NovoTHOR® Regulatory

Standards to which the NovoTHOR is tested

ANSI/AAMI/IEC 60601-1
Medical electrical equipment — Part 1: General Requirements for Basic Safety and Essential Performance (Third Edition, Amendment 1 2012),"

IEC 60601-1-2:2014
Medical electrical equipment — Part 1–2: General requirements for basic safety and essential performance — Collateral Standard: Electromagnetic disturbances — Requirements and tests

IEC 60601-2-57
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

IEC 60601-1-6:2010
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

IEC 60825
Safety of lasers

Mandatory for a NOVOTHOR to be sold in the USA:

IEC 62366:2015
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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