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ITC
new gas chromatograph in laboratory of analytical chemistry

In August 2018 our laboratory of analytical chemistry purchased a brand new gas chromatograph, mass spectrometer Shimadzu GCMS-QP2020, equipped by a thermal desorption unit TD-30, which is used for analysis of emissions of organic substances.

 

The spectrometer has a superior sensitivity for organic substances in orders of micro-grams per kg of sample. The system is mainly used for analysis of volatile organic substances (VOC) and condensable substances (FOG) according to the requirements of automotive standard VDA 278, but also for emission measurement of polymer samples to investigate additive system, smell, NIAS (not-intentionally added substances in plastics) etc.

 

Contact for such types of analysis: Franky Puype, phone: +420 577 601 703, e-mail: fpuype@itczlin.cz


New general director

Announcement of change in ITC management.

 

New general director of the Institute for Testing and Certification has been appointed Mgr. Jiri Hes.

 

RNDr. Radomir Cevelik remains in the position of Board of Directors Vice President.


Determination of phthalic acid esters according to requirements of CPSC

In June 2018 analytical laboratory ITC accredited new procedure for determination of phthalic acid esters in consumer products according to requirements of CPSC (Consumer Product Safety Commission) No. CPSC-CH-C1001-09.4. New standard came in force on April 25, 2018 and released old one No. CPSC-CH-C1001-09.3.

More information concerning phthalate testing are available here


FachPack 2018

Dear business friends, we invite you to visit our exposition at the International Trade Fair for the packaging industry FachPack 2018, which will be held 25. 9. – 27. 9. 2018 in Nuremberg. Hall 9, Stand no. 9-211. Vouchers for entry are available, if you are interested, please contact Mrs Ing. Barbora Hajkova, email: bhajkova@itczlin.cz 


Analytical laboratory had implemented new methods for testing of volatile organic compounds (VOC) from car interior parts according to Hyundai and Toyota requirements, namely

Hyundai Engineering Standard - MS300-55 - Determination of volatile organic compounds from moulded parts in the vehicle interior

and

Toyota Engineering Standard TSM 0508G – Volatile component measurement method using sampling bag

Tests are using sampling bags for emission tests, followed by chromatography determination of emitted substances.
For further information and quotation please, contact Ing. Jitka Balakova, e-mail: jbakalova(at)itczlin.cz, phone: +420 577 601 453


In-vitro diagnostic medical devices

Products certification, 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 fax e-mail
Ing. Tomas Zavisek +420 577 601 254 +420 577 104 855 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: 3.1.2018
 
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