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With industry-leading certifications, PlatinumLED ensures every device meets the highest standards for safe, effective light therapy.
FDA Medical Device
Certification
FDA medical device certification is a process that ensures that a medical device is safe and effective, and that the organization that produces it can consistently meet the standards of the United States Food and Drug Administration (FDA)
FDA Class II Medical Device.
Electrical Testing Laboratories
Certification
ETL certification, or the ETL Listed Mark, is a product safety certification that indicates a product meets North American safety standards. ETL stands for Electrical Testing Laboratories, and the certification is issued by Intertek, an international certification organization.
ANSI/AAMI ES60601-1:2005+A1;A2 - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.
IEC 60601-1-6:2010 Ed.3+A1;A2 - Medical Electrical Equipment – Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability.
CSA C22.2#60601-1-6:2011 Ed.3+A1;A2 - Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability.
IEC 60601-2-57:2011 Ed.1 - Medical Electrical Equipment - Part 2-57: Particular Requirements For The Basic Safety And Essential Performance Of Non-Laser Light Source Equipment Intended For Therapeutic, Diagnostic, Monitoring And Cosmetic/Aesthetic Use.
CSA C22.2#60601-2-57:2011 Ed.1 - Medical Electrical Equipment – Part 2–57: Particular Requirements for the Basic Safety and Essential Performance of Non-Laser Light Source Equipment Intended for Therapeutic, Diagnostic, Monitoring and Cosmetic/Aesthetic Use.
Conformité Européenne
Certifications
CE certification, or Conformité Européenne, is a regulatory standard that indicates a product meets EU safety, health, and environmental requirements.
EN IEC 55015:2019 + A11:2020 - Limits and methods of measurement of radio disturbance characteristics of electrical lighting and similar equipment.
EN IEC 61000-3-2:2019 + AI:2021 - Limits for harmonic current emissions.
EN 61000-3-3:2013 + AI:2019 + A2:2021 - Limits for harmonic current emissions.
EN IEC 61547:2023 - Equipment for general lighting purposes. EMC immunity requirements (British Standard).
EN 60335-1:2021 + AC:2014 +A11:2014 + A13:2017 + A1:2019 + A2:2019 + A15:2021 - Safety of electrical appliances for household environment and commercial purposes.
EN 6223:2008 + AC:2008 - Measurement for electromagnetic fields of household appliances and similar apparatus with regard to human exposure.
Federal Communications
Commission’s Certifications
FCC certification is a mandatory requirement in the United States that ensures electronic devices meet the Federal Communications Commission's (FCC) standards for radio frequency interference and electromagnetic compatibility. It's a mark of approval that indicates a product operates within specified parameters and doesn't interfere with other electronic devices.
FCC 47 CFR Part 15 Subpart B, Class B (SCoC) – Unintentional Radio Frequency Emissions Testing and Compliance.
ANSI C63.4-2014 - American National Standard for Methods of Measurement of Radio-Noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz.
Restriction of Hazardous
Substances Certification
RoHS certification, or Restriction of Hazardous Substances certification, is a regulation that limits the use of hazardous materials in electrical and electronic equipment (EEE).
IEC 62321-1:2013 - Screening analysis of five substances, specifically lead (Pb), mercury (Hg), cadmium (Cd), total chromium (Cr) and total bromine (Br) in uniform materials found in electrotechnical products, using the analytical technique of X-ray fluorescence (XRF) spectrometry.
IEC 62321-3-1:2013 - screening analysis of five substances, specifically lead (Pb), mercury (Hg), cadmium (Cd), total chromium (Cr) and total bromine (Br) in uniform materials found in electrotechnical products, using the analytical technique of X-ray fluorescence (XRF) spectrometry.
IEC 62321-4:2013 + A1:2017 - Describes the use of four test methods for mercury in polymers, metals and electronics, namely CV-AAS (cold vapour atomic absorption spectrometry), CV-AFS (cold vapour atomic fluorescence spectrometry) ICP-OES (inductively coupled plasma optical.
IEC 62321-5:2013 - Describes the four test methods for lead, cadmium and chromium in polymers, metals and electronics.
IEC 62321-6:2015 - Specifies one normative and two informative techniques for the determination of polybrominated biphenyls (PBB) and diphenyl ethers (PBDE) in polymers of electrotechnical products.
IEC 62321-7-1:2015 - Determination of certain substances in electrotechnical products - Part 7-1: Hexavalent chromium - Presence of hexavalent chromium (Cr(VI)) in colourless and coloured corrosion-protected coatings on metals by the colorimetric method.
IEC 62321-7-2:2017 - Determination of certain substances in electrotechnical products - Part 7-2: Hexavalent chromium - Determination of hexavalent chromium (Cr(VI)) in polymers and electronics by the colorimetric method.
IEC 62321-8:2017 - Determination of certain substances in electrotechnical products - Part 8: Phthalates in polymers by gas chromatography-mass spectrometry (GC-MS), gas chromatography-mass spectrometry using a pyrolyzer/thermal desorption accessory (Py-TD-GC-MS).
IEC 62321-2:2021 - Determination of certain substances in electrotechnical products - Part 2: Disassembly, disjointment and mechanical sample preparation.
With 13+ years of innovation, PlatinumLED is the trusted leader in safe, effective Red Light/NIR therapy.
