3 General information on the device
3.1 Standards/ approvals/ certifications
Dentsply Sirona
Instructions for Use Primeprint
20
67 45 173 D3691
D3691.201.01.01.02 04.2021
3
General information on the device
3.1
Standards/ approvals/ certifications
CE mark
This product bears the CE mark in accordance with the provisions of
Council Directives 2014/53/EU (RED), 2006/42/EC (Machinery
Directive), 2014/30/EC (EMC Directive) and 2011/65/EU (RoHS)
including 2015/863/EC as Annex II. As such, the following standards
apply: ETSI EN 301 489-3 V2.1.1 (2017-03), DIN EN 61010-1:2011-07,
DIN EN ISO 14971:2013-04 and DIN EN 61326-1:2013-07.
CAUTION
CE mark for connected products
Further products which are connected to this unit must also bear the
CE mark. These products must be tested according to the applicable
standards.
Examples of CE mark for connected products:
● EN 60601
● EN 61010-1
● EN 60950
● EN 62368-1
● UL 60950
● UL 62368-1
RoHS compliance
This symbol indicates that this product does not contain any toxic or
hazardous substances or components above the maximum concen-
tration value set out in the Chinese standard SJ / T 11364-2014, and
can be recycled following disposal and should not be carelessly dis-
carded.