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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).


Mark "Safe toys"

Products certification, CE » Voluntary certification

ITC has been providing professional services in the field of toys testing and certification for more than 15 years. In 2004, ITC was approached by the Italian Institute for Toys Safety (IISG), which was looking for a suitable partner for extension of the “Safe Toys“ project into East European countries. ITC became one of the project's licensees and can now provide to the Czech producers and dealers services allowing them to mark high quality and safe toys with a yellow logo with “Safe Toys“ inscription.

 

Application
  Client's handbook  
Searching the database of certificates   Project Information
 
General rules for using "SAFE TOYS" mark        

”SAFE TOYS“ CERTIFICATION MARK

ITC has been providing professional services in the field of toys testing and certification for more than 15 years. In 2004, ITC was approached by the Italian Institute for Toys Safety (IISG), which was looking for a suitable partner for extension of the “Safe Toys“ project into East European countries. ITC became one of the many project’s licensees and can now provide to the Czech producers services allowing them to mark high quality and safe toys with a yellow logo with “Safe Toys“ inscription.
The “Safe Toys“ project brings a suitable solution for manufacturers and distributors that seek very careful assessment of the product considering all possible risks. Buying a product bearing the “Safe Toys“ mark is a good choice for the final consumer as well as a guarantee of safety provided through certification by a competent body. Continuous supervision of the product quality and safety throughout its introduction to the market provides a high degree of assurance that the toy will not cause temporary or permanent injury to the child’s health.

FOR WHOM IS THE MARK INTENDED?

  • The certification mark is intended for all toys defined by the EC Directive 2009/48/EC:
  • Games, combination boxes, educational toys, puzzle
  • Dolls, figures, cars
  • Doll carriages, aquatic toys
  • Chemical toys, various sets for girls and boys
  • Bobby cars, children’s scooters, children’s bicycles, swings, slides, balls and functional toys
  • Toys for babies (rattles, teethers, toys to be used in sandpit, etc.)
  • Toys powered by battery, toys with remote control
  • Fancy dresses, masks, textile toys

CONDITIONS OF OBTAINING “SAFE TOYS“ CERTIFICATION MARK

  • Conditions for acquiring the right to mark the products with this certification mark are as follows:
  • Meeting the requirements guaranteeing higher level of safety, described in General Rules for Licence and Use of “Safe Toys“ Mark and obtaining the certificate from the body authorized for activities in the  “Safe Toys“ project
  • Positive results of periodical inspections carried out by a body authorized for activities in the “Safe Toys“ project
  • Signing a licensing agreement for the use of the “Safe Toys“ mark

LABORATORY EVALUATION OF TOYS IN “SAFE TOYS“ SYSTEM

  • Tests are carried out after prior hazard analysis and classification of toys according to the age category by a specially trained certification person.
  • Physical and mechanical tests
  • Chemical and hygienic analyses, radioactivity
  • Electrical tests
  • Flammability tests

QUALITY STABILITY CONTROL SYSTEM

  • Initial inspection
  • Supervision of product

CONTACTS

Person Phone fax e-mail
Ing. Ludmila Antosova
Head of Toys Certification Department
+420 577 601 364 +420 577 104 855 lantosovaPostaitczlin.cz


Post address:
Institute for testing and certification
Department of Toys and PPE 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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