General; Safety; Electromagnetic Compatibility; Environmental Compliance - AGFA 6005/100 6005/200 User Manual

Full Leg Full Spine DR Retrofit System | Introduction to the Full Leg Full Spine application | 19

General

• The DR Full Leg Full Spine detector positioner has been designed in
accordance with Regulation (EU) 2017/745 on medical devices (MDR).
• The external collimator 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

• IEC 60601-1
• IEC 60601-1-3
• IEC 60601-1-6
• IEC 60601-2-54
• ANSI/AAMI ES60601-1
• CAN/CSA-C22.2 No. 60601-1:14

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)
0326A EN 20211014 1141