Standards and regulations applied to centrifuges
Centrifuges are high-end technical products. They are subject to extensive testing and certification procedures
according to following standards and regulations applied in their current versions:
Electrical and mechanical safety for design and final testing:
Standard series: IEC 61010 (conform to standards of DIN EN 61010)
IEC 61010-1 "Safety requirements for electrical equipment for measurement, control, and laboratory use -
Part 1: General requirements" (Pollution Degree 2, Installation Category II)
IEC 61010-2-010 "Safety requirements for electrical equipment for measurement, control and laboratory use
- Part 2-010: Particular requirements for laboratory equipment for the heating of materials" (applied to
heated centrifuges only)
IEC 61010-2-020 "Safety requirements for electrical equipment for measurement, control, and laboratory
use - Part 2-020: Particular requirements for laboratory centrifuges"
Electromagnetic Compatibility:
EN 61326-1 "Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1:
General requirements"
The EMC standard refers to the following generic standards:
Emission:
Conducted emission
Radiated emission
Harmonic current emissions
Voltage fluctuations and flicker
Immunity to...
Electrostatic discharge
Electromagnetic fields
Electrical fast transients (Burst)
Surge
Conducted RF disturbances
Magnetic field
Voltage dips and short interruptions
European directives applied for conformity assessment procedures:
Low voltage directive 2006/95/EC
"directive related to electrical equipment designed for use within certain voltage limits".
EC conformity assessment procedure according to annex IV "Internal Production Control ".
Further partly applicable European directives:
Machinery Directive 2006/42/EC
EMC directive 2004/108/EC
Certified quality management system according to
ISO 9001 "Quality management systems – Requirements"
ISO13485 "Medical devices - Quality management systems - Requirements for regulatory purposes"
Environmental management system according to
ISO 14001 "Environmental management systems - Requirements with guidance for use"
6/87
EN 55011 Class B
EN 55011 Class B
EN 61000-3-2
EN 61000-3-3
EN 61000-4-2
EN 61000-4-3
EN 61000-4-4
EN 61000-4-5
EN 61000-4-6
EN 61000-4-8
EN 61000-4-11