Standards/Approvals - Sirona SINIUS Installation Requirements

4 Dimensions, technical data
4.7 Standards/Approvals
0123
SIRONA
Dental Systems
GmbH
64625 Bensheim
Fabrikstrasse 31
Z-64.1-14
44
4.7

Standards/Approvals

The treatment center SINIUS
Compliance with standards, without HF surgery
among others:
● IEC 60601-1 (electrical and mechanical safety plus software
reliability)
● IEC 60601-1-2 (electromagnetic compatibility)
● IEC 60601-1-6 / IEC 62366 (usability)
● IEC 62304 (software process)
● ISO 6875 (patient chair)
● ISO 7494-1 (dental treatment devices)
● ISO 7494-2 (dental treatment devices, water and air supply)
● ISO 9680 (operating light)
● ISO 11143 (amalgam separator), see also below
(provided amalgam separator option is available)
● EN 1717 (connection to the drinking water system), see also below
and chapter "Connection to the public drinking water supply" [ → 11]
Original language of this document: German
This product bears the CE marking in accordance with the provisions of
CE mark, general
Council Directive 93/42/EEC of June 14, 1993 concerning medical
devices.
The treatment center complies with the requirements of the RoHS
RoHS Directive
Directive 2011/65/EU.
The amalgam separator achieves a separation efficiency of >95%. The
Ü and AFNOR marks of the amalgam separator, also for France
unit thus fulfills the requirements of ISO 11143.
Separating procedure type 1: Centrifugal system
The amalgam separator is approved by the German Institute for
Structural Engineering (DIBt) and by the AFNOR (France).
When equipped with a disinfection system, the treatment center complies
DVGW-certified safe connection for Germany, disinfection system
with the technical rules and requirements on safety and hygiene for
connection to the public drinking water supply. The unit is certified
according to the requirements of the DVGW (German Gas and Water
Association). It is intrinsically safe in accordance with worksheet W540.
The unit thus fulfills the requirements of EN 1717, see also the chapter
entitled "Connection to the public drinking water supply" [ → 11].
This unit meets the requirements of BELGAQUA and may therefore be
BELG AQUA for Belgium
connected to the public drinking water supply in Belgium.
Sirona Dental Systems GmbH
Installation Requirements SINIUS / SINIUS CS / SINIUS TS
®
complies with the following standards,
D3561.021.01.06.02 12.2014
63 22 668 D3561