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Quality Testing

Our quality control team coordinates the manufacturing, in-house testing, including the third-party testing process according to international regulations, procedures, and criteria for the certification of medical devices for medical HBOT & wellness applications.

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Safety and Compliance

Safety standards and certifications play a vital role in guaranteeing the quality and reliability of hyperbaric chambers used for hyperbaric oxygen therapy (HBOT).

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Certifications

Komjet hyperbaric chambers comply with a wide range of international regulatory standards to ensure safety, quality, and operational excellence.
These certifications are categorized based on their focus, covering medical device compliance, pressure vessel safety, product and occupational safety, quality management, and regional market approvals.

 
 

ISO 13485 – Medical Devices Quality Management System

This certification confirms that Komjet adheres to internationally recognized standards for medical device manufacturing, ensuring quality control throughout the product lifecycle.

2014/35/EU - Low Voltage

This directive (LVD) is particularly relevant for the introduction of electrical products on the European market. It must be ensured that electrical products meet the necessary safety standards in order to reduce or ideally virtually eliminate the risk of electric shocks or other potentially dangerous situations.

EN/IEC 61000-6-1 - Immunity standard for residential, commercial and light-industrial environments

Applies to electrical and electronic apparatus intended for use in residential, commercial and light-industrial environments. Immunity requirements in the frequency range 0 Hz to 400 GHz are covered.
This standard applies to apparatus intended to be directly connected to a low-voltage public mains network or connected to a dedicated DC source which is intended to interface between the apparatus and the low-voltage public mains network.

ISO 9001 – Quality Management System

This directive ensures the mechanical safety of hyperbaric chambers, covering aspects such as moving parts, emergency stops, and user interfaces to protect operators and patients from mechanical hazards.

EN/IEC 60204-1 - Safey of Machinery

This directive is a European standard focused on the electrical safety of machinery.It outlines the general requirements for electrical, electronic, and programmable electronic equipment and systems used in machines that are not hand-portable during operation.The standard aims to ensure the safety of both people and property associated with the machine's electrical equipment.

2014/30/EU - Electromagnetic Compatibility

This directive (2014/30/EU) is part of the CE marking system that deals with the electromagnetic compatibility (EMC) of electrical and electronic equipment. The EMC Directive ensures that products imported into the European Economic Area (EEA) meet certain safety, health and environmental requirements.

EN/IEC 6100-6-3 - Emission standard for equipment in residential environments

EN IEC 61000-6-3:2021 details emission requirements for electrical and electronic equipment intended for use at residential locations in order to ensure that radio reception is adequately protected.