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the Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices

On May 5, 2017 the Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC was published in the Official Journal of the European Union.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 26 May 2020. By way of derogation, see the Article 123 Entry into force and date of application.


Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices

On May 5, 2017 the Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU was published in the Official Journal of the European Union.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 26 May 2022. By way of derogation, see the Article 113 Entry into force and date of application.


Electronic communication – restriction of attachments in ZIP format.

ITC applied the restriction by which it will not be possible to deliver the electronic message with an attachment in ZIP format.

For delivery of large quantities of electronic documents, use a different method than compress into ZIP format.

Thank you for your understanding.


Termination of the contractual cooperation with the company Sastek, Turkey

On 31st August 2015 was terminated a contractual cooperation with the Turkish sales representative of ITC - the company “SASTEK Conformity Assessment Services Co.”.


Testing of Collectors according to ISO 9806

The testing standard for thermal solar collectors with liquid medium, EN 12975-2, has been was replaced with the new standard EN ISO 9806. The new standard reflects the latest development in production and testing of collectors.


News

// 20.10.2014
nanotechnology - the analytical laboratory of ITC engage in cooperation with the Technical University of Dresden


The analytical laboratory of ITC engage in cooperation with the Technical University of Dresden in the project " nanotechnology – guidance on detection and identification of nano-objects in complex matrixes", which is demanded by the French Bureau of Standards (Association Francaise de Normalisation).

The aim of this theoretical work is charting of available, missing and emerging techniques for measuring the presence of nano-particles in difficult matrixes combined with their identification. The final document will be used for standardization purpose and give guidance for measurements at the nano-scale.

The analytical laboratory at ITC has also techniques for measuring of nanoparticle dimensions with electron microscopy and by use of single-particle ICP-MS the laboratory is able to count and size nanoparticles. In this area we have already realized commercial contracts for dimensional measurement and counting distribution of nanoparticles in different matrices.

Contact: F. Puype +420 737 203 199


 
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