With effect from 18.07.2020, ITC extended the scope of notification to perform the activities of Notified Body No. 1023 for the assessment of products under Act 90/2016 and under Regulation 2016/425/EU of the European Parliament and of the Council regarding to personal protective equipment for "Equipment providing respiratory system protection - Filtering half masks to procect against particles and conformity assessment procedures / modules referred to in Article 19 (b), (c) to (i) of Annexes V and VII to the Directive 2016/425/EU: "EU type-examination (Module B) - Annex V"; "Conformity to type based on internal production control plus supervised product checks at random intervals (Module C2) - Annex VII ".
- PPE certification:
Ing. Elena Tomanová email@example.com +420572779928
download: notification (NANDO)
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).
This regulation has significantly changed the scope of evaluation of elements and primary aromatic amines and the way of evaluation of articles for repeated use – HERE you can find more information. ITC labs are already prepared to test and evaluate the articles according to new rules.
Mrs. Sarka Kopeckova, firstname.lastname@example.org,
tel: +420 577 601 705
Mr. Daniel Vit, email@example.com,
tel. +420 577 601 704
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.
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 | firstname.lastname@example.org
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