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CR 10-X DIGITIZER
5
SAFETY
Region
Regulation
X-ray
Laser
Europe
EN/IEC 60601-1 edition 2
Regulation: 1987
EN 60825 - 1:2001
EN/IEC 60601-1 edition 3
EN 60825 - 1:2007
EN/IEC 60601-1-2
USA
UL 60601-1
DHHS/FDA 21 CFR
DHHS/FDA 21
21CFR part 820: good
part 1002, subchapter B
CFR parts 1040, 10
manufacturing practice for
and 1040, 11
medical devices
Canada
CSA22.2 No.601.1 No.601.1.2
CSA E60825-1 (R2007)
