C z e c h  M e t r o l o g y  I n s t i t u t e  
Okružní 31,  638 00  
Brno  
 
1. ------IND- 2010 0776 CZ - EN- ------ 20101224 --- --- PROJET 
 
The Czech Metrology Institute (CMI), as the competent local body for stipulating metrological and 
technical requirements for a specified measuring device and for the stipulation of test method s for type 
approval and for verification of a specified measuring device pursuant to Section 14(1) of Act No. 
505/1990 Coll., on Metrology, as amended, and pursuant to provisions of Section 172 et seq. of Act 
No. 500/2004 Coll., the Administrative Code, as  amended (hereinafter the "AC"), has on 1 6 July 2010 
commenced ex officio proceedings pursuant to Section 46 of the AC, and based on su pporting doc u-
ments issues this:  
 
 
I. 
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 -C017 -10 
reference  no. 0313/010/10/Pos.,  
publication date: 11 October 2010  
 
stipulating metrological and technical requirements for specified measuring devices, 
including test methods for verifying specified measuring devices:  
"activity meters for diagnostic and therapeutic  preparations applied to patients in 
vivo"  
 
1   Basic definitions  
For the purposes of this measure of a general nature, terminology and definitions contained in the 
VIM1) and the following apply:  
1.1   activity meter for diagnostic and therapeutic preparat ions applied to patients in vivo, r a-
dionuclide calibrator: a device consisting of a well -type ionization chamber and an analysis unit with 
appropriate electronics, providing the transfer of a measured low chamber current using defined cal i-
bration coefficie nts on the displayed activity value  
1.2   calibration coefficient: determines what current (in pA) in the chamber elicits ionizing radi ation 
emitted from the sample of a certain radionuclide with unit activity (in Mbq)  
1.3   reference position: the sample position specified by the manufacturer for which calibration coe f-
ficients are stipulated  
                                                      
1)   International V ocabulary of Metrology - Basic and General Concepts and Associated Terms (VIM)  Measure of a General Nature No. 0111 -OOP -C017-10 
2 1.4   system linearity: relation of expected and measured activity values, ascertained over the entire 
measurement range stipulated by the manufacturer, or if this is not possible, at least over the range in 
which the measuring device is usually used  
1.5   reference activity source: a calibrated radionuclide activity source  
1.6   device accuracy: estimated total possible measurement result deviation including measur e-
ment uncertainty from the activity values of the reference source  
1.7    coefficient of variation  v: the level of relative data dispersion; is calculated as the ration of 
standard deviation (s) to the arithmetic average (
x ) in percent, i .e. 
 100 
xνs
 
2   Metrological requirements  
2.1   Stipulated service conditions  
Radionuclide calibrators must meet metrological requirements over the service temperature range 
specified by the manufacturer. If the manufacturer does not specif y service temperatures, a service 
temperature range of 10  °C to 40  °C applies.  
2.2   Measurement range  
The measurement range of the radionuclide calibrator is specified by the manufacturer.  
2.3   Device accuracy  
Measured activity values of the reference so urce above 3.7 ×  106 Bq must be within ±  10 % during 
measurement in the reference position.  
When measuring activity levels below 3.7 ×  106 Bq, these limits are not binding, but each device that 
shall be used for such measurements must have its actual devia tion determined.  
2.4   Measurement repeatability  
When making repeated measurements of a reference activity source with the same measuring device in 
the same geometry, the coefficient of variation must not exceed 1  %. 
2.5   Long -term repeatability  
For repea ted measurements of a reference activity source during the course of at least one month, at 
approximately identical time intervals, with the same measuring device and maintaining the same g e-
ometry, the coefficient of variation must not exceed 2 %.  
2.6   System linearity  
Measured and reference value deviations over the range of activities used must not exceed 5 %.  
3   Technical requirements  
3.1   Design  
A radionuclide calibrator consists of a well -type ionization chamber and an analysis unit, the two 
forming  an integrated system.  Measure of a General Nature No.. 0111 -OOP -C017-10 
3 Shielding in which the measuring device's ionization chamber is usually located has an influence on 
measurement results, especially on device accuracy. If shielding is part of the radionuclide calibrator, 
the manufacturer must list c alibration coefficients for the system including shielding.  
3.2    Electromagnetic compatibility  
3.2.1     Resistance to electrical and electromagnetic interference.  
Measuring devices must not be influenced by ambient electrical and electromagnetic interfer ence and 
must meet requirements of special legislation2). 
3.2.2     Electromagnetic field radiation  
When working, measuring devices must not radiate an electromagnetic field that could have a negative 
effect on other systems.  
3.3   Protection from unauthori zed use  
Parts of the measuring device that are important for its metrological characteristics must be designed 
so that they can be secured in a way that gives proof of any unauthorized tampering.  
3.4  Safety  
The measuring device must be safe pursuant to ba sic principles of safety of devices with ionizing r a-
diation and requirements of relevant technical regulations under conditions of normal use for its i n-
tended purposes.  
4   Markings  
4.1   Markings on the measuring device  
The measuring device, which can con sist of two functionally independent parts, must have the follo w-
ing data listed on each part:  
a) the manufacturer,  
b) measuring device type,  
c) ionization chamber and analysis unit serial number,  
d) type approval mark,  
e) data on the safety of the ionizing radiation meas uring device.  
All markings and labels must be legible, permanent, unambiguous and impossible to remove in a reg u-
lar manner.  
4.2   Verification marks  
The location of verification marks on the ionization chamber and analysis unit is specified in the type 
approval certificate.  
If possible, marks are placed on the front panel of the display unit so that they do not cover any of the 
information listed on the measuring device.  
                                                      
2) Government Order No. 616/2006 Coll., on technical requirements for products with respect to their electr o-
magnetic compatibility.  Measure of a General Nature No. 0111 -OOP -C017-10 
4 5   Type approval  
5.1   In general  
The approval process for a measuring device includes  the following tests:  
a) external inspection,  
b) device accuracy test,  
c) repeatability test,  
d) long-term repeatability test,  
e) linearity test  
f) EMC tests.  
5.2   External inspection  
The following is assessed during an external inspection:  
a) that prescribed tec hnical docume ntation is complete, including the user manual,  
b) that metrological and technical characteristics specified by the manufacturer in documentation 
conform to requirements of this regulation listed in sections 2 and 3,  
c) that the measuring device's functional who les are complete and in accordance with prescribed 
technical documentation,  
d) that the software (SW) version of the measuring device is the same as the version specified by 
the man ufacturer.  
5.3   Functional tests  
5.3.1   Test equipment  
5.3.1.1    Reference so urce of activity  
The activity value and radionuclide impurities of the reference source must be known as of the given 
date and time.  
The design of the reference source must correspond as closely as possible to sources normally mea s-
ured in facilities that u se the measuring device.  
5.3.1.2    Calibration coefficients  
Calibration coefficients for individual radionuclides are listed by the manufacturer in accompanying 
documentation based on a direct comparison of measured values and conventional activity source ref-
erence values of the relevant radionuclide. If the calibration coefficient is determined only by calcul a-
tion, this manner of its determination must be clearly stated in the accompanying documentation.  
5.3.2    Device accuracy test  
The device accuracy tes t is performed by measuring reference sources of selected and most often used 
radionuclides over the entire measurement range of the measuring device. For each reference source, 
the measured value is calculated as the arithmetic average of at least ten act ivity indications.  
During the device accuracy test, the result of measuring the activity of the relevant reference source 
must lie between the limits listed in Article 2.3.  
5.3.3    Repeatability test  
The repeatability test consists of 10 repeat activity me asurements of the same reference activity 
source.  Measure of a General Nature No.. 0111 -OOP -C017-10 
5 The calculated coefficient of variation must meet the requirements of Article 2.4.  
5.3.4.    Long -term repeatability  
The long -term repeatability test is performed by measuring a reference radionuclide activi ty source 
with a longer half -life during the course of at least one month over at least ten identical time intervals.  
The calculated coefficient of variation must meet the requirements of Article 2.5.  
5.3.5    Linearity test  
This test uses one of the follow ing procedures:  
a) A radionuclide with a shorter half -life is used, and in intervals that are at most 1/5 of the half -
life, the value of the reference activity source is measured at least over the range the radion u-
clide calibrator is normally used. For each m easurement, the ratio of the reference value to the 
measured value is calculated.  
b) A set of reference activity sources of one radionuclide with a known activity and identical g e-
ometry is used, covering at least the activity range over which the radionuclide  calibrator is 
normally used. For each measurement, the ratio of the reference value to the measured value is 
calculated.  
The ratio of measured values to expected values must meet the requirements of Article 2.6.  
5.4   Electromagnetic compatibility tests  
EMC tests are performed with the radionuclide calibrator connected in accordance with  manufacturer 
specifications.  
These tests must prove that the radionuclide calibrator conforms to the requirements of relevant sp e-
cial legislation2). 
5.4.1    Resistance to electrostatic discharge  
Resistance to electrostatic discharge is tested with the device switched on, with a co ntact discharge of 
6 kV and with an 8 kV air discharge. The discharges are applied to conductive surfaces and coupling 
plates.  
After this test, du ring the next device accuracy test the measured deviation must not exceed limits 
listed in Article 2.3.  
5.4.2    Resistance to radiated electromagnetic fields at radio frequencies  
Resistance to a radiated high -frequency electromagnetic field is tested with the device switched on, in 
the 80 MHz to 1 GHz frequency range with field intensity of 10 V/m, 1.4 GHz to 2 GHz with field 
intensity of 3  V/m, and 2 GHz to 2.7 GHz with field intensity of 1 V/m. Amplitude modul ation 80  % 
AM/1  kHz sin.  
After this test, duri ng the next device accuracy test the measured deviation must not exceed limits 
listed in Article 2.3.  
5.4.3    Resistance to bursts (transients)  
Resistance to rapid transient electrical phenomena/impulse groups is tested with the device switched 
on. A test voltage of ±  1 kV is applied through a coupling circuit to the power source.  
After this test, during the next device accuracy test the measured deviation must not exceed limits 
listed in Article 2.3.  Measure of a General Nature No. 0111 -OOP -C017-10 
6 5.4.4    Resistance to electrical surges  
Resistance to el ectrical surges is tested by applying a test voltage of ±  1 kV between power condu c-
tors. 
After this test, during the next device accuracy test the measured deviation must not exceed limits 
listed in Article 2.3.  
5.4.5    Resistance to interference caused by  power lines, induced by high -frequency fields  
Resistance to interference caused by power lines, induced by high -frequency fields is tested with the 
device switched on, over a frequency range of 150 kHz to 80 MHz. Amplitude modulation 80  % 
AM/1  kHz, voltag e level 3 V.  
After this test, during the next device accuracy test the measured deviation must not exceed limits 
listed in Article 2.3.  
5.4.6     Resistance to voltage dips, short interruptions and slow voltage variations  
Resistance to short mains voltage d ips, short interruptions and slow voltage variations are tested with 
the device switched on by applying a voltage dip of 0  % Ut for 10 ms.  
After this test, during the next device accuracy test the measured deviation must not exceed limits 
listed in Article  2.3. 
6   Initial verification  
6.1   In general  
The following is performed during initial verification:  
a) external inspection,  
b) device accuracy test,  
c) repeatability test.  
6.2   Visual inspection  
The following is assessed during visual inspection of the radionu clide calibrator:  
a) that the measuring device is the same as the approved type,  
b) that the measuring device is complete in accordance with  the type approval certificate,  
c) that individual parts of the measuring device are undamaged and functional,  
d) that the SW ve rsion matches the version approved during type approval.  
6.3   Functional tests  
6.3.1    Device accuracy test  
A device accuracy test is performed in accordance with  Article 5.3.2.  
6.3.2    Repeatability test  
A repeatability test is performed in accordance wi th Article 5.3.3.  
7   Subsequent verification  
Subsequent verification is performed using the same procedure as initial verification pursuant to Se c-
tion 6.  Measure of a General Nature No.. 0111 -OOP -C017-10 
7 8   Notified standards  
To specify metrological and technical requirements for measuring devices and t o specify verific ation 
test methods stemming from this measure of a general nature, the CMI notifies Czech technical sta n-
dards, other technical standards or technical documents of international or foreign organizations or 
other technical documents containi ng detailed technical requirements (hereinafter "notified sta n-
dards"). The CMI shall publish a list of these notified standards, with their assignation to relevant 
measures, along with the measure of a general nature, in a manner available to the public (o n the we b-
site www.cmi.cz).  
Compliance with notified standards or parts thereof is considered to be, to the extent and under the 
conditions stipulated by a measure of a general nature, to be compliance with those requirements 
stipulated by this measure to w hich these standards or parts thereof apply.  
 
 
II. 
J U S T I F I C A T I O N  
The CMI issues, towards the implementation of Section 24c of Act No. 505/1990 Coll., on metrology, 
as amended, this measure of a general nature, stipulating metrological and tech nical requirements for 
specified measuring devices and test methods for verification of these specified measuring devices.  
In Decree No. 345/2002 Coll., specif ying measuring devices for mandatory verification and measuring 
devices subject to type approval,  as amended, the annex "List of Specified Measuring Device Types" 
classifies " activity meters for diagnostic and therapeutic preparations applied to patients in vivo"  under 
item 8.2 as measuring devices subject to type approval and verific ation. 
The CMI th us issues, towards the implementation of Section 24c of Act No. 505/1990 Coll., on m e-
trology, as amended, for the measuring device type specified as " activity meters for diagnostic and 
therapeutic preparations applied to patients in vivo" , this measure of a general nature, stipulating me t-
rological and technical requirements for  activity meters for diagnostic and therapeutic preparations 
applied to patients in vivo  and test methods for type approval and verification of these specified mea s-
uring d evices.  
 
 
III. 
N O T I C E  
 
A measure of a general nature cannot be appealed (Section 173 (2) of Act No. 500/2004 Coll., the 
Administrative Code, as amended (hereinafter the "Administrative Code").  
Pursuant to provisions of Section 172 (5) of the Administrative Code, a decision on objections cannot 
be appealed in any manner.  
The conformance of a measure of a general nature with legislation can be assessed in review procee d-
ings pursuant to Section 94 to 96 of the Administrative Code. A participant may submit a request f or a 
review to the administrative body that issued this measure of a general nature. If the administrative 
body does not find reasons for commencing review proceedings, it shall notify the applicant within 
thirty days of this fact along with its reasons. A  decision on commencement of review proceedings 
can, in accordance with  Section 174 (2) of the Administrative Code, be issued within three years of the 
effective date of the measure of a general nature.  Measure of a General Nature No. 0111 -OOP -C017-10 
8  
 
IV. 
E F F E C T I V E  D  A T E  
This measure of a ge neral nature takes effect on the fifteenth day following the day of its publication 
(Section 24d of Act No. 505/1990 Coll., on metrology, as amended).  
This measure of a general nature shall be published for a period of 15 days.