Thermo Scientific 75004250, Instructions For Use Manual

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1
Introduction and Description
Directives, Standards and Guidelines
1-4 Multifuge X1 / X1R Thermo Scientific
Directives, Standards and Guidelines
Table 1- 3 . Directives, Standards and Guidelines
Region Directive Standard
98/79/EC In Vitro Diagnostics
2011/65/EU RoHS
Directive on the Restriction of the use of
certain Hazardous Substances in electrical
and electronic equipment
Protective golas of:
2006/42/EC Machinery
2014/35/EU Low Voltage
2014/30/EU Electromagnetic Compatibility
(EMC)
EN 61010-1
EN 61010-2-020
EN 61010-2-101
EN 61326-1 Class B
EN 61326-2-6
EN ISO 14971
EN ISO 13485
USA & Canada
ANSI/UL 61010-1/CAN/CSA-C22.2 No. 61010-1
IEC 61010-2-020
IEC 61010-2-101
EN ISO 14971
EN ISO 13485
Emitted interference FCC Part 15 CLASS A
NOTE: This equipment has been tested and found to comply
with the limits for a Class A digital device, pursuant to Part 15
of the FCC Rules.
These limits are designed to provide reasonable protection
against harmful interference when the equipment is operated in
a commercial environment. This equipment generates, uses,
and can radiate radio frequency energy and, if not installed and
used in accordance with the instruction manual, may cause
harmful interference to radio communications. Operation of this
equipment in a residential area is likely to cause harmful
interference in which case the user will be required to correct
the interference at his own expense.
Japan
China
IEC 61010-1
IEC 61010-2-020
IEC 61010-2-101
IEC 61326-2-6
IEC 61326-1 Class B
EN ISO 14971
EN ISO 13485
Europe
CFDA listed
FDA listed
Product code JQC
centrifuges for clinical use
Device class 1