“Standardisation in H2020 projects’ increases their impact and facilitates the exploitation of their results into the market”
Standardisation is a voluntary agreement among the interested stakeholders, defining common provisions that facilitate their technical, commercial or managerial activities. Those common provisions conform the content of the standards, developed under the guaranteeing rules of the standardisation organizations.
Elena Ordozgoiti, UNE’s representative in Optogenerapy project, addresses in this interview the main reasons of why standardisation in H2020 projects is a key activity for maximising their impact and details the main standardisation tasks executed during the project.
What are the main benefits of standardisation in H2020 projects?
One of the main benefits of standardisation activities is to facilitate technological cooperation and knowledge transfer.
For Horizon 2020 projects such as Optogenerapy, standardisation is a way to increase their impact outside the consortium, in particular to the Industry and Society, by providing dissemination and facilitating exploitation of their results.
How standardisation helps to ensure the success of an innovation and facilitate its exploitation?
Standards are a powerful tool for any research and innovation project since they contain high level and up to date information in many fields, from purely technical solutions to management models. Standards are the playing rules of industry and international trade.
Therefore, for the success of an innovation it is important to consider existing standards, in order to ensure compatibility and interoperability with current practices. But it is also very important to be covered by standards, helping to provide market access through reliability and users’ confidence, also removing any potential barrier.
This can be achieved by participating in existing standardisation initiatives inside Technical Committees, or by proposing and generating new ones, as necessary.
How standardisation can be used as a dissemination tool?
The standardisation system is a wide network of professionals, companies, research institutes and governmental and societal organizations. It scales from the national activity to the European and International environment, which are all interconnected.
Participation in these networks provides a fast and wide visibility of the project into a qualified audience and allows also to exchange information and knowledge.
Moreover, the inclusion of project outcomes into new standards allows this knowledge to be accessed, recognized and used by all market and societal players, even after the end of the project itself.
Which existing standards and technical committees apply to Optogenerapy device?
Being Optogenerapy a multi-disciplinary project with the participation of many areas of knowledge, there are many technical committees into which we could look for standards supporting the research or exchange of knowledge. Some of the most relevant include:
The most relevant topic of active implantable medical devices is the subject of a joint committee between two of the European standardization bodies, CEN and CENELEC: CEN/CLC/JTC 16.
Sterilisation of medical devices is included in the CEN/TC 204 field of competence.
In the field of biological evaluation of medical devices there are the CEN/TC 206 and ISO TC 194. Very relevant in this area is the series EN-ISO 10993. Being European standards, they adopt the ISO standard, therefore concentrating a superlative degree of consensus.
For optics and photonics, we could look into CEN TC 123 and ISO TC 172, the main reference being the fundamental standards of the ISO 10110 series.
The in vitro diagnosis and testing systems are dealt within the CEN/TC 140 and ISO/TC 212.
What standardisation activities have been done during the project?
The first action has been the identification of a thorough list of existing and under development standards that can support the different Optogenerapy project’s tasks.
Secondly, the partners in the Consortium have been asked to identify any needs for new standards that are not yet in the catalogue of the European and international standardization bodies and the Consortium will be making its proposals briefly.
In the next months, the Consortium will take advantage of the standardization network to disseminate Optogenerapy main features and point the identified needs for standards.
And finally, there is a potential topic resulting from the conducted research that can be proposed as the basis for a new European standard, under the umbrella of the European Committee for Standardization (CEN).
In your opinion, which specific aspects developed during the project are prone to be included in future standards?
The Consortium is assessing the feasibility to develop a European standard document on the minimum optimum frequency required to power an implanted medical device, such as Optogenerapy’s one, specially having in mind the later use in human beings.
The above-mentioned European standard could be a CEN Workshop Agreement (CWA), a fast-track (pre)standard document well suited to include emerging knowledge or technologies, making them available to the industry and society in a short time. The CWA can later evolve into a full European or International Standard, following the necessary process and consensus requirements.
About Elena Ordozgoiti
Elena Ordozgoiti has large experience in standardization in several fields, assuming direct responsibilities in European and International technical bodies. She has cooperated with projects comprising East European countries to help them to upgrade their standardization competencies.