Safety Compliance - AGFA CR 35-X User Manual

CR 35-X D
IGITIZER

Safety compliance

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.
Certificates
The CR 35-X complies with:
•
the general safety standards:
IEC 60601-1: 2005,
EN 60601-1: 2006,
EN 60601-1 :1990 / A1:1993, A2:1995, A13:1996,
EN 60601-1-2 :2001,
IEC 60601-1 :1988/A1 :1991, A2 :1995,
IEC 60601-1-1 / EN 60601-1-1,
UL 60601-1:2003,
CAN / CSA C22.2 No.601.1-M90.
•
the laser safety standards:
EN 60825-1: 1994 / A1:2002, A2:2001,
DHHS/FDA 21 CFR, Parts 1040.10 and 1040.11,
ANSI Z 136-1980.
•
EN ISO 14971:2000,
EN 1041:1998,
EN 980:1996/A1.
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Safety compliance
Note: The Digitizer is in compliance with the EG regulation 93/42/EEC
Directive (Medical Device).
4454C EN 2013-05-14