AGFA DR 400 - X-Ray Accuracy; Environmental Compliance; Biocompatibility; Usability

• IEC 60601-2-28
For USA
The system conforms to DHHS radiation Standards of 21CFR subchapter J as
of the date of manufacture.
X-Ray Accuracy
The system fulfills the X-ray radiation accuracy according EN IEC 60601-2-54
with a variation of max. 0.05 (5%).
Environmental Compliance
• European Council Directive 1907/2006 (REACH)
• European Council Directive 2011/65/EU (RoHS 2)
• European Council Directive 2012/19/EU (WEEE)
Biocompatibility
• EN ISO 10993-1
Usability
• IEC/EN 62366
• IEC/EN 60601-1-6
DR 400 | Product Information | 221
3231E EN 20210708 1530