General; Safety; Electromagnetic Compatibility; X-Ray Devices - AGFA DR 18M User Manual

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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) amended by European Directive
2007/47/CE.

Safety

• EN 60601-1:2006 + A1:2013
• IEC 60601-1:2015 + A1:2012

Electromagnetic Compatibility

• IEC 60601-1-2:2005, EN 60601-1-2:2007

X-ray devices

• EN 62220-1-2:2007
DR 18M, DR 24M | Introduction to the DR Detector | 25
0380A EN 20180703 1429

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Dr 24m5400/5275400/528

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