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Classifications, Quality Control & Research Sources

  • Circadian Eyewear is registered as a Class 1 Medical Device with The Norwegian Medicines Agency in accordance with EU directive. 

  • Norwegian Radiation Protection Authority periodically and randomly tests our ORPHEUS lenses to ensure they block 99% of the blue light waves.  

  • Circadian Eyewear is designed and developed based on numerous research from multiple reputable sources. 

      Please find more detailed information below. 

MEDICAL CLASSIFICATION
Our eyewear is registered with the Norwegian Medicines Agency and classified as a Class 1 medical device within European Union (EU) in accordance with The Medical Device Directive, Article 1 paragraph 2a of Directive 93/42/EEC. 

Statens legemiddelverk

The Norwegian Medicines Agency is a department under the Ministry of Health and Care in Norway. Their mission is to evolve and safeguard public and animal health by ensuring the efficacy, quality and safety of medicines and to administer and enforce the medical devices regulation.
Their tasks include:
  • Administer, interpret and enforce the medical devices legislation
  • Provide information and guidance regarding the medical devices regulations to manufacturers, importers, wholesalers, and users
  • Monitoring of the market and the actors involved

Reporting of Adverse Incidents Involving Circadian Eyewear

Incidents with our products, as well as injuries, accidents, and failures where our medical devices are or may have been involved, shall be reported to us at Circadian Eyewear. We are obliged to further report to the Norwegian Medicines Agency. 


CE CONFORMITY MARKING  
Our eyewear has CE Marking which is a manufacturer's declaration that the product complies with the essential requirements of the relevant European health, safety, and environmental protection legislation, in practice by many of the so-called Product Directives.  

Conformity Marking


ISO INTERNATIONAL STANDARD 
Our eyewear are produced in accordance with Standard EN ISO 12312-1:2013.  ISO International Standards ensure that products and services are safe, reliable and of good quality.  

The International Organization for Standardization is an international standard-setting body composed of representatives from various national standards organizations. 


QUALITY CONTROL 
Our ORPHEUS lenses are regularly tested by The Norwegian Agency of Radiation to ensure they block minimum 99% of the blue light rays.  

Testing in laboratory by the Norwegian Radiation Protecting Agency.
Testing performed by the Norwegian Radiation Protection Agency.

Statens Strålevern

The Norwegian Agency of Radiation  is responsible for ensuring the safe use of radiation sources in medicine, manufacturing, and research.  

RESEARCH SOURCES 
You will find related research with links throughout this website. We only cite research from reputable sources.  

PubMed Health provides information for consumers and clinicians on prevention and treatment of diseases and conditions. It specializes in reviews of clinical effectiveness research, with easy-to-read summaries for consumers as well as full technical reports.  

The National Center for Biotechnology Information advances science and health by providing access to biomedical and genomic information. 

Taylor & Francis Group is an international company originating in England that publishes books and academic journals. Taylor & Francis Group's journal content is hosted on Taylor & Francis Online. 

 

Medichron Publications LLC is a publishing company for the online health and medical community. It is providing on-line publications, in the nature of non-downloadable journals and articles in the fields of health, wellness, and nutrition.The company specializes in research in the field of chronobiology and news pertaining to a chronobiological approach to health. 

 

Chronobiology.com is a website published by Medichron. It is dedicated to the history, findings, and advancements of chronobiology, a field of biology that studies how our body’s natural cycles—mental, physical and emotional—are affected by solar and lunar rhythms.

 

Wiley Online Library hosts the world's broadest and deepest multidisciplinary collection of online resources covering life, health and physical sciences, social science, and the humanities. It delivers seamless integrated access to over 6 million articles from over 1500 journals, over 20,000 online books, and hundreds of reference works, laboratory protocols, and databases.

 

The Journal of Physical Fitness and Sports Medicine (JPFSM) is the official peer-reviewed journal of the Japanese Society of Physical Fitness and Sports Medicine, published by the Japanese Society of Physical Fitness and Sports Medicine. It is a free access journal that publishes all aspects of interdisciplinary sciences such as physical fitness, sports medicine, exercise physiology, biomechanics, training sciences and health sciences are covered.

 

Sleep Medicine Reviews is a bimonthly peer-reviewed medical journal covering research on the diagnosis and therapy of sleep disturbances and disorders. It was established in 1997 and is published by Elsevier.