Czech Metrology Institute  
 
Okružní 31, 638 00 Brno  
 
1.------IND- 2017 0352 CZ - EN- ------ 20170808 --- --- PROJET 
 
 
 
Contact person:  Mgr.  Tomáš Hendrych  
Phone:  +420  545 555 414 
 
P U B L I C   N O T I C E 
 
As the authority with substantive and territorial jurisdiction for stipulating metrological and technic al 
requirements for legally controlled measuring instruments and stipulating test methods for type 
approval and verification of legally controlled measuring instruments pursuant to §  14(1) of Act 
No 505/1990, on metrology, as amended (hereinafter the ‘Metr ology Act ’), and in accordance with 
the provisions of §  172 et seq. of Act No  500/2004, the Code of Administrative Procedure (hereinafter 
the ‘CAP ’), the Czech Metrology Institute (hereinafter the ‘CMI’) commenced ex officio proceedings 
on 22  January  2016 pursuant to §  46 of the CAP, and based on supporting documents issues the 
following:  
 
 
I. 
D R A F T   M E A S U R E   O F   A   G E N E R A L   N A T U R E 
number:  0111 -OOP -C040 -16 
 
laying down the metrological and technical requirements for legally contro lled measuring 
instruments, including test methods for type approval and verification of the following legally 
controlled measuring instruments:  
‘breathalysers ’ 
1   Basic definitions  
For the purposes of this Measure of a General Nature, the terms and defin itions pursuant to VIM and 
VIML1) and the terms and definitions below shall apply.  
                                                      
1) International Vocabulary of Metrology – Basic and General Concepts and Associated T erms (VIM) and 
International Vocabulary of Terms in Legal Metrology (VIML) are part of the technical harmonisation 
compendium ‘Terminology in the Area of Metrology ’, which is publicly accessible at www.unmz.cz.  Measure of a General Nature No  0111 -OOP -C040 -13 
2 1.1 
breathalyser  
a measuring instrument intended for determining the mass concentration of ethanol in air exhaled by 
the tested individual; detection takes place through a h ighly selective measurement method (e.g. an 
electrochemical cell, IR)  
1.2 
stationary breathalyser  
a breathalyser intended for use inside buildings or on premises with stable ambient conditions  
1.3 
mobile breathalyser  
a breathalyser intended for mobile appl ications (e.g in a car)  
1.4 
portable breathalyser  
a portable measuring instrument intended for outdoor or indoor use, e.g. a hand -held device powered 
by an autonomous battery, which may also be equipped with a separate mobile printer  
1.5 
breath alcohol mea surement  
determination of the mass concentration of ethanol in exhaled air generated in the pulmonary alveoli 
of the tested person, in mg/L  
Under existing legislation in the Czech Republic, the results of this measurement method are 
converted by the analys er from breath alcohol concentration to blood alcohol concentration and 
expressed in units of ‰ (per mille) or g/kg (grams of alcohol per kilogram of blood).  
NOTE Mass concentration of alco hol in breath is the proportion  by mass of ethanol in a volume of e xhaled air at 
a temperature of 34  °C and pressure of 1013  hPa. Mass concentration of alcohol in blood is the proportion by 
mass of ethanol in a volume (mass) of blood at a temperature of 20  °C and pressure of 1013  hPa. 
According to Henry ’s law, breath alco hol concentration (BrAC  – breath alcohol concentration ) depends on blood 
alcohol concentration (BAC  – blood alcohol concentration ). In the Czech Republic, breathalysers shall be 
adjusted to convert the value using the ratio BAC  : BrAC = 2100  : 1. This rati o is statistically the most 
commonly used in European countries for determining the mass concentration of alcohol directly in units of ‰. 
This means that in the Czech Republic analysers shall be adjusted to use the ‰ (per mille)  : mg/L conversion 
ratio of 2.1 : 1. 
1.6 
exhaled (alveolar) air  
air contained in the alveoli, where the gaseous exchange takes place between the blood and gases 
contained within the alveoli  Measure of a General Nature No  0111 -OOP -C040 -13 
3 1.7 
end expiratory breath  
air considered sufficiently representative of alveolar air (as oppos ed to dead anatomical volume)  
1.8 
expiratory reserve volume  
the volume of respiratory gases that can still be exhaled after normal expiration has occurred  
1.9 
residual lung volume  
the volume of air that cannot be exhaled even with determined effort by the test subject to exhale 
completely  
1.10 
dead anatomical volume  
airway volume up to the terminal bronchioles.  It may be increased by the volume of alveoli that are 
incapable of  respiratory  gases exchange.  
1.11 
blood alcohol measurement  
determination of mass concentration of ethanol in the blood in g/kg or in ‰ (per mille)  
NOTE Devices for measuring breath alcohol concentration can express the mass concentration of ethanol 
determined in mg/L or convert this value using the analyser into mass concentration of a lcohol in the blood in ‰ 
(per mille), for which a conversion constant of 2.1 is used in the Czech Republic.  
1.12 
breathalyser measuring mode  
in this mode, the breathalyser provides results of measurements of breath alcohol concentration in the 
form of a sp ecific numerical value in the desired units  
1.13 
breathalyser standby mode  
a mode whereby only certain circuits are energised in order to conserve power and prolong the 
lifetime  of the device’s individual components . In this mode, the device attains the me asuring mode 
more rapidly than from the un -powered state.  
1.14 
breathalyser maintenance mode  
a mode in which the device can be adjusted and is subject to metrological control  Measure of a General Nature No  0111 -OOP -C040 -13 
4 1.15 
maintenance equipment  
equipment used to configure the breathalyser when it i s in maintenance mode  
1.16 
automatic check  
an internal device or process that checks whether the breathalyser is suitably adjusted.  This check may 
involve an internal checking element (stability or temperature check) or an external element, for 
example a c ylinder with a gas of known concentration  
1.17 
drift  
a change in indications that occurs after the passage of a certain amount of time between 
measurements at a given mass concentration of ethanol  
1.18 
memory effect  
dependence of the value indicated by the  measuring instrument on the value indicated by the same 
measuring instrument for the preceding sample  
2   Metrological requirements  
The metrological requirements are based on the requirements of Recommendation OIML  R 1262) 
‘Evidential breath analysers ’ and standard ČSN EN 15964 Breath alcohol test devices other than 
single use devices - Requirements and test methods.  During verification, measuring instruments type 
approved prior to the effective date of this regulation shall be subject to metrological requ irements 
applicable at the time they were put into circulation.  
NOTE If, for the sake of measurement accuracy, the number of measurements (analyses) or the period of time 
after which the breathalyser needs to be adjusted to reference values are limited, th e manufacturer shall specify 
this time limit in the documentation for the measuring instrument and/or ensure that the measuring instrument 
directly signals that this limit has been reached.  
2.1 Description of the measuring instrument and measurement  
In gen eral, determination of breath alcohol concentration consists of three stages: sampling, sample 
analysis, determination, presentation, storage and printing of the result.  
2.1.1 Sampling  
A disposable mouthpiece should always be used if during sampling the su bject ’s mouth or lips come 
into contract with the device.  This allows hygienic handling of the device.  Condensation of the 
sample shall be avoided during sampling.  
2.1.2 Sample analysis  
The ethanol concentration in the air exhaled from the pulmonary alveol i has to be determined.  The 
analysis shall not be influenced by influences during sampling or by ambient conditions.  
                                                      
2) OIML R 126 e12 ‘Evidential breath analyser s’, freely available at www.oiml.org  Measure of a General Nature No  0111 -OOP -C040 -13 
5 2.1.3 Determination, presentation, storage and printing of results  
The determined ethanol concentration shall be indicated on the display  of the device . Simultaneously  
the measured value shall be stored in the device.  It shall be possible to print the measurement result.  
For all display and storage methods, the result shall have the same format (e.g. the same decimal 
mark), along with all ass ociated information (e.g. time and date).  The entire user environment shall be 
in Czech and use Czech symbols.  
2.1.4 Unit of measurement and decimal mark  
The breathalyser shall provide results in units of mass concentration of alcohol in a specified volume  
of air.  The unit of measurement shall be milligrams of ethanol per litre of exhaled air (mg/L).  The 
device shall provide the option to switch the unit of measurement to mass blood ethanol 
concentration.  The unit of measurement shall then be grams of ethan ol per kilogram of blood (g/kg) or 
per mille ( ‰). 
Either a comma or a dot may be used as the decimal marker.  
2.2 Measuring range  
The measuring range of the breathalyser shall be specified by the manufacturer and shall be from 
0.00 mg/L to at least 2.00  mg/L. The breathalyser shall be capable of indicating (including as a 
numerical value) that the upper limit of the measuring range has been exceeded.  
2.3 Resolution  
The resolution in measuring mode shall be 0.01 mg/L.  If the device has a higher resolution, it  shall 
round the result down to two decimal places.  The value is always rounded down (e.g. a measurement 
result of 0.427 mg/L shall be rounded to 0.42 mg/L).  
In maintenance mode, it shall be possible to display the result with three decimal places; hence, the 
resolution has to be 0.001  mg/L.  The name or symbol of the unit of measurement used shall be 
indicated on the display in close proximity to the numerical result of the measurement.  
2.4 Preservation of metrological properties  
The breathalyser shall be d esigned to maintain its metrological properties for the entire period of 
validity of verification.  
2.5 Operating conditions  
2.5.1.  Operating conditions for using the measuring instrument  
The breathalyser operating conditions are provided in Table  1. While all devices must meet these 
requirements, the manufacturer may apply for approval of operating conditions beyond the scope of 
the requirements stipulated in Table  1 for a specific type of measuring instrument.  If, based on this 
application, the measuring i nstrument is approved for use beyond the use of operating conditions 
specified in Table  1, this fact shall be stated in the documentation for the given type of measuring 
instrument and on the device itself.  
Table 1:  Operating conditions for using breathaly sers 
Ambient temperature  Low +5 °C for stationary breathalysers  
-5 °C for mobile breathalysers  
-5 °C for portable breathalysers  
High  +30 °C for stationary breathalysers  
+40 °C for mobile breathalysers  
+40 °C for portable breathalysers  Measure of a General Nature No  0111 -OOP -C040 -13 
6 Relati ve humidity  Devices shall be capable of measurement in humidity of up to 85  %. 
Atmospheric pressure  860 hPa - 1060 hPa  
Random vibrations  Negligible for stationary breathalysers;  
Frequency range 10 Hz - 150 Hz  
RMS:7 ms-2 
ASD 10 – 20 Hz:  1 m2s-3 
ASD 20 – 150 Hz:  -3 dB/octave  
for mobile and portable breathalysers  
DC power voltage  According to manufacturer specifications  
AC power voltage  Unom - 15 % to U nom + 10 %  
AC power frequency  fnom - 2 % to f nom + 2 %  
Internal battery voltage  The entire range of voltages between a new or freshly charged battery and the 
lowest voltage at which, according to the manufacturer ’s specifications, the 
device is capable of operation  
Vehicle battery voltage  12 V battery  9 V - 16 V  
24 V battery  16 V - 32 V  
Ambient hydro carbon 
concentration  ≤ 5 ppm  
2.5.2 Exhalation parameters  
If the exhalation parameters are not met, the breathalyser shall display an error message.  
Volume of exhaled air:  1.2 L  
Flow:  6 L/min  
Exhalation time:  5 s 
Back pressure:  25 hPa (at a flow of 12 L/min)  
2.5.3 Reference op erating conditions  
Reference operating conditions apply to ambient conditions in a laboratory where breathalysers are 
verified.  Reference operating conditions are provided in Table 2.  
Table 2:  Reference operating conditions  
Ambient temperature  18 - 28 °C  
Ambient pressure  860 - 1060 hPa  
Test gas flow  0.20 - 0.35 L/s  
Gas volume  1.2 L  
2.5.4 Warm -up time  
Under reference conditions, the measuring instrument shall be capable of proper measurement:  
- after a warm -up period specified by the manufacturer - not m ore than 15 minutes after the 
measuring instrument has been switched on,  Measure of a General Nature No  0111 -OOP -C040 -13 
7 - in less than 5 minutes after it has been switched from sleep (standby) mode to measuring 
mode.  
If these requirements are not met, the relevant periods shall be clearly indicated on the measuring 
instrument and stated in the manufacturer ’s documentation.  
2.6 Maximum permissible error (MPE)  
2.6.1 Maximum permissible error for type approval, verification and after repair  
Maximum permissible errors (positive or negative) for each measure ment are given in Table  3. 
Table 3  – Maximum permissible errors  
Mass concentration of ethanol in exhaled air  (mg/L)  Maximum permissible error  (mg/L)  
< 0.4  0.020  
≥ 0.4 and ≤ 2.0 5 % *) 
> 2.0  (reference value/2) – 0.90 
*) Values in percent are relative t o the measured value of mass concentration of ethanol.  
2.6.2 Maximum permissible error for the results of verification of legally controlled 
breathalysers  
Table 4 - Limits for verification of legally controlled breathalysers  
Mass concentration of ethanol in exhaled air  (mg/L)  Maximum permissible error  (mg/L)  
< 0.4  0.030  
≥ 0.4 and ≤ 2.0 7.5 % *) 
> 2.0  reference value*(3/4) – 1.35 
*) Values in percent are relative to the measured value of mass concentration of ethanol.  
2.7 Repeatability of measurement  
The repeatability of measurement expressed as the standard deviation o f a given number of 
measurements.  Repeatability is expressed mathematically by formula (1).  
The maximum standard deviation for all concentrations shall not exceed one third of the maximum 
permissible error.  
1) (
12



nYY
sn
ii
(1) 
Where:   S standard devi ation  
 n number of measurements  
 Yi the ith measurement for the given concentration  
 Ȳ the arithmetic mean of measured values  
 Measure of a General Nature No  0111 -OOP -C040 -13 
8 2.8 Drift  
Zero drift and short -term drift at 0.40  mg/L shall be less than 0.010  mg/L in 4 hours.  
Long -term drift at 0.40  mg/L shall be less than 0.020  mg/L in two months.  
2.9 Memory effect  
The memory effect shall b e less than 0.010  mg/L.  
2.10 Small changes in mass concentration of gas, residual effect  
When alternately measuring two test gases, the measurement results for the test gas (CRM) with 
lower mass concentration shall not differ by more than 0.010 mg/L.  
3 Tec hnical requirements  
The technical requirements are based on the requirements of Recommendation OIML R  1262) 
‘Evidential breath analysers ’. When verifying measuring instruments type approved prior to the 
effective date of this regulation, they shall be subj ect to technical requirements applicable at the time 
they were put into circulation.  
3.1 In general  
A portable breathalyser shall be designed for outdoor or indoor use and allow connection to a mobile 
printer.  
If the breathalyser converts the calculated br eath alcohol concentration value to per mille, the 
indicated value shall be a 2.1 -multiple of the value in mg/L.  (This value is accepted in European 
countries as the conversion factor for official purposes; the conversion error has been determined by 
exper imental measurements and does not exceed 0.20 ‰ when converted into blood alcohol 
concentration).  
The exhaled volume shall be at least 1.2 L and this value shall correspond to an exhalation time of at 
least 4 seconds.  The minimum gas flow rate shall be 6  L/min.  
The breathalyser shall perform a measurement only if the sample taken is a sample of alveolar air.  
The analyser shall in particular inhibit a measurement if the exhalation is discontinuous, or if the 
exhaled air is from the upper respiratory tract.  In the case of discontinuous exhalation or exhalation 
from the upper respiratory tract, the measurement result shall not be indicated by the breathalyser as a 
numerical value.  
The breathalyser shall inhibit a measurement if air is inhaled instead of exhaled . If air is inhaled 
instead of exhaled, the breathalyser shall not evaluate the measurement result as a numerical value.  
Before each test, the measuring instrument shall make an automatic adjustment and check that it is 
capable of making a correct measurem ent. If this verification reveals that not all the conditions for 
correct operation of the breathalyser have been fulfilled, the breathalyser shall automatically inhibit 
measurement.  
A breathalyser shall be used only with mouthpieces specified by the manuf acturer and in compliance 
with the mouthpieces indicated for the particular approved measuring instrument type.  
3.2 Printer  
The measurement results at the printer output shall be identical to those shown on the display of the 
measuring instrument, includin g the symbol of the measurement unit used.  In the case of portable Measure of a General Nature No  0111 -OOP -C040 -13 
9 breathalysers, the printer shall be a separate part of the measuring instrument.  A mobile printer shall 
be connected to the measuring instrument by a separate cable or wireless connection.  
3.3 Software  
Software critical for metrological properties shall be identifiable by the manufacturer as a separate, 
numbered version that conforms to the approved measuring instrument type.  Software identification 
shall be possible in a simple manner while  the measuring instrument is in routine operation.  The 
installed software shall be secured by the manufacturer against accidental or unauthorised outside 
interference (e.g. by means of a maintenance password).  If the software needs to be reinstalled (as 
part of measuring instrument maintenance), new verification of the measuring instrument ’s 
metrological characteristics shall be conducted.  
3.4 Physiological factors influencing measurement  
If the exhaled air contains components of pharmaceuticals or products  of abnormal human 
metabolism, or other gases, these substances may influence the measurement result.  The extent of 
such influence shall not be greater than specified in Table  11 in Section 5.3.6, especially when 
assessed in relation to the limit below whi ch the result of the breath alcohol content test is considered 
negative (i.e. if it does not exceed 0.20  ‰ when converted into blood alcohol concentration).  
Breathalysers shall be based on a highly selective measurement principle (e.g. an electrochemical c ell, 
infrared spectrometry) that makes it impossible to identify another chemical substance as ethanol 
during measurement.  Identification of the influence of interfering components is part of the test of the 
measuring instrument pursuant to Article  5.3.6.  
3.5 Resistance to environmental influences  
External disturbances affecting the breathalyser referred to in Chapters  3.5.1 and 3.5.2 shall not lead 
to measurement errors that would exceed the maximum permissible error of the breathalyser pursuant 
to Article  2.6. 
If significant errors or significant faults occur, they shall be detected and reported by the checking 
facility contained in the breathalyser.  
In such cases, the breathalyser shall not indicate the measurement result as a numerical value.  
3.5.1 Resis tance to mechanical influences  
The design of the breathalyser and the materials used shall provide sufficient strength, stability, and 
immunity to mechanical vibrations and shocks.  
3.5.2 Resistance to climatic influences  
When switched off, breathalysers sh all withstand, without damage, the limit temperatures of –20 °C 
and +70  °C, unless specified otherwise by the manufacturer.  After returning to the operating 
temperature range, they shall operate within the limits of the maximum permissible error.  
Breathaly sers shall not be sensitive to relative ambient humidity, whether in operation or while in 
storage.  
3.5.3 Electromagnetic compatibility (EMC)  
Breathalysers may not be affected by electrical or electromagnetic interference  or they shall respond 
to it in a c ertain specific manner, e.g. by reporting an error, inhibiting measurement, etc. They shall 
not emit unwanted electromagnetic fields.  
When tested for electromagnetic compatibility in a laboratory, the breathalyser shall function 
normally.  Measuring instrum ent restart as a response to interference is permitted.  Measure of a General Nature No  0111 -OOP -C040 -13 
10 3.6 Supply voltage  
Breathalysers powered by DC from a battery shall operate normally within at least the voltage range 
specified by the manufacturer ( Umin to Umax). When outside of this specified supp ly voltage range, the 
measuring instrument shall switch itself off or switch to a mode in which measurement is not possible.  
3.7 Resistance to unauthorised tampering  
The breathalyser shall be designed such that any mechanical actions performed on this meas uring 
instrument that may influence measurement accuracy will result in permanent visible damage to the 
measuring instrument or official marks.  
4   Markings  
All of the information below indicated on the breathalyser shall be indelible, non -removable and 
legible throughout the entire period of use.  
4.1 Labelling of breathalysers  
Every breathalyser shall indicate at least the following information:  
– the manufacturer ’s insignia or name,  
– the type approval mark of the measuring instrument,  
– the serial number and y ear of manufacture*), 
– measuring range in mg/L,  
– ambient operating temperature range in °C.  
*) The device ’s serial number shall also be easy to identify in its menu.  
5   Type approval  
5.1 In general  
5.1.1 Tests to be performed  
The type approval of a breathal yser shall comprise the following:  
a) external inspection,  
b) functional tests of the breathalyser:  
– an accuracy and repeatability test,  
– a test of zero drift, short -term and long -term drift,  
– a memory effect test,  
– a residual effect test , 
– a test of volume influence  (flow rate change),  
– a test of influence of interfering components and CO 2, 
c) tests of resistance to mechanical influence:  
– an impact resistance test,  
– a free -fall test,  Measure of a General Nature No  0111 -OOP -C040 -13 
11 – a test of influence of random mechanical vibrations,  
d) tests of resistance to climatic condi tions:  
– a cold test (in both off and on mode),  
– a dry heat test,  
– a damp heat test (in both off and on mode),  
e) a test of influence of supply voltage,  
f) tests for electromagnetic compatibility (EMC):  
– an electrostatic discharge immunity test,  
– a test of immunity to  radiated high -frequency electromagnetic fields,  
– a test of immunity to TETRA signals.  
5.1.2  Test equipment  
The measuring instruments, certified reference materials and equipment specified below shall be used 
for testing breathalysers:  
– certified reference m aterials (CRM);  
Gas mixtures of the required composition (see Table  5) shall be used; these shall be primary 
reference materials - gas mixtures or secondary CRM - gas mixtures traceable to a suitable 
primary certified reference material.  If needed, prior t o type approval, the device shall be set 
to the mass concentration recommended by the measuring instrument ’s manufacturer.  The 
mole fractions of the certified reference gases shall be converted to mass concentrations at 
34 °C at atmospheric pressure.  
Table  5 - Certified reference materials  
CRM No  Mass concentration of ethanol in nitrogen (mg/L)  
1 0.04 
2 0.10 
3 0.25 
4 0.40 
5 0.70 
6 0.95 
7 1.50 
8 1.95 
9 90% of the maximum range in mg/L  
 
Expanded uncertainty values of the CRM for ethanol in nitrogen shall not exceed 2  % (with a 
coverage factor of k = 2).  The manufacturing tolerance for the mass concentration of ethanol 
in the reference materials shall be ±15  %. 
– a flow meter with a measuring range of at least 0  L/s to 0.40  L/s, 
– a stopwatch with an accu racy of 0.1  s, 
– a thermo -hygro -barometer for monitoring laboratory conditions,  
– reducing valves with adjustable output gas pressure,  Measure of a General Nature No  0111 -OOP -C040 -13 
12 – test equipment for connecting and measuring the breathalyser.  
5.2 External inspection  
The following is assessed during an ext ernal inspection of the breathalyser:  
a) the completeness of the prescribed technical documentation, including operating instructions,  
b) the conformity of the metrological and technical characteristics specified by the manufacturer 
in the documentation with the  requirements of this regulation specified in chapters  2, 3, and 4,  
c) the completeness and condition of the breathalyser according to the prescribed technical 
documentation,  
d) conformity of the software version of the breathalyser with the version specified by  the 
manufacturer.  
5.3 Breathalyser functional tests  
Prior to the test, the breath alcohol analyser shall be warmed up in accordance with the requirements 
of Article  2.5.4.  The functional tests themselves shall be performed under the reference conditions 
specified in Article  2.5.3.  
Gas mixtures of the specified composition shall be fed into the breathalyser from cylinders with 
CRMs for gas mixtures, as per Table  5. Measurements shall be made sequentially from gas mixtures 
with lower mass concentrations to m ixtures with higher mass concentrations.  At the beginning and 
end of measurement, i.e. after the measurement for the highest mass concentration (90% of the max. 
range in mg/L of ethanol in nitrogen) has been made, a ‘zero’ check shall be performed using a ‘zero’ 
gas, which is nitrogen in a cylinder with a purity of at least 4.0 (99.99  %). 
Evacuation of gases from the device connected to the cylinders with the CRMs for the gas mixtures 
(see Table 5) and the ‘zero ’ gas needs to be ensured during operations.  
5.3.1 Accuracy and repeatability test  
This test involves 20 measurements for each of the nine mass concentrations within the measuring 
range (nominal values:0.04  mg/L, 0.10  mg/L, 0.25  mg/L, 0.40  mg/L, 0.70  mg/L, 0.95  mg/L, 
1.50 mg/L, 1.95  mg/L and 90  % of t he upper limit of the measurement range for the given measuring 
instrument type).  
After completing measurement, the average mass concentration value 
  shall be calculated according 
to formula (2):  
nβ
βn
ii
1
(2) 
where  

 is the average mass concentration value  
ßi are the individual ethanol mass concentration values measured by the breathalyser when 
measuring gaseous CRM,  
n is the number of measured values, i.e. 20.  
The deviation of the measured value from the certified value of ethanol in the gaseous CRM shall be 
less or equal to the maximum permissible value according to Table  3 in Article  2.6, where evaluation 
takes into account the uncertainty of the measured value and the uncertainty of the certified ma ss 
concentration of ethanol in the measured gaseous CRM:  Measure of a General Nature No  0111 -OOP -C040 -13 
13 
MPE) )( 22
RM2
C RM    u(ββ u ββ 
where  

 is the arithmetic mean of the measured values of mass concentration of ethanol when 
measuring the gaseous CRM,  
)β(uc
 is the combin ed standard uncertainty,  
ßRM is the mass concentration of ethanol in the measured gaseous CRM,  
u(ß RM) is the standard uncertainty (obtained from expanded uncertainty using a coverage factor  of k = 
2), 
MPE  is the maximum permissible error of the breathalys er for the given measurement conditions 
and mass concentration of ethanol in the CRM (see Table  5). 
In order to assess repeatability, the standard deviation SD is calculated, which shall not be greater 
than one third of the maximum permissible error accord ing to Table  3 in Article  2.6.1 for the given 
mass concentration.  To calculate the standard deviation SD, the following relationship holds:  
1) (
12



nSDn
ii
 
where  
SD is the standard deviation  

 is the arithmetic mean of the measu red values of mass concentration of ethanol when 
measuring the gaseous CRM,  
ßi is the measured value.  
Table  6 may be used to record and evaluate the test.  
Table 6 - Accuracy and repeatability test  
Reference mass 
concentration 
(ßRM) 0.04 
mg/L  0.10 
mg/L  0.25 
mg/L  0.40 
mg/L  0.70 
mg/L  0.95 
mg/L  1.50 
mg/L  1.95 
mg/L  90 % of max. 
range mg/L  
Accuracy  
Average mass 
concentration 
(
)          
Determined error 
difference
RMββ
          
U (k = 2)          
Maximum 
permissible err or < 0.020 
mg/L  < 0.020 
mg/L  < 0.020 
mg/L  5 % 5 % 5 % 5 % 5 % (reference 
value/2) – – 
0.90 mg/L  
Repeatability  
Standard 
deviation ( SD)          Measure of a General Nature No  0111 -OOP -C040 -13 
14 Maximum 
permissible 
standard 
deviation  < 0.007 
mg/L  < 0.007 
mg/L  < 0.007 
mg/L  <1.7%  <1.7%  <1.7%  <1.7%  <1.7%  < [(reference 
value/2) – 
0.90] / 3  
5.3.2 Drift test and long -term and short -term drift tests  
The device stability test shall consist of three parts - drift, short -term drift, and long -term drift.  The 
drift and short -term drift tests shall involve ten measur ements of a test gas repeated after four hours.  
Measurements with the zero gas (no ethanol content) and test gas with mass concentration of 0.40 
mg/L ethanol in nitrogen (see Table 3, CRM No 4) for drift and for short -term stability shall follow 
the proced ure below:  
– ten measurements with the zero gas - 4-hour break - ten measurements with the zero gas,  
– ten measurements with the test gas - 4-hour break - ten measurements with the test gas.  
The drift obtained from both measurements shall meet the requirements  of Article  2.5. 
Long -term drift is monitored in the same way as short -term stability, but the subsequent measurement 
using the test gas shall be made after two months; the requirement of Article 2.8 for maximum 
permissible drift of 0.020  mg/L shall be met . Table  7 may be used to record and evaluate this test.  
Table 7 Drift and short -term and long -term drift  
Measurement 
number  Zero gas  Test gas 0.40 mg/L  Test gas 0.40 mg/L  
measureme
nt time  measureme
nt time + 4 
h measureme
nt time  measureme
nt time + 4 
h measurement 
date measurement 
date + 2 
months  
1       … 
      
10       
Mean value        
Drift     
Max. permissible 
drift 0.01 mg/L  0.01 mg/L  0.02 mg/L  
5.3.3 Memory effect test  
The memory effect test shall be performed using the following procedure:  
Step 1: ten measurements shall be performed with a mass concentration of 0.10  mg/L ethanol 
in nitrogen (see Table  5, CRM No  2), 
Step 2:  alternating measurements shall be performed using gas with mass concentration of 
1.95 mg/L ethanol in nitrogen (see Table  5, CRM No  8) or 1.50  mg/L ethanol in 
nitrogen (see Table  5, CRM No  7), for measuring instruments with a range up to 
2 mg/L, and measurements using gas with mass concentration of 0.10  mg/L of ethanol 
in nitrogen (see Table  5, CRM No  2). 
Step 2 shall be repeate d ten times, resulting in ten measured values at a high mass concentration and 
ten measured values at a low mass concentration.  The memory effect shall meet the requirements of 
Article  2.9. 
Every individual measurement shall comply with the maximum permiss ible error for the given mass 
concentration pursuant to Article  2.6. Table  8 may be used to record and evaluate this test.  Measure of a General Nature No  0111 -OOP -C040 -13 
15 Table 8 - Memory effect  
Measurement number  Pre-test 0.10  mg/L  (Step 
1) Alternating measurement of two concentrations (Step  2) 
1.95 mg/L or  (1.50  mg/L)  0.10 mg/L  
1    … 
   
10    
Mean value  1 - - - 2 
Difference ( 1 – 2)  
5.3.4 Residual effect test  
The residual effect test shall be performed using the following procedure:  
Step 1:  ten measurements shall be performed with a mass concentration of 0.25  mg/L ethanol 
in nitrogen (see Table  5, CRM No  3), 
Step 2:  alternating measurements shall be performed  using gas with mass concentration of 
0.40 mg/L ethanol in nitrogen (see Table  5, CRM No  4) and using gas with mass 
concentration of 0.25 mg/L of ethanol in nitrogen (see Table  5, CRM No  3). 
Step 2 is repeated ten times resulting in ten measured values measured at the higher mass 
concentration and ten measured values at the lower mass concentration.  
The residual effect shall meet the re quirements of Article  2.10.  Every individual measurement shall 
comply with the maximum permissible error for the given mass concentration pursuant to Article  2.6. 
Table  9 may be used to record and evaluate this test.  
Table 9 - Residual effect  
Measurement n umber  Pre-test 0.25  mg/L  Alternating measurement of two concentrations  
0.40 mg/L  0.25 mg/L  
1    … 
   
10    
Mean value  1 – 2 
Difference ( 1 – 2)  
5.3.5 Test of volume influence (flow rate change)  
The influence of the gas inflow volume shall be t ested using a test gas with a mass concentration of 
0.40 mg/L ethanol in nitrogen (see Table  5, CRM No  4) at gas volumes of 1.5  L and 3  L and flow 
rates of 0.20  L/s to 0.35  L/s. The difference between measurements shall not exceed 0.010 mg/L.Each 
of these ten measurements shall comply with the maximum permissible error for the given mass 
concentration pursuant to Article  2.6. Table 10A may be used to record and evaluate this test.  
Table 10A - Volume influence (flow rate change)  
Measurement number  Gas volume  of 1.5 L  Gas volume of 3 L  Difference  
1    … 
   
10    Measure of a General Nature No  0111 -OOP -C040 -13 
16 Max. difference     
 
If the breathalyser checks the volume of exhaled air automatically, measurements at higher volumes 
of exhaled air are irrelevant.  
In such a case, measurements shall be performe d using a test gas with mass concentration of 
0.40 mg/L ethanol in nitrogen (see Table  5, CRM No  4) at a flow rate within the maximum range of 
0.15 L/s to 0.40  L/s or at the minimum gas flow rate possible (0.15 to 0.20)  L/s and two higher flow 
rates of the  reference gas (0.25 to 0.30)  L/s and (0.35 to 0.40)  L/s. Ten measurements shall be 
performed at each chosen gas flow rate.  Again, the difference between measurements shall not exceed 
0.010 mg/L.  Each of these ten measurements shall comply with the maximum  permissible error for 
the given mass concentration pursuant to Article  2.6. Table 10B may be used to record and evaluate 
this test.  
Table 10B - Volume influence (flow rate change)  
Measurement number  gas flow rate  (0.15 
to 0.20)  L/s gas flow rate  (0.25 
to 0.30)  L/s gas flow rate  (0.35 
to 0.40)  L/s Difference  
1     … 
    
10     
Max. difference      
5.3.6 Test of influence of interfering components and CO2  
This test shall be performed to check compliance with Article  3.4 by means of ten measurements 
using  dry gas with a mass concentration of 0.40  mg/L ethanol in nitrogen (see Table  5, CRM No  4) 
without and with the interfering component.  The maximum influence of a given interfering 
component shall not exceed the values specified in Table  11 and the sum of all specified interfering 
components and CO 2 shall not exceed 0.40  mg/L.Table  11 may be used to record and evaluate this 
test. 
Table 11 - Influence of interfering components and CO 2 
Interfering component (±5  %) Acetone  
0.50 mg/L  Methanol  
0.10 mg/L  Isopropa nol 
0.10 mg/L  CO 
0.20 mg/L  Toluene  
0.20 mg/L   
Measurement using pure gas        
Measurement with the 
interfering component        
Influence        
Max. influence  0.05 mg/L  0.10 mg/L  0.10 mg/L  0.08 mg/L  0.08 mg/L   
(continued)  
 
Table 11 - Influence of int erfering components and CO 2(continued)  
Interfering component ( 5 %) Methane  
0.30 mg/L  Acetaldehyde  
0.15 mg/Ls  CO 2 100 mg/L  Total  
Measurement using pure gas     – 
Measurement with the 
interfering component     – Measure of a General Nature No  0111 -OOP -C040 -13 
17 Influence      
Max. influence  0.08 mg/L  0.10 mg/L  0.05 mg/L  0.40 mg/L  
5.4 Tests of resistance to mechanical influences  
5.4.1 Shock resistance test  
This test to check compliance with the requirements of Article 3.5.1 shall be performed on the 
breathalyser without a carrying case under the following conditions:  
–  every shock shall have an intensity of 10  gn, where acceleration 1  gn = 9.81 m/s2, 
–  duration:  6 ms, 
– frequency:  2 Hz,  
–  number of shakes:  1000 in each axis perpendicular to the sample.  
When at least two hours have elapsed after completion of the  test, the measuring instrument shall 
meet the requirements specified in Article  2.6 when tested within the operating temperature range.  
5.4.2 Free -fall test  
During the free -fall test applied to check compliance with the requirements of Article  3.5.1, the 
breathalyser under test shall be allowed to fall freely from a height of 500  mm on a rigid test pad.  The 
measuring instrument shall be allowed to fall on three sides: on its rear and on its right and left side.  
The test shall not be performed for the front  side (where the display is located).  The test shall be 
repeated two times for each side of the measuring instrument , i.e. a total of six free falls.  
Immediately after the free falls, the measuring instrument is checked for changes in appearance.  No 
change s in indication may occur during the test.  After at least one hour has passed since the 
completion of the test, the measuring instrument shall comply with the requirements of Article  2.6 in 
an accuracy test at reference temperature.  
5.4.3 Test of influence  of random mechanical vibrations  
In this test of compliance with the requirements of Article 3.5.1, the measuring instrument shall be 
exposed to broadband vibrations in three perpendicular axes under the following conditions:  
– frequency range from 10  Hz to 150 Hz, 
– spectral density of acceleration from 10  Hz to 20  Hz: 0.02 gn/Hz, 
– spectral density of acceleration from 20  Hz to 150  Hz: -3 dB per octave,  
– duration of 5 minutes in each axis.  
After at least one hour has passed since the completion of the test, the measuring instrument shall 
comply with the requirements of Article  2.6 in an accuracy test at reference temperature.  
5.5 Tests of resistance to climatic conditions  
5.5.1 Cold test  
The breathalyser in on -mode shall be placed in a temperature chamber at a te mperature of –5 °C. 
Under these climactic conditions, an accuracy test shall be performed ten times using dry gas with 
mass concentration of 0.40  mg/L ethanol in nitrogen (see Table  5, CRM No  4). Each of these ten 
measurements shall comply with the maximum  permissible error for the given mass concentration 
pursuant to Article  2.6. Measure of a General Nature No  0111 -OOP -C040 -13 
18 5.5.2 Dry heat test  
The breathalyser in on -mode shall be placed in a temperature chamber at a temperature of +40  °C. 
Under these climactic conditions, an accuracy test shall be pe rformed ten times using dry gas with 
mass concentration of 0.40  mg/L ethanol in nitrogen (see Table  5, CRM No  4). Each of these ten 
measurements shall comply with the maximum permissible error for the given mass concentration 
pursuant to Article  2.6. 
5.5.3  Damp heat test  
a) A cyclic damp heat test (a 12 h + 12 h cycle) shall be performed using two cycles within a 
temperature range of 25  °C at a relative humidity above 95  % to 55  °C at a relative humidity of 93  %. 
The measuring instrument shall be switched o ff during the test.  
The measuring instrument shall be inspected for changes in appearance immediately after the test.  
When one hour has passed after the completion of the test and the measuring instrument stabilised at 
20 °C, shall comply with the requirem ents of Article  2.6 at the reference temperature in an accuracy 
test using dry gas with mass concentration of 0.40 mg/L ethanol in nitrogen (see Table  5, CRM No  4). 
b) The damp heat test shall be performed at 20  °C at a relative humidity of 85  %. The measu ring 
instrument shall be switched on during the test.  Under these climactic conditions, an accuracy test 
shall be performed ten times using dry gas with mass concentration of 0.40  mg/L ethanol in nitrogen 
(see Table  5, CRM No  4). Each of these ten measurem ents shall comply with the maximum 
permissible error for the given mass concentration pursuant to Article  2.6. 
5.5.4  Test of storage conditions  
a) The test of influence of storage conditions shall be performed within a temperature range of -25 °C 
to +70  °C. The device shall first be placed in a chamber at -25 °C, where it shall be kept for 6 hours.  
After the measuring instrument is removed from the chamber, it shall be allowed to stabilise under the 
reference conditions specified in Chapter 2.5.5 and five measurements shall be performed using CRM 
No 4. 
b) In the high temperature test, the measuring instrument shall be exposed to a temperature of +70  °C 
for 6 hours, after which it shall be removed from the chamber.  After the measuring instrument is 
removed f rom the chamber, it shall be allowed to stabilise under reference conditions  for one hour  
and five measurements shall be performed using CRM No 4.  
The measuring instrument shall be inspected for changes in appearance immediately after the test.  
All ten mea surements shall comply with the maximum permissible error for the given mass 
concentration pursuant to Article  2.6. 
5.6 Test of supply voltage influence  
The test of supply voltage influence shall be performed for battery -powered breathalysers with the 
supp ly voltage set at Umax = Ubat.max  and then at Umin = Ubat.min for measuring instruments, where Ubat.min 
is the battery ’s lowest operating voltage, as specified by the measuring instrument ’s supplier for an 
ambient temperature of 20  °C and  Ubat.max  is the v oltage of a new battery under zero load.  
In an accuracy test using a dry gas with mass concentration of 0.40 mg/L ethanol in nitrogen (see 
Table 5, CRM No 4), the measuring instrument shall exhibit normal functionality within the limits of 
the maximum perm issible error specified in Article 2.6.  Measure of a General Nature No  0111 -OOP -C040 -13 
19 5.7 Electromagnetic compatibility (EMC) tests  
5.7.1 Test of immunity to electrostatic discharge  
Immunity to electrostatic discharge shall be tested with the measuring instrument switched on, 
preferably using a 6  kV c ontact discharge or an 8  kV air discharge where contact discharge cannot be 
used.  The discharges shall be applied to the enclosure of the measuring instrument or a coupling plane 
adjacent to the breathalyser.  
During the test, ten measurements shall be perf ormed using test gas for each discharge voltage 
polarity.  One discharge shall be applied during each measurement.  The delay between discharges 
shall be at least 10  s. 
The difference between the values obtained under the conditions of interference and those  without 
interference shall be less than 0.040  mg/l when using dry gas with mass concentration of 0.40  mg/L 
ethanol in nitrogen (see Table  5, CRM No  4). 
After this test, the measuring instrument shall exhibit normal functionality within the limits of the 
maximum permissible error specified in Article 2.6 in an accuracy test without interference using dry 
gas with mass concentration of 0.40  mg/L ethanol in nitrogen (see Table  5, CRM No  4). 
5.7.2 Test of immunity to high -frequency electromagnetic field radiat ion 
Immunity to a radiated radio -frequency electromagnetic field shall be tested with the measuring 
instrument switched on, within the frequency range of 26  MHz to 3  000 MHz at a test field intensity 
of 10  V/m when measuring without modulation.  
The test fi eld shall be amplitude -modulated to a depth of 80  %; the modulation signal shall have a 
sinusoidal waveform with a modulation frequency of 1  kHz.  
The tested measuring instrument shall be irradiated vertically and horizontally with a polarised field 
from fo ur mutually perpendicular directions.  
The test shall be performed at the following frequencies:(26, 40, 60, 80, 100, 120, 144, 150, 160, 180, 
200, 250, 350, 400, 435, 500, 600, 700, 800, 934, 960, 1  000, 1  200, 1  400, 1  700, 1  800, 1  900, 2  000, 
2 400, 2  700 and 3  000) MHz.  One measurement using test gas shall be performed at each frequency.  
If the measuring instrument is found to have been influenced at any of these frequencies, testing shall 
be performed in the region of this frequency to locate the point  of maximum influence at a frequency 
resolution of approximately 1  %. 
The difference between the values obtained under the conditions of interference and those without 
interference shall be less than 0.040  mg/l when using dry gas with mass concentration of  0.40 mg/L 
ethanol in nitrogen (see Table  5, CRM No  4). 
After this test, the measuring instrument shall exhibit normal functionality within the limits of the 
maximum permissible error specified in Article 2.6 in an accuracy test without interference using dry 
gas with mass concentration of 0.40  mg/L ethanol in nitrogen (see Table  5, CRM No  4). 
5.7.3 Test of immunity to TETRA system signals  
Immunity to TETRA system signals shall be tested with the measuring instrument switched on by 
irradiating it using a fi eld with vertical and horizontal polarisation sequentially in four mutually 
perpendicular directions.  
The breathalyser shall be tested using at test frequencies (380, 385, 390, 395, 400, 405, 410, 415 and 
420) MHz ±0.1  MHz.  
At each frequency, the test fiel d intensity shall be gradually increased in 3 dB steps from 12 dB below 
the set test limit until the test limit is reached.  The level at which any influence is observed to begin to 
develop shall be recorded and included in the test report.  Measure of a General Nature No  0111 -OOP -C040 -13 
20 The test limit i s given as the peak value of a modulated signal measured using a peak value detector 
calibrated according to the equivalent effective value of the sinusoidal signal causing the same 
deflection.  The test limit for devices not used inside vehicles shall be 6 5 V/m.  
For tests of immunity to TETRA system signals, amplitude modulation using a square -wave signal 
with a frequency of 18  kHz and modulation depth of >  98%, further keyed with a frequency of 17  Hz, 
shall be used.  The keying duty cycle shall be 50  %. 
The difference between the values obtained under the conditions of interference and those without 
interference shall be less than 0.040  mg/l when using dry gas with mass concentration of 0.40  mg/L 
ethanol in nitrogen (see Table  5, CRM No  4). 
After this test, the measuring instrument shall exhibit normal functionality within the limits of the 
maximum permissible error specified in Article 2.6 in an accuracy test without interference using dry 
gas with mass concentration of 0.40  mg/L ethanol in nitrogen (see Tab le 5, CRM No  4). 
6   Initial verification  
6.1 In general  
6.1.1 Tests to be performed  
The initial verification process for breathalysers shall comprise the following tests:  
a) visual inspection,  
b) an accuracy test.  
6.1.2  Test equipment  
The same measuring instrum ents and equipment as that used for type approval pursuant to Article 
5.1.2 shall be used for initial verification tests of breathalysers.  In addition, secondary CRM for 
ethanol in nitrogen traceable to a suitable primary reference material for the relevan t gas mixture mole 
(mass) fractions according to Table  12 shall be used.  
Table 12 - Certified reference materials  
CRM No  Mass concentration of ethanol in 
nitrogen (mg/L)  Number of 
measurements using 
the given gas  
1 0.14 10 
2 0.48 10 
3 0.90 5 
4 1.40 5 
6.2 Visual inspection  
The purpose of visua l inspection shall be to assess  that: 
a) the measuring instrument submitted for verification conforms to the approved type,  
b) the measuring instrument is complete and undamaged,  
c) markings and inscriptions are complete, a ccurate and legible, in conformity with the approved 
type of the measuring instrument  
d) the software version installed is the same as that specified by the manufacturer and conform to 
the approved measuring instrument type.  Measure of a General Nature No  0111 -OOP -C040 -13 
21 6.3 Accuracy and repeatability tes t 
During initial verification, the breathalyser test shall be performed pursuant to the requirements of 
Articles  5.3 and 5.3.1 and the CRM used and the number of tests using a given gas shall be as 
specified in Table  12 in Article  6.1.2.  
The combined stand ard uncertainty of this arithmetic mean of mass concentration 
  consists of 
standard uncertainty evaluated using method A - 
)(Au  and standard uncertainty evaluated using 
method B 
)(Bu : 
2 2)( )( )(  B A C u u u  
 
Standard uncertainty evaluated using method A shall be calculated from the standard deviation of the 
arithmetic mean multiplied by a coefficient dependent on the number of measurements:  
A l A sk u )(
 
where  
kl is the coefficient dependent on the number of measurements n: 
n 2 3 4 5 6 7 8 9 10 or 
more  
kl 7.0 2.3 1.7 1.4 1.3 1.3 1.2 1.2 1.0 
 
sA standard deviation of the arithmetic mean,  
)1 () (
12



nnsn
ii
A
 
where  

 is the arithmetic mean of the mass concentrations of e thanol obtained when measuring the 
gaseous CRM,  
ßi is the value obtained,  
n is the number of measurements.  
NOTE Type B uncertainty of the values obtained is given by the uncertainty of the certified content of CRM used 
when configuring the breathalyser, th e uncertainty caused by non -linearity, indication uncertainty, and in some 
cases uncertainty of the influence of deviation of the true temperature of exhalation into the analyser from 34  °C 
(determined during type approval of the measuring instrument), the  influence of sensitivity to other gas 
components, influence due to changes in barometric pressure (if the measuring instrument does not provide for 
automatic correction), influence of changes in calibration gas flow rate, influence of other factors relate d to 
various principles of the measuring instrument used, etc.  
For the purposes of verification and to ensure unambiguous and correct assessment of the 
breathalyser, type B uncertainty shall be estimated only from the standard uncertainty of the mass 
conce ntration of ethanol in the measured gaseous CRM u(ßRM) and the standard uncertainty of display 
resolution uind: 
2)(ind2
RM)u uB  u(β
 
where  
u(ßRM) is the standard uncertainty of mass concentration of ethanol in the measured gaseous CRM 
(obtained, for exam ple, from expanded uncertainty with coverage factor k = 2),  Measure of a General Nature No  0111 -OOP -C040 -13 
22 uind is the standard uncertainty of measuring instrument display (rounding):  
32ind
indru
 
where  
rind is the resolution of values read from the breathalyser display.  
Other measured value uncertainties that play a role in the standard uncertainty evaluated using method 
B need not be specified during verification.  
6.4 Correct measuring instrument configuration  
The analyser delivered for verification by the customer shall be correctly configu red, with minimal 
standard uncertainty of measured values.  Otherwise, prior to measuring instrument verification, the 
breathalyser shall be configured for reference values.  
7   Subsequent verification  
A procedure identical to initial verification pursuant to Chapter  6 shall be applied during subsequent 
verification.  
8   Notified standards  
For the purposes of specifying metrological and technical requirements for measuring instruments and 
specifying the type approval and verification testing methods stemming  from this measure of a 
general nature, the CMI shall provide notification of Czech technical standards, other technical 
standards or technical documents of international or foreign organisations or other technical 
documents containing detailed technical r equirements (hereinafter ‘notified standards ’). The CMI 
shall publish a list of these notified standards attached to the relevant measures, together with the 
measure of a general nature in a manner accessible to the public (on the www.cmi.cz  website).  
Compliance with notified standards or parts thereof is considered, to the extent and under the 
conditions stipulated by this Measure of a General Nature, to be compliance with those requirements 
stipulated by this measure to w hich these standards or parts thereof apply.  
II. 
REPEALING AND TRANSI TIONAL PROVISIONS  
Measure of a General Nature number:0111 -OOP -C040 -13, stipulating metrological and technical 
requirements for legally controlled measuring instruments, including test met hods for verification of 
legally controlled measuring instruments:  ‘breathalysers ’ is hereby repealed.  The notified standards 
remain in force.  
III. 
G R O U N D S 
Pursuant to §  14(1)(j) of the Metrology Act, the CMI has issued this Measure of a General Natu re to 
implement§  6(2), §  9(1) and (9), and  § 11a(3) of the Metrology Act, laying down metrological and 
technical requirements for legally controlled measuring instruments and tests for type approval and 
verification of legally controlled measuring instrume nts - ‘breathalysers ’. Measure of a General Nature No  0111 -OOP -C040 -13 
23 Under item 7.4. 2 in the Annex ‘List of the Types of Legally Controlled Measuring Instruments ’ to 
Implementing Decree No  345/2002 specifying the measuring instruments whose verification is 
mandatory and measuring instruments subject t o type approval, as amended, this type of measuring 
instruments is classified as measuring instruments subject to mandatory verification.  
This legislation (Measure of a General Nature) will be notified in accordance with Directive (EU) 
2015/1535 of the Eur opean Parliament and of the Council of 9  September  2015 laying down a 
procedure for the provision of information in the field of technical regulations and of rules on 
Information Society services.  
IV. 
I N S T R U C T I O N S 
In accordance with §  172(l), in  conjunction with §  39(l) of the APC, the CMI has stipulated a time 
limit for comments of 30  days from the posting of the draft.  Comments submitted after this time limit 
will not be considered.  
The persons concerned are hereby invited to comment on this dr aft Measure of a General Nature.  
With a view to the provisions of §  172(4) of the APC, the comments shall be submitted in writing and 
meet the requirements for submissions in accordance with §  37 of the APC.  
The comments shall include the particulars referred to in §  37(2) of the APC, stating clearly who is 
making the comments, which measure of a general nature they concern, to what extent the comments 
challenge the measure, how it contradicts legislation or h ow the measure of a general nature or the 
procedure that preceded it is inaccurate, which matters the comments concern and what is being 
proposed; they must also identify the administrative authority to which they are addressed and be 
signed by the person making them.  
The supporting documents for this draft Measure of a General Nature may be consulted at the Czech 
Metrological Institute, Department of Legal Metrology, Okružní 31, 638 00 Brno, after making 
arrangements by phone.  
This Measure of a General Nat ure shall be posted for a period of 15  days.  
 
 
 
 
 
 
...………………………… ..............  
RNDr.  Pavel Klenovský  
Director -General  
 
 
Person responsible for accuracy:  Mgr.  Tomáš Hendrych  
 
Posted on:  24 May 2017  
Signature of the authorised person confirming posting:  ....................................................  Measure of a General Nature No  0111 -OOP -C040 -13 
24  
Removed on:  
Signature of the authorised person confirming removal:  ....................................................