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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).


Electromagnetic compatibility - EMC

Products certification, CE » Conformity assessment (CE)

Electromagnetic compatibility signifies the capacity of equipment to function satisfactorily in an electromagnetic environment without the equipment itself producing an intolerable level of electromagnetic disturbance to other equipment in this environment. Any equipment, apparatus, fixed-installation, assemblage of equipment or appliance must, prior to its marketing, be assessed in accordance with Directive 2004/108/EC on the approximation of the laws of the Member States in regard to electromagnetic compatibility. Conformity of the product is certified by an EC declaration of conformity and by the labelling of the product with the CE marking.

 

Application for conformity assessment   Client's Handbook  
Searching the database of certificates    
 

SERVICES PROVIDED IN CONNECTION WITH ASSESSMENT OF ELECTROMAGNETIC COMPATIBILITY OF ELECTRICAL EQUIPMENT

  • Testing in the Accredited Laboratory No. 1004 and No. 1004.3
  • Conformity assessment by the Notified Body No. 1023 according to the requirements of the Council Directive 2004/108/EC, laying down the technical requirements for products in terms of their electromagnetic compatibility
  • Technical inspection – statistical inspections, inspection certificates
  • Voluntary certification
  • Certification mark „ITC certified quality
    • ITC grants a license for the use of the quality mark, which is granted to the products where high standard of safety and quality parameters has been proved by certification and where meeting the prerequisites of the producer for continuous quality compliance has been proved through inspection visits.
  • Standardization services – search for standards, analyses of technical information, borrowing of standards
  • Certification of management systems (ISO 9001, ISO 14001, OHSAS 18001)

PRODUCTS ASSESSED IN ITC ACCORDING TO the Council Directive 2004/108/EC

  • Institute for Testing and Certification, a joint-stock company is authorized as the Notified Body No. 1023 for conformity assessment of low voltage electrical equipment in the scope as follows:
    • Slot machines;
    • Household appliances;
    • Office and IT equipment;
    • Devices in industrial facilities;
    • Devices on residential premises, commercial facilities and light industry facilities;
    • Electrical machines and lighting fittings and parts thereof;
    • Electrical measuring, control and laboratory equipment;
    • Audio, video, audio-visual and control equipment of entertainment lighting for professional use;
    • Games and toys machines
    • Office machines and computers

CONTACTS

Person Phone fax e-mail
Ing. Pavel Vavra +420 572 522 242 +420 572 522 191 pvavraPostaitczlin.cz


Post address:
Institute for testing and certification, a.s.
Testing laboratory of electrical products
Sokolovská 573
686 01 Uherske Hradiste
Czech Republic

The person responsible for accuracy of data: Ing. Pavel Vavra

Updated: 10.1.2017
 
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