Thermo Scientific Medifuge Centrifuge
15
3. Directives, Standards and Guidelines
Region
Directive
Standard
Europe
220–230 V,
50/60 Hz
98/79/EC
in vitro diagnostic
medical devices (IVD)
2014/35/EC
Low Voltage
(protective goals)
2006/42/EC
Machinery
(protective goals)
2014/30/EC
Electromagnetic
Compatibility (EMC)
(protective goals)
2011/65/EC RoHS
– Directive on
the Restriction of the use of certain
Hazardous Substances in electrical
and electronic equipment
EN 61010-1, 3
rd
Edition
IEC 61010-2-020, 3
rd
Edition
IEC 61010-2-101, 3
rd
Edition
EN 61326-1 Class B
EN 61326-2-6
EN 62304
EN 62366
EN ISO 14971
EN ISO 13485
North America
(USA & Canada)
230 V, 60 Hz
120 V, 60 Hz
FDA
Product Code JQC
Device Class 1
Centrifuges for Clinical Use
EN 61010-1, 3
rd
Edition
IEC 61010-2-020, 3
rd
Edition
IEC 61010-2-101, 3
rd
Edition
EN 61326-1 Class B
EN 61326-2-6
EN 62304
EN 62366
EN ISO 14971
EN ISO 13485
Japan
100 V, 50/60 Hz
China
220 V, 50 Hz
EN 61010-1, 3
rd
Edition
IEC 61010-2-020, 3
rd
Edition
IEC 61010-2-101, 3
rd
Edition
EN 61326-1 Class B
EN 61326-2-6
EN 62304
EN 62366
EN ISO 14971
EN ISO 13485