General; Safety; Electromagnetic Compatibility - AGFA DR 10s User Manual

30 | DR 10s | 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 14971

Safety

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

Electromagnetic Compatibility

• IEC 60601-1-2
0351A EN 20190319 1349 *