G/TBT/N/CZE/214  
 
6 August 2018  
(18-4949) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member: CZECH REPUBLIC   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible: Czech Metrology Institute  
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
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   
3. Notified under Article 2.9.2 [ X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable): Pure-tone 
audiometers; Measuring instruments (ICS 17.040.30).  
5. Title, number of pages and language(s) of the notified document: 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 ver ification of the following specified measuring instruments: 'pure -tone 
audiometers' (12 page(s), in Czech; 11 page(s), in English)    
6. Description of content: Pure-tone audiometers are placed on the market in the Czech 
Republic pursuant to Council Direct ive 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 2 001/104/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 Septem ber 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.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: In the Czech Republic, pure -tone audiometers are specified measuring 
instruments that are subjec t to mandatory type approval and verification.  G/TBT/N/CZE/214  
 
- 2 - 
 
  8. 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   
9. Proposed date of adoption: October 2018 
Proposed date of entry into force: October 2018  
10. Final date for comments: 60 days from notification  
11. Texts available from: National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other  body:   
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  
https://members.wto.org/crnattachments/2018/TBT/CZE/18_4190_00_e.pdf  
https://members.wto.org/crnattachments/2018/TBT/CZE/18_4190_00_x.pdf