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Standards
Acoustic
EN IEC 60601-2-37:2008/AMD1:2015 - Medical electrical equipment - Part 2-37: Particular
requirements for the basic safety and essential performance of ultrasonic medical
diagnostic and monitoring equipment
Biocompatibility
EN ISO 10993-1:2009 -Biological evaluation of medical devices - Evaluation and
testing within a risk management process
EN ISO 10993-5:2009 -Biological evaluation of medical devices - Tests for in vitro
cytotoxicity
ISO 10993-10:2010-Biological evaluation of medical devices. Tests for irritation
and skin sensitization
Chemical
REACH 02006R1907:2015-03-23 - REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL of 18December2006 concerning the Registration, Evaluation, Authorization and
Restriction of Chemicals (REACH), establishing a European Chemicals Agency. LU700 Ultrasound
Imaging System meets the minimum requirements for compliance with the European Union's
Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU and its amendments.
Labeling
ISO 15223-1:2016 (Medical devices - Symbols to be used with medical device labels, labelling and
information to be supplied - General requirements)
Battery
UN 38.3 -Lithium Battery Transportation
EN IEC 62133 -Safety requirements for portable sealed secondary cells, and for batteries made from them,
for use in portable applications.
Wireless
Waste Electrical and Electronic Equipment Directive 2002/96/EC(WEEE)- Directive 2002/96/EC;
EN 300 328 V2.1.1；2016 -Wireless Radio Frequency Wideband Transmission);
EN301 489-1& EN301 489-17:2017 03 (Wireless Electromagnetic Compatibility Standard
Waterproof
IEC 60529 edition2.2:2013 -Degrees of protection provided by enclosures (IP Code
P60
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