Sirona Intego - Unit description; Standards;Approvals

64 57 498 D3543
D3543.201.01.05.02 08.2016
23
Sirona Dental Systems GmbH 3Unit description
Operating Instructions INTEGO 3.1Standards/Approvals
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3
Unit description
3.1
Standards/Approvals
Compliance with standards, without HF surgery
The INTEGO / INTEGO pro treatment centers comply with the following
standards:
● 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" [ → 16]
Original language of this document: German
CE marking, INTEGO / INTEGO pro
INTEGO / INTEGO pro bear the CE marking in accordance with the
provisions of Council Directive 93/42/EEC of June 14, 1993 concerning
medical devices.
RoHS Directive
INTEGO / INTEGO pro comply with the requirements of the RoHS
Directive 2011/65/EU.
MET for Canada
The treatment center meets the requirements in accordance with CAN/
CSA-C22.2 No. 60601-1 and AAMI/ANSI ES 60601-1.
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: Centrifuge system
The amalgam separator is approved by the German institute for building
technology (DIBt) and AFNOR (France).
DVGW safe for Germany, disinfection system or fresh water bottle
When equipped with a disinfection system or fresh water bottle with no
connection to the public drinking water supply, the treatment center
complies with the technical regulations 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
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SIRONA
Dental Systems
GmbH
64625 Bensheim
Fabrikstrasse 31
Z-64.1-14