? intended, with pharmacological or immunological means n? by metabolic process but whose function can be assisted by such means;

  • art. 5 cm 1
    The placing on the market and putting into service, in the Italian territory, of devices bearing the CE marking referred to in Article 16 and assessed on the basis of Article 11 is permitted.

  • art. 11 cm 5
    For devices belonging to class I, with the exception of custom-made devices and those intended for clinical investigations, the manufacturer for the purpose of affixing the CE marking, follows the procedure set out in Annex VII and draws up, before being placed in trade, the declaration of conformity? CE requested, sending a copy to the Ministry of health.

  • VICTORY THE BACTERIA'S KILLER products comply with the European directives on general product safety 2001/95 / EC implemented with Legislative Decree 21 May 2004 n 172.