Type of Notification
regular notification
Date of Distribution
2018.08.06
WTO Country
Agency Responsible
Czech Metrology Institute
Regions Affected
Czech Office for Standards Metrology and Testing WTO/TBT Enquiry Point P. O. Box 49 Biskupsky dvur 1148/5 110 00 Prague 1-Czech Republic Telephone: (+420) 221 802 212 Telefax: (+420) 221 802 440 E-mail: wto.tbt@unmz.cz
Notified Document Details
<p style="margin:2px !important;">Draft General Measure number:0111-OOP-C064-16, laying down the metrological and technical requirements for specified measuring instruments, including testing methods for type approval and verification of the following specified measuring instruments: 'pure-tone audiometers'</p>
ICS Code
Covered Products
<p style="margin:2px !important;">Pure-tone audiometers</p>
Description of Content

Pure-tone audiometers are placed on the market in the Czech Republic pursuant to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended by Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998, Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000, Directive 2001/104/EC of the European Parliament and of the Council of 7 December 2001, Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003, and Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007.Once they have been put into use, they become subject to national metrology regulation – verification at specified intervals. This notified legislation only applies to the verification of measuring instruments that have already been put into use. It does not concern placing them on the market or putting them into use.

Objectives & Rationale
<p style="margin:2px !important;">In the Czech Republic, pure-tone audiometers are specified measuring instruments that are subject to mandatory type approval and verification. </p>
Relevant Documents

Reference(s) to basic text(s):

- Act No 505/1990 on metrology
- § 171 et seq. of Act No 500/2004, the Administrative Procedure Code, as amended

Final Date of Comments
2018.10.05
Contact Details
If there will be a problem with downloading document, you can contact us: Czech Office for Standards Metrology and Testing WTO/TBT Enquiry Point P. O. Box 49 Biskupsky dvur 1148/5 110 00 Prague 1-Czech Republic Telephone: (+420) 221 802 212 Telefax: (+420) 221 802 440 E-mail: wto.tbt@unmz.cz
Document Online Link (EN)
Notified Under
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