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Standards and regulations which apply to this device
The device is a high-end technical product. It is subject to extensive testing and certification procedures according to
the following standards and regulations in their respectively valid version:
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”
• IEC 61010-2-101 ”Safety requirements for electrical equipment for measurement, control and laboratory use
- Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment“
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
• Voltage dips and short interruptions EN 61000-4-11
European directives applied for conformity assessment procedures:
In vitro diagnostic device directive 98/79/EG
EC conformity assessment procedure according to annex III “EC DECLARATION OF CONFORMITY“ – self-
declaration by the manufacturer
Further partly applicable European directives:
• Machinery Directive 2006/42/EC
• EMC directive 2004/108/EC
• Low voltage directive 2006/95/EC
Applied medical device regulations outside Europe:
• USA: QSR, 21CFR 820 “CFR Title 21 - Food and Drugs: TITLE 21- FOOD AND DRUGS, CHAPTER I -
FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES,
SUBCHAPTER H - MEDICAL DEVICES, Part 820 QUALITY SYSTEM REGULATONS“
• Canada: CMDR, SOR/98-282 “Medical Devices Regulations”
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”
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