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Medical Devices - summarizing the current situation in area of preparation / transfer of notified bodies to the new legislation

The European Associtiation for Medical devices of Notified Bodies (TEAM NB) on web site, in the section "Latest News", published on December 14, 2018 a document called "White Paper: One Year of Application" summarizing the current situation in area of preparation / transfer of notified bodies to the new legislation regarding to Medical Devices Regulation (MDR) and In-Vitro Medical Devices Regulation (IVDR).


FOR ARCH 2020

Dear business friends, we invite you to visit our exposition at the International Trade Fair for Building components, Materials, Electrical engineering and Heating FOR ARCH 2020 (forarch.cz) which will be held 22. 9. – 26. 9. 2020 in Congress Hall, PVA EXPO Prague. Our stand will be located in Hall 1 Stand 1H101. For detailed information please contact Ms Barbora Hajkova, e-mail: bhajkova@itczlin.cz. 
 

The fair will take place under increased hygienic conditions.


new ICP spectrometer in ITC labs

Analytical laboratory has recently purchased new ICP spectrometer Agilent 5800. The spectrometer is intended for determination of elements in water solutions, leachates and mineralisates. It is used mainly for evaluation of food-contact materials, products for children, material analysis of plastics, rubbers and metals. Spectrometer can be also used for determination of elements, which are limited in electro-products by RoHS 3 directive. High sensitivity enable evaluation of products according to many national and European legislations.  


DETERMINATION OF INDIVIDUAL ORGANIC COMPOUNDS (VOC) AND IDENTIFICATION OF THE EMITTED COMPOUNDS BY GC-MS/FID

In autumn 2019 our laboratory of analytical chemistry purchased gas chromatograph Shimadzu GCMS QP 2020 NX with mass spectromecter and flame ionization detector, which is used for analysis of emission of organic substances (VOC) mainly for automotive materials.

Determination of VOC by this method meets the requirements:
- VW 50180 (CLP classification of VOC emission in accordance with Regulation (EC) 1272/2008 included)
- PV 3341
- VDA 277
- VCS 1027,2759


Laboratory is on the List of accepted service laboratories by the VW Group for test according to PV 3341!


Contact: Jitka Bakalová | +420577601453 | jbakalova@itczlin.cz


Trade Fair AMPER 2020 - cancellation

Dear business friends, unfortunately, we have to inform you that the Fair Amper 2020 is cancelled due to the spreading disease COVID-19. For the fair administration is protecting the health of all involved an absolute priority. However, they would not be able to ensure this in the event of the fair being held at the original date, in particular by the inability to prevent the entry of persons at risk. We apologize for any inconvenience.


In-vitro diagnostic medical devices

CERTIFICATION OF PRODUCTS | CE » Conformity assessment (CE)

In-vitro diagnostic medical devices (IVDs) are used for measuring the amounts of specific substances in the blood (or urine or other body fluids), for the measurement of the physical properties of the sample, for the microscopic evaluation of cells, for growing microbiological cultures and for similar purposes. The IVD must meet the relevant requirements of Council Directive 98/79/EC. The IVD must undergo the appropriate method of compliance assessment, on the basis of which the EC declaration of conformity is issued and for which each product carries the CE marking. Institute for testing and certification is a member of TEAM-NB and is a  signature of an ethics code (Code of Conduct).

 

Preliminary questionaire   Manual for clients
Application for conformity assessment   Searching the database of certificates
GFA (general framework agreement)   News
Legislation and  other documents for conformity assessment      

SERVICES PROVIDED IN CONNECTION WITH CONFORMITY ASSESSMENT OF MEDICAL DEVICES

  • Conformity assessment by the Notified Body No. 1023 according to the requirements of the:
    • Council Directive 98/79/EC, laying down the technical requirements for in vitro diagnostic medical devices
    • Council Directive 2006/95/EC, laying down the technical requirements for low voltage electrical equipment
    • Council Directive 2004/108/EC, laying down the technical requirements for products in terms of their electromagnetic compatibility
  • Testing in the Accredited Laboratory No. 1004 and No. 1004.3
  • 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 – analyses of technical information
  • Certification of management systems (ISO 13485, ISO 9001, ISO 14001, OHSAS 18001)
  • Technical inspection – statistical inspections, inspection certificates

PRODUCTS ASSESSED IN ITC ACCORDING TO the Council Directive 98/79/EC

Institute for Testing and Certification, Inc. is notified as the Notified Body No. 1023 for conformity assessment of all in vitro diagnostic medical devices.

CONTACTS

Person Phone e-mail
Tomas Zavisek, Ing.,
Head of department medical devices certification
+420 572 779 955 tzavisekPostaitczlin.cz


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

The person responsible for accuracy of data: Ing. Tomas Zavisek

Updated: 30.1.2020
© ITC - Institut pro testování a cetfifikaci, a.s. | Tel.: +420 572 779 922 | E-mail: itc@itczlin.cz
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