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Statement of Electrotechnical Testing Institute’s regarding recent information questioning European system of medical devices conformity assessment
In the last few days foreign and consequently Czech newspaper published several articles questioning the European system of conformity assessment of medical devices in the Czech Republic.
Within the European Union, there is a well-defined system of conformity assessment of medical devices and their market placement. There is an existing set of legislative rules for subjects that place products on market as well as for independent Notified Bodies which provide conformity assessment.
Notified Bodies are not the regulators of the market; neither do they set the requirements for the products. Their only role is to certify conformity of the product with the demands of relevant EU legislation, providing they receive clear evidence that the product is safe and in conformity with legislative demands.
We would like to ensure our customers that Electrotechnical Testing Institute respects and always will respect legislative requirements and cooperates with market surveillance authorities and with other government institutions of the Czech Republic and the EU. At the same time, we believe that the same applies to the other Notified Bodies all over EU for the manufacturers from EU and also outside EU.
Management of Electrotechnical Testing Institute
New EN ISO 13485:2003 certification requirements in accordance with the European document IAF MD 9:2011
In April 2012 the Czech Accreditation Institute, o.p.s that is the EZU´s accreditation agency, announced the document IAF concerning the application of ISO/IEC 17021 standard in the quality management systems for medical devices according to EN ISO 13485.
Special tests, part 1 - Microbiological testing
Electrotechnical Testing Institute, state-owned entreprise, (hereinafter EZU) offers to their customers not only the electrotechnical and mechanical tests, but also a lot of other special tests which may seem to be unusual, even out of the field of the electrotechnical testing that remains always under the competence of the technical experts and their modern and specialized electrotechnical laboratories. What needs to be emphasized is that these special non electrotechnical tests play an important role in completing the whole range of the tests that may verify all major characteristics and parameters of the products.
Welcome to use the homologation service we provide according the regulation EHK OSN 116
The regulation EHK OSN 116 specifies the unified technical provisions for the protection of the motor vehicles against the unauthorised use.
„The device for the protection against the unauthorised use“ stands for the system designed to prevent the unauthorized standard launching of either motor starter or other main driving force of a motor vehicle in combination with at least one more system that can either block the driving or the gear transmission or the gear shifting or put the brakes into operation.
The regulation EHK OSN 116 refers to the homologation of:
1 vehicles and their devices against the unauthorized used,
2 alarm systems in vehicles,
3 vehicles and their alarm system,
4 immobilizers and vehicles and their immobilizers.
Due to the fact that the systems for the protection of vehicles have the voltage feed of 12V the homologation testing carried out according this regulation focuses especially on the checking of the function under the abnormal conditions, the climate and mechanical resistance and the electromagnetic compatibility.
It is indispensable to ensure the permanent conformity of the product to the requirements in this regulation and that is why the supervision of the production processes should be also an integral part of the homologation.
The Electrotechnical Testing Institute has been given the authority by the Czech Ministery of Transport to provide the homologation in accordance with the regulation EHK OSN 116 that is covering the whole scope of the listed homologation area.