KANBrief 3/25
Are the processes of standards development – international, European or national – as transparent, efficient and sustainable as they ideally should be? Based on his personal experience, gained over two decades of active involvement in standardization activity, Peter Paszkiewicz, Head of the test and certification body at the Institute for Occupational Safety and Health of the DGUV (IFA), sees an urgent need to ensure that decisions taken in the standards development process continue to be transparent over the long term.
As I have seen from my own experience at the German Social Accident Insurance (DGUV), one aim of expensive and time-consuming research is to set out requirements in standards for the safe design of products and to develop the corresponding test procedures. On the one hand, product requirements are formulated as a result of accident investigations; on the other, pre-normative research is used to develop test procedures that may be very complex. The extensive preparatory work may ultimately be summarized in just a few sentences in the text of a standard. These sentences are, however, scientifically validated.
This presents a problem in that generally, no systematic record is available, either internally within the standards bodies and their committees or publicly, that would readily permit scrutiny at any time in the future of the requirements and of the form of the test set out in the standards. As a result, when the experienced experts working at the forefront of standardization retire, as many are about to do, and are replaced, hardly anyone will be left who is familiar with the background to the provisions in the standards and able to verify them. As a result, the next generation might dispense with evidence-based decisions and provisions that have been in place for decades, and might do so with neither discretion nor warning.
A good example is the recent revision of the 2013 version of ISO 1999, Acoustics – Estimation of noise-induced hearing loss. Like the versions preceding it, the 2013 version is based on sound scientific research conducted in the 1970s. In the course of the revision, the standards committee sought to build on more recent but poorly validated findings. These could have led to significant problems in the form of excessively strict occupational safety measures at high-noise workplaces. Only through intervention by one of the last remaining experts to have been actively involved in production of the 1990 version, and objection by KAN in 2024 (see KANBrief 4/24), was it possible to halt the current revision efforts. This provision of the standard has now been left unchanged. Might this intervention have been completely unnecessary, if clear and fully documented validation of the requirements had been available?
Another example is the intensive dialogue between European parties to the standardization of respiratory protection in the early 2000s, following observation of unexpected deviations in round-robin tests of particle-filtering half masks. Owing to new requirements, parts of the testing apparatus were seen to have a significant and hitherto unknown influence on the measurement result. Consequently, the requirements upon the apparatus were revised. Will important findings like these, which have been obtained by European experts at great expense through numerous meetings and comprehensive laboratory tests, survive the next rounds of revision? Would it not be advantageous in this case, too, to document and preserve these studies clearly together with the standard?
It is important that the public also be allowed to participate in the deliberations and background for the establishing of normative requirements, rather than access to supporting documents being limited to experts actively involved on committees. This can be seen from the example of the formal objection raised by Germany in 2023 to the EN 149 standard for particle-filtering half masks, which as a result of the pandemic became known as “FFP2 masks”. The objection criticized certain design and testing requirements. Perhaps the formal objection would not have been raised at all had the background to the standardization activity been presented transparently and in a form accessible to the public, thereby also allowing committed experts who were not involved in the committee work to participate?
It’s time we learnt from the numerous examples like these. The essential points – i.e. those defining the parameters relevant to safety – of the scientific and technical background to all important requirements and test procedures in standards must be comprehensible to future generations of standardization experts, and must be documented thoroughly and in ways that also permit their inspection by the public. The practice of the MAK Commission could serve here as a model: when setting limit values for hazardous substances, it prepares extensive documentation of reasoning for each substance. The current working methods in standardization are neither transparent nor sustainable. Standardization claims to be scientific. This must therefore be reflected in all steps and at all levels of its activity.
Peter Paszkiewicz
peter.paszkiewicz@dguv.de