#Industry News
CERTIFIED BEDHEAD UNITS
REGULATIONS
The production system follows a qualitative process for the certification of the electromedical devices. The products, whose warranty can be extended up to 5 years, are subject to final testing before being put on the market, through specific tests in line with the requirements of the reference normative. According the directive 93/42/CEE, ATENA LUX bedhead units are medical devices belonging to class I, IIa, IIb. The bedheads units without predisposition for medical gases are included in class I. ATENA LUX bedhead units of class II are suitable for the installation or implementation of medical gases and anesthetics. Versions on which oxygen gas is not provided are classified on class IIa, whereas in case of the presence of oxygen gas they are part of class IIb. Bedhead units of class IIa and IIb are certified from the ITALCERT national authority with reference to the 074-02-02-DM certificate number.
