Dentsply Sirona
Operating Instructions Primescan Connect
3 Product description
3.5 Certification
67 97 216 D3801
D3801.201.01.03.02 2022-09
23
3.5
Certification
CE mark
This product is compliant with EU Medical Device Regulation
2017/745 including all amendments.
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 in accordance
with standard IEC 60601-1:2005 + A1:2012 (+A2:2020) chapter 16
through a combination with other devices is responsible for ensuring
that the requirements of this standard are met to the full extent in order
to ensure the safety of patients, operators and the environment. The
combination with a PC is such a creation of a medical electrical system.
