Virtually all standards published by British Standards Institution are agreed internationally, and are either truly International (through ISO or IEC) or European (through CEN or CENELEC). So it was a rare event when last March the BSI published a British (i.e. UK-specific) standard; two in fact! This was due to the concern of the relevant BSI Technical Committee (PS2/3) at the rapid introduction into the UK of Intense Pulsed Light (IPL) systems and their widespread installation in clinics and beauty salons countrywide.
IPL equipment generates high intensity broadband incoherent light usually in the visible or near infrared wavelengths. Specific wavelengths for use are selected by filters. Such systems are predominantly used in the cosmetic/beauty industry on the high street for such procedures as hair removal, the treatment of vascular and pigmented lesions and photorejuvenation (an alternative some say to the use of Botox). Although the HealthCare Commission regulates the use of this equipment through the Care Standards Act 2000 and its associated Regulations, the growth of the use of IPL systems has been, and is likely to continue to be, dramatic.
A major weaknesses with using IPL equipment is the lack of a specification for protective eyewear for operators (and others) and guidance for the use of that protective eyewear. Of course the Personal Protective Equipment Directive as applied in the UK requires workers and others to be protected and to use approved equipment for that purpose. The Standards issued in March of this year provide that specification in BS 8497-1:2008 'Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical application'. Part 1 is a specification for products and part 2 is guidance on use.
Protective eyewear for intense light sources (ILS) is required to protect against excessive exposure during normal operation and foreseeable accidental exposure due to equipment malfunction or human error. The protection includes accidental and cumulative exposure and discomfort associated with viewing bright reflections. The specification covers optical radiation within the spectral range 180nm to 3000nm. (N.B. This specification is not intended to give protection against laser radiation – this is covered by the standards EN207 and EN208.)
Within the body of BS 8497-1, specifications are given for the luminous transmittance and colour of the protective filters together with allowable material and surface defects, construction, labelling and user information. The requirement for active filters is also defined. Of great benefit to users is the guidance given in the informative annex of the standard which suggests methods for determining the Filter Protective Factor (FPF). The assessments can be complex as much IPL equipment has different attachment tools (applicators) to allow light of different wavelength to be emitted, depending on the procedure being conducted by the clinician. The FPF is required to be evaluated for each case, so that suitable eyewear can be selected from a manufacturer’s range.
Standard BS 8497-2 gives practical guidance on the application of protective eyewear when using IPL equipment. It refers to the European Directive 2006/25/EC (the Physical Agents (Artificial Optical Radiation) Directive), which requires risk assessments to be made and for protection to be given to those within the hazard area. BS8497-2 also requires an assessment of the risk of injury from optical radiation when exposure is likely to be in excess of exposure limit values (ELV’s). IPL equipment can emit a series of pulses in a broad spectrum and ELV’s depend on the wavelength of the radiation, the pulse duration or exposure time, the tissue at risk and the size of the retinal image. ELV's therefore vary with the type of equipment and the optical properties of the applicator in use.
The Part 2 guidance document recommends that control measures should reduce the hazard as far as reasonably practicable by engineering controls. Personal protection should only be used when engineering and administrative controls are impracticable or incomplete. Such protective eyewear should provide comfort and clear vision taking into account the ambient lighting in the treatment environment. This standard concludes with practical examples for making assessment of the retinal thermal hazard together with further information of the filter protection factor (FPF) and luminous transmittance.
These standards are essential reading for those in control of establishments using IPL equipment and Laser Protection Advisers working in the medical/cosmetic industry. Users of IPL will probably need to seek guidance to ensure total compliance. Should the current proposals of the HealthCare Commission to de-regulate the use of Class 3B and 4 lasers together with IPL come to pass these standards will be vital to all clinics and high street beauty salons to ensure the current good safety record for use of this equipment. Meanwhile the standard writers are taking these standards into the International arena for global adoption.
Contact us to discuss your particular requirements:
Phone: +44 (0)1235 550522
Fax: +44 (01235 550499
Email: training@prolaser.co.uk
