Conformity - EOS RELAX Notice De Montage, D'utilisation Et D'entretien

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 – Part 1: General require-
ments for basic safety and essential performance.
Medical electrical equipment – Part 1-2: – Basic require-
ments for safety and essential performance. Accompanying
standards: electromagnetic compatibility – requirements
and tests.
Medical electrical equipment – Part 2-52 : Special require-
ments for the safety and essential features of medical beds.
Risk management for medical equipment.
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