2 Dimensions, technical data
Sirona Dental Systems GmbH
Installation Requirements C5
+
, C5
+
Turn
60 27 978 D3415
30
D3415.021.03.08.02
2.4 Standards/Approvals
Standards/Approvals
The C5
+
, C5
+
Turn treatment center complies with the following stan-
dards, among others:
•
IEC 60601-1 (electrical and mechanical safety plus software reli-
ability)
•
IEC 60601-1-2 (electromagnetic compatibility)
•
IEC 60601-1-6 (serviceability)
•
ISO 6875 (Patient chair)
•
ISO 7494-1 (Dental treatment devices)
•
ISO 7494-2 (dental treatment units, water and air supply)
•
ISO 9680 (Operating light)
•
ISO 11143 (amalgam separator), see also below
(if amalgam separator option is present)
•
EN 1717 (connection to the drinking water system),
Original language: German
This product bears the CE marking in accordance with the provisions of
the Council Directive 93/42/EEC of June 14, 1993 concerning medical
devices.
The treatment center meets the requirements of the Canadian Standard
Association (CSA) in accordance with CAN/CSA-C22.2 No. 60601-1.
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 Struc-
tural Engineering (DIBT) and by the French International Organization
for Standardization (AFNOR).
When equipped with a disinfection system, the treatment center com-
plies 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 German Tech-
nical and Scientific Association for Gas and Water (DVGW). It is intrin-
sically safe in accordance with worksheet W540. The unit thus fulfills the
requirements of EN 1717, see also the chapter „Connection to the pub-
lic drinking water supply” on page 7.
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