C z e c h  M e t r o l o g y  I n s t i t u t e  
Okružní 31, 638 00  
Brno  
 
1. ------IND- 2014 0039 CZ - EN- ------ 20140203 --- --- PROJET 
Executive summary for the EC (not part of this legislation)  
Breath alcohol analysers are subject national metrological regulations and are placed on the market and 
made operational in the Czech  Republic following type approval and initial verification in accordance 
with Act No 505/1990 on metrology, as amended. The subject of this notified regulation is to lay down 
metrological and technical requirements for specified measuring instruments, incl uding the testing 
methods for the type approval and verification of specified measuring instruments.  
This regulation sets forth the metrological level required for the certificates of type approval and 
verification of measuring instruments issued abroad t o be recognised.  
The requirements to which these measuring instruments are subject are also based on European 
standard EN 15964:2011 and take account of the draft recommendation OIML R 126:2012.   
(End of executive summary.)  
 
 
 
As the authority with subs tantive and territorial jurisdiction in the matter of laying down the 
metrological and technical requirements for specified measuring instruments and laying down the testing 
methods for type approval and verification of specified measuring instruments unde r § 14(1) of Act No 
505/1990 on metrology, as amended (hereinafter referred to as the “Metrology Act”), and in accordance 
with the provisions of §  172 et seq. of Act No 500/2004, the Administrative Procedure Code 
(hereinafter referred to as the “APC”), the  Czech Metrology Institute (hereinafter referred to as the 
“CMI”) commenced ex officio proceedings on 22 November 2013 under § 46 of the APC and, based on 
the supporting documents, issues the following:  
 
 
I. 
G E N E R A L    M E A S U R E  
number: 0111 -OOP -C040-13 
ref. no. 0313/011/13 -Po, 
 
laying down the metrological and technical requirements for specified measuring instruments, 
including the testing methods for type approval and verification of the following specified 
instruments:  
“breath alcohol analysers ” General Measure No 0111 -OOP -C040 -13 
2 
 1   Basic definitions  
For the purposes of this General Measure, the terms and definitions according to VIM and VIML1) and 
the definitions below shall apply.  
1.1 
breath alcohol (concentration) analyser   
a measuring instrument designed to determine ethanol  concentration in the air exhaled by the tested 
person;  the detection is based on an electrochemical method of measurement  
1.2 
portable breath alcohol analyser   
a moveable measuring instrument intended for use outside or inside buildings, e.g. a handheld d evice 
powered by an autonomous battery, which may also be equipped with a separate mobile printer  
1.3 
measurement of alcohol in breath   
determination of the mass concentration of ethanol in exhaled air generated in the pulmonary alveoli of 
the tested perso n, in mg/L  
Under existing legislation in the Czech Republic, the results of this measurement method are converted 
by the analyser from breath alcohol concentration to blood alcohol concentration and expressed in units 
of % (per mille).  
NOTE Mass  concentra tion of alcohol in exhaled breath is the proportion by mass of ethanol in a volume of 
exhaled air at the temperature of 34°C and pressure of 1013 hPa. Mass concentration of alcohol in the blood is 
the proportion by mass of ethanol relative to the volume or  mass of blood at the temperature of 20°C and 
pressure of 1013 hPa.  
According to Henry’s law, breath alcohol concentration (BrAC) depends on blood alcohol concentration 
(BAC). In the Czech Republic, breath alcohol analysers must be adjusted to convert the value using the 
BAC/BrAC ratio of 2100:1. This ratio is statistically the most commonly used in European countries for 
determining the mass concentration of alcohol directly in units of BAC. This means that in the Czech Republic 
analysers must be adjusted to use the % (per mille) / mg/L conversion ratio of 2.1:1.  
1.4 
alveolar air   
the air exhaled by the tested person in a strong exhalation involving contractions of abdominal and 
internal intercostal muscles; alveolar air is generally obtained in the last th ird of the period of  exhalation  
1.5 
measurement of alcohol in the blood   
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 e thanol 
determined in mg/L or convert this value using the analyser into mass concentration of alcohol in the blood in 
% (per mille), for which the conversion constant of 2.1 is used in the Czech Republic (see measuring device 
adjustment).  
                                                   
1) International vo cabulary of metrology – Basic and general concepts and associated terms (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 acces sible at www.unmz.cz  General Measure No 0111 -OOP -C040 -13 
3 
 1.6 
active mode of the breath alcohol analyser   
in this mode, the breath alcohol analyser provides results of measurements of breath alcohol 
concentration in the form of a specific numerical value in the desired units  
1.7 
drift  
a change in the measuring instrument indica tions which occurs during a stated period of time at a given 
mass concentration of ethanol in air  
1.8 
memory effect   
dependence of the value indicated by the measuring instrument on the value indicated by the same 
measuring instrument for the preceding sam ple 
2   Metrological requirements  
The metrological requirements are based on the requirements under Recommendation OIML R  1262) 
“Evidential breath analysers ”. Measuring instruments type approved prior to the entry into force of this 
regulation shall be sub ject to the metrological requirements 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 breath alcohol analyser needs to be adju sted to reference values are limited, the manufacturer 
must specify this time limit in the documentation for the measuring instrument and/or ensure that the 
measuring instrument directly indicates that this limit has been reached.  
2.1.   Operating conditio ns 
2.1.1    Operating conditions for use of the measuring instrument  
The operating conditions for the breath alcohol analyser shall be specified by the manufacturer for the 
particular type of measuring instrument. If not specified, the requirements below sh all apply.  
The ambient operating temperature range must be at least –10°C to +40°C.  
The relative humidity limits must be at least 10% to 85%.  
Atmospheric pressure must be within the range of 860  hPa to 1  060 hPa. 
2.1.2    Reference operating conditions  
The reference ambient temperature during a laboratory test must be within the range of 19°C to 27°C.  
The relative humidity limits must be at least 20% to 80%.  
Atmospheric pressure must be within the range of 860  hPa to 1  060 hPa. 
Carbon dioxide mass concentra tion must be less than 10%.  
The flow rate of the test gas (CRM for ethanol in nitrogen) must be within the range of 0.20  L/s to 
0.35 L/s. 
                                                   
2) OIML R 126 “Evidential breath analyzers”, freely accessible at www.oiml.org  General Measure No 0111 -OOP -C040 -13 
4 
 Back pressure must not exceed 25 hPa (at the flow rate of 0.25  L/s). 
The volume of the test gas analysed in the breat h alcohol analyser must be at least 1.2  L. 
The time of exhalation into the breath alcohol analyser must be at least 4 seconds.  
2.1.3    Temperature stabilisation period  
Under reference conditions, the measuring instrument should be capable of accurate measu rement:  
– following temperature stabilisation as specified by the manufacturer - no more than 15 
minutes after the measuring instrument has been switched on,  
– in less than 5 minutes after it has been switched from the sleep (standby) mode to the 
measuring mod e. 
If these requirements are not met, the relevant times must be clearly indicated on the measuring 
instrument and stated in the manufacturer’s documentation.  
2.2   Measuring range  
The measuring range of the breath alcohol analyser must be from 0.00  mg/L t o no less than 2.00  mg/L.  
The upper limit of the measuring range shall be specified by the manufacturer and must not exceed 
3.00 mg/L.  
A breath alcohol analyser must be capable of indicating (including as a numerical value) that the upper 
limit of the meas uring range has been exceeded.  
A breath alcohol analyser must be capable of displaying the results of measurement:  
a) in mg/L (mg of ethanol per L of exhaled air);  
b) in % (per mille corresponding to g/kg of exhaled air).  
2.3   Maximum permissible error  
Maximum permissible errors (positive or negative) for each measurement are given in Table 1.  
Table 1  – 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  (refer ence value/2) – 0.90  
*)   Values in percent are relative to the measured value of mass concentration of ethanol.  
2.4   Repeatability of measurement  
The repeatability of measurement is expressed as the standard deviation of a given number of 
measurements , which must be less than the values given for each measuring range in Table 2.  
TABLE 2  – Repeatability of measurement  
Mass concentration of ethanol in exhaled air  
(mg/L)  Maximum permissible standard deviation  
(mg/L)  General Measure No 0111 -OOP -C040 -13 
5 
 < 0.4  0.010  
≥ 0.4 and ≤ 2.0  2.5%*) 
> 2.0  [(reference value/2) – 0.90] / 3  
*)   Values in percent are relative to the measured value of mass concentration of ethanol.  
2.5   Drift  
Zero drift and short -term drift at 0.40  mg/L must be less than 0.007 mg/L in 4 hours.  
Long -term drift at 0.40  mg/L must be less than 0.014 mg/L in two months.  
2.6   Memory effect  
The memory effect must be less than 0.010 mg/L.  
2.7   Small changes in mass concentration of gas, residual effect  
When alternately measuring two test gases, the m easurement results for the test gas (CRM) with lower 
mass concentration must not differ by more than 0.010 mg/L.  
3   Technical requirements  
The technical requirements are based on the requirements of Recommendation OIML R  1262) 
“Evidential breath analyser s”. Measuring instruments type approved prior to the entry into force of this 
regulation shall be subject to the technical requirements applicable at the time they were put into 
circulation.  
3.1   General  
A portable breath alcohol analyser shall be designe d for use outside or inside buildings and allow 
connection of a mobile printer.  
If the breath alcohol analyser converts the breath alcohol concentration value into per mille, the 
indicated value must represent a 2.1 -multiple of the value expressed in mg/L . (This value is accepted in 
European countries as the conversion factor for official purposes; the conversion error has been 
determined by experimental measurements and does not exceed 0.20 % when converted into blood 
alcohol concentration).  
The exhaled v olume must be at least 1.2 L and this value must correspond to an exhalation time of at 
least 4 seconds. The effect of the volume of the passing air shall be tested in accordance with Article 
5.3.5.  
The breath alcohol analyser shall perform a measurement o nly 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 contains breath from the upper respiratory tract. In the case of discontinuous 
exhalation or exhalation from the upper respiratory tract, the measurement result must not be indicated 
by the breath alcohol analyser as a numerical value.  
The breath alcohol analyser shall inhibit a measurement if air is inhaled instead of exhaled. The 
measuring in strument must inhibit detection when air is “sucked” instead of “blown” - in such cases, the 
measurement result must not be indicated by the breath alcohol analyser as a numerical value.  
Before each measurement operation, the measuring instrument shall mak e an automatic adjustment and 
verify automatically that it is capable of making a correct measurement. If this verification reveals that General Measure No 0111 -OOP -C040 -13 
6 
 not all the conditions for correct operation of the breath alcohol analyser  have been fulfilled, any 
measurement made b y the breath alcohol analyser must be automatically inhibited.  
The breath alcohol analyser must be used only with a mouthpiece specified by the manufacturer and in 
compliance with the mouthpieces indicated for the particular approved type of measuring inst rument.  
3.2   Indicating device  
The scale interval for normal operation of the measuring instrument shall be to the order of 0.01  mg/L. 
The breath alcohol analyser may have resolution to the order of 0.001 mg/L only when state 
metrological controls on the measuring instrument are being carried out.  
If the breath alcohol analyser is capable of resolution to the order of 0.001  mg/L, then in normal 
operation the measuring instrument must round the values obtained down to two decimal places, i.e. to 
0.01 mg/L, e.g. 0.427  mg/L shall be rounded and displayed as 0.42  mg/L.  
The name or symbol of the unit of measurement used must be shown on the display in close proximity 
to the numerical result of the measurement.  
3.3   Printer  
The measurement results of the printer  output must be identical to those shown on the display of the 
measuring instrument, including the symbol of the measurement unit used. The printer must constitute a 
separate part of the measuring instrument. A mobile printer must be connected to the measu ring 
instrument by a separate cable or wireless connection.  
3.4   Software  
Software critical for metrological characteristics must be identifiable by the manufacturer as a separate, 
numbered version, which conforms to the approved measuring instrument type . Software identification 
must be possible while the measuring instrument is being operated. The installed software must be 
secured by the manufacturer against accidental or unauthorised outside interference (e.g. by means of a 
service password). If the so ftware needs to be reinstalled (as a maintenance intervention in the 
measuring instrument), new verification of the measuring instrument’s metrological characteristics must 
be conducted.  
3.5 Physiological factors influencing measurement  
If components of ph armaceuticals or products of abnormal metabolism contained in solvents or industrial 
products, such as toluene vapours, acetaldehyde and other gases, are present in exhaled breath, these 
substances may influence the measurement result. The extent of such i nfluence must be negligible, especially 
when assessed in relation to the limit below which the result of breath alcohol content test is considered 
negative (i.e. it must not exceed 0.20% when converted into blood alcohol concentration). Breath alcohol 
analysers must be based on a highly selective electrochemical principle of measurement. Identification of the 
influence of interfering components forms part of the test of the measuring instrument under Article 5.3.6.  
3.6   Resistance to external influences  
External disturbances affecting the breath alcohol analyser referred to in Chapters 3.6.1 and 3.6.2 must 
not lead to measurement errors which would exceed the maximum permissible error of the breath 
alcohol analyser under Article 2.3.  
If significant errors o r significant faults occur, they must be detected and reported by the checking 
facility contained in the breath alcohol analyser.  General Measure No 0111 -OOP -C040 -13 
7 
 In such cases, the breath alcohol analyser must not indicate the measurement result as a numerical 
value.  
3.6.1    Resistance to mechanical influences   
The design of the breath alcohol analyser and the materials used must provide sufficient strength, 
stability and resistance to mechanical vibrations and shocks.  
3.6.2    Resistance to climatic influences  
In the off -mode, breath al cohol analysers must withstand, without damage, the limit temperatures of –
20°C and 70°C and after returning to the operating temperature range, they must operate within the 
limits of the maximum permissible error.  
Breath alcohol analysers must not be sens itive to relative ambient humidity, whether in operation or 
while in storage.  
3.6.3    Electromagnetic compatibility (EMC)  
Breath alcohol analysers must not be affected by electrical or electromagnetic interference, or must 
respond to it in certain specific  manners, e.g. by reporting an error, inhibition of measurement etc. They 
must not emit unwanted electromagnetic fields.  
When tested for electromagnetic compatibility in a laboratory, the breath alcohol analyser must be 
functioning normally. It is allowed to restart the measuring instrument as a response to interference.  
3.7   Supply voltage  
Breath alcohol analysers powered by direct current from batteries must be operated without difficulty, 
at least within the range specified by the manufacturer ( Umin to Umax). When outside of this specified 
supply voltage range, the measuring instrument must switch itself off or switch to a mode in which 
measurement is not possible.  
3.8   Resistance to unauthorised tampering  
The breath alcohol analyser must be designed su ch that any mechanical actions performed on this 
measuring instrument that may influence measurement accuracy result in permanent visible damage to 
the measuring instrument, or the imprint of official marks.  
4   Markings  
All of the information below must b e indicated on the breath alcohol analyser in a manner ensuring that 
it is indelible, non -removable and legible throughout the period of use.  
4.1   Labelling of breath alcohol analysers  
Each breath alcohol analyser shall indicate, at least, the information  below:  
– the manufacturer's insignia or name,  
– type approval mark of the measuring instrument,  
– serial number and year of manufacture,  
– measuring range in mg/L,  
– ambient operating temperature range in °C.  General Measure No 0111 -OOP -C040 -13 
8 
 5   Type approval  
5.1   General  
5.1.1    Tests to be perf ormed  
The type approval of a breath alcohol analyser shall comprise the following:  
a) external inspection,  
b) functional tests of the breath alcohol analyser:  
– accuracy and repeatability test,  
– drift test, short - and long -term stability tests,  
– memory effect test,  
– residual effect test,  
– test of volume influence (flow rate change),  
– test of influence of interfering components and CO 2, 
c) tests of resistance to mechanical influence:  
– test of impact resistance,  
– free-fall test,  
– test of influence of random mechanical vibration s, 
d) tests of resistance to climatic conditions:  
– cold test (in both off and on mode),  
– dry heat test,  
– damp heat test (in both off and on mode),  
e) test of supply voltage influence,  
f) tests for electromagnetic compatibility (EMC):  
– electrostatic discharge immunity t est, 
– test of resistance to radiated high -frequency electromagnetic fields,  
– test of resistance to TETRA signals.  
5.1.2    Test equipment  
The measuring instruments, certified reference materials and equipment specified below shall be used 
for testing breath a lcohol analysers:  
– certified reference materials (CRM),  
Gas mixtures of the required composition (see Table 3) shall be used; these shall be primary 
reference materials for the relevant gas mixture mole (mass) fractions or secondary CRM for 
ethanol in nitro gen, traceable to a suitable primary reference gas mixture. If necessary, prior to 
type approval, the device shall be adjusted to the mass concentration recommended by the 
manufacturer of the measuring instrument (e.g. 0.48 mg/L of ethanol in nitrogen, whi ch 
corresponds to around 1.008 g/kg or mass % of ethanol in the blood). The mole fractions of the 
certified reference gases shall be converted to mass concentrations at 34°C at atmospheric 
pressure.  General Measure No 0111 -OOP -C040 -13 
9 
 Table 3 - Certified reference materials  
CRM no  Mass conce ntration 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 must 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%.  
– flow meter with a measuring range of at least 0  L/s to 0.40  L/s, 
– stopwatch with an accuracy of 0.1  s, 
– thermo -hygro -barometer for monitoring the co nditions in the laboratory,  
– reducing valves with adjustable gas pressure on the output,  
– test equipment for connecting and measuring the breath alcohol analyser.  
5.2   External inspection  
The purpose of external inspection of the breath alcohol analyser sha ll be to assess:  
a) the completeness of the required technical documentation, including operating instructions,  
b) the conformity of the metrological and technical characteristics specified by the manufacturer in 
the documentation with the requirements under thi s regulation as referred to in Chapters 2, 3 
and 4,  
c) the completeness and condition of the breath alcohol analyser according to the prescribed 
technical documentation,  
d) conformity of the software version of the breath alcohol analyser with the version specif ied by 
the manufacturer.  
5.3   Functional tests of the breath alcohol analyser  
Prior to the test, the breath alcohol analyser shall be prepared in accordance with the requirements of 
Article 2.1.3. The functional tests shall be performed under the referenc e conditions specified in Article 
2.1.2.  
Gas mixtures of the specified composition shall be fed into the breath alcohol analyser from cylinders 
with CRMs for gas mixtures, as per Table 3. Measurements shall be made sequentially from gas 
mixtures with lower  mass concentrations to mixtures 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. General Measure No 0111 -OOP -C040 -13 
10 
 range in mg/L of ethanol in nitrogen) has been made, a “zero” check sh all be performed using “zero” 
gas, which is nitrogen in a cylinder with a purity of at least 4.0 (99.99%).  
The actual operating conditions in the laboratory (temperature, humidity and pressure) shall be recorded 
by the sensors of the measuring instrument being tested.  
Evacuation of gases from the device connected to the cylinders with the CRMs for the gas mixtures (see 
Table 3) and the “zero” gas needs to be ensured during operations.  
5.3.1    Accuracy and repeatability test  
This test shall involve 20 measu rements shall be made for each of the nine mass concentrations within 
the measuring range (nominal values of 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 the upper limit of the measuring range specified  for the given 
type of measuring instrument).  
When measurements have been completed, the average mass concentration value 
  shall be calculated 
according to the relationship:  
nβ
βn
ii
1
 
where  
ßi are the individual values of m ass concentration of ethanol measured by the breath alcohol 
analyser 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 concentration in the gaseous 
CRM must be l ess than or equal to the maximum permissible error according to Table 1 under Article 
2.3, while the evaluation shall  take into account the uncertainty of the measured value and uncertainty 
of the certified mass concentration of ethanol in the gaseous CRM measured:  
MPE) )( 22
RM2
C RM
 u(ββu ββ
 
where  
 is the arithmetic mean of the mass concentrations of ethanol obtained when measuring the gaseous 
CRM,  
)β(uc
 is the combined standard uncertainty,  
ßRM is the mass concentration of etha nol in the gaseous CRM measured,  
u(ß RM) is the standard uncertainty (derived from the expanded uncertainty with the expansion 
coefficient k = 2),  
MPE  is the maximum permissible error of the breath alcohol analyser for the given measurement 
conditions and level of mass concentration of ethanol in the CRM (see Table 1).  
In order to assess repeatability, standard deviation SD shall be calculated, which must not be greater 
than the maximum permissible standard deviation according to Table 2 under Article 2.4 f or the given 
mass concentration.  
The following relationship holds for the calculation of standard deviation SD: 
1) (
12
nSDn
ii
 
where  General Measure No 0111 -OOP -C040 -13 
11 
 
 is the arithmetic mean of the mass concentrations of ethanol obtained when measuring the gaseous  
 CRM,  
ßi is the value obtained.  
Table 4 may be used for recording and evaluation of the test.  
Table 4  – Accuracy and repeatability test  
Reference mass 
concentration 
(
RM) 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 the max. 
range in 
mg/L  
Accuracy  
Average mass 
concentration 
(
)          
Error detected - 
difference 
RMββ
          
U (k = 2)          
Maximum 
permissible error 
(see Table 1)  < 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)          
Maximum 
permissible 
standard 
deviation (see 
Table 2)  < 0.010 
mg/L  < 0.010 
mg/L  < 0.010 
mg/L  <2.5%  <2.5%  <2.5%  <2.5%  <2.5%  < [(reference 
value/2) – 
0.90] / 3  
5.3.2    Drift test and short -term and long -term stability tests  
The device stability test shall comprise three parts – drift, short -term stability and long -term stability. 
Drift and short -term stability tests shall involve 10 measurements of test gas repea ted after four hours. 
Measurements to determine drift and short -term stability shall be made using zero gas (with no ethanol 
content) and test gas with mass concentration of 0.40 mg/L of ethanol in nitrogen (see Table 3, CRM no 
4) according to the followin g procedure:  
– 10 measurement using zero gas - 4-hour break - 10 measurements using zero gas,  
– 10 measurement using test gas - 4-hour break - 10 measurements using test gas.  
The drift obtained from both measurements must comply with the requirements under Art icle 2.5.  
Long -term stability shall be monitored in the same way as short -term stability, but the subsequent 
measurement of test gas shall be made after two months; the maximum permissible drift of 0.014 mg/L, 
as required under Article 2.5, must be complie d with. Table 5 may be used for recording and evaluation 
of this test.  General Measure No 0111 -OOP -C040 -13 
12 
 Table 5  – Drift and short - and long -term stability  
Measurement no  Zero gas  Test gas 0.40 mg/L  Test gas 0.40 mg/L  
time of 
measureme
nt time of 
measureme
nt + 4 hrs  time of 
measureme
nt time of 
measureme
nt + 4 hrs  date of 
measurement  date of 
measurement 
+ 2 months  
1       …       
10       
Mean value        
Drift     
Max. permissible 
drift 0.007 mg/L  0.007 mg/L  0.014 mg/L  
 
5.3.3    Memory effect test  
The memory effect test shall be perfo rmed using the following procedure:  
Step 1:  10 measurements shall be made using gas with mass concentration of 0.10 mg/L of 
ethanol in nitrogen (see Table 3, CRM no 2),  
Step 2:  alternating measurements using gas with mass concentration of 1.95 mg/L of et hanol in 
nitrogen (see Table 3, CRM no 8) or, 1.50 mg/L of ethanol in nitrogen (see Table 3, 
CRM no 7) for measuring instruments with a measuring range of up to 2 mg/L, and 
measurements using gas with mass concentration of 0.10 mg/L of ethanol in nitrogen (see 
Table 3, CRM no 2).  
Step 2 shall be repeated ten times, thereby obtaining 10 values measured at high mass concentrations 
and 10 values measured at low mass concentrations. The memory effect must comply with the 
requirements under Article 2.6.  
Each i ndividual measurement must comply with the maximum permissible error for the given mass 
concentration as referred to in Article 2.3. Table 6 may be used for recording and evaluation of this test.  
Table 6  – Memory effect  
Measurement no  Pre-test - 0.10 mg/L  
(Step 1)  Alternating measurements 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)  General Measure No 0111 -OOP -C040 -13 
13 
  
5.3.4    Residual effect test  
The residual effect test shall be performed using the f ollowing procedure:  
Step 1:  10 measurements shall be made using gas with mass concentration of 0.25 mg/L of 
ethanol in nitrogen (see Table 3, CRM no 3),  
Step 2:  alternating measurements using gas with mass concentration of 0.40 mg/L of ethanol in 
nitroge n (see Table 3, CRM no 4) and measurements using gas with mass concentration 
of 0.25 mg/L of ethanol in nitrogen (see Table 3, CRM no 3).  
Step 2 shall be repeated ten times, thereby obtaining 10 values measured at the higher mass 
concentration and 10 valu es measured at the lower mass concentration.  
The residual effect must comply with the requirements under Article 2.7. Each individual 
measurement must comply with the maximum permissible error for the given mass concentration as 
referred to in Article 2.3 . 
Table 7 may be used for recording and evaluation of this test.  
Table 7  - Residual effect  
Measurement no  Pre-test - 0.25 mg/L  Alternating measurements 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 influence of volume (flow rate change)  
The influence of the delivered volume of gas shall be tested using test gas with mass concentration of 
0.40 mg/L of ethanol in nitrogen (see Table 3, CRM no 4) at volumes of 1.5  L and 3  L and gas  flow 
rates of 0.20  L/s to 0.35  L/s. The difference between measurements must not exceed 0.010 mg/L. Each 
of these 10 measurements must comply with the maximum permissible error for the given mass 
concentration as referred to in Article 2.3. Table 8A may b e used for recording and evaluation of this 
test. 
Table 8A  – Influence of volume (flow rate change)  
Measurement no  Gas volume - 1.5 L  Gas volume - 3 L Difference  
1    … 
   
10    
Max. difference     
 
If the breath alcohol analyser checks the volume of e xhaled air automatically, measurements at higher 
volumes of exhaled air are irrelevant.  General Measure No 0111 -OOP -C040 -13 
14 
 In such a case, measurements shall be made using test gas with mass concentration of 0.40 mg/L of 
ethanol in nitrogen (see Table 3, 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 for each 
chosen gas flow rate. A gain, the difference between measurements must not exceed 0.010 mg/L. Each 
of these 10 measurements must comply with the maximum permissible error for the given mass 
concentration as referred to in Article 2.3. Table 8B may be used for recording and evalua tion of this 
test. 
Table 8B  – Influence of volume (flow rate change)  
Measurement no  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 i nfluence of interfering components and CO 2 
This test shall be performed to check compliance with Article 3.5 by means of ten measurements using 
dry gas with mass concentration of 0.40  mg/L of ethanol in nitrogen (see Table 3, CRM no 4) without 
the interfer ing component and with the interfering component. The maximum influence of a given 
interfering component must not exceed the values indicated in Table 9 and the sum of all interfering 
components and CO 2 must not exceed 0.40  mg/L. Table 9 may be used for re cording and evaluation of 
this test.  
Table 9 - Influence of interfering components and CO 2 
Interfering component (
 5%) Acetone  
0.50 mg/L  Methanol  
0.10 mg/L  Isopropanol  
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 9 - Influence of interfering components and CO 2 (continued)  
Interfering component (
 5%) Methane  
0.30 mg/L  Acetalde hyde  
0.15 mg/ CO 2 
100 mg/L L  Total  
Measurement using pure gas     – 
Measurement with the 
interfering component     – 
Influence      
Max. influence  0.08 mg/L  0.10 mg/L  0.05 mg/L  0.40 mg/L  General Measure No 0111 -OOP -C040 -13 
15 
  
5.4   Tests of resistance to mechanical influences  
5.4.1    Test of resistance to impact  
This test, which is applied to verify compliance with the requirements under Article 3.6.1, must be 
performed with the breath alcohol analyser without a carrying case under the following conditions:  
– every impact must have the intens ity of 15  gn, where acceleration 1  gn = 10 m/s2, 
– duration: 11  ms, 
– number of impacts: 1 for each axis perpendicular to the sample.  
When at least two hours have elapsed after completion of the test, the measuring instrument must 
comply with the requirements referred to in Article 2.3 when tested within the reference temperature 
range.  
5.4.2    Free -fall test  
The free fall test, which is applied to verify compliance with the requirements under Article 3.6.1, the 
breath alcohol analyser under test shall be allow ed to fall freely from the height of 500 mm onto a rigid 
test surface. The measuring instrument shall be allowed to fall on 3 sides, specifically the back, right 
and left sides. The test shall not be performed for the front side (where the display is locat ed). 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 shall be checked for changes in appearance. 
No changes in indication may occur d uring the test. When at least one hour has elapsed after completion 
of the test, the measuring instrument must comply with the requirements referred to in Article 2.3 in an 
accuracy test at reference temperature.  
5.4.3    Test of influence of random mechani cal vibrations  
In the test of compliance with the requirements under Article 3.6.1, the measuring instrument must 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 1 h for each axis.  
When at least one hour has elapsed after completion of the test, the measuring instrument must comply 
with the requirements referred to in Article 2.3 in an accuracy test at reference temperature.  
5.5   Tests of resistance to climatic conditions  
5.5.1    Cold test  
a)   The breath alcohol analyser in off -mode shall be placed in a temperature chamber a t the temperature  
of  
–20°C for the period of 2 hrs.  
When one hour has elapsed after completion of the test, the measuring instrument, stabilised at 20°C, 
must comply with the requirements under Article 2.3 in an accuracy test using dry gas with mass 
conce ntration of 0.40  mg/L of ethanol in nitrogen (see Table 3, CRM no 4) at reference temperature.  General Measure No 0111 -OOP -C040 -13 
16 
 2)   The breath alcohol analyser in on -mode shall be placed in a temperature chamber at the temperature 
of –10°C. An accuracy test using dry gas with mass concen tration of 0.40 mg/L of ethanol in nitrogen 
(see Table 3, CRM no 4) shall be performed ten times under these climatic conditions. Each of these 10 
measurements must comply with the maximum permissible error for the given mass concentration as 
referred to i n Article 2.3.  
5.5.2    Dry heat test  
This test involves placing the breath alcohol analyser in off -mode in a temperature chamber at the 
temperature of +70°C for the period of 6 hrs.  
Immediately after completion of the test, it shall be checked for changes in appearance. The appearance 
of the measuring instrument must not change and the material and surface must not be cracked, swollen 
or changed in colour.  
When one hour has elapsed after completion of the test, the measuring instrument, stabilised at 20°C,  
must comply with the requirements under Article 2.3 in an accuracy test using dry gas with mass 
concentration of 0.40  mg/L of ethanol in nitrogen (see Table 3, CRM no 4) at reference temperature.  
5.5.3    Damp heat test  
a)   A cyclic damp heat test (A cycl e of 12 + 12  Hrs) shall be performed using two cycles within the 
range of 25°C at a relative humidity of over 95% to 55°C at a relative humidity of 93%. The measuring 
instrument shall be switched off during the test.  
Immediately after the test, the measuri ng instrument shall be checked for changes in appearance.  
When one hour has elapsed after completion of the test, the measuring instrument, stabilised at 20°C, 
must comply with the requirements under Article 2.3 in an accuracy test using dry gas with mass  
concentration of 0.40  mg/L of ethanol in nitrogen (see Table 3, CRM no 4) at reference temperature.  
b)   The damp heat test shall be performed at the temperature of 20°C at a relative humidity of 85%. 
The measuring instrument shall be switched on during t he test. An accuracy test using dry gas with 
mass concentration of 0.40 mg/L of ethanol in nitrogen (see Table 3, CRM no 4) shall be performed ten 
times under these climatic conditions. Each of these 10 measurements must comply with the maximum 
permissible  error for the given mass concentration as referred to in Article 2.3.  
5.6   Test of influence of supply voltage  
The test of influence of supply voltage shall be performed for breath alcohol analysers powered by 
batteries with the supply voltage adjusted t o Umax = Ubat.max  and to Umin = Ubat.min, where Ubat.min is the 
lowest operating battery voltage as specified by the supplier of the measuring instrument for ambient 
temperature of 20°C, and Ubat.max  is the no -load voltage of a new battery.  
The measuring i nstrument must be functioning normally within the limits of the maximum permissible 
error referred to in Article 2.3 in an accuracy test using dry gas with mass concentration of 0.40  mg/L 
of ethanol in nitrogen (see Table 3, CRM no 4).  
5.7  Tests for elect romagnetic compatibility (EMC)  
5.7.1    Electrostatic discharge immunity test  
Electrostatic discharge immunity shall be tested with the measuring instrument switched on, preferably 
using a 6 kV contact discharge or an 8 kV air discharge, where contact disch arges cannot be applied. 
The discharges shall be applied to the enclosure of the measuring instrument or a coupling plane 
adjacent to the breath alcohol analyser.  General Measure No 0111 -OOP -C040 -13 
17 
 During the test, 10 measurements for each discharge polarity shall be made sing measuring gas . One 
discharge shall be applied during each measurement. The delay between the discharges should be at 
least 10 seconds.  
The difference between the values obtained under the conditions of interference and with no interference 
must be less than 0.040  mg/l when dry gas with mass concentration of 0.40 mg/L of ethanol in nitrogen 
(see Table 3, CRM no 4) is used.  
After this test, the measuring instrument must be functioning normally within the limits of the maximum 
permissible error referred to in Article 2.3 in an accuracy test with no interference performed using dry 
gas with mass concentration of 0.40  mg/L of ethanol in nitrogen (see Table 3, CRM no 4).  
5.7.2    Test of immunity to radiated high -frequency electromagnetic fields  
Immunity to radiated high -frequ ency electromagnetic fields is tested with the measuring instrument 
switched on within the frequency range of 26 MHz to 3000 MHz at test field intensity of 10 V/m when 
measuring without modulation.  
The test field is amplitude modulated to a depth of 80% an d the modulation signal has a sinusoidal 
waveform with modulation frequency of 1 kHz.  
The measuring instrument under test is irradiated vertically and horizontally with a polarised field from 
4 directions that are perpendicular to each other.  
The tests sh all 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 shall be made at each frequency using 
measuring gas. If the measuring instrument is found to be influenced at any of the frequencies, testing in 
the region of this frequency shall be performed to locate the point of maximum influence with a 
frequency resolution of appro x. 1%.  
The difference between the values obtained under the conditions of interference and with no interference 
must be less than 0.040  mg/l when dry gas with mass concentration of 0.40 mg/L of ethanol in nitrogen 
(see Table 3, CRM no 4) is used.  
After th is test, the measuring instrument must be functioning normally within the limits of the maximum 
permissible error referred to in Article 2.3 in an accuracy test with no interference performed using dry 
gas with mass concentration of 0.40  mg/L of ethanol in  nitrogen (see Table 3, CRM no 4).  
5.7.3    Test of immunity to TETRA signals   
Immunity to TETRA signals shall be tested with the measuring instrument switched on by irradiation 
with a vertically and horizontally polarised field, gradually from four directi ons that are perpendicular 
to each other.  
The breath alcohol analyser shall be tested at the test frequencies of (380, 385, 390, 395, 400, 405, 410, 
415, and 420) MHz ±0.1 MHz.  
At each frequency, the of the test field level shall be gradually increased in 3 dB steps from 12 dB below 
the specified 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.  
The test limit is expressed as the peak value of the m odulated signal measured with a peak value 
detector calibrated according to an equivalent effective value of the sinusoidal signal causing the same 
deflection. The test limit for devices that are not used inside vehicles shall be 65  V/m.  
Amplitude modulati on by a square -wave signal with the frequency of 18 kHz and modulation depth of 
> 98% further keyed with the frequency of 17  Hz must be used for tests of immunity to TETRA signals. 
The keying duty cycle shall be 50%.  General Measure No 0111 -OOP -C040 -13 
18 
 The difference between the values obtai ned under the conditions of interference and with no interference 
must be less than 0.040  mg/l when dry gas with mass concentration of 0.40 mg/L of ethanol in nitrogen 
(see Table 3, CRM no 4) is used.  
After this test, the measuring instrument must be funct ioning normally within the limits of the maximum 
permissible error referred to in Article 2.3 in an accuracy test with no interference performed using dry 
gas with mass concentration of 0.40  mg/L of ethanol in nitrogen (see Table 3, CRM no 4).  
6   Initial verification   
6.1   General  
6.1.1    Tests to be performed  
The process of initial verification of a breath alcohol analyser shall comprise the following tests:  
a) visual inspection,  
b) accuracy test.  
6.1.2    Test equipment  
Initial verification tests of breath alc ohol analysers shall be performed using the same measuring 
instruments and equipment as those used for type approval in accordance with Article 5.1.2. In addition, 
secondary CRM for ethanol in nitrogen traceable to a suitable primary reference material for  the 
relevant gas mixture mole (mass) fractions according to Table 10 shall be used.  
Table 10  – 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 the visual inspection shall be to check that:  
a) the measuring instrument submitted for verification conforms to the approved type,  
b) the measuring instrument is complete and undamaged,  
c) markings and inscription s are complete, accurate and legible in conformity with the approved 
type of the measuring instrument,  
d) the software version installed is identical to that specified by the manufacturer and conforms to 
the approved type of the measuring instrument.  
6.3   Accuracy and repeatability test   
The initial verification test of the breath alcohol analyser shall be performed using CRMs in accordance 
with the requirements under Articles 5.3 and 5.3.1; the numbers of measurements for each gas are given 
in Table 10 in Ar ticle 6.1.2.  General Measure No 0111 -OOP -C040 -13 
19 
 The combined standard uncertainty of this arithmetic mean concentration 
  comprises 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 is calculated from the standard deviation of the 
arithmetic mean multiplied by a coefficient which depends on the number of measurements:  
A l A sk u
 )(
 
where  
kl coefficient which depends on the number of measurements n: 
n 2 3 4 5 6 7 8 9 10 and 
more  
k l 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 concentration s of ethanol obtained when measuring the gaseous 
CRM,  
ßi the value obtained,  
n number of measurements.  
NOTE Type  B uncertainty of the measured values is determined by the uncertainty of the certified content of 
the CRM used for adjustment of the breath alc ohol analyser, the uncertainty caused by deviation from linearity, 
uncertainty of indication and/or uncertainty of the influence of deviation of temperature of the exhaled breath 
from 34°C (detected in type approval of the measuring instrument), influence of sensitivities of other gas 
components, influence of changes in barometric pressure (if the measuring instrument does not provide 
automatic correction), influence of changes in the flow rate of the calibration gas, influence of other factors 
related to t he different principles of the measuring instruments used, etc.  
For the purposes of verification and to ensure unambiguous and correct assessment of the breath alcohol  
analyser, type B uncertainty shall be estimates only from the standard uncertainty of th e mass 
concentration of ethanol in the measured gaseous CRM u(ßRM) and the standard uncertainty of display 
resolution uind: 
2)(ind B u u
2
RM) u(β
 
where  
u(ß RM) is the standard uncertainty of the mass concentration of ethanol in the measured gaseous CRM 
(derived from, e.g., the expanded uncertainty with coverage factor k = 2),  
uind  is the standard uncertainty of the display of the measuring instrument (rounding):  
32ind
indru
 
where  General Measure No 0111 -OOP -C040 -13 
20 
 rind  is the resolution of the values read from the display of the bre ath alcohol analyser.  
Other uncertainties of the measured values that contribute to standard uncertainty evaluated using 
method B does not need to be determined in the verification.  
6.4   Correct adjustment of the measuring instrument   
An analyser delivere d for verification by the customer shall be correctly adjusted, with the minimum 
standard uncertainty of the measured values. Otherwise, adjustment of the breath alcohol analyser to 
reference values needs to be performed prior to the verification of the me asuring instrument.  
7   Subsequent verification  
Subsequent verification shall follow a procedure identical to that for initial verification provided under 
Chapter 6.  
8   Notified standards  
For the purposes of specifying the metrological and technical requi rements for measuring instruments 
and specifying the testing methods for their type approval and verification arising from this General 
Measure, the CMI shall provide notification of the Czech technical standards, other technical standards 
or technical doc uments of international or foreign organisations, or other technical documents 
containing more detailed technical requirements (hereinafter referred to as “notified standards”). The 
CMI shall publish a list of these notified standards attached to the relev ant measures, together with the 
general measure, in a manner accessible to the public (on the www.cmi.cz  website).  
Notified standards or parts thereof shall be considered complied with within the scope of and under the 
conditions laid down in this General Measure, if the requirements laid down in this measure, to which 
these standards or parts thereof apply, are complied with.  
 
 
II. 
G R O U N D S  
The CMI has issued this General Measure laying down metrological and technical  requirements for 
specified measuring instruments and the testing methods for the verification of these specified measuring 
instruments so as to implement § 24c of the Metrology Act.  
Under item 7.4.2 of the Annex “List of the Types of Specified Measuring I nstruments” to Decree No 
345/2002 Coll. specifying the measuring instruments whose verification is mandatory and the 
measuring instruments subject to type approval, as amended, breath alcohol analyser are classified as 
measuring instruments subject to type  approval and verification.  
As such, the CMI has issued this General Measure laying down metrological and technical requirements 
for breath alcohol analysers and the testing methods for type approval and verification of these specified 
measuring instrument s in order to implement § 24c of the Metrology Act for this particular type of 
measuring instrument - breath alcohol analysers.  
This regulation (General Measure) has been notified in accordance with Directive 98/34/EC of the 
European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of General Measure No 0111 -OOP -C040 -13 
21 
 information in the field of technical standards and regulations and of rules on Information Society 
services, as amended.  
 
 
III. 
I N S T R U C T I O N S  
In accordance with § 173(2) of th e APC, no appeals may be made regarding general measures.  
In accordance with the provisions of § 172(5) of the APC, decisions on objections are final and appeals 
may not be made against them.  
Conformity of a general measure with legislation may be assessed  in review proceedings pursuant to §§ 
94 to 96 of the APC. A party to the proceedings may initiate review proceedings to be conducted by the 
administrative authority which issued the general measure. If the administrative authority finds no 
reason to comme nce the review proceedings, it shall communicate and provide grounds for this within 
thirty days. Pursuant to § 174(2) of the APC, a ruling on the commencement of review proceedings may 
be issued within three years of the entry into force of the general me asure.  
 
 
IV. 
E N T R Y    I N T O    F O R C E  
This General Measure shall enter into force on the fifteenth day of the date of publication (§  24d of the 
Metrology Act).  
 
 
 
...…………………………..............  
RNDr. Pavel Klenovský  
Director General