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

General

• The product has been designed in accordance with Regulation (EU)
2017/745 on medical devices (MDR)

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.
DX-D 300 | Introduction | 33
0172G EN 20230627 1651