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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.”.


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).


Accreditation




The Institute for testing and certification has accredited testing rooms according to ČSN EN ISO/IEC 17 025. The national accredited authority - Czech Institute for accreditation – gave ITC Certificate of accreditation the testing room for first institute in the Czech Republic in 1991. The accreditation provide to the clients following:

  • The guarantee of the independent and objective high-grade services
  • At the same time the accreditation is the standard of the technical competence of the workplace

Flexible range of accreditation was awarded to the testing laboratory and the Product certification body – i.e. they have the possibility to introduce new methods or standards within their flexible range of accreditation in accordance with current needs of their customers. Then these procedures are identified in the output documents as flexibly accredited. The awarded range of flexible accreditation is given in annex to the accreditation certificate of testing laboratory and Product certification body.

THE RANGE OF ACCREDITATION CARRIED OUT BY INSTITUTE FOR TESTING AND CERTIFICATION, A. S.:

  • Accredited testing laboratory No. 1004
    Raw materials and semi-finished products testing (polymers, hides, strings, textiles, building materials, composite materials, chemicals) and the products from them
     - flexible accreditation

    certification of accreditation - see scope - application of flexible accreditation
  • Accredited testing laboratory No. 1004.3
    Climatic and mechanic tests, testing of electromagnetic compatibility and electric safety.

    Certification of accreditationsee scope

  • Accredited Technical inspection No. 4035
    Inspection body of type A for inspection of new and operated gameing machines and technical equipment for pools including accessories to the extent as specified in the appendix to this Certificate.

    certification of accreditation - see scope - Client's Handbook
     
  • Product certification body No. 3020
    Products certification.

    certification of accreditationsee scope

    At the International Accreditation Forum (IAF) General Assembly held in Rio de Janeiro in October 2012, the members agreed to a three year transition (IAF Resolution 2012-09) from ISO/IEC Guide 65 to ISO/IEC 17065:2012. As a consequence, the list of MLA signatories and IAF PR4 will not be updated to reflect ISO/IEC 17065:2012 until the transition period is completed on 15 September 2015.)

  • Management systems  Certification body No. 3002
    Certification of quality management systems in the field of production and services including manufacture of medical devices, environmental management system (EMS), OHS management system, food safety management system (FSMS) and critical control point system (HACCP) and social responsibility management systems (CSR).

    certification of accreditation - see scope

  • Accredited calibration laboratory No. 2222
    Gauges calibration of the electric quantities, temperature and pressureInspection body of type A for inspection of new and operated gameing machines and technical equipment for pools including accessories to the extent as specified in the appendix to this Certificate.

    certification of accreditation (in Czech) - see scope (in Czech)


Person responsible for accuracy of data: Ing. Tatana Pasiakova

Updated: 10.1.2017
 
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