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 14971
Safety
• IEC 60601-1
• UL 60601-1
• CAN.CSA-C22.2 No. 601.1
Electromagnetic Compatibility
• IEC 60601-1-2
30 | DR 14s | Introduction to the DR Detector
0350B EN 20190319 1349 *
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