Sirona Dental Systems GmbH 3 Technical description
C3
+
3.1 Standards / Approvals
59 06 404 D 3390
D 3390.201.01.18.02
17
3 Technical description
3.1 Standards / Approvals
The C3
+
treatment center complies with the following
standards, among others:
• IEC 60601-1 (electrical, mechanical, and software
safety)
• IEC 60601-1-2 (electromagnetic compatibility)
• IEC 60601-1-6 (serviceability)
• ISO 6875 (patient chair)
• ISO 7494-1 (dental treatment units)
• ISO 7494-2 (dental treatment units, 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 the section "Connection to the
public drinking water system" on page 12
Original language: German
This product bears the CE mark in accordance with the
provisions of the Council Directive 93/42/EEC of
June 14, 1993 concerning medical devices (MDD).
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 effi-
ciency of > 95 %. The requirements of the ISO 11143
standard are thereby fulfilled.
Type 1 separation process: Centrifugal system
The amalgam separator is approved by the German
Institute for Structural Engineering (DIBt) and by the
AFNOR (France).
Original language of the present document: German
The treatment center fulfills the requirements of the
directive on the restriction of hazardous substances,
2011/65/EU.
When equipped with a disinfection system, the treatment
center complies with the technical rules and require-
ments on safety and hygiene for connection to the public
drinking water supply.
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