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).
Safety
• IEC 60601-1
Electromagnetic Compatibility
• IEC 60601-1-2
X-Ray Safety
• IEC 60601-1-3
• IEC 60601-2-54
• IEC 60601-2-28
For USA
The system conforms to DHHS radiation Standards of 21CFR subchapter J as
of the date of manufacture.
Laser Safety
• IEC 60825-1
DR 100s | Product Information | 161
0411D EN 20220627 1040
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