Standards - AGFA Drystar AXYS User Manual

Standards

ISO 14971:2000, Medical devices - Application of risk management to medical
devices
IEC 60601-1-2 It specifies the manufacturer of the medical equipment or medi-
cal system. It also provides information to the responsible organization that is
essential in determining the suitability of the medical equipment or medical
system for the electromagnetic environment of use, and in managing the elec-
tromagnetic environment of use to permit the medical equipment or medical
system to maintain basic safety and provide its essential performance without
disturbing other equipment.
Seismic (earthquake) requirements
The printer meets the CA (Californian) requirements.
Safety standards
IEC 60601-1, Ed. 3: Medical electrical equipment - Part 1: General requirements
for basic safety and essential performance
IEC 60601-1 + A1 + A2
EN 60601-1 + A1 + A2
UL 60601-1
CSA 22.2 No. 601.1-M90
GB4943-2001 (for CCC-Mark)
EMC
FCC Rules 47 CFR part 15 subpart B
IEC 60601-1-2
CISPR 11, class A
CISPR 22, class A
IEC 61000-4-3
2852 A EN 20070205
D AXYS
RYSTAR
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