Red and Blue Light Therapy Devices and EU Compliance

As the demand for light therapy devices grows, and the industry along with it, widespread call for regulation within the field has been made. From workplace health and safety practices to greater classification and differentiation between devices, many aspects of the burgeoning industry were to be considered. All of these issues are addressed under European Directive 2006/25/EC, an important piece of legislature in regards compliance for manufacturers of lamp/light devices, including those manufacturing red or blue light therapy devices.

Directive 2006/25/EC regulates a variety of health and safety requirements for manufacturers with a special focus on the safety of workers. Based on the 89/391/EEC European Council directive (focused on creating measures to ensure worker safety in the workplace), 2006/25/EC sets a number of parameters manufacturers must operate within in order to be compliant in cases where staff members are working in areas exposed to UVR or where workers are at risk of exposure to artificial optical radiation.

The directive puts the onus on manufacturers to conduct regular internal risk assessments to avoid unnecessary exposure to URV or AOR. It also designates that information and training be provided to workers, as well as regular health surveillance and screening (to be carried out by a qualified health professional) within the bounds of national laws and requirements. It is also the duty of each European member state to ensure proper records are being kept in regards each individual.

Lamps and light devices affected by Directive 2006/25/EC are classified by risk, ranging from lowest to highest, to ensure manufacturers can adhere to all Good Manufacturing Processes accordingly. Classifications are as follows:

  • Exempt

Devices not covered by the directive. They cause no discernible damaging effects, even in cases of long-term use

  • Risk Group 1

Low Risk. Devices accepted as safe for general use, though may have long term effects due to excessive use or direct viewing

  • Risk Group 2

Moderate Risk. Devices that pose no major risk of optical hazard if used correctly and under the right conditions

  • Risk Group 3

High Risk. Devices that have a high potential for personal damage even with brief interactions

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For more information on European Directive 2006/25/EC, the compliance route for products affected by the directive, or for regulatory advice, contact Obelis today.

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