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ITC
new liquid chromatograph with tandem mass spectrometry Shimadzu LC-MS/MS 8045

At the beginning of 2018 department of analytical chemistry purchased brand new liquid chromatograph with tandem mass spectrometry Shimadzu LC-MS/MS 8045, which is used for trace analysis of organic substances. Spectrometer has superior sensitivity for organic substances in orders of nano-grams per litre of sample. In June first analytical procedures successfully passed accreditation after the validation. Contact for such a special analytical techniques – RNDr. Lukas Rozsypal, tel: +420 577 601 452, e-mail: lrozsypal@itczlin.cz


Conformity assessment of personal protective equipment

Institute for Testing and Certification is newly included in the NANDO database as the Notified Body for the Conformity Assessment of Personal Protective Equipment in accordance with Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016.

Detailed information HERE


Regulation (EU) 2016/425 on personal protective equipment - Guidance document on the implementation of Article 47

Good day.
Regulation (EU) 2016/425 on personal protective equipment - Guidance document on the implementation of Article 47 on transitional provisions. Awailable on web page HERE.


Testing of hydraulic brake hose assemblies by Standard SAE J1401

Institute for testing and certification offers a new service in a field of automotivetesting of Hydraulic Brake Hose Assemblies by Standard SAE J1401. For detailed informations please contact our expert from Physical Testing Laboratory mr. Radek Matejka rmatejka@itczlin.cz.


New method for determination of organometallic complexes

Our analytical laboratory has implemented new method for determination of organometallic complexes (i.e. alkyl mercury) by cation chromatography, coupled to ICP-MS detection. This group of substances is represented for example by Trimerosal, used as fungicide or fungistatic agent. Such a substances can be limited for example in vaccines or contact lens solutions. Contact: Laboratory of Analytical Chemistry, fpuype@itczlin.cz, analyt@itczlin.cz


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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