General; Safety; Electromagnetic Compatibility; Radio Frequency - AGFA DX-D 60C User Manual

24 | DX-D 60C, DX-D 60G | Introduction to the DR Detector

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
• ISO 14971

Safety

• EN 60601-1
• IEC 60601-1
• UL 60601-1
• CAN.CSA-C22.2 No. 601.1

Electromagnetic Compatibility

• IEC 60601-1-2

Radio Frequency

Declaration of conformity
U.S.A.
European Union (and EEA)
South Korea
Topics:
• Local regulations
• Specific absorption rate (SAR)
0294B EN 20190221 1131
FCC Part 15.107(b) / Part 15.109(b)
FCC Part 15 Subpart E 15.407
FCC Part 15 Subpart C 15.247
ETSI EN 301 489-1 V1.9.2:2011 (EMC)
ETSI EN 301 489-17 V2.2.1:2012 (EMC)
EN 300 328 V1.8.1
EN 301 893 V1.7.1 (RF)
KN 301 489-1
KN 301 489-17