Compliance; For Usa - AGFA DX-D 100 User Manual

DX-D 100 | Introduction | 29

Compliance

The DX-D 100 has been designed in accordance with the MEDDEV Guidelines
relating to the application of Medical Devices and have been tested as part of
the conformity assessment procedures required by 93/42/EEC MDD
(European Council Directive 93/42/EEC on Medical Devices).
The system is compliant with specific directives and standards:
• IEC 60601-1
• IEC 60601-1-2

For USA

The system conforms to DHHS radiation Standards of 21CFR subchapter J as
of the date of manufacture.
0187K EN 20191024 1609