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Verfügbare Sprachen
Verfügbare Sprachen
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Regulatory Information
EN / IEC 62304: Medical device software - Software life cycle Processes
EN ISO 10993: Biological evaluation of medical devices
ISO 14971: Medical devices - Application of risk management to medical devices
EN / ISO 15223-1: Medical devices - Symbols to be used with medical device labels, labeling
and information to be supplied - Part 1: General requirements
EN ISO 20417: Medical devices — Information to be supplied by the manufacturer
ISO 9687: Dentistry - Graphical symbols for dental equipment
AAMI TIR 12: Designing, testing and labeling reusable medical devices for reprocessing in
health care facilities: A guide for medical device manufacturers
AAMI TIR 30: A compendium of processes, materials, test methods, and acceptance criteria for
cleaning reusable medical devices
EN / IEC 62133-2: Secondary cells and batteries containing alkaline or other non-acid
electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made
from them, for use in portable applications - Part 2: Lithium systems
EN 50566: Product standard to demonstrate the compliance of wireless communication
devices with the basic restrictions and exposure limit values related to human exposure to
electromagnetic fields in the frequency range from 30 MHz to 6 GHz: hand-held and body
mounted devices in close proximity to the human body.
EN 301489-1: Electromagnetic compatibility (EMC) standard for radio equipment and services;
Part 1: Common technical requirements; Harmonized Standard covering the essential
requirements of article 3.1(b) of Directive 2014/53/EU and the essential requirements of article
6 of Directive 2014/30/EU
EN 301489-17: Electromagnetic Compatibility (EMC) standard for radio equipment and
services; Part 17: Specific conditions for Broadband Data Transmission Systems; Harmonized
Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU
EN 301893: 5GHz RLAN; Harmonized Standard covering the essential requirements of article
3.2 of Directive 2014/53/EU
Classification in Accordance with EN/IEC 60601-1
Type of protection against electric shock: Internally powered
Degree of protection against electric shock: Type BF Applied Part
Mode of operation: Continuous operation
Flammable anesthetics: Not suitable for use in the presence of flammable anesthetics or a
mixture of flammable anesthetics with air or oxygen or nitrous oxide.
Conformity with EN/IEC 60601-1-2
IEC 60601-1-2 EMC requirements and tests, Medical Electrical Equipment including CISPR 11
Group 1, Class B.
Electromagnetic Compatibility Precautions
Medical electrical equipment requires special precautions regarding electromagnetic
compatibility (EMC). Medical equipment must be installed and put into service according to
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