X-Ray Safety; X-Ray Accuracy; Environmental Compliance; Biocompatibility - AGFA Valory User Manual

176 | Valory (system with floor mounted column) | Product Information

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.

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
0426A EN 20220804 1858