Sirona Dental Systems GmbH 2 Dimensions, technical data
Installation Requirements C3
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, C4
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, C4
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Cart
60 27 945 D3382
D3382.021.02.12.02
29
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2.5 Standards/Approvals
Standards/Approvals
The C3
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, C4
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, C4
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Cart treatment center complies with the following
standards, 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 DVGW
(Deutscher Verein für Gas und Wasser = German Gas and Water Asso-
ciation). It fulfills the requirements of W270 and KTW (plastics in water-
ways) as well as the EN1717 standard, see also chapter „Connection to
the public 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
.
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