DKE on the Way to SMART Standards - A Decade Characterized by Digitalization in Standardization

The topic of digital standards was still in its infancy in October 2016.  Nevertheless – or perhaps even precisely why – the DKE placed it on the agenda of the General Meeting of the International Electrotechnical Commission (IEC), which the DKE had the honor of hosting in Frankfurt that year. The basis for this development was provided by the so-called “Standardization 2020” program, which promises nothing less than a complete transformation. The preparation of standards is to be carried out on online platforms, data management made significantly more efficient, and the application of standards is to become much easier. At the same time, DKE studies demonstrate how standards can be integrated directly into engineering processes as digital twins. While the market showed keen interest, it was unable to imagine what the actual impact might turn out to be. Damian Czarny, then head of the digitalization division at DKE noted: “Of course, even back then, there were myriad complaints about how complicated it was to apply standards using traditional PDF files and hundreds of pages. But to carry out improvements it wasn’t enough to introduce just one or two new tools. We were faced with a complete digital transformation of all of our standardization processes – from preparation to data management, all the way through to application – the scope of which only a few really understood in 2016.”

Everyday obvious

Things in our everyday lives just seem to work without us even thinking about them: products are safe, technologies are compatible and innovations find their way into our lives. Behind this sense of normality are people who think ahead. Join us as we follow a young woman through her everyday life, where the impact of standardisation becomes clear.

An exceptional case is represented by the medical device manufacturer Dräger in Lübeck. With total sales of EUR 3.4 bn in the year 2024, approximately 16,000 employees, and business locations in more than 190 countries around the world, this family-owned enterprise is a textbook example of a “hidden champion”. And the company’s conviction is that standardization must become digital. Matthias Marzinko, director of international standards management at Dräger, describes how labor-intensive it can be to work with standards in conventional PDF formats. For example, in order to develop new ventilators experts evaluate a plethora of standards, interpret the relevant provisions, incorporate the requirements of the respective standard into the product documentation, and subsequently test the prototypes. Parallel to this they have to track and account for any updates to the standards. And then there are the approval processes that are becoming increasingly sophisticated. Meanwhile, around 40 different countries and regions regulate their medical device markets in in their own particular ways – compared to just four in the year 2000. Yet standards remain at the core of these regulations.

Perhaps a world without standards would be better? “Under no circumstances. That would be downright life-threatening when it comes to medical devices. Or would you want to be treated in a hospital with untested equipment?” asks Matthias Marzinko. At the same time, internationally valid standards are a prerequisite for Dräger in order to be able to sell their products worldwide. And this is absolutely essential given the often relatively small quantities. Thus: Standards are indispensable. However, their implementation could be a lot easier – and digital solutions are paving the way.

SMART Solutions for Standards: Why now is the moment to act

SMART solutions for standards are no longer a future concept – they are becoming a defining factor for how standards deliver value in a digital world.

Why this shift affects the entire IEC community and why everybody now have a unique opportunity to benefit explained Maria Lazarte and Francis Pernel in our interview.

It quickly becomes clear that the path to digital solutions is a joint effort.  In the year 2018 the DKE, together with DIN, founded the Initiative Digital Standards (IDiS) that now includes a network of 130 market participants. From the very outset the aim  has been to move forward and promote the development of SMART Standards – that provide all of the relevant information for people and machines in the appropriate format, anytime and anywhere – through close cooperation. The added value quickly comes to light. An IDiS study determined that the use of SMART Standards in standard applications reduces costs by more than 60 percent. Dräger is one of the initiative’s founding members and Matthias Marzinko refers to it as the “Club of the Willing”: “DKE has created a remarkable framework here in order to exchange ideas on key issues. What should standardized exchange formats look like? How do we ensure machine readability? And what needs to be done so that we can verify compliance with standards in product development with a single mouse click in both a comprehensive and reliable manner in the future – with the welcome aid of artificial intelligence?”

Marzinko is looking forward to much more efficiency, fewer errors in the transfer of standards, and greater legal certainty through IT-supported conformity and quality assessments. Another reason is that the willingness to adopt digital solutions in the standards sector has increased dramatically in recent years. The reasons for this include growing pressure to innovate and a perceptible shortage of skilled workers in the standards community. In addition, employees are now much more open to digital solutions. In essence, this is a worldwide development. “In this environment the German economy benefits from the fact that DKE is also promoting this issue on a global level,” comments Matthias Marzinko.

Conformity Assessment – the Free Flow of Goods Worldwide

The term “conformity assessment” is widely known – yet it is oftentimes quite intangible. Conformity assessment essentially provides for the free flow of goods within one or more markets around the world. Numerous national laws as well as international guidelines and regulations are employed in order to assess goods, processes, and services. In addition, the requirements of conformity assessment procedures vary in different industries – such as the toy industry, medical technology, or electrical engineering. Our technical article on conformity assessment summarises the key points and provides answers to frequently asked questions.

DKE has in fact invested heavily in SMART Standards over the past decade. To this end, the organization established a dedicated business segment and specialized roles such as community and digital transformation managers, data scientists, and software developers were created. The implementation of digital standardization formats was decisively advanced in close cooperation with the IEC. The further development and provision of appropriate SMART Services is now being outsourced to a separate company with successful establishment of the technical and organizational foundations – namely, the newly founded VDE SIS GmbH.  At the same time, DKE is continuing to develop the internal structures of its digitalization activities: The DKE Digital Hub is the motive force behind digital innovation within DKE. This gives rise to two divisions: DKE remains responsible for the fundamentals of a digital standard (expert knowledge, data models, international harmonization), while VDE SIS GmbH adapts these for specific applications in order to integrate them into customer solutions.

Context: SMART Standards are much more than just a new technology. They engender a comprehensive transformation process that affects the entire value chain – from preparation of a standard to its application. Damian Czarny: “As the DKE we made a conscious decision to invest and take the risk. Our aim is not just the ‘optimum’ application of standards, but to exploit their full potential. We see ourselves not only as service providers, but as pioneers, resolutely advancing the digitalization of the standardization industry.” “This approach is gaining wide acceptance – far beyond Germany.”

DKE experts are in fact invited to give presentations worldwide and see themselves almost like sales representatives for SMART Standards. Their participation in the respective IEC committees and joint IEC-ISO committees where the topic of digitalization is advanced through close global cooperation and coordination is particularly relevant. Thus, for example, the DKE played a key role in co-developing the Online Standards Development Tool (OSD). This tool makes it possible for experts in standardization to collaborate across borders via a shared web browser, accelerates the consensus-building process, and lays the groundwork for creating standards that are machine-readable from the outset.

Dräger eagerly anticipates this brave new world of SMART Standards. And it is becoming increasingly real. For example, the 60601 series of standards – which defines basic safety and performance requirements for medical devices – is currently being revised and will be completed by the year 2030. The highlight: The standard will not be prepared using Word, but instead in a digital online environment and made available through new distribution channels. Matthias Marzinko: “A milestone that would be inconceivable without the commitment of the German standards organizations.”

The world is going digital – and with it, standardisation. As the central organisation for electrotechnical standardisation in Germany, DKE is actively shaping this change. For us, digitalisation means more than just automating existing processes or using new technologies. It is a fundamental transformation process that is redefining the way we work, our products and our role in the standardisation ecosystem. Further information on this subject area can be found in the