Burton Medical Products is committed to providing you with the safest and most effective medical lights for all your applications.  We have designed our lights to meet the most stringent regulatory standards and our facilities are certified to the highest standards for medical device manufacturing companies. 

ORGANIZATIONAL CERTIFICATIONS

Burton Medical Products is certified by Underwriter’s Laboratories to the ISO 9001:2000 and ISO 13485:2003 standards.    

“ISO 9001:2000 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 of the system and the assurance of conformity to customer and applicable regulatory requirements.

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 13485:2003 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 an FDA registered medical device manufacturer.

Companies must be a registered facility and authorized by the FDA to manufacture medical devices.  This registration requires Burton to follow the FDA Quality System Regulations and to go through periodic audits with FDA personnel to ensure the quality system is intact and functioning well.

PRODUCT CERTIFICATION

The majority of our products are tested and certified to UL 60601-1, IEC 60601-1-2, and IEC 60601-2-41.

UL 60601-1 is the general requirement for product safety.  This standard can be applied to several different industries and different types of products.  It states equipment that is operated under normal conditions and maintained per the instructions will not cause any safety hazards while the equipment is in use.  Some examples of hazards addressed in the standard are fire and electrical shock.

IEC 60601-1-1 specifies the safety requirements necessary for protecting the patient, the user and the surrounding areas.  This is a collateral standard to IEC 60601-1 that is intended for medical equipment.

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

IEC 60601-2-41 specifies the requirement for the safety of surgical and diagnostic luminaires.  This is a particular standard which emphasizes the safety of luminaires within the vicinity of the patient. 60601-2-41 requires the luminaires to be manufactured and tested in a controlled environment using components certified by the third party testing facility.