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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).


Pressure equipments

Products certification, CE » Conformity assessment (CE)

Introduction of pressure equipment for domestic use (cooking purposes) to the EU market is regulated by Directive of the European Parliament and of the Council 2014/68/EU, setting out the technical requirements for pressure equipment. The safety design of pressure cookers is verified by conformity assessment procedures consistent with at least one of the modules intended for pressure equipment in category III.

 

Application for conformity assessment   Client's Handbook  
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SERVICES PROVIDED IN CONNECTION WITH CONFORMITY ASSESSMENT OF PRESSURE COOKERS

  • Conformity assessment by the Notified Body No. 1023 according to the Directive of the European Parliament and of the Council 2014/68/EU, laying down the technical requirements for pressure equipment. Essential safety requirements are derived in the usual method based on PS*V product. Pressure cookers for domestic use which show the value under 50, are classified as the category I. However, the design assessment stage shall be carried out according to one of the modules for the category III. A decision upon selection of a module is usually made by the producer based on consulting the staff of the Notified Body No.1023.
  • Testing pressure cookers in the Accredited Laboratory No. 1004 and No. 1004.3
    Testing pressure cookers according to harmonized standards:
    • EN 12778  Cooking ware – Pressure cookers for domestic use and related standards
    • EN 12983-1  Ovenware – Domestic ovenware designed for stoves, cookers or cooking hobs – Part  1: General Requirements.
  • Granting licenses for voluntary 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 (standardization) and technical information
  • Certification of management systems (ISO 9001, ISO 14001, OHSAS 18001)
  • Technical inspection

PRODUCTS ASSESSED IN ITC ACCORDING TO Directive 2014/68/EU

Institute for testing and certification, a joint-stock company is notified as the Notified Body No. 1023 for the activities of conformity assessment of pressure equipment. The subject of conformity assessment includes pressure cookers for domestic use, which are to be introduced in the EU market with CE marking.

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.
Certification division
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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