941.216 order of the FDJP on audiometric measures (Ordinance on audiometry) of March 9, 2010 (Status January 1, 2015) the federal Department of justice and police (FDJP), view the art. 5, al. 2, 8, al. 2, 16, al. 2: 17, al. 2: 24, al. 3, and 33 of the Ordinance of 15 February 2006 on measuring instruments (Ordinance on measuring instruments), stop: art. 1 purpose this order regulates: a. requirements for audiometric measuring instruments; (b) the procedure for placing on the market of the audiometric measuring instruments; c. the procedures to maintain the stability of the audiometric measuring instruments measure.
Art. 2 scope of application are subject to this order the measuring instruments which are used for audiometric controls health, namely: a. the audiometers; b. audiometry booths.
Art. 3 definitions in this order, means: a. audiometric examination: a review to the determination of the hearing; b. audiometer: an instrument of measure used to determine the threshold of audibility of sounds of different frequencies or the comprehensibility of speech, including the sound sources like reproduction with their media files and sound devices , as well as the transducers acoustic such as helmets of listening, ossivibrateurs or speakers in free field; c. audiometry cabin: a cabin from which the lining absorbs sounds and measure in which audiometric tests are carried out.
Art. 4 requirements audiometers and audiometry cabins must meet the essential requirements laid down in Schedule 1 of the Ordinance on measuring instruments and the corresponding requirements set out in the schedule to this order.
Art. Audiometers and audiometry cabins 5 procedure for placing on the market are subject to a regular approval and initial verification according to annex 5 of the Ordinance on measuring instruments.
When installing a new audiometry cabin, a measure of control must be carried out by the Institute of Metrology (METAS) or by a verification laboratory.
The name of the administrative unit has been adapted to 1 Jan. 2013 in application of art. 16 al. 3 o from 17 nov. 2004 on official publications (RS 170.512.1). This mod has been taken throughout the text.
Art. 6 subsequent verification of audiometers audiometers must be submitted each year to a subsequent audit according to annex 7, section 1 of the Ordinance on measuring instruments.
The subsequent audit is performed by METAS or by a verification laboratory.
For certain measuring instruments or for certain types, METAS may extend or shorten the time limits for the subsequent verifications If the metrological characteristics allow or require.
Art. 7 subsequent verification of the audiometry cabins later verification of audiometry booths held every six years.
If the audiometry cabin undergoes a modification of its construction, a new measure of control must be made in accordance with art. 5, al. 2 art. 8 transitional provision the measuring instruments that have been put on the market before the entry into force of this order may continue to be used to the extent where they meet the requirements of art. 4 art. 9 entry into force this order comes into force on April 1, 2010.
Annex (art. 4) requirements for the verification of audiometers and audiometry cabins 1 Introduction 1.1 verification of audiometers and audiometry cabins requirements are included in the tables and explanations below. 1.2 may be appealed to the standards and recommendations as guidelines of execution: a. OIML International Recommendation R104: Pure Tone Audiometers; b. OIML International Recommendation R122 : Equipment for speech audiometry; c. IEC 60645-1: Audiometers, Part 1: Pure-tone audiometers; d. IEC 60645-2: Audiometers, Part 2: Equipment for speech audiometry; e. ISO 8253: Acoustics - Audiometric test methods.
2 verification of audiometers 2.1 tables 1-4 distinguished two audit procedures, designated 'A' and 'B '. Audiometers are subject to two audit procedures at each facility, regardless of whether the first time after purchase or after a new installation as during a move. Then, they are audited every year, alternately according to the method A or B, starting with A process. An audit includes measurements made with:-headphones and an artificial ear for air conduction: table 1;-an ossivibrateur and a mastoid for bone conduction: table 2;-a speaker in the cabin for the free field: table 3; - electrical signals pure to control linearity: table 4.
2.2 for speech audiometry, must also carry out the following checks not only through headphones, but also in free field: - control of the instrument for reading; - calibration of the level in the coupler and field free for all readers used (if necessary, completion of a list of values of adjustment for different players);-control of the noise in the cabin control the noise of ventilation;
2.3 for the verification of the speech signal, the level must be indicated in dB SPL: the measurement is done with Impuls and Linear frequency settings. It is performed over 10 sentences.
Table 1 air Conduction: measures with helmet and artificial ear Type of signal parameter field of measure Tolerance side process Signal sinusoidal frequency 125 Hz to 8 kHz (11 points of measurement) to a level between 75 and 110 dBHL ± 5% left (L) and right (R) A and B level ± 3 dB (125 Hz-4 kHz) ± 5 dB (4 kHz-8 kHz) distortion 125 Hz to 4 kHz (9 points measurement) to a level between 75 and 110 dBHL 2.5% noise narrow band level 125 Hz to 8 kHz (11 points of measurement) to a level between 60 and 80 dBHL ± 3 dB (125 Hz-4 kHz) ± 5 dB (4 kHz-8 kHz) white noise to a level between 70 and 90 dBHL speech signal level must be measured with the Linear settings / Impuls and the adjustment must be carried out without correction factor.
± 5 dB noise voice Signal voice table 2 Bone Conduction: measures with ossivibrateur and mastoid Type of signal parameter field of measure Tolerance side process Signal sinusoidal frequency 250 Hz to 6 kHz (8 measure points) at a level between 20 and 60 dBHL ± 5% left (L) and right (R) A and B level ± 3 dB (250 Hz-4 kHz) ± 5 dB (4 kHz-6 kHz) distortion 250 Hz to 4 kHz (8 measure points) at a level between 20 and 60 dBHL 5.5% noise narrow band level 250 Hz to 6 kHz (8 measure points) at a level between 20 and 60 dBHL ± 3 dB (250 Hz-4 kHz) ± 5 dB (4 kHz-6 kHz) free white noise at a level between 20 and 60 dBHL ± 5 dB noise voice Signal voice table 3 free field: measurements with speaker in the cabin Type of signal parameter field of measure Tolerance side process ulule sound level 125 Hz to 8 kHz (11 points of measurement) to a level between 60 and 90 dBHL ± 3 dB (125 Hz-4 kHz) ± 5 dB (4 kHz-8 kHz) left (L) and right (R) A Bruit narrow band at a level between 60 and 90 dBHL ± 5 dB and B white noise noise voice Signal voice table 4 electrical measurements Type signal parameter field of measure Tolerance side process Signal linearity sinusoidal, 20 dB to 120 dB increments of 5 dB ± 3 dB on the field; ± 1 dB between each slice;
Left (L) and right (R) B 3 audit of the audiometry cabins 3.1 eligible maximum background noise level is the result of the following requirements: - binaural measures in free field must be possible up to 0 dB HL; - the possible minimum test frequency must be 125 Hz; - the maximum uncertainty due to background noise can reach 5 dB.
3.2 it is student at: frequency (Hz) level of noise background maximum eligible (dB ref. 20 µPa) frequency (Hz) level of noise background maximum eligible (dB ref. 20 µPa) 31.5 60 630 13 40 52 800 12 50 46 1000 12 63 40 1250 12 80 35 1600 13 100 30 2000 13 125 25 2500 11 160 22 3150 9 200 20 4000 7 250 18 5000 9 315 16 6300 14 400 14 8000 20 500 13
Update according to ch. I O of the FDJP 19 nov. 2914, in force since Jan. 1. 2015 (2014 4549 RO).
State on January 1, 2015