C z e c h  M e t r o l o g y  I n s t i t u t e  
Okružní 31, 638 00  
Brno  
 
1. ------IND- 2014 0034 CZ - EN- ------ 20140130 --- --- PROJET 
Executive summary for the EC (not part of this legislation)  
This national legislation fully respects the fact that placing of mechanical contact ocular tonometers 
on the EU’s internal market is  governed by Directive 93/42/EEC, therefore, it does not concern their 
placement on the market , including the Czech Republic  market.  
With a view to the importance of ocular tonometers for the protection of social interests (protection of 
health), the Czech  Republic has introduced the obligation to regularly examine measuring instruments 
placed on the market, once they have been put into use in the Czech Republic.  
This legislation lays down the procedures for testing measuring instruments and the metrologic al 
requirements to be applied when testing measuring instruments that are in use. These requirements 
have been laid down so that they respect the right of the manufacturer to implement the metrological 
and technical parameters of the measuring instrument w ithin the scope provided by Directive 
93/42/EEC when placing it on the market.  
Furthermore, the harmonised standards EN  ISO 15004 -1 and EN  ISO 8612 have also been used to lay 
down the metrological requirements for mechanical contact ocular tonometers.  
(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 
Coll. 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 Coll., the Admi nistrative 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 -C038 -13 
ref. no.  0313/009/13/Pos.,  
 
laying down metrological and technical requirements for specified measuring instruments, 
including the testing methods for verification of the following  specified instruments:  
“mechanical and electronic contact ocular tonometers”  General Measure No 0111 -OOP -C038 -13 
2  
This legislation lays down the metrological and technical requirements for mechanical and electronic 
contact ocular tonometers to be applied after they have been placed on the m arket or put into use, in 
their subsequent verification or initial verification after repair.  These requirements comply with the 
requirements under Go vernment Order No 336/2004  laying down the technical requirements for 
medical devices1) 1(hereinafter refe rred to as the “Government Order on Medical Devices ”), while 
applying the relevant requirements under European standards.  
The verification of devices type approved under the Metrology Act, i.e. prior to the transposition of 
Council Directive 93/42/EEC, as amended, into Czech law, shall be subject to metrological 
requirements applicable at the time they were put into circulation.  
If a mechanical or electronic contact ocular tonometer that has been put into use fails to comply with 
any of the requirements und er Chapters 2, 3 and 4 when being verified, with the exception of the 
maximum permissible error, this shall constitute a reason to reject verification only if it deviates from 
the specifications indicated by the manufacturer.  
1   Basic definitions  
For the purposes of this General Measure, the terms and definitions according to VIM and VIML2)2 
and the definitions below shall apply.  
1.1 
ocular tonometer   
an apparatus for measuring intraocular pressure  
1.2 
contact ocular tonometer   
an ocular tonometer for meas uring intraocular pressure by means of direct or indirect contact of the 
measuring device with the cornea of the eye  
1.3 
intraocular pressure (IOP)   
the pressure inside the eye measured in millimetres of mercury (mmHg) or kilopascals (kPa)  
1.4 
impression m ethod of measuring intraocular pressure   
the application of a static load of a defined mass to the footplate of an impression tonometer in vertical 
direction and the simultaneous pressing of a contact plunger along the axis of the footplate using 
weights o f a defined total weight causing indentation of the cornea and thus vertical displacement of 
the plunger whereby intraocular pressure can be determined  
1.5 
impression (Schiøtz) ocular tonometer   
an ocular tonometer (designed by Hjalmar Schiøtz) for measure ment using the impression method by 
direct contact of the plunger with the cornea of the eye along the axis of the footplate at a defined 
static load  
                                                   
1) This Government Order transposed Council Directive 93/42/EEC of 14 June 1993 concern ing medical devices, 
as amended, into Czech legislation.  
2) 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 harmonisatio n 
compendium “Terminology in the Area of Metrology”, which is publicly accessible at www.unmz.cz  General Measure No 0111 -OOP -C038 -13 
3 1.6 
applanation method of measuring intraocular pressure   
force is exerted by the contact head (designed b y Goldmann) or a contact sensor on the cornea causing 
a constant flattening of the cornea of a defined diameter, on the basis of which intraocular pressure can 
be determined by measuring the force exerted; alternatively, a constant force of a defined magni tude is 
exerted on the cornea by the applanation head causing a flattening of the cornea whereby intraocular 
pressure can be determined by measuring the diameter of the ﬂattened area (as described by 
Maklakov)  
1.7 
Goldmann applanation ocular tonometer   
an ocular tonometer for measurement using the applanation method by direct contact of the 
applanation head with the cornea creating an applanation diameter of 3.06 mm (as described by Hans 
Goldmann) under slit illumination  
NOTE  This includes ocular tonometers  placed on a slit lamp or mobile designs with a mechanical scale or 
display.  
1.8 
electronic contact ocular tonometer   
an ocular tonometer for measuring intraocular pressure either by means of direct contact or indirect 
contact of a sensor with the cornea o f the eye  
2   Metrological requirements and technical requirements  
The metrological requirements are based on the requirements under the Government Order on Medical 
Devices1). Medical devices with a measuring function must be designed and manufactured in s uch a 
way as to provide adequate accuracy and stability within appropriate limits of accuracy and taking 
account of the intended purpose of the device.  The limits of accuracy shall be indicated by the 
manufacturer so that the devices do not compromise the clinical condition, health or safety of the 
patient when used under the specified conditions and for their intended purpose.  
If the limits of accuracy and the conditions under which they apply are not indicated by the 
manufacturer, the metrological require ments provided below, which fall within the scope of the 
relevant requirements under European standards, shall be applied.  
2.1   Rated operating conditions  
The rated operating conditions shall be specified by the manufacturer.  If not specified by the 
manuf acturer, the requirements for the maximum permissible error of the device must be complied 
with at least within the ambient temperature range of 15  °C to 35  °C and relative humidity range of 
10% to 90%.  
2.2   Measuring interval  
The minimum measuring interv al of a contact ocular tonometer must be within the range of 7 mmHg 
to 50 mmHg, but no greater than 80 mmHg, as per the manufacturer’s specifications.   
Intraocular pressure indicated by an electronic contact ocular tonometer which is less than 7 mmHg 
must be displayed in the form of a number or indicated as “low value”.  Readouts higher than 50 
mmHg must be displayed in the form of a number or indicated as “high value”.  
2.3   Maximum permissible error of an applanation ocular tonometer  
The maximum permissibl e error of indication of intraocular pressure shall be specified by the 
manufacturer.  If not specified by the manufacturer, the maximum permissible errors given in Table 1 
shall apply.   General Measure No 0111 -OOP -C038 -13 
4 Table 1  – Maximum permissible errors  
Measuring range  Maximum permissib le error  
7 mmHg to ≤ 16 mmHg  ±1.5 mmHg  
> 16 mmHg to < 23 mmHg  ±2.0 mmHg  
≥ 23 mmHg  ±3.0 mmHg  
3   Technical requirements  
The technical requirements are based on the requirements under the Government Order on Medical 
Devices1).  
If not indicated by the ma nufacturer in the specifications of the measuring instrument or if not 
indicated differently from those provided below, the technical requirements provided below, which are 
proportionate to the relevant requirements under European standards, shall apply.  
3.1   Impression ocular tonometers  
The accuracy of the impression method for measuring intraocular pressure is dependent on adherence 
to mass and longitudinal parameters.   
3.1.1    Mass parameters  
The specific mass of the tonometer and additional masses shal l be determined according to Table 2.   
Table  2 – Mass parameters of the impression ocular tonometer  
Mass of the tonometer, without handle  (16.5 ±0.5) g  
Additional masses with inscription  7.5 (2.00 ±0.02) g  
10.0 (4.50 ±0.02) g  
15.0 (9.50 ±0.02) g  
NOTE  The inscriptions 7.5, 10.0 and 15.0 on the additional masses indicate the sum of 
the actual masses and the effective mass of 5.5 g.  
3.1.2    Effective mass  
The effective mass is the sum of the masses of the lever, pointer and plunger in the vertical posit ion 
and shall be:  
(5.50 
 0.15)  g when indicating scale division 5,  
(5.50 
 0.20)  g when indicating scale division 10.  General Measure No 0111 -OOP -C038 -13 
5 3.1.3    Longitudinal parameters of the plunger and the footplate  
 
Key 
1 Plunger  
2 Air gap between the plunger and the footplate  
3 Footplat e 
Figure 1 - Dimensions of the footplate and the plunger of the impression ocular tonometer  
Table 3 - Dimensions of the footplate for the impression ocular tonometer  
Footplate item  Dimensions (mm)  
diameter ( d1) 10.1 
 0.2 
radius of curvature of the spheri cal front surface ( r1) 15.00 
 0.25 
minimum outer diameter of the spherical front surface ( d2) 
minimum radius of the outer edge curvature ( r3) 
either  – inner diameter ( d4) of the footplate recess up to the height ( h1) 
 – minimum radius of the inner edge cu rvature ( r2) 
or – diameter of the bore hole at the transition to the recess ( d3) between ( r1) 
and the inner edge ( r2) 9.00 +0.1  
0.2 
3.3 – 0.1 
0.2 
 
3.7 – 0.1 
minimum height of the recess ( h1) ≥ 1.5  General Measure No 0111 -OOP -C038 -13 
6 Table 4 - Dimensions of the plunger for the impression oc ular tonometer  
Plunger item  Dimensions (mm)  
plunger diameter ( d4) at the height ( h2) 3.00 
 0.03 
minimum height ( h2)  1.5 
radius of the spherical front surface of the plunger ( r4) 15.00 
 0.75 
radius of the edge curvature ( r5) 0.25 
 0.03 
maximum extensi on of the plunger below the curvature of the footplate  3.0 
 
The clearance between the plunger and the footplate shall be half of the difference between the inner 
diameter of the footplate d7 and the guiding diameter of the plunger d6 and shall not exceed 0.05 mm.  
3.1.4    Scale  
The scale must be inclined to the axis of the plunger.  The scale must be divided into at least 15 
linearly distributed divisions from –1 to 15 or from 0 to 15.  A single scale division must be equal to a 
plunger displacement of 0.05 m m.  
Table 5 - Displacement of the plunger of the impression ocular tonometer   
Scale divisions in total  
from – to Plunger displacement  
mm Permissible error limit  
mm 
0 – 5 0.25 ±0.01  
0 – 10 0.50 ±0.02  
0 – 15 0.75 ±0.03  
0 – 18 0.90 ±0.05  
–1 – 15 0.80 ±0.03 
3.1.5    Pointer  
The distance between the pointer and the scale must not be greater than 1.0 mm at any point of the 
scale.  
3.1.6    Footplate with the contact plunger  
The friction between the plunger along the axis of the footplate and the plunger sleeve  must not 
influence the result of the measurement.  The plunger must begin to move within the footplate before 
the angle of the axis of the impression ocular tonometer relative to the horizontal position exceeds 25°.  
The contact surface of the plunger and t he footplate must be ground and polished.  The surface must be 
smooth and without protrusions and scratches that could damage the cornea of the eye or influence 
measurement results.   
3.1.7    Position of use of the impression ocular tonometer  
Between the 5th  and 10th scale division, the plunger axis and the plane through the surface of the lever 
must form a right angle at the point of contact.   
3.1.8    Test block of the impression ocular tonometer  
Every single impression ocular tonometer must be equipped with  a test block whose curvature is either 
(as per the manufacturer) Rk = (16.00  
0.05)  mm, for which the indication on the scale of the General Measure No 0111 -OOP -C038 -13 
7 tonometer must be (0.0 ±0.2), or a standard block Rk = (15.00  ± 0.05)  mm, for which the indication on 
the scale of the tonometer must be ( –1.0 ±0.2).  
3.2   Applanation ocular tonometers  
3.2.1    Diame ter of the applanation circle of the Goldmann tonometer  
The diameter of the applanation circle shall be (3.06  ±0.02)  mm. 
3.2.2    Surface of the prismatic head or the pressure measuring sensor  
The front surface of the prismatic head or the pressure measurin g sensor must be smooth for contact 
with the cornea and without any protrusions.  The surface of the head must be smooth and without any 
protrusions and scratches, which could damage the eye or optically influence measurement results.  
3.2.3    Diameter of th e prismatic head  
The prismatic head must have a diameter of at least 6.0 mm in the area of direct contact with the 
cornea of the eye.  
3.2.4    Measuring force requirements  
The measuring force must be continuously adjustable within the minimum range extendin g from 
9.81 mN to 49.0  mN, without the use of auxiliary masses.  The measured value of the force must be 
clearly legible.  
3.2.5    Accuracy of the measuring force  
When the prismatic head is adjusted to the verification position, the permissible error of the force 
within the measuring interval must not be greater than ±1.5% of the nominal value or greater than 
±0.49 mN.  
3.2.6    Hysteresis effect  
The effect of hysteresis for the measuring force must not exceed ±0.49 mN.  
3.2.7    Mass of the prismatic head  
Mass s hall be specified by the manufacturer according to the type of the tonometer.  
3.2.8    Scale  
The conversion factor between scale value and force in mN shall be 9.81.  The minimum permissible 
range shall be 10 mmHg to 50 mmHg, the maximum permissible range sh all be 0 mmHg to 80 mmHg.  
Where 0.1 scale division is used, one scale unit shall represent 0.98 mN, where 0.2 scale division is 
used, it shall represent 1.96 mN.  
Where the scale is displayed on a display, the above range in mmHg shall apply.  
3.2.9    Shape of the arm and position of the prismatic head  
The geometric shape of the arm, the position of the prismatic head and the permissible tolerances shall 
be determined by the manufacturer in the specifications.  
4   Measuring instrument markings  
Each ocular ton ometer must bear, at least, the following markings:  
name of the manufacturer or supplier,  
name and type of the ocular tonometer,   General Measure No 0111 -OOP -C038 -13 
8 serial number.  
Each ocular tonometer, with the exception of the prismatic applanation head, must be marked with the 
same seria l number.   
5   Type approval of measuring instruments  
Measuring instruments are placed on the market and put into use after conformity assessment in 
accordance with the Government Order on Medical Devices1), therefore, they are not subject to type 
approval  within the meaning of the Metrology Act.  
6   Initial verification  
Measuring instruments shall be placed on the market and put into use after conformity assessment in 
accordance with the Government Order on Medical Devices1). 
The initial verification proce dure after repair of a measuring instrument is identical to that for 
subsequent verification under Chapter 7.  
7   Subsequent verification  
7.1   Verification of impression ocular tonometers  
7.1.1    Overview of the tests performed  
Subsequent verification of  impression ocular tonometers shall comprise the following tests performed 
sequentially:  
visual inspection,  
accuracy test,  
check of the specific masses of the impression tonometer,  
check of the effective mass of the impression tonometer,  
check of the dimen sions of the footplate, plunger and pointer.  
check of plunger displacement,  
test of the friction between the plunger and the footplate.  
7.1.2    Visual inspection  
The purpose of the visual inspection shall be to check:  
that the ocular tonometer submitted fo r verification conforms to the approved type or design of the 
measuring instrument for which conformity was declared when it was placed on the market,  
that the measuring instrument is complete and the serial numbers on the tonometer and all of its 
componen ts are identical,  
that it shows no obvious signs of damage or contamination,  
the surface and shape of the plunger for damage, protrusions and scratches using optical equipment,  
the surface of the test block (see Article 3.1.8) for damage, protrusions and s cratches,  
completeness and legibility of the required inscriptions and markings referred to in Chapter 4.  
7.1.3    Test equipment  
The following equipment shall be used for the tests:  General Measure No 0111 -OOP -C038 -13 
9 a) scales with an upper limit of the measuring interval of at least 18 g and maximum permissible 
error of less than 0.005 g,  
b) two micrometers, one with an upper limit of the measuring interval of at least 5  mm and the 
other up to 25  mm, with maximum permissible error of less than 0.003  mm, 
c) a calliper with an upper limit of the measu ring interval of up to 150 mm and maximum 
permissible error of less than 0.02 mm,  
d) testing blocks with the radius Rk:   
1   Rk = (15.00  
0.05)  mm, 
2   Rk = (16.00  ±0.05)  mm, 
3   Rk = (14.75  ±0.05)  mm, 
e) a protractor with a maximum permissible error of less th an 2°,  
f) a projection microscope with magnification of at least 80×.  
7.1.4    Accuracy test  
The accuracy test shall comprise checks and tests referred to below in Articles 7.1.4.1 to 7.1.4.5.  
If all longitudinal and mass parameters are complied with, includin g friction between the plunger and 
the footplate, correct function and accuracy of the measuring instrument are guaranteed.  
7.1.4.1    Check of the specific masses of the impression tonometer   
The mass parameter values referred to in Article 3.1.1 shall be checked by weighing.  
7.1.4.2    Check of the effective mass of the impression tonometer  
The effective mass values of the tonometer in the vertical position referred to in Article 3.1.2 shall be 
checked by weighing.  
7.1.4.3    Check of the dimensions of the f ootplate, plunger and pointer  
The dimensions of the impression ocular tonometer according to the manufacturer's specifications or 
according to Articles 3.1.3, 3.1.5, 3.1.7 and Tables 3 and 4 shall be checked.  
7.1.4.4    Plunger displacement test  
Plunger dis placement as specified under Article 3.1.4 and Table 5 shall be measured using a micrometer 
and compliance with the permissible error limit shall be observed.  
7.1.4.5    Test of the friction between the plunger and the footplate  
When the impression tonomete r is placed into the horizontal position and moved slowly into the vertical 
position with the plunger at the upper stop, the tonometer must begin to move downwards before the 
angle of the tonometer axis relative to the horizontal exceeds 25° as referred to  in Article 3.1.6.  
7.2   Verification of Goldmann applanation ocular tonometers  
7.2.1    Overview of the tests performed  
Subsequent verification of applanation ocular tonometers shall comprise the following tests performed 
sequentially:  
visual inspection,  
accuracy test,  
check of the diameter of the applanation circle of the prismatic head,   General Measure No 0111 -OOP -C038 -13 
10 check of the front diameter of the prismatic head,  
test of accuracy of the measuring force and its hysteresis.  General Measure No 0111 -OOP -C038 -13 
11 7.2.2    Visual inspection  
The purpose of the visual inspec tion shall be to check:  
that the ocular tonometer submitted for verification conforms to the approved type or design of the 
measuring instrument for which conformity was declared when it was placed on the market,  
that it shows no obvious signs of damage or  contamination,  
the surface of the prismatic head,  
completeness and legibility of the required inscriptions and markings referred to in Chapter 4.  
7.2.3    Test equipment  
The following equipment shall be used for the tests:  
a) force measuring test equipment wi th an upper limit of the measuring interval of at least 80  mN 
and with a maximum permissible error of less than 0,17  mN for the range of 9  mN to 50  mN 
and 0.20  mN for the range of over 50  mN; 
b) a microscope with magnification of at least 10x and with a cross -hair reticule;  
c) a glass -etched reticule with a maximum permissible error of less than ±0.002 mm.   
7.2.4    Accuracy test  
The accuracy test shall comprise tests specified by the manufacturer or tests and checks referred to 
below in Articles 7.2.4.1 to 7.2.4. 5. 
If all the defined technical parameters and force values are complied with, including the force 
hysteresis value, correct function and accuracy of the measuring instrument are guaranteed.  
7.2.4.1    Check of the diameter of the applanation circle of the prismatic head  
The diameter of the applanation circle shall be determined in two directions, perpendicular to each 
other.  
The measured value must meet the requirements under Article 3.2.1.  
7.2.4.2    Check of the front diameter of the prismatic head  
The dia meter of the prismatic head shall be determined in two directions, perpendicular to each other.  
The measured value must meet the requirements under Article 3.2.3.  
7.2.4.3    Test of accuracy of the measuring force and hysteresis   
The test of the measuring f orce values shall be performed on a test bench using a force measuring 
instrument or on a pointer system using measuring weights . The test shall be performed with the 
prismatic head in the verification position continuously from the minimum to the maximum value and 
back to the initial position; the measuring force error within the whole range must not be more than 
±1.5% of the nominal value or ±0.49 mN.   
Two measurements shall be performed.  The measured values shall be recorded and the results shall be 
used to calculate hysteresis, which must not be more than ±0.49 mN.  The measurement results must 
take the uncertainty of the measuring equipment into account.   
7.3   Verification of electronic contact ocular tonometers   
7.3.1    Overview of the tests performed  
Subsequent verification of electronic contact ocular tonometers shall comprise the following tests 
performed sequentially:  General Measure No 0111 -OOP -C038 -13 
12 visual inspection,  
accuracy tests,   
determination of hysteresis.  
7.3.2    Visual inspection  
The purpose of the visual inspection shal l be to check:  
that the ocular tonometer submitted for verification conforms to the approved type or design of the 
measuring instrument for which conformity was declared when it was placed on the market,  
that it shows no obvious signs of damage or contamin ation,  
the surface and dimensions of the contact sensor according to the manufacturer's specifications,  
the required functions, including zeroing of the measuring instrument, as per the manufacturer's 
specifications,  
completeness and legibility of the requ ired inscriptions and markings referred to in Chapter 4.  
7.3.3    Test equipment  
The tests shall be performed using test equipment supplied by the manufacturer for the given type of 
the electronic contact ocular tonometer.  
7.3.4    Accuracy test  
The procedur e for testing electronic contact ocular tonometers, which measure by means of direct 
contact with the cornea or without direct contact through the eyelid, shall be specified by the 
manufacturer.   
The test of accuracy of the intraocular pressure values in m mHg shall be performed on a test bench.  
The test shall be performed with the contact sensor in the verification position from 7 mmHg to 50 
mmHg, unless otherwise specified by the manufacturer.  The pressure values indicated on the display 
must fall within t he limits below, unless otherwise specified by the manufacturer:   
7 mmHg to ≤ 16 mmHg  ±1.5 mmHg  
> 16 mmHg to < 23 mmHg  ±2.0 mmHg  
≥ 23 mmHg  ±3.0 mmHg  
 
Three measurements shall be performed.   
7.3.5    Hysteresis test  
The measured values shall be used to ca lculate hysteresis, which must not be more than 
 1 mm Hg.   
8   Notified standards  
For the purposes of specifying the metrological and technical requirements for measuring instruments 
and specifying the testing methods for verification based on 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 (hereina fter 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 .czwebsite).  General Measure No 0111 -OOP -C038 -13 
13 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 app ly, are complied with.  
 
 General Measure No 0111 -OOP -C038 -13 
14 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 verificat ion of these specified 
measuring instruments so as to implement § 24c of the Metrology Act.  
Under item 2.3.1a) of the Annex “List of the Types of Specified Measuring Instrume nts” to Decree No 
345/2002  specifying the measuring instruments whose verification  is mandatory and the measuring 
instruments subject to type approval, as amended, mechanical ocular tonometers are classified as 
measuring instruments subject to verification.  
As such, the CMI has issued this General Measure laying down metrological and te chnical 
requirements for mechanical or electronic contact ocular tonometers and the testing methods for the 
verification of these specified measuring instruments in order to implement § 24c of the Metrology 
Act for this particular type of measuring instrum ent - mechanical and electronic contact ocular 
tonometers.  
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 
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 accordanc e 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 f or 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 shal l enter into force on the fifteenth day from  the date of publication (§  24d of 
the Metrology Act).  
 
 
 
...…………………………..............  
RNDr. Pavel Klenovský  
Director General