General; Safety; Electromagnetic Compatibility; Environmental Compliance - AGFA 5400/516 User Manual

General

• The DR Retrofit Solution has been designed in accordance with the
MEDDEV Guidelines relating to the application of Medical Devices and has
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).
• The DR Generator Sync Box has been designed in accordance with
Regulation (EU) 2017/745 on medical devices (MDR).
• IEC 62366
• ISO 14971

Safety

• IEC 60601-1
• AAMI ES 60601-1
• CSA C 22.2 No.60601-1

Electromagnetic Compatibility

• IEC 60601-1-2

Environmental Compliance

• European Council Directive 1907/2006 (REACH)
• European Council Directive 2011/65/EU (RoHS 2)
• European Council Directive 2012/19/EU (WEEE)
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