Conformity - philrouge EOS RELAX Mode D'emploi

7.

Conformity

The EOS Relax is manufactured in accordance with the ISO 9001:2008 stand-
ard and complies with the European Medical Devices Directive 93/42/EEC
and all related harmonised standards:
EN 60601-1
EN 60601-1-2
EN 60601-2-52
EN ISO 14971
Medical electrical equipment
for basic safety and essential performance.
Medical electrical equipment
ments for safety and essential performance. Accompanying
standards: electromagnetic compatibility
tests.
Medical electrical equipment
ments for the safety and essential features of medical beds.
Risk management for medical equipment.
Part 1: General requirements
Part 1-2:
Part 2-52 : Special require-
94
Basic require-
requirements and