European standardization is meant to
buttress companies’ competitiveness and contribute to product safety. On 28
October 2019, the European Commission presented its annual Work Programme and Annexe for 2020. This programme sets out the contracts
envisaged by the Commission aiming to develop or revise harmonized European
standards as well as its extended strategic priorities for the coming year.
Standardization mandates to bolster EU legislation
From the perspective of the German Social
Insurance, the focus is to be set on such fields as health, labour protection,
as well as the standardization to support compliance with accessibility
requirements for products and services.
In line with Council Directive
96/29/Euratom laying down basic safety standards for the protection of the
health of workers and the general public against the dangers arising from
ionizing radiation, the Commission intends to mandate harmonized standards for
the design, manufacture, setting up, utilization, and performance check of
radionuclide calibrators. The Commission intends to make a contribution to the
dose optimization process by reviewing the radiation dose administered to
patients through radionuclide calibrators.
The revision of standards aiming to support
the implementation of the directive 2014/34/EU on the harmonization of the laws
of the Member States relating to equipment and protective systems intended for
use in potentially explosive atmospheres is meant to help us stay abreast of
The Commission also intends to mandate
harmonized standards to support compliance with accessibility requirements for
products and services under Directive (EU) 2019/882. The aim is to harmonize
the approaches used by manufacturers and service providers to comply with
certain accessibility features.
Strategic orientation of standardization
Besides standardization aimed to support
existing EU legislation, the strategic focus, too, is of interest to the
European standardization system. The focus is, among other things, on cyber
security and cyber defence, which in view of the machine safety and the
handling of these machines in the workplace appear to be of growing importance
for labour protection. The Commission wants European standardization organizations
to concentrate on the development of standards helping to improve safety
protocols, early detection and containment of cyber attacks as well as of those
ensuring the interoperability of diverse Internet of Things networks.
Another focus is on the European
interchange format for electronic patient records. The Commission wants the
standardization organizations to support the deployment of the format it has
recommended. To achieve this goal, standards for the protection of patient
records should be developed and the safety of network and information systems
serving as a basis for electronic patient records should be guaranteed.
As the Commission sees it, European
standardization organizations should give high priority to the subject of
“artificial intelligence” and the development of standards which reflect the
European approach to the operation of systems based on AI. Standardization is
meant to assist in coping with challenges resulting from AI technologies,
especially with regard to safety, liability and ethic aspects.
As has been announced in its European
Standardization Work Programme for 2019, the Commission intends to take a closer look at the
economic and socio-political implications of standardization. To this end, the
Commission will launch a study, the results of which will be available in 2021.