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Technical Specifications
1. 3. 1. Directives and Standards
Region
Directive
Standards
Europe
98/79/EC
In Vitro Diagnostics
(EU) 2017/746*
In Vitro Diagnostics Medical Devices
2006/42/EC
Machinery Directive
2014/35/EU
Low Voltage (Protective Goals)
2014/30/EC
Electromagnetic Compatibility (EMC)
2011/65/EC RoHS and all applicable
amendments and additions
Directive on the Restriction of the use of
certain Hazardous Substances in electrical
and electronic equipment
EN 61010-1 3.1 Edition
EN 61010-2-020 3rd Edition
EN 61010-2-011 2nd Edition
EN 61010-2-101 3rd Edition
EN 61326-1 Class B
EN ISO 14971
ISO 13485
North America
FDA listed
Product code JQC
centrifuges for clinical use
Device class 1
ANSI/UL 61010-1 3.1 Edition
UL 61010-2-020 3rd Edition
UL 61010-2-011 2nd Edition
UL 61010-2-101 3rd Edition
FCC Part 15
ICES-001
EN ISO 14971
ISO 13485
China
CFDA listed
IEC 61010-1 3.1 Edition
IEC 61010-2-020 3rd Edition
IEC 61010-2-011 2nd Edition
IEC 61010-2-101 3rd Edition
IEC 61326-1 Class B
EN ISO 14971
ISO 13485
Table 7:
Directives and Standards
* dependent on EU implementation date