Burton is committed to providing you with the safest and more effective medical lights for all your applications. Our lights are designed and manufactured to meet all applicable regulatory requirements and our facilities are certified to the global standard for medical device manufacturing companies.

International Standards Organization Certifications

Burton is certified to the ISO 13485 standards by TÜV SÜD America.

“ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.”

Burton is also registered as a medical device manufacturer by the United States Food and Drug Administration (FDA) and by Health Canada.

Companies must be registered by the FDA to manufacture medical devices in the United States. This registration requires Burton to follow the FDA Quality System Regulation.

Product Certifications

Burton’s products are tested and certified to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-41 and CAN/CSA C22.2 NO. 60601 standards.

IEC 60601-1 is the general requirements for basic safety of medical electrical equipment. It includes requirements for electrical, mechanical, radiation and flammability hazards and also requirements for structural components, labelling and accompanying documents. This standard is applicable to all electrical medical devices.

IEC 60601-2-41 specifies the requirements for the essential performance of surgical luminaires and luminaires for diagnosis.

The products are also CE marked according to the requirements of the Medical Device Directive MDD 93/42/EEC for distribution in the European Union.

CoolSpot - Model II - Exam & Procedure Lights - Brochure

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