Regulatory Standards

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Regulatory Standards

Regulatory Standards

Burton is committed to providing you with the safest and most 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 9001 and ISO 13485 standards by TÜV SÜD America.

“ISO 9001 specifies requirements for a quality management system where an organization needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement.

All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size, and product provided.”

“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 and essential performance of medical electrical equipment. It includes requirements for electrical, mechanical, radiation and flammability hazards and also requirements for structural components, labeling and accompanying documents. This standard is applicable to all electrical medical devices.

IEC 60601-1-2 defines the requirement for ensuring the product is safe with regard to electromagnetic compatibility or EMC. Lights designed and tested to IEC 60601-1-2 do not emit excess radiation which could interfere with other electronic medical devices in use.

IEC 60601-2-41 specifies the requirements for the safety of surgical and 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.

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