Czech M etrology Institute -...

C z e c h M e t r o l o g y I n s t i t u t e

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Brno

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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, including 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 to 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 substantive 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 under § 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

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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 device

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 person, 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 concentration 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 third 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 ethanol

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 vocabulary 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 accessible at www.unmz.cz


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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 indications 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 sample

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 subject 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 adjusted 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 conditions

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 shall 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 concentration 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

http://www.oiml.org/


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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 breath 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 measurement:

– 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 mode.

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 to 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 measuring 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 (reference 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)


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< 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 measurement 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 analysers”. 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 designed 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 volume 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 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 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 instrument 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 make an automatic adjustment and

verify automatically that it is capable of making a correct measurement. If this verification reveals that


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not all the conditions for correct operation of the breath alcohol analyser have been fulfilled, any

measurement made by 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 instrument.

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 measuring

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 software 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 pharmaceuticals 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 influence 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 or significant faults occur, they must be detected and reported by the checking

facility contained in the breath alcohol analyser.


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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 alcohol 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 sensitive 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 such 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 be 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.


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5 Type approval

5.1 General

5.1.1 Tests to be performed

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 CO2,

c) tests of resistance to mechanical influence:

– test of impact resistance,

– free-fall test,

– test of influence of random mechanical vibrations,

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 test,

– 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 alcohol 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 nitrogen, 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, which

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.


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Table 3 - 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 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 conditions 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 shall 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 this 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 specified 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 reference 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.


10

range in mg/L of ethanol in nitrogen) has been made, a “zero” check shall 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 measurements 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:

n

β

β

n

i

i

1

where

ßi are the individual values of mass 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 less 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))(2 2

RM

2

CRM u(ββuββ

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 ethanol in the gaseous CRM measured,

u(ßRM) 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 for the given

mass concentration.

The following relationship holds for the calculation of standard deviation SD:

1

)(1

2

nSD

n

i

i

where


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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 repeated 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 following 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 Article 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 complied with. Table 5 may be used for recording and evaluation

of this test.


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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 performed 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 ethanol 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 individual 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)


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5.3.4 Residual effect test

The residual effect test shall be performed using the following 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

nitrogen (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 values measured at the lower mass concentration.

The residual effect must comply with the requirements under Article 2.7. Each individual

measurementmust 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 be 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 exhaled air automatically, measurements at higher

volumes of exhaled air are irrelevant.


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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. Again, 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 evaluation 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 influence of interfering components and CO2

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 interfering 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 CO2 must not exceed 0.40 mg/L. Table 9 may be used for recording and evaluation of

this test.

Table 9 - Influence of interfering components and CO2

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 CO2 (continued)

Interfering component ( 5%) Methane

0.30 mg/L

Acetaldehyde

0.15 mg/

CO2

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


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 intensity 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 allowed 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 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 shall be checked for changes in appearance.

No changes in indication may occur during 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 mechanical 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 at 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

concentration of 0.40 mg/L of ethanol in nitrogen (see Table 3, CRM no 4) at reference temperature.


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 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.

5.5.2 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.




5.5.3 Damp heat test

a) A cyclic damp heat test (A cycle 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 measuring instrument shall be checked for changes in appearance.




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 the 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 to 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 instrument 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 electromagnetic 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 discharges 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.


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-frequency 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% and 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 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 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 approx. 1%.







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 directions 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 modulated 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 modulation 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%.


18







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 alcohol 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 inscriptions 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 Article 6.1.2.


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 :

22 )()()( BAC uuu

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:

AlA sku )(

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(

)(1

2

nns

n

i

i

A

where


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 alcohol 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 the 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 the mass

concentration of ethanol in the measured gaseous CRM u(ßRM) and the standard uncertainty of display

resolution uind:

2)( indB uu 2

RM )u(β

where

u(ßRM) 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):

32

indind

ru

where


20

rind is the resolution of the values read from the display of the breath 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 delivered 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 measuring 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 requirements 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 documents 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 relevant 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 Instruments” 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 instruments 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

http://www.cmi.cz/


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 the 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 commence 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 measure.

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

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