Risk Analysis beyond the Standard


We can advise how to design a safe product “beyond” the standard and how to characterise the actual risk.  

The classification of a product according to IEC 60825-1 and IEC 62471 provides a reasonable basic information and a standardised assessment of the basic and rough extent of hazard concerning the accessible radiation. But at the same time, due to standardisation (the same procedure has to be applied to all products), the classification still has failings with regard to some products or it might not be applicable at all. It is therefore possible, that the actual extent of hazard concerning a specific product is completely overrated by the classification, or in some cases (e.g. large beam diameters and exposures by means of large binoculars) even underestimated (i.e. Class 1 lasers could cause eye-damage).

During a risk analysis, the actual expected exposure durations and the level of exposure are taken into account and compared to the appropriate limits relating to the eye and the skin. In a probabilistic risk analysis, the probability of exposure of the eyes (to a certain level) can also be taken into account. Such a risk analysis can for example prove why a class 3B line laser, that has been installed on the ceiling of a factory hall, is safe for normal appropriate use and it also explains in what situations (e.g. cleaning of the laser optics) specific measures are required. In these cases, where a standard classification is over-restrictive, the manufacturer’s need for risk analysis will automatically arise and undoubtedly be requested by users and work-safety authorities.

It is a legal requirement that a product has to be “safe”. European law (for placing a product on the market) stipulates that a manufacturer has to carry out a risk analysis. The hazards have to be characterised on the part of the manufacturer and – in order to obtain a safe product in the full sense – the warnings and constructive measures have to be determined accordingly. Compared to these requirements and the variety of products that contain lasers, technical standards are not always specific enough. The user has to be instructed about the actual risks for the eye and the skin as well as about other hazards. If these hazards can be averted in a constructional way, engineering safety-measures have to be prioritised when designing a product (especially in cases of particularly high risk). However, designing a laser or a warning label that complies with the standard is not in all cases sufficient to be regarded as compliant with legal requirements (at least not in Europe). A Class 3B laser that is not encapsulated and has the warning label “Avoid exposure to the beam “ is not allowed to be marketed as a household device just as a toxic toy with the warning label “Do not suck” is not allowed to be marketed.

As leading “co-author“ of the standards IEC 60825-1 and IEC 62471, our senior consultant, Karl Schulmeister, knows their limitations and has in addition to that studied the basic legal requirements for a “safe” product in Europe to the extent that lead to the publication of an e-book (in German language only). 

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