Czech Metrology Institute  
Okružní 31, 638 00 Brno  
 
1. ------IND- 2018 0339 CZ - EN- ------ 20180803 --- --- PROJET 
Executive summary for the EC (not part of this legislation)  
Non-spectrometric activity meters and dosimeters used to monitor compliance with limits in the area 
of radiation protection or nuclear safety and for emergency measurement – electronic personal 
dosimeters for measuring gamma radiation and X -rays are placed  on the market and put into use in 
the Czech Republic 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 
these measuring instruments. The legislat ion establishes further tests for purposes of type approval 
and verification.  
(End of executive summary.)  
 
Contact person: Mgr. Tomáš 
Hendrych  
Phone: 545 555 414  
 
 
P U B L I C  D E C R E E  
 
As the authority with substantive and territorial jurisdiction in the matter of laying down metrological 
and technical requirements for specified  measuring instruments and stipulating the testing methods for 
type approval and verification of specified  meas uring instruments pursuant to §  14(1) of Act 
No 505/1990, on metrology, as amended (hereinafter the ‘Metrology Act ’), and in accordance with the 
provisions of §  172 et seq. of Act No  500/2004, the Code of Administrative Procedure (hereinafter the 
‘CAP ’), the Czech Metrology Institute (hereinafter the ‘CMI’) commenced ex officio proceedings on 4 
April  2016 pursuant to §  46 of the CAP, and, based on supporting documents, issues the following:  
 
I. 
D R A F T  M E A S U R E  O F  A  G E N E R A L  N A T U R E  
number: 0111 -OOP -C078 -16 
laying down the metrological and technical requirements for specified  measuring 
instruments, including testing methods for type approval and verification of the 
following specified  measuring instruments:  
‘non-spectrometric activity meters and dosimeters us ed to monitor compliance with limits 
in the area of radiation protection or nuclear safety and for emergency measurement – 
electronic personal dosimeters for measuring gamma radiation and X -rays’ 
 General Measure No 0111 -OOP -C078 -16 
2 1 Basic definitions  
 For the purposes of this General Measu re of a General Nature, t erms and definitions pursuant to VIM 
and VIML1) as well as the following terms and definitions apply:  
1.1 
personal dose equivalent  Hp(d) 
The dose equivalent in soft tissue, at a specified point in the human body at a depth of d. For penetrating 
radiation, a depth of 10 mm is recommended and for non -penetrating radiation, a depth of 0.07 mm is 
recommended.  
The unit of personal dose equivalent is Sv (J/kg).  
1.2 
personal equivalent dose rate    
The proportion of d Hp(d)/dt, in which dHp(d) is the increase in spatial dose equivalent at a temporal 
interval of d t. 
The unit of personal equivalent dose rate  is Sv /s (mSv /h). 
1.3 
measuring instrument for personal dose equivalent  
A device intended for measuring personal dose equivalent with a  digital dose indicator.  
1.4 
reference point of measuring instrument  
A physical mark or marks on the external surface of the measuring instrument intended for positioning 
the measuring instrument on the test point.  
1.5 
test point  
The p oint at which the reference value of the measured quantity is set and into which the measuring 
instrument’s reference point is positioned for the purpose of the tests.  
1.6 
measuring instrument response  
Response for the reference value of the quantity Hr,0 measured under spe cific conditions:  
 (1) 
in which Gr,0 is the corresponding specification of the measuring instrument.  
1.7 
reference response  
the ratio given under reference conditions by the relation ship: 
 (2) 
                                                      
1)  TNI 01 0115 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.  
)(dpH
0,0,
0
rr
HGR
HGRGeneral Measure No 0111 -OOP -C078 -16 
3 in which G is the measuring instrument’s specification and H is the reference value of the measured 
quantity under reference conditions.  
1.8 
relative response  
Ratio of R and reference response R0: 
 (3) 
in which G is the measuring instrument’s specification and H is the reference value of the quantity  
1.9 
effective  measurement range  
The r ange of values of the measured quantity that meets the requirements of the standard.  
1.10  
lower limit of effective measurement range H0 
The lowest value of dose equivalent or dose rate that falls within the effective measurement ran ge. 
1.11  
upper limit of effective measurement range H0 
The highest value of dose equivalent or dose rate  that falls within the effective measurement range.  
1.12  
coefficient of variation v 
A measure of the relative dispersion of the data determined as a proportion of standard deviation to the 
arithmetical mean in percent.  
1.13  
relative expanded uncertainty Urel 
The sum of the standard measurement uncertainty and the coefficient of expansion k (k = 2 corresponds 
to a probability of coverage of approximatel y 95 %).  
1.14  
conventional true value of dose equivalent  
The best estimate of the true value of the dose equivalent  
2 Metrological requirements  
2.1 Categorisation of measuring instruments  
The categorisation of measuring instruments is specified in Table 1.  
Table 1 – Categorisation of measuring instruments  
Main 
category  Symb
ol Minimum required 
range of use  Energy range  For dose 
equivalent  For equivalent 
dose rate  
Hp(10) 
gamma 
radiation  G energy:  
80 keV – 1.5 MeV  
 
equivalent dose rate : 
0.5 µSv/h – 1 Sv/h  
 m:  
lower limit 60 keV  
l:  
lower limit 20 keV  
h:  f:  
lower limit 10 µSv  a: emergency  
upper limit  
10 Sv/h  
 
e: environment  
HGRGeneral Measure No 0111 -OOP -C078 -16 
4 dose equivalent:  
100 µSv – 10 Sv  including 6 MeV  lower limit  
0.05 µSv/h  
 
Hp(10) 
X 
radiation  X energy : 
20 keV – 150 keV  
 
equivalent dose rate : 
0.5 µSv/h – 1 Sv/h  
 
dose equivalent:  
100 µSv – 10 Sv  l:  
lower limit 10 keV  
h:  
including 300 keV  f:  
lower limit 10 µSv  a: emergency  
upper limit  
10 Sv/h  
 
e: environment  
lower limit  
0.05 µSv/h  
 
Hp(0.07)  
gamma 
and X 
radiation  S energy:  
20 keV – 150 keV  
equivalent dose rate : 
5 µSv/h – 1 Sv/h  
dose equivalent:  
1 mSv – 10 Sv  l:  
lower limit 15 keV  
n:  
lower limit 10 keV  
 g:  
lower limit 100 µSv  a: emergency  
upper limit  
10 Sv/h  
 
e: environment  
lower limit  
0.5 µSv/h  
 
2.2 Reference conditions and standard test conditions  
Reference conditions and standard test conditions are specified in Table 2 and apply unless the 
manufacturer states otherwise.  
Table 2 – Reference conditions and standard test conditions  
Influencing quantity  Reference conditions  Standard test conditions  
Photon radiation energy for:  
1 – Hp(10) – personal dose 
equivalent  
2 – Hp(0.07) – directional personal 
dose equivalent  gamma radiation:  
137Cs or 60Co (ISO 4037 -3) 
 
N-80 or 241Am (ISO 4037 -3) gamma radiation:  
137Cs or 60Co (ISO 4037 -3) 
 
N-80 or 241Am (ISO 4037 -3) 
Angle of incidence of radiation  reference direction given by the 
manufacturer  given direction ±5°  
Dose equivalent:  
Hp(10) 
Hp(0.07)   
0.3 mSv  
3 mSv   
0.1 mSv to 10 mSv a) 
0.5 mSv to 50 mSv a) 
Equivalent dose rate : 
Hp(10) 
Hp(0.07)   
0.3 mSv/h  
3 mSv/h   
0.1 mSv/h to 10 mSv/h a) 
0.5 mSv/h to 50 mSv/h a) 
Stabilisation time  15 minutes  ≥ 15 minutes  
Temperature  20 °C  18 °C to 22 °C a) 
Relative humidity  65 % 50 % to 75  % a) 
Air pressure  101.3 kPa  86.0 kPa to 106.6 kPa a) 
Supply voltage  nominal supply voltage  battery charged up to half of its 
service life  
External electromagnetic field  negligible  less than the smallest value causing 
the disturbance  General Measure No 0111 -OOP -C078 -16 
5 External magnetic induction  negligible  less than two times the value of 
Earth’s magnetic field  
Measuring instrument orientation  will be specified by the 
manufacturer  specified orientation ± 5°  
Measuring instrument control  setting s for ordinary operation  setting s for ordinary operation 
Radiation background  2 µSv/d  lower than 0.25 µSv/h  
Contamination with radioactive 
particles  negligible  negligible  
a) Actual value determined in test  
2.3 Maximum permissible error  
2.3.1 Linearity and statistical response fluctuation  
Under standard conditions, the measuring instrument’s response  deviation  over the entire effective 
measurement range may not exceed −17 % to +25%.  
Under standard conditions, the coefficient of variation over the entire effective measurement range may 
not exceed:  
for Hp(10):  
for H0 ≤ H < 11H0 (16 − H/H0) % 
for H ≥ 11H0 5 % 
for p(10):  
for < 10 µSv/h  20 %  
for 10 µSv/h ≤  < 60 µSv/h  [21 − / (10 µSv/h)] %  
for  ≥ 60 µSv/h  15 %  
2.3.2 Energy and directional dependence of response  
The measuring instrument’s relative response caused by the angle of radiation incidence over a  range of 
0 ° to ±60 ° ( relative to the reference direction of radiation incidence) and over an energy range of 80 
keV to 1.5 MeV (for gamma radiation) or 20 keV to 150 keV (for X radiation) must be within 0.71 to 
1.67.  
2.3.3 Storage of measured dose equivalent data  
The measured dose equivalent data must be stored on the device for at least 8 hours. At the same time, 
this value may not change by more than ±2 %.  
Likewise, it is necessary to store the dose equivalent data for 24 hours after a power loss The value 
stored may not differ by more than ±5 % after battery  replacement . 
2.3.4 Overload  
2.3.4.1 Equivalent dose rate  
If the measuring instrument is exposed to a equivalent dose rate  the exceeds  the maximum measurement 
range, the measuring instrument must indicate the maximum value of the measurement range and 
simultaneously indicate an overload.  
H
H
H
H
HGeneral Measure No 0111 -OOP -C078 -16 
6 2.3.4.2 Dose equivalent  
If the measuring instrument is exposed to a dos e equivalent greater than that of the maximum 
measurement range, the measuring instrument must indicate the maximum value of the measurement 
range and simultaneously indicate an overload.  
2.3.4 Indication that the set level has been exceeded   
2.3.5.1 Response ti me for equivalent dose rate  measurement and alarm  
The response time is defined as the period of time after which the measuring instrument’s specification 
reaches the final specification of the equivalent dose rate  in the event of a sudden rise or drop in 
equivalent dose rate . The measuring instrument’s required response time limit is 10 seconds. 
Exceedance of the set level must be signalled within 2 seconds. The requirements apply to a equivalent 
dose rate  ≥ 1 mSv/h.  
2.3.5.2 Accuracy of signalling that the set equivalent dose  level has been exceeded  
Under standard conditions, a measuring instrument exposed to 0.87 times the pre -set value may not 
signal exceedance of this value.  
A measuring instrument exposed to 1.18 times the pre -set value must signal an ex ceedance of this 
value.  
2.3.5.3 Accuracy of signalling that the set equivalent dose rate  level has been exceeded  
Under standard conditions, a measuring instrument exposed to (1 − 2·ν max) times the pre -set value may 
not signal exceedance of this value for longer than 5% of the total time.  
A measuring instrument exposed to (1 − 2·ν max) times the pre -set value must signal exceedance of this 
value for longer than 95% of the total time.  
2.3.6 Response to beta radiation  
The measuring instrument must be as insensitive to beta radiation as possible. The indicated equivalent 
dose (input) must be lower than 10% of the value of equivalent dose  (input) to which the measuring 
instrument is exposed.  
2.3.7 Resistance to mechanical shocks  
If the measuring instrument is subjected to mechanical shocks during operation, the change in response 
caused by the shocks must be less than ±0.7 H0 (the lower limit of effective measurement range). No 
mechanical damage may be caused and no information saved on the measuring instrument may be lost.  
2.3.8 Resistance to vibrations  
If the measuring instrument is subjected to vibrations during operation, the change in response caused 
by the vibrations must be less than ±0.7 H0 (lower limit of e ffective measurement range). No mechanical 
damage may be caused and no information saved on the measuring instrument may be lost.  
2.3.9 Resistance to falls during transport  
A measuring instrument packaged for transport purposes must be resistant to falls. If the measuring 
instrument is subjected to falls during operation, the change in response caused by the falls must be less 
than ±0.7 H0 (the lower limit of effective measurement range). In the event of a fall, no mechanical 
damage may be caused and the dev ice must exhibit normal functioning upon being turned on.  General Measure No 0111 -OOP -C078 -16 
7 2.3.10 Ambient temperature  
Changes in the measuring instrument’s response caused by a change in ambient temperature (stable 
temperature, thermal shock , and turning on at low temperatures) over a ran ge of −10  °C to +40 °C may 
not exceed −13 % to +18 % of the measuring instrument’s response under standard test conditions. In 
the case of measuring instruments intended solely for indoor  use, this requirement applies over a 
temperature range of +5 °C to + 40 °C. Such measuring instruments must  for example  be labelled as ‘for 
indoor use only ’. 
2.3.11 Relative humidity  
Changes in the measuring instrument’s response caused by a change in ambient humidity over a range 
of 40  % to +90 % may not exceed a deviation  from -9 % to +11 % in comparison with the measuring 
instrument’s response under standard test conditions. In measuring instruments intended for outdoor  
use, the measuring instrument’s protection rating  must be at least IP 53.  
2.3.12 Atmospheric pressure  
Changes in the measuring instrument’s response caused by a change in atmospheric pressure over a 
range of 86.0  kPa to +106.0 kPa may not exceed a deviation from -9 % to +11 % in comparison with 
the measuring instrument’s response under standard test conditi ons. 
2.3.13 Resistance to electromagnetic interference  
The maximum change in response (temporary and permanent) caused by electromagnetic interference 
must not be greater than ±0.7 H0 (lower limit of effective measurement range).  
2.3.14 Power supply source  test 
The capacity of the primary batteries must be such that the maximum change in the measuring 
instrument’s relative response is within −0.09 to +0.11 after 100 hours of uninterrupted use (at a 
equivalent dose rate  from 0.01 mSv/h to 0.1 mSv/h). The mea suring instrument must not indicate low 
battery capacity.  
The measuring instrument must be able to produce an audio signal and display that the set threshold  has 
been exceeded  for at least 15 minutes immediately after new batteries have been inserted.  
The capacity of the secondary batteries (rechargeable batteries) must be such that the maximum change 
in the measuring instrument’s relative response is within -0.09 to +0.11 after 24 hours of uninterrupted 
use (at a equivalent dose rate  from 0.01 mSv/h to 0.1  mSv/h).  
The measuring instrument must be able to produce an audio signal and display that the set threshold  has 
been exceeded  for at least 15 minutes immediately after the batteries have been recharged.  
3 Technical requirements  
3.1 Unit indication  
The me asuring instrument must display a value in Sv or Sv/h.  
3.2 Minimum measurement range  
The minimum measurement range of a measuring instrument for personal equivalent dose rate must be 
from 1 µSv to 10 Sv.  The minimum measurement range of a measuring instrument for personal dose 
equivalent must be from 1 µSv to 1 Sv.  General Measure No 0111 -OOP -C078 -16 
8 3.3 Information on operating status  
The measuring instrument must indicate operating conditions under which accuracy  of the dose 
equivalent reading is not ensured, for example if the battery is depleted, a detector is malfunctioning , or 
if the equivalent dose rate  has been exceeded.  
3.4 Easy decontamination  
The measuring instrument must be designed and built to allow easy decontamination.  
3.5 Protection from unauthorised tampering  
The measuring instrument must be built to prevent  the operator from  inadvertently chang ing any factor 
of the settings. Parts of the measuring instrument that are essential to its metrological properties must 
be design ed so that they can be secured by a means that provides proof of any tampering . Regulation 
elements must either be inside the measuring instrument and inaccessible from outside without the use 
of tools, or must be clearly marked and fitted with a scale so that they can be precisely adjusted in 
accordance with the capacity of the measuring instrument 's resolution , and then blocked so as to prevent 
any acci dental change to the settings. It must impossible to change corrective factors and calibration  
coefficie nts saved digitally unless the operator enters a security code (or password) or changes the 
position of a blocked or inaccessible switch.  
3.6 Safety  
The measuring instrument must be safe in the sense of the basic principles of radiation safety with 
ionisin g radiation and the requirements of the relevant technical regulations under ordinary conditions 
of use for the intended purpose.  
4 Measuring instrument markings  
4.1 Markings on the measuring instrument  
On measuring instruments that may be composed of two functionally separate parts, the following 
information must be specified on each part:  
a) manufacturer identification;  
b) type designation of the measuring instrument;  
c) serial number of the measuring instrument itself;  
d) type approval mark;  
e) measured quantity and ty pe of radiation;  
f) effective measurement range.  
The position of the reference point must be marked on the measuring instrument. The type and polarity 
of the batteries used must be marked on the measuring instrument. All inscriptions and marks must be 
legible , permanent, unambiguous , and indelible . 
4.2 Official mark placement  
The positioning of official marks on the measuring instrument and evaluation unit is specified in the 
type approval certificate.  
If possible, the marks are to be positioned on the front panel of the display unit in such a manner that 
they do not conceal  any of the information shown on the measuring instrument.  General Measure No 0111 -OOP -C078 -16 
9 5 Type approval of the measuring instrument  
5.1 General information  
The t ype approval process for  a measuring instrument includes the following tests:  
a) an external inspection;  
b) a test of  response  linearity and statistical fluctuation;  
c) a test of  energy and directional dependence of  the response;  
d) a measured quantity  storage test ; 
e) a test of resistance to overload;  
f) a response time test;  
g) a test of the accuracy of indication that the set level has been exceeded;  
h) a test of response to beta radiation;  
i) a mechanical resistance test;  
j) a test of resistance to climatic influences;  
k) EMC tests;  
l) a power supply test.  
5.2 External inspection  
The following is assessed during an external inspection:  
a) whether  the required technical documentation, including operating instructions , is complete ; 
b) whether the metrological and technical characteristics specified by the manufacturer in the 
documentation comply with the requirements under this regulation as referred to in Chapters 2, 3 
and 4.1;  
c) the completeness and condition of the measuring instrument’s funct ional units according to 
prescribed  technical documentation;  
d) whether the measuring instrument’s software version matches the version specified by the 
manufacturer.  
5.3 Radiation tests  
5.3.1 Test of  response  linearity and statistical fluctuation  
The lineari ty test is conducted by irradiating the measuring instrument in a collimated beam of gamma 
or X radiation of reproducible geometry and field size. The measured value is compared with the 
reference value obtained for this quantity using a reference gauge.  The test is conducted using various 
values of equivalent dose rate  and dose equivalent at three test points within each decade of the 
measurement range (at 20  %, 40  % and 80  % of the decade).  
The response fluctuation test is conducted at the same time as th e linearity test. The coefficient of 
variation after repeated measurement is determined at all test points.  
Deviations in the measured values from the reference value may not exceed the limits pursuant to Article 
2.3.1.  
The coefficient of variation of the dosimetric values may not exceed the limits pursuant to Article 2.3.2 
by more than 1.5 times. The specific value of the permissible multiplier is determined according to the 
actual number of test points and the actual number of measurements.  
5.3.2 Test of  energy and directional dependence of  the response  
The energy dependence of response test is conducted by irradiating the measuring instrument in a 
collimated beam of X or gamma radiation with reproducible geometry and field size in the required General Measure No 0111 -OOP -C078 -16 
10 energy rang e and the required angle range. The measured value is compared with the value measured of 
a quantity determined for the reference conditions with a reference gauge.  
Deviations in the measured values from the reference value may not exceed the limits pursua nt to Article 
2.3.2.  
5.3.3 Storage of measured dose equivalent data  
The measuring instrument is exposed to a dose equivalent value t hat will  make the subsequent influence 
of the natural background negligible. Afterwards, the saved reading is read each hour for a  period of 8 
hours and compared with the original value.  
In the next test, the measuring instrument is likewise exposed to a dose equivalent value that will make 
the influence of the natural background negligible. The batter ies are  then removed , and after 24 hours  
have passed are re -inserted into the measuring instrument . The stored data  is compared to the original 
value.  
Deviations in the measured values from the reference value may not exceed the limits pursuant to Article 
2.3.3.  
5.3.4 Test of resistance  to overload  
5.3.4.1 Test of resistance to dose equivalent overload  
The test consists of irradiating the measuring instrument 10 times with a dose equivalent that is higher 
than the upper limit of the measurement range  (though no higher than 10 Sv) . When i rradiating the 
measuring instrument in a collimated beam of gamma radiation with reproducible geometry and field 
size, the measuring instrument must display the maximum measurement range and indicate that it has 
been exceeded.  
The measuring instrument’s b ehaviour when overloaded must meet the requirements of Article 2.3.4.  
5.3.4.2 Test of resistance to equivalent  dose rate  overload  
The test consists of exposing the measuring instrument to a n equivalent dose rate  that is 10 times (max. 
10 Sv/h) the upper li mit of the measurement range. When irradiating the measuring instrument in a 
collimated beam of gamma radiation with reproducible geometry and field size, the measuring 
instrument must indicate an overload. When the radiation source is removed, the measuri ng instrument 
should return to normal measuring mode within 10 seconds.  
The measuring instrument’s behaviour when overloaded must meet the requirements of Article 2.3.4.  
5.3.5 Indication that the set level has been exceeded   
5.3.5.1 Response time for equiv alent dose rate  measurement and alarm  
The test of the accuracy of indication that the set level has been exceeded is conducted by irradiating 
the measuring instrument in a collimated beam of gamma radiation with reproducible geometry and 
field size at each  of the measurement ranges of the effective measurement range.  
The measuring instrument is exposed to a rise or drop in equivalent dose rate , and the time required for  
the measuring instrument’s response to reach 90  % of the change in reference value of th e equivalent 
dose rate  is recorded . 
The measuring instrument’s response time may not exceed the limits pursuant to 2.3.5.1.  
5.3.5.2 Accuracy of indication that the set dose equivalent level has been exceeded  
The test of the accuracy of indication that the set level has been exceeded is conducted by irradiating 
the measuring instrument in a collimated beam of gamma radiation with reproducible geometry and General Measure No 0111 -OOP -C078 -16 
11 field size. The test is conducted at a test point near the upper limit of the effective measure ment range 
and at a test point near the second -lowest order  of magnitude  of the effective measurement range.  
The measuring instrument is exposed to an equivalent dose rate  that does not result in indication that  
the dose equivalent has been exceeded  for at least  100 seconds. Then the time at which the measuring 
instrument begins to indicate that the set level has been exceeded  is recorded . The ratio of the set 
indication level set and the product of the irradiation  time and the equivalent dose rate  used mu st lie 
within 0.87(1 − Urel) to 1.18(1 − Urel), where  Urel is the expanded ( k = 2) uncertainty of the conventional 
true dose equivalent value.  
The measuring instrument’s behaviour must meet the requirements of Article 2.3.5.2.  
5.3.5.3 Accuracy of signallin g that the set equivalent dose rate  level has been exceeded  
The test of the accuracy of indication that the set level has been exceeded is conducted by irradiating 
the measuring instrument in a collimated beam of gamma radiation with reproducible geometry and 
field size. The test is conducted at a test point near the upper limit of the effective measurement range 
and at a test point near the second -lowest order  of magnitude  of the effective measurement range.  
The equivalent dose rate  measuring instrument  is exposed to (1 − Urel − 2·ν max) times the set equivalent 
dose rate  value for 15 minutes and the cumulative time is measured after which the measuring instrument 
indicates that the set level has been exceeded. This period of time may not be longer than 5  % of the 
total time.  
The measuring instrument is then exposed to (1 + Urel + 2·ν max) times the set equivalent dose rate  value 
and the cumulative time is measured after which the measuring instrument signals tha t the set level has 
been exceeded. This period of time may not be shorter than 95  % of the total time.  
The measuring instrument must meet the requirements of Article 2.3.5.3.  
5.3.6 Response to beta radiation  
In this test, the measuring instrument is expos ed to beta radiation 90Sr/90Y in a direction of radiation 
incidence of 0°.  
Deviations in the measured values from the reference value may not exceed the requirements pursuant 
to Article 2.3.6.  
5.4 Tests of resistance to environmental influences  
5.4.1 Mecha nical resistance tests  
5.4.1.1 Shocks  
An inspection of the measuring instrument’s physical condition is conducted and its data is recorded. 
While in measuring mode, t he measuring instrument is subjected to 60 falls (10 from each side) onto a 
steel surface from a height of 10 cm. After the test, another inspection of the measuring instrument’s 
physical condition is conducted and its data is recorded. Dose data saved before the test may not be lost.  
The measured value may not exceed the permissible change limits pursuant to Article 2.3.7.  
5.4.1.2 Vibrations  
An inspection of the measuring instrument’s physical condition is conducted and its data is recorded. 
While in measuring mode, t he measuring instrument is exposed to vibration  loading  of 20 m/s2 for 15 
minutes in each direction for one frequency between  10 Hz to 21 Hz and  22 Hz to 33 Hz. The indicated 
value is read after each vibration interval (15 minutes). After the test, another inspection of the 
measuring instrument’s physical condition is conducted.  
The measured value may not exceed the permissible change limits pursuant to Article 2.3.8.  General Measure No 0111 -OOP -C078 -16 
12 5.4.1.3 Drop test 
The measuring instrument, switched off and packaged for transport, is subjected to 6 drops (one from 
each side) onto a concrete surface from a heig ht of 1 m. After the test, an inspection of the measuring 
instrument’s physical condition is conducted, the measuring instrument is turned on, and its data is 
recorded once it has reached operating status. Dose equivalent data saved before the test must not be 
lost. 
The measured value must not exceed the permissible change limits pursuant to Article 2.3.9.  
5.4.2 Tests of resistance to climatic influences  
5.4.2.1 Test of ambient temperature influence  
Stable temperature:  
The test is conducting while irradiating the measuring instrument with the dosimetric quantity  at a 
constant rate . The measured values of the quantity determined as the arithmetic  mean  of at least ten 
measurements at the maximum and minimum of the required temperature range are compar ed to the 
reference value of the measured quantity determined at standard temperature. The measuring instrument 
must be  subjected to individual temperatures for at least 4 hours; the measuring instrument’s reading is 
recorded during the last 30 minutes of this period.  
Temperature shock:  
The test is conducting while irradiating the measuring instrument with the dosimetric quantity  at a 
constant rate  at standard temperature after stabilising the temperature for at least 60 minutes. The 
temperature is changed to the required values as quickly  as possible and the measuring instrument’s 
response is read every 15 minutes for a period of 2 hours. The values obtained are compared to the 
reference value of the measured quantity determined at standard temperature.  
Switching the measuring instrument on at low temperature:  
The switched -off measuring instrument is placed in a climate chamber that is set to  the minimum value 
of the required temperature range. The measuring instrument is left in the chamber for a period of 4 
hours. After that, the measuring instrument is turned on and its behaviour is observed.  
The measured values must not exceed the permissible change limits pursuant to Article 2.3.10.  
5.4.2.2 Humidity influence test  
The test is conducting while irradiating  the measuring instrument with the dosimetric quantity  at a 
constant rate . The measured values of the quantity determined as the arithmetical mean of at least ten 
measurements at a relative humidity within 40 % to 90 % at a temperature of +35 °C  are compar ed to 
the reference value of the measured quantity determined under standard conditions. The time measuring 
instrument must be subjected to individual moisture values for at least 24 hours; the measuring 
instrument’s reading is recorded during the last 30 minutes of this period.  
The measured value may not exceed the permissible change limits pursuant to Article 2.3.11.  
5.4.2.3 Test of atmospheric pressure influence  
The test is conducting while irradiating the measuring instrument with the dosimetric quantit y at a 
constant rate . The measured values of the quantity determined as the arithmetical mean of at least ten 
measurements at pressure values of 86 kPa and 106.6 kPa are compared to the reference value of the 
measured quantity determined at the reference a tmospheric pressure of 101.3 kPa.  
The measured value may not exceed the permissible change limits pursuant to Article 2.3.12.  General Measure No 0111 -OOP -C078 -16 
13 5.4.3 Electromagnetic compatibility (EMC) tests  
5.4.3.1 Immunity to electrostatic discharge  
Immunity to electrostatic discharge is  tested with the measuring instrument switched on in its most 
sensitive measurement range via contact discharge of 4 kV or air discharge of 8 kV (in the case of 
measuring instruments with insulated surfaces). Discharges are applied to various external part s of the 
measuring instrument with which the operator may come into contact when using the measuring 
instrument. The total number of discharges is 10/hour.  
In this test, the measured value may not exceed the limits specified in Article 2.3.13.  
5.4.3.2 Immu nity to a high-frequency electromagnetic field   
Immunity to a high -frequency electromagnetic field is tested with the measuring instrument switched 
on in its most sensitive range in the frequency range of 80  MHz to 2.7  GHz at a test field amplitude of 
30 V/m.  
In this test, the measured value may not exceed the limits specified in Article 2.3.13.  
5.4.3.3 Immunity to disturbances caused by rapid transient s 
Immunity to disturbances caused by rapid transient s is tested at a voltage of ±2 kV. The total number of 
transient s is 10/hour.  
In this test, the measured value may not exceed the limits specified in Article 2.3.13.  
5.4.3.4 Immunity to disturbances caused by overvoltage  
Immunity to disturbances caused by overvoltage is tested at a voltage of ±1 kV or ±2 kV. The total 
number of disturbances is 10/hour.  
In this test, the measured value may not exceed the limits specified in Article 2.3.13.  
5.4.3.5 Immunity to interference caused by induced high-frequency fi elds 
Immunity to interference caused by  induced  high-frequency fields is tested with the measuring 
instrument switched on in its most sensitive range in the frequency range of 150 kHz to 80 MHz at a 
voltage of 10 V. This test is only carried out on measuri ng instruments that have at least one conductor 
cable (e.g. for conducting a signal).  
In this test, the measured value may not exceed the limits specified in Article 2.3.13.  
5.4.3.6 Immunity to a 50 Hz/60 Hz magnetic field  
Resistance to a magnetic field i s tested with the device switched on in its  most sensitive range at a 
frequency of 50 Hz or 60 Hz and a field intensity of 30 A/m. The test is conducted with the measuring 
instrument exposed to the magnetic field in two positions (0 ° and 90 °).  
In this te st, the measured value may not exceed the limits specified in Article 2.3.13.  
5.4.3.7 Immunity to drops in voltage and brief interruptions  
Resistance to drops in voltage and brief interruptions is tested at 500 ms (30  % drop), 200 ms (60  % 
drop) and 5000 m s (100  % drop) , at least 10/hour.  
In this test, the measured value may not exceed the limits specified in Article 2.3.13.  
5.4.4 Power supply test  
Battery capacity is tested with the measuring instrument switched on , with new batteries or fully charged 
rechargeable batter ies, exposed to a equivalent dose rate  between 10 µSv/h and 100 µSv/h. The 
measuring instrument is then left in uninterrupted operation for a period of 100 hours (primary battery) 
or 24 hours (rechargeable batteries).  
The measuring instrume nt’s behaviour must meet the requirements specified in Article 2.3.14.  General Measure No 0111 -OOP -C078 -16 
14 6 Initial verification  
6.1 General information  
The following tests are conducted during initial verification:  
a) visual inspection;  
b) device response linearity test;  
6.2 Visual inspection  
The purpose of the visual inspection of the measuring instrument is to check that:  
a) the measuring instrument  conforms  with the approved type;  
b) the measuring instrument  is complete  according to the type approval certificate;  
c) individual parts of the measuring instrument are  not damaged and are functional;  
d) the software version matches the version approved during type approval.  
6.3 Function tests  
6.3.1 Device response linearity test  
The device response linearity test is conducted pursuant to Article 5.3.1.  
7 Fol low-up verification  
The follow -up verification is conducted by way of the same procedure as the initial verification pursuant 
to 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 incorrect measuring instrument, proceed according to Chapter 7. Two 
times the maximum permitted errors pursuant to Chapter 7 will be applied as the maximum permitted 
errors.  
9 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 fro m this General 
Measure, the CMI will 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 requirem ents (hereinafter referred to as ‘notified standards ’). The 
CMI will publish a list of these notified standards attached to the relevant measures, together with the 
measure of a general nature , in a manner accessible to the public (on www.cmi.cz ). 
Compliance with notified standards or parts thereof is considered, to the extent and under the conditions 
stipulated by a measure of a general nature , to be compliance 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 technical solution guaranteeing an equivalent or 
higher level of pr otection of legitimate interests.  General Measure No 0111 -OOP -C078 -16 
15 II. 
G R O U N D S  
The CMI issues, pursuant to §  14(1)(j) of the Metrology Act, for the implementation §  6(2), §  9(1) 
and (9) as well as §  11a(3) of the Metrology Act, this measure of a general nature, stipulating 
metrological an d technical requirements for specified measuring instruments and test methods 
during type approval and verification of these specified measuring instruments – ‘non-
spectrometric activity meters and dosimeters used to monitor compliance with limits in the a rea of 
radiation protection or nuclear safety and for emergency measurement - electronic personal dosimeters 
for measuring gamma radiation and X -rays’.  
Decree No  345/2002 laying down measurement instruments for mandatory validation and measurement 
instrum ents subject to type approval, as amended, classifies the measuring instruments under Items  8.5, 
8.7, and 8.8 in the Annex to the Second List of Specified Measurement Instruments of the specified type 
as measurement instruments subject to type approval and  mandatory validation.  
This legislation (Measure  of a General Nature ) 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 i n the field of technical regulations and of rules on Information Society 
services.  
 
III. 
L E G A L  I N S T R U C T I O N S  
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 post ing on the official notice board. Comments submitted 
after this time limit will not be considered.  
The persons concerned are hereby invited to comment on this draft General Measure. In light of the 
provisions of §  172(4) of the APC, the comments are submi tted in written form.  
In accordance with the provisions of § 174(l) APC in conjunction with §  37(l) APC, it must be clear 
who is making the comments, which measure of a general nature  they address, how it contradicts 
legislation or how the measure of a gen eral nature  is inaccurate, and the signature of the person making 
the comment must be included.  
The supporting documents for this draft Measure of a General Nature may be consulted at the Czech 
Metrological Institute, Department of Legal Metrology, Okružn í 31, 638 00 Brno, upon appointment by 
telephone.  
This measure of a general nature  will be posted for 15  days.  
 
 
 
 
 
 
 ...…………………………..............  
RNDr. Pavel Klenovský  
Director -General  
 General Measure No 0111 -OOP -C078 -16 
16  
Person responsible for accuracy: Mgr. Tomáš Hendrych  
Posted on:  
Signature of the authorised person confirming posting:  ....................................................  
Removed on:  
Signature of the authorised person confirming removal:  ....................................................