CZE/214
WTO/TBT
CZ Czech Republic
  • 17 - Metrology and measurement, Physical phenomena
2018-10-05
2018-08-13

Pure-tone audiometers; Measuring instruments (ICS 17.040.30).

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' (12 page(s), in Czech; 11 page(s), in English)

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.