EN 60601-1-2:2015 Medical electrical equipment. General requirements
for basic safety and essential performance. Collateral standard.
Electromagnetic compatibility. Requirements and tests.
IEC 60601-1-6 2010 AMD12013 Medical Electrical Equipment – Part 1
General Requirements for Basic Safety and Essential Performance
– Collateral Standard: Usability.
IEC/EN60601-1-11:2015 Medical electrical equipment – Part 1-11: General
requirements for basic safety and essential performance –Collateral
standard: Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
IEC/EN 60601-2-57:2011 Medical electrical equipment. Particular
requirements for the basic safety and essential performance of non-laser
light source equipment intended for therapeutic, diagnostic, monitoring
and cosmetic/aesthetic use.
EN 62471:2008 Photobiological Safety of Lamps and Lamp Systems
EN 62366-1:2015 Application of usability engineering to medical devices.
EN ISO 10993-1:2010-04 Biological evaluation of medical devices Part 1:
Evaluation and testing
EN ISO 15223-1:2017 Medical Devices – Symbols to be used with medical
device labels, labelling and information to be supplied – Part 1: General
requirements
EN ISO 14971:2012 Medical devices - Application of risk management to
medical devices
IEC62133:2012 2nd ed. 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
BS EN 55014-2:2015 Electromagnetic compatibility. Requirements for
household appliances, electric tools and similar apparatus. Immunity.
Product family standard Restriction of Hazardous Substances (RoHS)
Directive (2011/65/EU)
The Déesse Pro™ Express device is cleared for marketing in the United
states of America K191629 Registration, Evaluation, Authorisation and
Restriction of chemicals (REACH) directive (EC 1907/2006)
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