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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).


Toys

Products certification, CE » Conformity assessment (CE)

Every toy that is to enter the EU market must meet the technical requirements (the "basic requirements") defined in the Directive 2009/48/EC of the European parliament and of the council and specified in the special standards (or harmonised standards). It is obligatory for the manufacturer or his/her authorised representative to market toys that carry the CE marking and information for consumers. Although the involvement of the Notified Body is not requisite in this process, toys usually undergo the procedure of an "EC type examination" in which they are tested by an accredited laboratory and an EC type certificate is subsequently issued.

 

Application form - Certification of Toys   Application form - “Safe Toys“ mark  
Client's Handbook   Searching the database of certificates  
Harmonised standards of Directive 2009/48/EC on the safety of toys        

SERVICES PROVIDED IN CONNECTION WITH CONFORMITY ASSESSMENT OF TOYS

  • Conformity assessment by the Notified Body No. 1023 according to the Directive 2009/48/EC of the European parliament and of the council, laying down the technical requirements for toys
    • EC type examination
  • Testing of toys in the Accredited Laboratory No. 1004 and No. 1004.3
    • Chemical and hygienic properties
    • Physical properties
    • Mechanical properties
    • Electrical properties
    • Flammability
  • Granting licences for voluntary certification mark “Safe Toys Special voluntary assessment of toys completed by a licence for use of the mark.
  • Standardization services and technical information Technical Standardization Centre specialized in products for children acts within ITC
  • Certification of management systems (ISO 9001, ISO 14001, OHSAS 18001)
  • Technical inspection

PRODUCTS ASSESSED IN ITC ACCORDING TO the EC Directive 2009/48/EC ITC (NB 1023)

  • Games, combination boxes, educational toys, puzzle
  • Dolls, figures, cars
  • Doll carriages, aquatic toys
  • Chemical toys, various sets for girls and boys
  • Bobby cars, swings, slides, balls and functional toys
  • Toys for babies (rattles, teethers, shape sorters, mobiles for placing over the crib, toys to be used in sandpit etc.)
  • Toys powered by battery, toys with remote control
  • Fancy dresses, masks

CONTACTS

Person Phone fax e-mail
Ing. Ludmila Antosova +420 577 601 364 +420 577 104 855 lantosovaPostaitczlin.cz


Post address:
Institute for testing and certification, a.s.
Department of toys certification
trida Tomase Bati 299, Louky, 763 02 Zlin
Czech Republic

The person responsible for accuracy of data: Ing. Ludmila Antosova

Updated: 10.1.2017
 
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