DIN Deutsches Institut für Normung E.V.

Short Name: DIN

Country: DE

Organization description:

DIN is a non-profit organization recognized as a German National Standards Body (NSB) representing Germany within CEN, the European Committee for Standardization, and ISO, the International Organization for Standardization. Today, roughly 85% of all national standards projects are European or international in origin.

DIN prepares standards as services for the economy, state, and community. Standardization is considered as a strategic instrument to support economy and the society in general. It reduces the need for legislation and supports convergence in technology whilst allowing for a wide range of local solutions if needed.

DIN supports any R&D projects with the concept of R&D Phase Standardization, which covers any activity with the aim of early identification of standardization potential of products and services, establishment of standardization processes and assistance with public availability of the results of these processes. Because of this the sustainable transfer of knowledge and technology will be enhanced and accelerated in innovative fields.

External specialists use their expertise to develop the content of standards, with DIN’s project managers ensuring the entire process runs smoothly. DIN staff members coordinate national, European and international projects, making sure all internal rules of procedure are followed. This increases the global acceptance of DIN Standards.

DIN’s main business field is national, European, and international standardization.

Expertise:

DIN is qualified of submitting new project proposals to relevant Technical Committees as well as to perform networking activities with other European and international committees. This can especially be done to build awareness of European projects under development within pan-European and international experts’ communities, and to get input from such liaison partners during official voting processes.

Facilities:

Standardization work needs the existing interlinked committee structures of DIN, CEN and ISO, including the project management expertise, and quality control systems enabling the transfer of research results into standardization.

DIN is going to use its modern Conference Center and its internal ICT suitable for physical and virtual meetings to support the standardization activities. Furthermore, DIN is going to use its internal databases, e.g. Perinorm, to perform the research of standards, standards under development, and further standardization activities. Perinorm is a bibliographic database dedicated to helping with standards and technical regulations enquiries. It is the world’s leading bibliographic database of national, European and international standards from more than 200 standards publishing organizations in 23 countries, with a total of more than 1,400,000 records. Available in three languages (English, French, and German), Perinorm comes with a monthly update. The quality of information is guaranteed by monthly delivery of records direct from each standards publisher. With powerful and flexible search features Perinorm allows to quickly and easily make documentation queries and manage international standards compliance.

DIN is going to use its proficiency in standardization project management at International, European and national levels to support the standardization activities. DIN holds the relevant European Secretariat for CEN/TC 140 “In vitro diagnostic medical devices”. As such, DIN is the process owner of the technical work in this field and responsible for the document management, meeting management and compliance. Existing national mirror committees and structures enable the project partners to directly submit project related research results and standardization proposals to be subject to European standardization. The management of accepted projects can be handled by DIN within the dedicated CEN/TC 140/WG 3 “Quality management in the medical laboratory”.

Other European projects:

DIN has participated in a large number of EU-funded research projects (FP5, FP6, and FP7) and in national research projects and is currently participating in H2020 projects. This participation is governed by the idea that standardization is an excellent tool to disseminate research findings to a larger community and to facilitate the market access of new technologies and services.

DIN has contributed to standardization activities of European research projects such as:

SPIDIA – Standardization and Improvement of Pre-analytical Procedures for in vitro Diagnostics (FP7, Collaborative Project)
SFERA – Solar Facilities for the European Research Area (FP7, Combination of Collaborative Project and Coordination and Support Action)
SustainValue – Sustainable value creation in manufacturing networks (FP7, Collaborative project)
iNTeg-Risk – Early Recognition, Monitoring and Integrated Management of Emerging, New Technology Related Risks (FP7, Collaborative Project)
NanoSTAIR – Establishing a process and a platform to support standardization for nanotechnologies implementing the STAIR approach (FP7, Coordination and Support Action)
SMARTDIAGNOS – Rapid detection of Sepsis (Horizon 2020)
SPIDIA4P: SPIDIA for Personalized Medicine – Standardisation of generic Pre-analytical procedures for Invitro DIAgnostics for Personalized Medicine (Horizon 2020)

Role in the project:

DIN will support standardization activities through use of appropriate methods to transfer the results into European/International standardization, where possible. On the basis of project outcomes, standardization activities will be initiated aiming to result in the contribution to or the preparation of one or more standard document(s) (e.g. European or International Standard(s) and/or Technical Specification(s)) making use of the standardization infrastructure of ISO/CEN available for documentation and dissemination of results.DIN will be responsible of the WP 7 leadership as well as the guidance of all Task leaders under WP 7.

Key personnel:

Ulrike Schröder

Ulrike Schröder, (female), M.Sc. in Biomedical Technologies, is a project manager at DIN, Standards Committee Medicine responsible for the development of standards in the field of healthcare and medical technologies and the secretary of CEN/TC 140/WG 3 “Quality management in the medical laboratory”. She is currently participating in the Horizon2020 projects SPIDIA4P and SMARTDIAGNOS. Role in project: Project Manager for DIN’s contribution to the project, i.e. guidance regarding standardisation issues to the consortium.

Elisabeth Beck

Elisabeth Beck, (female), is Head of DIN Technical Group 1.2 and employed at DIN since 1996. Focus topic of DIN Technical Group 1.2 is standardization for the Medical and the Optics and Photonics sectors. During her career she has been responsible for the project management of various projects, mainly related to International and European standardization in the optics and photonics field. Since 2007 she is Head of DIN Technical Group 1.2. Technical Group 1.2 consists of a team of 16 Project Managers and 8 Assistants. Role in project: Supervisor for DIN’s contribution to the project; reports and finance.

Main publications and awards:

Publications:

CEN/TS 16826-3:2018, Molecular in vitro diagnostic examinations – Specifications for pre- examination processes for snap frozen tissue – Part 3: Isolated DNA

CEN/TS 17305:2019, Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for saliva – Isolated human DNA

FprCEN/TS 17390 – series, Molecular in vitro diagnostic examinations – Specifications for pre- examination processes for circulating tumor cells (CTCs) in venous whole blood

EN ISO-series 20166, Molecular in vitro diagnostic examinations – Specifications for pre- examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue’.

EN ISO-series 20184, Molecular in vitro diagnostic examinations – Specifications for pre- examination processes for frozen tissue

EN ISO-series 20186, Molecular in vitro diagnostic examinations – Specifications for pre- examination processes for venous whole blood