Standards to which the NovoTHOR is tested
Medical electrical equipment — Part 1: General Requirements for Basic Safety and Essential Performance (Third Edition, Amendment 1 2012),"
Medical electrical equipment — Part 1–2: General requirements for basic safety and essential performance — Collateral Standard: Electromagnetic disturbances — Requirements and tests
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, and Cosmetic/Aesthetic use (2012).
IEC 60601-2-22:2007 + AMD1:2012
Medical electrical equipment. Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Usability
BS EN ISO 14971:2007/(R)2010
Medical devices. Application of risk management to medical devices
BS EN 62471
Photobiological safety of lamps and lamp systems
Safety of lasers
Mandatory for a NOVOTHOR to be sold in the USA:
Medical devices. Application of usability engineering to medical devices
ISO 10993-1: October 2009
Biological evaluation of medical devices. Evaluation and testing within a risk management process
PD IEC/TR 60878:2015
Graphical symbols for electrical equipment in medical practice
BS EN ISO 780:2015
Distribution packaging. Graphical symbols for handling and storage of packages
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