C z e c h  M e t r o l o g y In s t i t u t e 
Okružní 31, 638 00  
Brno  
 
1. ------IND- 2014 0032 CZ - EN- ------ 20140124 --- --- PROJET 
Executive summary for the EC (not part of this legislation)  
This national legislation fully respects the fact that placing of electronic non -contact ocular tonometers 
on the EU’s internal marke t is governed by Directive 93/42/EEC, therefore, it does not concern placing 
of the products on the market, including the Czech Republic's 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, after they have been put into use in the Czech Republic. This legislation lays down 
the procedures for testing measuring instruments and the metrological 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 measurin g 
instrument within the scope provided by the Directive when placing it on the market.  
Furthermore, the h armonised standard EN ISO 15004 -1 has also been used to lay down the 
metrological requirements for electronic non -contact ocular tonometers.  
(End of e xecutive summary.)  
 
 
 
 
 
As the authority having 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 Administ rative Procedure 
Code (hereinafter referred to as the “C AP”), the Czech Metrology Institute (hereinafter referred to as the 
“CMI”) commenced ex officio proceedings on 22 November 2013 under § 46 of the C AP 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 -C039 -13 
ref. no. 0313/010/13/Pos.,  
 
laying down metrological and technical requirements for specified measuring instruments, 
including the testing methods for the verification of the following  specified instruments:  
“electronic non -contact ocular tonometers”  
 General Measure No 0111 -OOP -C039-13 
2 This General Measure lays down the metrological and technical requirements for electronic non -
contact ocular tonometers to be applied after they have been placed on the market or put into use, in 
the subsequent verification or initial verification of these devices after repair. These requirements 
comply with the requirements under Government Order No 336/2004 Coll. laying down the technical 
requirements for medical devices1) (hereinafter re ferred to as the “Government Order on Medical 
Devices).  
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 
requirem ents applicable at the time they were put into circulation.  
If an electronic non -contact ocular tonometer that has been put into use fails to comply with any of the 
requirements under Chapters 2, 3 and 4 when being verified, 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) and 
the definitions below shall apply.  
1.1 
ocular tonometer   
an apparatus for measuring intraocular pressure  
1.2 
non-contact ocular tonometer   
an ocular tonometer using an air pulse to determine intraocular pressure  
1.3 
intraocular pressure (IOP)   
the pressure inside the eye measured in millimet res of mercury (mmHg) or kilopascals (kPa).  
2   Metrological 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 manufactur ed in such 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 compromi se 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 requirements provided below shall be applied.  
2.1   Rated operating conditions  
The rated operating conditions shall be specified by the manufacturer. If not specified by the 
manufacturer, the requirements for the maximum permissible error must be complied with at least 
within the ambient temperature range of 10°C to 35°C and relative humidity range of 30% to 90%.  
                                                   
1)   This Government Order transposed Council Directive 93/42/EEC of 14 June 1993 concerning 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 harmonisation 
compendium “Termi nology in the Area of Metrology”, which is publicly accessible at www.unmz.cz  General Measure No 0111 -OOP -C039-13 
3 2.2   Measuring interval  
A non -contact ocular tonometer must have an intraocular pressure measuring interval from 0 mmHg to 
at least 40 mmHg, unle ss specified otherwise by the manufacturer.  
2.3   Maximum permissible error  
The maximum permissible error of indication of intraocular pressure shall be specified by the 
manufacturer. If not specified by the manufacturer, the maximum permissible errors giv en in Table 1 
shall apply.  
Table 1  – Maximum permissible errors  
Measurement range  Maximum permissible error  
0 mmHg to 19 mmHg  ±2 mmHg  
over 19 mmHg to 35 mmHg  ±3 mmHg  
over 35 mmHg  ±4 mmHg  
 
3   Technical requirements  
The technical requirements are based  on the requirements under the Government Order on Medical 
Devices1). 
If not indicated by the manufacturer in the specifications of the measuring instrument or if not 
indicated differently from those provided below, the technical requirements provided belo w shall 
apply.  
3.1   Construction of the measuring instrument  
A non -contact ocular tonometer consists of an optical tracking system, an air pulse generating device, 
an evaluation unit and an indicating device.  
The optical tracking system is used to place t he air pulse generating device at the desired distance and 
position relative to the eye being measured. It must always clearly identify that the air pulse generating 
device has reached the ideal position relative to the eye being measured.  
If the course o f the measurement is evaluated as non -standard by the evaluation unit, the measured 
value shall either not be displayed at all or shall be displayed in a manner clearly and unambiguously 
indicating that it is non -standard.  
4   Measuring instrument marking s 
Electronic ocular tonometers must bear, at least, the following markings:  
– trade mark or name of the manufacturer,  
– measurement unit (mmHg or kPa),  
– power supply information,  
– type approval mark or the CE marking with the identification number of the notifi ed person.  
In addition, any further information provided by the manufacturer of the medical device, including the 
appropriate graphical symbols, shall be attached to these tonometers.  General Measure No 0111 -OOP -C039-13 
4 5   Type approval of measuring instruments  
Measuring instruments are pla ced on the market and put into use after conformity assessment in 
accordance with the Government Order on Medical Devices1), therefore, measuring instruments are 
not subject to type approval within the meaning of Act No 505/1990 Coll. on metrology, as amen ded. 
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 procedure after repair of a measuring inst rument is identical with that for 
subsequent verification under Chapter 7.  
7   Subsequent verification  
7.1   General  
7.1.1 Overview of the tests performed  
Subsequent verification of non -contact electronic ocular tonometers shall comprise the following test s 
performed sequentially:  
a) visual inspection,  
b) accuracy test.  
7.1.2    Test equipment  
The following equipment shall be used for the tests:  
a) the test equipment specified by the manufacturer for testing the relevant non -contact ocular 
tonometer , 
b) a thermometer ab le to measure within the temperature range of 10 to 35°C in increments of 
0.1°C.  
7.2   Visual inspection  
The purpose of the visual inspection shall be to check:  
– that the ocular tonometer submitted for verification conforms with 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,  
– completeness and legibility of the required labels and marks referred to in Chapter 4.  
7.3   Accuracy  test 
The test shall be performed at the operating conditions specified under Article 2.1. Prior to the test, the 
measuring instrument must be left at room temperature for at least 3 hours and turned on for at least 10 
minutes.  
The accuracy test shall be performed by directly comparing the data from the non -contact ocular 
tonometer being verified with data from standard test equipment. In this test, 10 measurements shall 
be taken with the non -contact ocular tonometer on all standard test equipment designed  for the 
relevant type of non -contact ocular tonometer. If measurement can be made  in an automatic, semi -
automatic or manual mode, measurements shall be taken in all modes.  General Measure No 0111 -OOP -C039-13 
5 The error of measurement detected by any of the measurements must not exceed the m aximum 
permissible error given in Article 2.3.  
8   Notified standards  
For the purposes of specifying the metrological and technical requirements for measuring instruments 
and for the purposes of 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 (hereinafter referred to as “notified standards”). The CMI shall 
publish a list of these notified standards assigned to the relevant measures, together with the General 
Measure, in a manner accessible to the public (on the www.cmi.cz website).  
Notified standards or parts thereof shall be considered to be complied with, within the scope of and 
under the conditions laid down by this General Measure, if the requirements laid down by this 
measure, to which these standards or pa rts thereof apply, are complied with.  
 
 
II. 
G R O U N D S   
The CMI issues this General Measure laying down metrological and technical requirements for 
specified measuring instruments and the testing methods for the verification of these specified 
measuring  instruments in order to implement § 24c of the Metrology Act.  
Under item 2.3.1b) of the Annex “List of the Types of Specified Measuring Instruments” to Decree No 
345/2002 Coll. specifying the measuring instruments whose verification is mandatory and measu ring 
instruments subject to type approval, as amended, electronic ocular tonometers are classified as 
measuring instruments that are subject to verification.  
Therefore , the CMI issues this General Measure laying down metrological and technical requirements  
for electronic non -contact ocular tonometer s 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 instruments - the electronic non -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 technica l 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  
Legal remedies pursuant to § 173(2) of the C AP may not be filed for G eneral Measures.  
In accordance with the provisions of § 172(5) of the  CAP, decisions on objections may not be revoked 
and appeals may not be made against them.  
The conformity of a general measure with legislation can be assessed in review proceedings pursuant to 
§§ 94 to 96 of the CAP. A party to the proceedings may initiat e review proceedings to be conducted by 
the administrative authority which issued the general measure. If the administrative authority finds no 
reasons to commence the review proceedings, it shall communicate and provide grounds for this fact General Measure No 0111 -OOP -C039-13 
6 within thirty  days. Pursuant to § 174(2) of the CAP, a ruling on the commencement of review 
proceedings can be issued within three years of the entry into force of the general measure.  
 
 
IV. 
E N T R Y    I N T O    F O R C E  
This General Measure shall enter into force on  the fifteenth day of the date of publication (§  24d of the 
Metrology Act).  
 
 
 
...…………………………..............  
RNDr. Pavel Klenovský  
Director General