Certification - Dentsply Sirona CEREC Primescan AC Notice D'utilisation

3 Product description

3.5 Certification

30
Certification
3.5
CE mark
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 and their changes.
NOTE
CE mark for connected products
Further products which are connected to this unit must also bear the
CE mark.
Compliance
Anyone creating or changing a medical electrical system through a
combination with other devices in accordance with standard EN
60601-1-1:2001 based on 60601-1-1:2000 (specification for the safety
of medical electrical systems)/UL 60601-1 Part 1: first edition 2003 is
responsible for ensuring that the requirements of these standards are
met to the full extent in order to ensure the safety of patients, operators
and the environment.
EAC certification
Mark of conformity of the Eurasian Economic Community
Dentsply Sirona
Operating Instructions
67 15 481 D3696
D3696.201.01.03.02 04.2019