General; Safety; Electromagnetic Compatibility; X-Ray Safety - AGFA DX-D 300 User Manual

32 | DX-D 300 | Introduction

General

• The product 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 Medical Device Directive (European Council Directive
93/42/EEC on Medical Devices).

Safety

• IEC 60601-1

Electromagnetic Compatibility

• IEC 60601-1-2

X-Ray Safety

• IEC 60601-1-3
• IEC 60601-2-54
• IEC 60601-2-7
For USA
The system conforms to DHHS radiation Standards of 21CFR subchapter J as
of the date of manufacture.
0172E EN 20181116 1653