Compliance - AGFA CR 10-X User Manual

Compliance

Topics:
• General
• Safety
• Laser Safety
• Electromagnetic Compatibility
• Environmental Compliance
• Equipment Classification
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 13485:2003
• IEC 62366:2007
• IEC 62304:2006
• ISO 14971:2007
Safety
• IEC 60601-1: 2005
• UL 60601-1:2003
• CAN/CSA C 22.2 No.601.1-M90
Laser Safety
• IEC 60825-1:1993
• IEC 60825-1:2007
Electromagnetic Compatibility
• IEC 60601-1-2:2007
• FCC Rules 47 CFR part 15 subpart B
• CAN/CSA 22.2 No. 60601-1-2-08
Environmental Compliance
• WEEE 2012/19/EC
• RoHS 2 Directive 2011/65/EU
CR 10-X, CR 12-X, CR 15-X | Introduction | 21
2491E EN 20150409 1543