63 22 668 D3561
44
D3561
.
021.01.06
.
02 12.2014
4 Dimensions, technical data
Sirona Dental Systems GmbH
4.7 Standards/Approvals
Installation Requirements SINIUS / SINIUS CS / SINIUS TS
4.7
Standards/Approvals
Compliance with standards, without HF surgery
The treatment center SINIUS
®
complies with the following standards,
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
CE mark, general
This product bears the CE marking in accordance with the provisions of
Council Directive 93/42/EEC of June 14, 1993 concerning medical
devices.
RoHS Directive
The treatment center complies with the requirements of the RoHS
Directive 2011/65/EU.
Ü and AFNOR marks of the amalgam separator, also for France
The amalgam separator achieves a separation efficiency of >95%. The
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).
DVGW-certified safe connection for Germany, disinfection system
When equipped with a disinfection system, the treatment center complies
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].
BELG AQUA for Belgium
This unit meets the requirements of BELGAQUA and may therefore be
connected to the public drinking water supply in Belgium.
0123
SIRONA
Dental Systems
GmbH
64625 Bensheim
Fabrikstrasse 31
Z-64.1-14
Summary of Contents for Sinius
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