General; Safety; Laser Safety; Electromagnetic Compatibility - AGFA DX-G 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
• IEC 62304
• ISO 14971

Safety

• IEC 60601-1
• UL 60601-1
• AAMI/ANSI ES 60601-1 1st Edition
• CAN/CSA C 22.2 No.60601.1

Laser Safety

• IEC 60825-1

Electromagnetic Compatibility

• IEC 60601-1-2
• FCC Rules 47 CFR part 15 subpart B
• CAN/CSA 22.2 No. 60601-1-2

Environmental Compliance

• WEEE 2012/19/EC
• RoHS 2 Directive 2011/65/EU
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