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Austrian Standards to provide sigificant discounts on international standards and technical specifications associated with the IVDR

Until November 20, 2020, you can save up to 50% on pre-analytical ISO standards & ISO 15189!

On the initiative of the Austrian Biobanking infrastructure BBMRI.at, Austrian Standards is offering international standards and technical specifications associated with the IVDR (In vitro Diagnostic Regulation) at a greatly reduced price. This promotion is on the occasion of the “LISAvienna Regulatory Conference for Medical Devices and In-Vitro Diagnostics” which is co-organized by LISAvienna, BBMRI.at and en.co.tec and on the occasion of the “BBMRI.QM webinar series on sample pre-analytic standards” from BBMRI-ERIC.

In the promotional period from September 23 to November 20, 2020, you will benefit from the following price reduction when ordering the standards mentioned:

  • 50% discount on relevant ISO standards and CEN / TS specifications “Molecular in vitro diagnostic examinations“ (see list of standards below)
  • 50% discount on ISO 15189:2014 “Medical laboratories - Requirements for quality and competence”
  • 20% discount on ISO 20387:2018 ”General requirements for biobanking”

The discounts are already taken into account and are valid for all language versions.

Did you know that the national versions of the European Standards are identical in content?

European standards are marked with the abbreviation "EN" - this means that all members of the European standardization organizations CEN and CENELEC have to adopt the standard nationally. Except for the language, the national versions of the European standards are identical in content (e.g. BS EN ISO 15189 = DIN EN ISO 15189 = ÖNORM EN ISO 15189).

Order the standards (in German and/or English versions) at the reduced rate here:

Why are the pre-analytics standards relevant?

The European Parliament passed a new EU regulation for in-vitro diagnostics (IVDR) in 2017. The transition period runs until May 2022. By then at the latest, manufacturers of in-vitro diagnostics will have to adapt to regulatory changes in order to secure access to the European market. 

The new regulations affect not only products that are still in the development stage, but also all products already available on the market. In addition, products manufactured and used in healthcare facilities (so-called Laboratory Developed Tests (LDT), "in-house" tests) are also affected. The IVDR requires addressing the sample pre-analytics to describe it in the technical documentation. In this context the pre-analytics standards "Molecular in vitro diagnostic examinations — Specifications for pre-examination processes" represent the state-of-the-art and are relevant norms.

The sender takes full responsibility for the content of this news item. Content may include forward-looking statements which, at the time they were made, were based on expectations of future events. Readers are cautioned not to rely on these forward-looking statements.

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