Fulford House Newbold Terrace,
LEAMINGTON SPA.
CV32 4EA.
United Kingdom
According to MDD 93/42/EEC, the décoLITE LED mask is classified as a cosmetic
device within the European union. However, for purposes of safety we have conducted
additional testing so that you can be ensured of the safety and efficacy of the décoLITE
system.
The décoLITE system has been tested to or complies with the following standards;
EN 60601-1:2006/A12:2014. Medical electrical equipment. General requirements for basic
safety and essential performance.
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
EN 55014-1.2006+A1: 2009+A2 2011 Electro Magnetic Compatibility – requirements for
household appliances, electric tools and similar apparatus – Part 1 emissions.
EN 55014-2:2015 Electromagnetic compatibility- requirements for household appliances
electric tools ad similar apparatus – part 2: immunity – product family standard.
Summary of Contents for Natural facelift decoLITE
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