General; Safety; X-Ray Safety; Electromagnetic Compatibility - AGFA DX-D 400 User Manual

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).
• ISO 13485
• IEC 62366
• ISO 14971

Safety

• IEC 60601-1
• UL 60601-1
• CAN/CSA C 22.2 No.601.1-M90

X-Ray Safety

• IEC 60601-2-54
For USA
The system conforms to DHHS radiation Standards of 21CFR subchapter J as
of the date of manufacture.

Electromagnetic Compatibility

• IEC 60601-1-2
DX-D 400 | Introduction to DX-D 400 | 27
0230D EN 20191209 1135