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A–2
Thermo Scientific Cryofuge 8 / 16 Centrifuges and Heavy Duty Centrifuges
Technical Specifications
1. Directives, Standards and Guidelines
Centrifuge
Region
Directive
Standard
Thermo Scientific
Cryofuge 8
Thermo Scientific
Cryofuge 16
Thermo Scientific
Cryofuge 16
Heavy Duty
Europe
Single Phase
220, 230 V, 50 / 60 Hz
Poly Phase
380, 400, 415 V, 50 Hz
93/42/EEC
Medical Devices
98/79/EC
In Vitro Diagnostics
or
(EU) 2017/746*
2006/42/EC
Machinery
(Protective Goals)
2014/35/EU
Low Voltage
(Protective Goals)
2014/30/EU
Electromagnetic
Compatibility (EMC)
(Protective Goals)
2011/65/EU RoHS
Directive on the Restriction of the use of
certain Hazardous Substances in
electrical and electronic equipment
EN 61010-1
IEC 61010-2-020
EN 61010-2-101
EN 61326-1 Class B
EN 62304
EN 61326-2-6
EN 62366-1
EN ISO 14971
EN ISO 13485
USA & Canada
Single Phase
208, 230, 240 V, 60 Hz
FDA listed
Product Code KSO
Centrifuge, Blood-Bank For In Vitro
Diagnostic Use
Device Class 1
ANSI/UL 61010-1
IEC 61010-2-020
IEC 61010-2-101
IEC 61326-1 Class B
EN 62304
EN 62366-1
EN ISO 14971
EN ISO 13485
FCC Part 15
Japan
Single Phase
200 V, 50 / 60 Hz
China
Single Phase
220 V, 50 Hz
Poly Phase
380 V, 50 Hz
CFDA listed
IEC 61010-1
IEC 61010-2-020
IEC 61010-2-101
IEC 61326-1 Class B
EN 62304
EN 62366-1
EN ISO 14971
EN ISO 13485
*Please see Declaration of Compliance which legislation was applied.
Table A–2:
Directives, Standards and Guidelines Cryofuge 8 / 16 and Cryofuge 16 Heavy Duty
NOTE This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15
of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential
installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee
that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct
the interference by one or more of the following measures:
Reorient or relocate the receiving antenna.
Increase the separation between the equipment and receiver.
Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.