Professional Support in Laser Safety

Product safety compliance for manufacturers

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 (see below) 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 labelled 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.


Hazard classification and product compliance

Bioptica can help manufacturers of laser equipment to comply with European and international safety standards, and to meet relevant requirements for product safety. We can determine the classification of your laser product, prepare a compliance report that identifies the labels and engineering features that are necessary, and help with the required safety documentation. Even better, if you talk to us soon enough, we can ensure that you ‘make it safe’ by helping you at the design stage to develop an inherently safe product, often reducing unnecessary hazards and eliminating the need for costly re-engineering. Through our associates we have access to optical design and laser engineering skills which, combined with our laser-safety expertise, offer unrivalled capabilities in laser-system development and safety compliance.


US safety requirements

We can also help manufacturers who export their products to the USA by explaining the compliance requirements and by preparing the necessary conformance documentation. Laser products sold in the United States must meet the requirements of the Federal Performance Standard for laser products (21 CFR 1040.10 and 1040.11), which differs in certain important respects from the EN and IEC standard. A Laser Product Report, prepared in a specified format, must be submitted to CDRH (the Center for Devices and Radiological Health, a division of the FDA), detailing how the product satisfies the requirements of the Federal Performance Standard. An accession number must then be issued by CDRH before the product can be imported and sold. CDRH will, however, accept products that have been classified and labelled in accordance with the IEC standard, provided specified conditions are met, a Product Report is submitted and an accession number is granted.

The assistance we provide to manufacturers for achieving US compliance is usually a two-part programme –

First we carry out a product assessment to determine the requirements that are applicable to your product, including protective housings, labelling, interlocks, etc., and also to identify the documentation that will be required to support the claim of compliance. Quite often, this work can be carried out entirely by email, although it is sometimes necessary, depending on the nature of the product, for us to visit your premises in order to discuss detailed aspects of the product’s design.

Using the information developed during the first stage, we then collate all the required information and compile the Laser Product Report for submission to CDRH. Once this has been sent and an accession number has been granted by CDRH, the product can be sold in the US.

By giving us as much information as you can about your product, we will be able to assess the effort, and hence the cost, of carrying out the two-part programme described above.

Note for importers: Laser products that have been manufactured in or for the USA but which are imported into Europe, including the UK, are likely to need relabelling and may need reclassifying because of the differences in the laser safety requirements between Europe and the US. Many imported laser products fail to properly meet European safety requirements.


Operating manuals & user instructions

Supplying clear instructions for safe use and giving adequate warnings of any potential hazard is obviously an important aspect of product safety. European, IEC and US safety standards all contain requirements concerning the safety documentation that has to accompany a laser product.

Manufacturers are often unsure what written warnings to include beyond the labels specified in the safety standard, and are unclear about the general guidance on laser safety that should be given. What is required will depend very much on the particular type of product, on its intended function, and on the awareness and competence of the people who are likely to use it. Bioptica can assist by identifying what needs to be included, and can help in drafting the relevant text. We can also review any documentation that has already been produced, and make any revisions that are needed.


Laser protective eyewear

Bioptica is also able to advise manufacturers and suppliers on the specification and test requirements for laser eye protection, and on the criteria that have to be satisfied in order for such protection to be CE-marked to indicate compliance with the European Directive on Personal Protective Equipment.


Manufacturers are also users!

Manufacturers of laser products are also laser users, and should ensure that they have adequate policies covering the safety of their development, demonstration and test activities. Appropriate written safety procedures must be prepared and staff should undergo regular training in laser safety. Please refer to other pages on this website for more detailed information on safe laser use and safety training.

Whatever your laser product, Bioptica can provide you with the help you need to ensure that it satisfies all relevant laser-safety requirements. Contact us to find out more.