1� 3� 1� Directives And Standards - Fisher Scientific Fisherbrand accuSpin Micro Series Instruction Manual

1. 3. 1. Directives and Standards
Region Directive
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
North America FDA listed
Product code JQC
centrifuges for clinical use
Device class 1
China CFDA listed
Table 7: Directives and Standards
* dependent on EU implementation date
Technical Specifications
16 / 89
Standards
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
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
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