Bioptica Laser Aesthetics
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Laser & IPL Manufacturers
Product safety compliance
Our LPAs (Laser Protection Advisers) are:
- Qualified and accredited to DoH and IHAS requirements
- Experienced with many years' involvement in lasers and ILs
- Active nationally and internationally in the development of safety standards
All lasers, and all equipment that incorporates a laser, should conform to the requirements of relevant safety standards. In Europe, this standard is EN 60825-1 (Safety of laser products – Part 1: Equipment classification & requirements), which is identical to the international standard IEC 60825-1. This standard is used to demonstrate conformance with various EU Directives, including the Low Voltage Directive and the Machinery Directive.
Unlike the USA it is not necessary in the UK for laser products to be registered, but it is a legal requirement that such products meet the Essential Safety Requirements of the applicable European Directives. To comply, laser products must be properly classified according to the level of their accessible laser emission. If this exceeds limits defined in EN 60825-1 the product must be labeled to indicate its class and to warn of possible laser exposure; it must incorporate engineering features as specified in the standard and must have adequate instructions for safe use. In addition, further safety requirements apply to certain types of laser equipment, including medical lasers, materials-processing lasers and optical communication systems.
In the case of medical lasers EN 60601-2-22 is also applicable (Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, therapeutic and diagnostic laser equipment).
For IPL equipment, the relevant standard is EN 60601-5-27 (Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use).
Standards are also currently being developed for home use aesthetic laser and IPL products.
For help with product compliance please contact us.