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
Earthquake resistance
Earthquake resistance is available on system configurations containing the
earthquake kit. After an earthquake, the system remains operational with
manual movements only.
• CBSC Title 24, Part 2 (OSHPD)
270 | DR 600 | Product Information
3261K EN 20210708 0808
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