Product Certifications And Classifications - biodex NxSTEP 950-485 Instructions For Use And Assembly

Product Certifications and Classifications

Unweighing System has received the following certifications, and falls within the
The NxStep
following classifications:
ANSI ES 60601-1
●
IEC 60601-1
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IEC 60601-1-2
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CAN/CSA C22.2 No. 60601-1:2014
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FDA Class I Equipment
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EU Class I Product
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CE Marked.
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Type B Applied Part
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Electromagnetic Compatibility: This equipment complies with the Medical Equipment ICC
●
60601-2 EMC Standard.
NOTE: Complete information on the Electromagnetic Compatibility for the NxStep system
can be found in the Compliance Supplement located on the Biodex website (www.biodex.com)
or can be obtained by contacting Biodex Customer Service (see Contact information).
Authorized European Community Representative:
Emergo Europe
Prinsessegracht 20
2514 AP, The Hague
The Netherlands
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