Czech Metrology Institute  
Okružní 31, 638 00 Brno  
 
 
1. ------IND- 2018 0341 CZ - CS- ------ 20180803 --- --- PROJET 
Executive summary for the EC (not part of this legislation)  
Installed measuring instruments, warning assemblies and monitors for dosimetric gamma radiation 
and X -rays with energies from 50 keV to 1.5 MeV are placed on the market and put into use in the 
Czech Republic pursuant to Act No 505/1990 on metrology, as ame nded.  
The purpose of this notified regulation is to lay down metrological and technical requirements for 
these measuring instruments. This regulation also stipulates tests for type approval and verification.  
(End of executive summary)  
 
 
Author:  Tomáš Hendrych  
Telephone: +420 545 555 414  
 
 
PUBLIC DECREE  
 
As the authority with substantive and territorial jurisdiction in the matter of laying down metrological 
and technical requirements for legally controlled measuring instruments and stipulating the testi ng 
methods for type approval and verification of legally controlled measuring instruments pursuant to 
§ 14(1) of Act No  505/1990 on metrology, as amended (hereinafter referred to as the ‘Metrology Act’), 
and in accordance with the provisions of §  172 et se q. 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 4 April 2017 pursuant to §  46 APC, and, on the basis o f 
supporting documents, issues the following:  
 
I. 
DRAFT GENERAL MEASUR E 
number: 0111 -OOP -C080 -16 
laying down the metrological and technical requirements for legally controlled 
measuring instruments, including testing methods for verification of the followi ng 
legally controlled measuring instruments:  
 
‘installed measuring instruments, warning assemblies and monitors for dosimetric 
gamma radiation and X -rays with energies from 50 keV to 1.5 MeV’  
 General Measure No 0111 -OOP -C080 -16 
2 1. Basic definitions  
For the purposes of this general measure, terms and definitions pursuant to VIM and VIML1 and the 
following shall apply:  
1.1 
spatial dose equivalent H*(10)  
a dose equivalent that would be produced in the corresponding aligned, expanded and oriented field at 
a depth of 10 mm in the ICRU sphere on t he radius opposing the direction of the aligned field. The spatial 
dose equivalent unit is Sv (J/kg).  
1.2 
spatial dose equivalent rate 
)10(*H  
quotient d H * (10)/d t, where d H*(10) is the increment of the spatial dose equivalent in the time in terval 
dt. 
The spatial dose equivalent rate unit is Sv/s (Sv/min; Sv/h).  
1.3 
kerma in the air Ka 
quotient dE (sum of the initial kinetic energies of all charged particles released by uncharged ionising 
particles in the given air mass) and dm (this weight).   
The kerma in the air unit is Gy (J/kg).  
1.4 
kerma in the air rate Ka 
quotient dKa/d t, where d Ka is the increment of kerma in the air in the time interval d t. 
The kerma in the air rate unit is Gy/s (Gy/min; Gy/h)  
1.5 
reference point of the measuring instr ument  
physical mark or marks on the external surface of the measuring instrument for placing the measuring 
instrument at the test point  
1.6 
test point  
the point where the reference value of the measured figure is determined and where the reference point 
of the measuring instrument is placed for testing purposes  
1.7 
measuring instrument response  
response for the reference value of the figure Hr,0 measured under specific conditions  
0,0,
0
rr
HGR
 (1) 
where Gr,0 is the suitable figure of the measuring instrument.  
                                                      
1  TNI 01 0115 International Vocabulary of Metrology – Basic and General Concepts and Associated Terms 
(VIM) and International Vocabulary of Legal Metrology (VIML) are part of the technical harmonisation 
compendium ‘Terminology in the field of metrology’, which is publicly available at www.unmz.cz.  General Measure No 0111 -OOP -C080 -16 
3 1.8 
reference response  
the ratio given under reference conditions by the relationship  
HGR
 (2) 
where G is the figure of the measuring instrument and H is the reference value of the mea surement 
figure for the reference conditions  
1.9 
relative response  
ratio of response R and reference response R0: 
HGR
 (3) 
where G is the figure of the measuring instrument and H is the reference value of the figure.  
1.10 
effective measur ing range  
range of measured values of the figure that meets the requirements of Article 2.3  
1.11 
lower limit of the effective measuring range H0  
lowest value of the dose equivalent or its rate that applies to the effective measuring range.  
1.12 
variation coefficient v 
rate of relative data dispersion determined as a percentage of the standard deviation to the arithmetic 
mean in per cent  
1.13 
dose rate monitor  
assembly that fulfils both the function of the dose rate monitor and the dose rate warning assemblies  
2 Metrological requirements  
2.1 Design and execution  
The device can be designed as a simple assembly in which the detector is attached to the assembly or 
part of the assembly or is separate from the rest of the device. In this case, the  detector may be up to 10 
m from the electronic part (main amplifier) and the detector and main amplifier from the indication and 
warning subassembly may be up to 100 m or more.  
The device must measure the dose rate of X and gamma radiation in the energy r ange of at least 80 keV 
to 1.5 MeV. A response to lower energy of up to 50 keV and higher energy of up to 7 MeV may be 
stated. The measuring range of the device must be at least three full decades of dose rate; many 
applications m ay require five or more de cades . Manually switching ranges must be avoided.  
The design of the device must take account of the practical use of the assemblies, it may be required to 
measure radiation fields coming from different angles relative to the location of the device. (Radia tion 
from distributed sources routinely emanates from walls and steel structures. Sometimes the ‘front’ 
layout (2π) corresponds best to the requirements, in other cases the ‘side’ layout, where it is required to 
be closer to the 4π geometry, but the ‘rear’  response requirements are lower).  General Measure No 0111 -OOP -C080 -16 
4 Assemblies shall be designed to minimise as far as possible undesirable responses to electromagnetic 
and ionising radiation other than X and gamma radiation.  
2.2 Reference conditions and standard test conditions  
The reference conditions and standard test conditions are listed in Table 1.  
Table 1 – Reference conditions and standard test conditions  
Influencing variable  Reference conditions  
(unless otherwise specified by the 
manufacturer)  Standard test conditions  
(unless  otherwise specified by the 
manufacturer)  
Reference source of gamma 
radiation  137Cs  137Cs 
Stabilisation period  30 minutes  >30 minutes  
Heat  20 °C  18 °C to 22 °C  
Relative humidity  65 %  50 % to 75 %  
Air pressure  101.3 kPa  70 kPa to 106 kPa  
continued  
 
Table 1 – continued  
Influencing variable  Reference conditions  
(unless otherwise specified by the 
manufacturer)  Standard test conditions  
(unless otherwise specified by the 
manufacturer)  
AC supply voltage  sinusoidal  sinusoidal with a total harmonic 
distortion of less than 5 %  
Radiation background  0.1 µGy/h  lower than 0.25 µGy/h  
Radiation impact angle  calibration direction provided by 
the manufacturer  Designated direction ±10°  
External electromagnetic field  negligible  less than the smallest value causing 
interference  
External magnetic field  negligible  less than twice the Earth's magnetic 
field value  
Assembly position  to be specified by the manufacturer  specified orientation ± 10 °  
Assembly controls  settings for normal mode  settings for normal mode 
Radioactive particle 
contamination  negligible  negligible  
2.3 Largest permissible error  
2.3.1 Linearity of response  
Under standard conditions, the relative response of the measuring instrument across the effective 
measuring range must not exceed ±30 %. General Measure No 0111 -OOP -C080 -16 
5 2.3.2 Statistical fluctuation of response  
Under standard conditions, the variation coefficient must not exceed 20 % in the most sensitive 
measurement range and 10 % in all other ranges.  
2.3.3 Energy dependence of response  
The relative response of the measuring instrument in the reference direction of the radiation incident in 
the energy range from 80 keV to 1.5 MeV must lie within the range of -25 % to +40 % relative to the 
reference gamma radiation 137Cs. 
2.3.4 Directional  dependence of response  
Directional dependence of the measuring instrument in the 80 keV to 1.5 MeV energy range must fulfil 
the following criteria:  
for 661.6 keV:   0 °, ±15 °, ±30 °, ±45 °, ±60 °   maximum deviation ±20 %  
for 83 keV:   0 °, ±15 °, ±30 °, ±45 °, ±60 °   must be defined by the manufacturer  
for 59.5/60 keV:   0 °, ±15 °, ±30 °, ±45 °, ±60 °   maximum deviation ±30 % (where applicable)  
2.3.5 Overloading  
The measuring instrument must indicate overloading when the upper limit of the measuring ra nge is 
exceeded. This requirement applies to all measuring ranges.  
If a dose equivalent measuring instrument is exposed to a sufficiently high dose equivalent rate, which 
may cause an incorrect measuring instrument readout, the measuring instrument must in dicate that it is 
unable to provide the correct data.  
After overloading, the measured value must not differ by more than ± 10 % from the value measured 
before this test.  
2.3.6 Period of response  
The period of response is understood to be the period after which, in the event of a sudden increase or 
drop in the dose equivalent rate, the measuring instrument reading of the dose equivalent rate (Ii + 0.9 
(If − Ii)) is reached, where Ii is the initial figure of the dose equivalent rate and If is the final figur e of the 
dose equivalent rate. The required response time limits for the measuring instrument are shown in Table 
2. 
Table 2 – Requirements for the measuring instrument response time  
Dose equivalent rate (PDE)  Period of response (s) 
<60 µGy/h (µSv/h)  <60 
60 µGy/h (µSv/h) - 1 mGy/h (mSv/h)  
)50)/ (/ 940)/ (/ 6060( hSvhGyhSvhGy PDE

 
>1 mGy/h (mSv/h)  <10 
2.3.7 Time constant and alert stability  
Under standard conditions, the measuring instrument must not be exposed to 0.9 times the set value and 
must indicate if this value has been exceeded. A measuring instrument exposed to twice the set value 
must indicate that this value has been exceeded imme diately.  General Measure No 0111 -OOP -C080 -16 
6 If the meter has multiple alarm levels, the above requirements apply to each alarm level.  
2.3.8 Response to beta radiation  
The measuring instrument must have as little sensitivity to beta radiation as possible. The value of the 
dose equivalent rate specified must be less than 10 % of the value of the dose equivalent rate to  which 
the measuring instrument is ex posed.  
2.3.9 Resistance to mechanical shock  
If the measuring instrument is subject to mechanical impacts during operation, the response -induced 
shock response is less than ± 15 % compared to the measuring instrument's response before the test. No 
alarms may be activated or functional changes made.  
2.3.10 Ambient temperature  
Changes in the measuring instrument's response caused by changing the  ambient temperature in the 
range from -25 °C to +40 °C must not exceed ± 15 % of the measuring instrument's response under 
standard test conditions. Changes in the measuring instrument's response caused by changing the 
ambient temperature in the range fro m +40 °C to +55 °C must not exceed ± 25 % of the measuring 
instrument's response under standard test conditions. For measuring instruments intended for indoor use 
only, this requirement is valid in the temperature range from +10 °C to +50 °C. Such measurin g 
instrument must be marked, for example, with the text ‘indoor use only’.  
2.3.11 Relative humidity  
Changes in the measuring instrument's response caused by changing the ambient humidity in the range 
from 40 % to 93 % must not exceed ± 15 % of the measurin g instrument's response under standard test 
conditions.  
2.3.12 Radiation interference  
Emission limits for electromagnetic radiation must be less than 30 dB (for the emission frequency range 
from 30 MHz to 230 MHz) and less than 37 dB (for the emission frequency range from 230 MHz to 1 
000 MHz).  
2.3.13 Resistance to electromagnetic interference  
The maximum change in response (transient and permanent) induced by electromagnetic interference 
must not exceed ± 15 %.  
3 Technical requirements  
3.1 Unit indication  
The measuring instrument must display the value in Sv (Sv/h) or in  Gy (Gy/h).  
3.2 Minimum measuring range  
The minimum effective measuring range of the measuring instrument must cover at least three digital 
places. In some cases, up to five or mo re measurement ranges may be required.  
3.3 Operating status information  
The measuring instrument must indicate operating conditions for which the accuracy of the dose 
equivalent figure is not guaranteed, such as a dead battery, a detector failure or the do se equivalent rate 
being exceeded.  General Measure No 0111 -OOP -C080 -16 
7 3.4 Alarms  
The measuring instrument must be designed and constructed to signal that the selected alarm has been 
exceeded.  
3.5 Protection against unauthorised tampering  
The measuring instrument must be designed to prevent  unintentional changes to any factor of the 
operation settings. The parts of the measuring instrument essential to its metrological characteristics 
must be designed to be secured in such a way as to provide proof of any unauthorised interference. The 
contr ol elements must either be inside the measuring instrument and inaccessible from the outside 
without using tools, or be clearly marked and fitted with a scale so that they can be precisely adjusted 
according to the resolution of the measuring instrument an d then locked in order for the settings not to 
be changed accidentally. Correction factors and calibration coefficients stored digitally may not be 
changed unless the operator enters the security code (or password) or changes the position of the blocked 
or inaccessible switch.  
3.6 Safety  
The measuring instrument must be safe in accordance with the basic principles of safety of ionising 
radiation installations and the requirements of relevant technical regulations under the conditions of 
normal use for the i ntended purposes.  
4 Measuring instrument markings  
4.1 Markings on the measuring instrument  
The following information must be provided on each part of the measuring instrument, which may 
consist of two functionally separate parts:  
a) Manufacturer identificatio n; 
b) Designation of the type of measuring instrument;  
c) Serial number of the measuring instrument itself and the assessment unit;  
d) Type approval mark;  
e) Measured quantity and type of radiation;  
f) Effective measuring range.  
The position of the reference point must be indicated on the measuring instrument. The type and polarity 
of the batteries used must be indicated on the measuring instrument. All labels and inscriptions must be 
legible, durable, unambiguous and unalterable.  
4.2 Placement of the official mark  
The p lacement of official marks on the measuring instrument and the assessment unit is specified in the 
type approval certificate.  
Where possible, marks are to be placed on the front panel of the display unit so that they do not cover 
any of the data on the measuring instrument.  
5 Type approval of the measuring instrument  
5.1 General  
The measuring instrument type approval process includes the following tests:  
a) External inspection;  
b) Linearity test and statistical fluctuation of response;  
c) Energy and direction dep endence of response test;  General Measure No 0111 -OOP -C080 -16 
8 d) Overload resistance test;  
e) Response time test;  
f) Test of exceeding the set level (response and alarm stabilisation periods);  
g) Stabilisation period test;  
h) Test of response to beta radiation;  
i) Mechanical resistance test;  
j) Tests of resistance to climatic influences;  
k) EMC tests.  
5.2 External inspection  
The external inspection assesses  
a) the completeness of the prescribed technical documentation, including the operating instructions;  
b) the conformity of the metrological and technical charac teristics specified by the manufacturer in 
the documentation with the requirements of this regulation set out in chapters 2, 3 and 4.1;  
c) the completeness and status of the functional units of the measuring instrument according to the 
prescribed technical do cumentation;  
d) the software version (SW) of the measuring instrument with the version specified by the 
manufacturer.  
5.3 Functional tests  
5.3.1 Linearity test and statistical fluctuation of response  
The linearity test is performed by irradiating the measurin g instrument in a collimated gamma or X beam 
with reproducible geometry and field size. The measured value, determined as the arithmetic mean of 
at least ten statistically independent measurements, is compared with the reference value of the measured 
value  determined by the standard. The test is performed at three test points for each dec ade of the 
measuring range (at 25 %, 50 % and 75 % of the dec ade). 
The deviations of the measured values from the reference value must not exceed the limits in Article 
2.3.1. 
The test of the statistical fluctuation of the response is carried out simultaneously with the linearity test. 
A variation coefficient is established at all test points.  
The variation coefficient must not exceed the limits specified in Article 2.3.2.  
5.3.2 Energy and direction dependence of response test  
The energy dependence response test is performed by irradiating the measuring instrument in the 
collimated X and gamma beam with reproducible geometry and a field size in the required energy range 
(83 k eV, 100 keV, 118 keV, 164 keV, 208 keV, 662 keV and 1 250 keV) and the required range of 
angles (0 °, ± 15 °, ± 30 °, ± 45 °, ± 60 °). The measured value, determined as the arithmetic mean of at 
least ten measurements, is compared with the value of the mea sured value determined by the standard 
for reference values.  
The measured value must not exceed the limits specified in Articles 2.3.3. (energy dependence) and 
2.3.4 (directional dependence).  
5.3.3 Overload resistance test  
The overload resistance test cons ists of subjecting the measuring instrument to a dose equivalent ( rate) 
value that is 10 times the upper limit of the measuring range. When the measuring instrument is 
irradiated in a collimated gamma beam with reproducible geometry and field size, the measuring 
instrument must indicate an overload. After removing the radiat ion source, the measuring instrument General Measure No 0111 -OOP -C080 -16 
9 should return to the normal measurement mode within 10 minutes or display a warning that this is not 
possible.  
The overload measuring instrument must comply with the requirements of Article 2.3.5.  
5.3.4 Response time test 
The dose equivalent rate measuring instrument is exposed to varying rates of increase or decrease in the 
dose equivalent rate, recording the time at which the measuring instrument response reaches 90  % of 
the change in the reference value of the dose equivalent rate. 
The response time of the measuring instrument must not exceed the limits specified in Article 2.3.6.  
5.3.5 Time constant and alert stability  
The time constant and alert stability test is performed by irradiating the measuring instrument in  a 
collimated gamma beam with reproducible geometry and field size. The test is performed at one test 
point of the dose equivalent rate.  
The measuring instrument of the dose equivalent is exposed to 0.9 times the set dose equivalent rate 
signalling level.  The measuring instrument must not signal the exceedance of the set signalling level for 
1 minute.  
The measuring instrument of the dose equivalent is exposed to double the set dose equivalent rate 
signalling level. The measuring instrument must immediately  signal the exceedance of the set signalling 
level for 1 minute.  
The same test is performed again after 24 hours.  
5.3.6 Stabilisation period test  
The test is performed by irradiating the measuring instrument in a collimated gamma beam with 
reproducible ge ometry and field size. When the measuring instrument is activated, the value of the 
measuring instrument is recorded for 30 minutes (reading every 30 seconds). 30 minutes after the 
measuring instrument is activated, the final measured value is determined f rom 10 measuring instrument 
readings.  
The stabilisation period is defined as the time from which the deviation of the measuring instrument 
readings from the final measured value is less than 10 %. The stabilisation period is compared with the 
manufacturer' s data.  
5.3.7 Response to beta radiation  
In this test, the measuring instrument is exposed to beta 90Sr/90Y radiation in the 0 ° radiation direction.  
The measured value must not exceed the requirements of Article 2.3.8.  
5.4 Tests of the dosimeter's resista nce to environmental influences  
5.4.1 Mechanical resistance test  
5.4.1.1 Shocks  
An inspection of the physical condition is carried out and a reading is taken from the measuring 
instrument. The measuring instrument in measuring mode is exposed to 18 shocks (3 on each side) of 1 
J of energy. After the test, the physical condition is again inspected and the measuring instrument read.  
The measured value must not exceed the permitted change limits specified in Article 2.3.9. No alarms 
may be activated or functio nal changes made.  General Measure No 0111 -OOP -C080 -16 
10 5.4.2 Tests of resistance to climatic influences  
5.4.2.1 Ambient temperature impact test  
The test is carried out by irradiating the measuring instrument with a constant dosimetric rate. The 
measured values of the quantity determined as th e arithmetic mean at the maximum and minimum 
temperatures of the desired temperature range are compared with the reference value of the measured 
value determined at the standard temperature. The exposure time of the measuring instrument at 
individual tempe ratures must be at least 16 hours, the measuring instrument readings are recorded every 
60 minutes.  
The measured value must not exceed the permitted change limits specified in Article 2.3.10.  
5.4.2.2 Humidity impact test  
The test is carried out by irradiating the measuring instrument with a constant dosimetric rate. The 
measured values of the quantity determined as the arithmetic mean at a relative humidity of up to 93 % 
at +35 °C are compared with the reference value of the measured quantity determined under standard 
conditions. The exposure time of the measuring instrument at individual humidities must be at least 24 
hours, the measuring instrument readings are to be recorded every 2 minutes.  
The measured value must not exceed the permitted change limits specified in Article 2.3.11.  
5.4.3 Electromagnetic compatibility (EMC) test  
5.4.3.1 Radiation interference  
The radiation interference must be tested on the measuring instrument at the most sensitive measuring 
range in the  frequency range of 30 MHz to 230 MHz and 230 MHz to 1 000 MHz with a 50 kHz 
bandwidth.  
In this test, the measured value must not exceed the limits given in Article 2.3.12.  
5.4.3.2 Resistance to electrostatic discharge  
Resistance to electrostatic discharge  is tested on the measuring instrument in the most sensitive 
measurement range with a contact discharge of 4 kV or an air discharge of 8 kV (for measuring 
instruments with insulated surfaces). The discharges are applied to the various external parts of the  
dosimeter that can be touched by the operator when using the measuring instrument. The total number 
of discharges is at least 5.  
In this test, the measured value must not exceed the limits given in Article 2.3.13.  
5.4.3.3 Resistance to a high -frequency el ectromagnetic field   
Resistance to a high -frequency electromagnetic field must be tested on the measuring instrument at the 
most sensitive range in the 80 MHz to 1 GHz and 1.4 GHz to 2.5 GHz frequency ranges at a test field 
amplitude intensity of 10 V/m.  
In this test, the measured value must not exceed the limits given in Article 2.3.13.  
5.4.3.4 Resistance to disturbances caused by rapid transients  
Resistance to disturbances caused by rapid transients is tested at a voltage of ±2 kV.  
In this test, the meas ured value must not exceed the limits given in Article 2.3.13.  
5.4.3.5 Resistance to disturbances caused by overvoltage  
Resistance to disturbances caused by overvoltage is tested at ±1 kV or ±2 kV.  
In this test, the measured value must not exceed the limit s given in Article 2.3.13.  General Measure No 0111 -OOP -C080 -16 
11 5.4.3.6 Resistance to induced interference by high -frequency fields  
Resistance to induced interference by high -frequency fields is tested on the measuring instrument at the 
most sensitive range in the 150 kHz to 80 MHz frequency range at 10 V. This test is only performed on 
measuring instruments with at least one conductive cable (e.g. for signal conduction).  
In this test, the measured value must not exceed the limits given in Article 2.3.13.  
5.4.3.7 Resistance to circular waves  
Resistance to induced interference must be tested on the measuring instrument at the most sensitive 
range at a frequency of 1 MHz + 10 %, a main voltage between 50 Hz and 400 Hz and an unsynchronised 
network frequency.  
In this test, the measured value must  not exceed the limits given in Article 2.3.13.  
5.4.3.8 Resistance to a magnetic field of 50 Hz/60 Hz  
Magnetic field resistance is tested on the measuring instrument at its most sensitive range of 50 Hz or 
60 Hz at a field strength of 30 A/m. The test is p erformed with the magnetic field measuring instrument 
in two positions (0 ° and 90  °). 
In this test, the measured value must not exceed the limits given in Article 2.3.13.  
5.4.3.9 Resistance to a drop in voltage and a short interruption  
Resistance to a dro p in voltage and a short interruption is tested at 500 ms (30 % decrease), 200 ms (60 
% decrease) and 5 000 ms (100 % decrease), at least 10 times per hour.  
In this test, the measured value must not exceed the limits given in Article 2.3.13.  
6 Initial veri fication  
6.1 General  
During initial verification, the following tests are performed:  
a) Visual inspection;  
b) linearity response test of the instrument.  
6.2 Visual inspection  
During visual inspection of the dosimeter, the following is assessed:  
a) compliance of the measuring instrument with the approved type;  
b) completeness of the measuring instrument according to the type approval certificate;  
c) whether the individual parts of the measuring instrument are damaged and whether they are 
functioning;  
d) the SW version with  the version approved during type approval.  
6.3 Functional tests  
6.3.1 Linearity response time test of the device  
The linearity response test of the measuring instrument is performed according to Article 5.3.1, while 
only one dose value of the dose equivalent rate is tested in each measuring range, at 50 % to 75 % of 
each dec ade. General Measure No 0111 -OOP -C080 -16 
12 7 Subsequent verification  
Subsequent v erification is carried out in the same way as the initial verification in chapter 6.  
8 Measuring instrument examination  
When examining measuring instruments pursuant to § 11a of the Metrology Act at the request of a 
person who may be affected by an incorre ct measurement, please proceed according to Chapter 7. The 
maximum permissible error used is double the maximum permissible errors pursuant to Chapter 7.  
9 Notified standards  
For the purposes of specifying the metrological and technical requirements for me asuring instruments 
and specifying the testing methods for their type approval and verification arising from this general 
measure, the CMI shall notify 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 gen eral measure, in 
a manner accessible to the public (on www.cmi.cz ). 
Compliance with notified standards or parts thereof is considered, to the extent and under the conditions 
stipulated by a general measure, to be complianc e with the requirements stipulated by this measure to 
which these standards or parts thereof apply.  
Compliance with notified standards is one way of demonstrating compliance with the requirements. 
These requirements may also be met by using another technic al solution guaranteeing an equivalent or 
higher level of protection of legitimate interests.  
II. 
GROUNDS  
The CMI issues, pursuant to §  14(1)(j) of the Metrology Act, towards the implementation of § 6(2), 
§ 9(1), §  9(9) and §  11a(3) of the Metrology Act, this general measure, laying down metrological and 
technical requirements for the specified measuring instr uments and test methods for the type approval 
and verification of the specified measuring instruments - ‘installed measuring instruments, warning 
assemblies and monitors for dosimetric gamma radiation and X -rays with energies from 50 keV to 1.5 
MeV’.  
Impl ementing Decree No 345/2002 specifying measuring instruments for mandatory verification and 
measuring instruments subject to type approval, as amended, classifies the measuring instruments under 
items 8.7, 8.8 and 8.11 in the annex entitled ‘List of legall y controlled measuring instruments’ as 
measuring instruments subject to type approval and mandatory verification.  
This legislation (general measure) will be notified in accordance with Directive (EU) 2015/1535 of the 
European Parliament and of the Council  of 9 September  2015 laying down a procedure for the provision 
of information in the field of technical regulations and of rules on Information Society services.  
 
III. 
INSTRUCTIONS  
In accordance with §  172(l) APC, in conjunction with §  39(l) APC, the CMI has stipulated a time limit 
for comments of 30  days as of the date of posting the draft on the official notice board. Comments 
submitted after this time limit will not be considered.   General Measure No 0111 -OOP -C080 -16 
13 The persons concerned are hereby invited to comment on this general draft measure. With regard to the 
provisions of § 172(4) APC, comments are to be submitted in writing.  
Pursuant to the provisions of § 174(1) APC, in conjunction with the provisions of §  37(1) APC, it must 
be clearly stated who is submitting the comments, which general measure the comments concern, how 
the draft contradicts legislation or how the general measure is inaccurate. The comments must also 
contain the signature of the person mak ing the comments.  
The supporting documents for this draft general measure may be consulted at the Czech Metrology 
Institute, Legal Metrology Department, Okružní 31, 638 00 Brno, after making arrangements by 
telephone.  
This draft general measure shall be p osted for 15  days.  
 
 
 
 
 
 
 ...…………………………..............  
 Pavel Klenovský  
Director -General  
 
 
Person responsible for accuracy:  Tomáš Hendrych  
Posted on:  
Signature of the authorised person confirming posting:  ....................................................  
Removed on:  
Signature of the authorised person confirming removal:  ....................................................