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4451C EN 2013-04-30 Introducing the CR 85-X
CR 85-X DIGITIZER
Safety compliance
The CR 85-X complies with:
• general safety standards:
IEC 60601-1: 2005,
EN 60601-1: 2006,
EN 60601-1:1990+A1:1993+A2:1995,
IEC 60601-1:1988+A1:1991+A2:1995,
IEC 60601-1-1 / EN 60601-1-1,
EN 60601-1-2,
UL 60601-1;
• laser safety standards:
EN 60825, DHHS/FDA 21 CFR, Parts 1040.10 and 1040.11, ANSI Z 136-1980.
Accessory equipment connected to any interfaces must be certified according
to the respective IEC standards (e.g. IEC 60950 for data processing equipment
or IEC 60601-1 for medical equipment). Furthermore all configurations shall
comply with the valid version of the system standard IEC 60601-1-1
respectively IEC 60601-1:2005. Everybody who connects additional
equipment to the signal input part or signal output part configures a medical
system, and is therefore responsible that the system complies with the
requirements of the valid version of the system standard IEC 60601-1-1
respectively IEC 60601-1:2005. If in doubt, consult your local service
organization.