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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
EN 55011 Class B
Radiated emission
EN 55011 Class B
Harmonic current emissions
EN 61000-3-2
Voltage fluctuations and flicker
EN 61000-3-3
Immunity to…
Electrostatic discharge
EN 61000-4-2
Electromagnetic fields
EN 61000-4-3
Electrical fast transients (Burst)
EN 61000-4-4
Surge EN
61000-4-5
Conducted RF disturbances
EN 61000-4-6
Magnetic field
EN 61000-4-8
Voltage dips and short interruptions
EN 61000-4-11
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”
