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Order Itc/3077/2007, Of October 17, Which Regulates The Metrological Control Of The Status Of Instruments For The Determination Of The Content Of Sugar In The Grape, In Concentrated Must And Concentrated Must Ground...

Original Language Title: Orden ITC/3077/2007, de 17 de octubre, por la que se regula el control metrológico del Estado de los instrumentos destinados a la determinación del contenido de azúcar en el mosto de la uva, en el mosto concentrado y en el mosto concentrado rectifi...

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TEXT

Law 3/1985, of 18 March, of Metrology, establishes the legal regime of the metrological activity in Spain, regime to which they must submit in defense of the safety, the protection of the health and the economic interests of consumers and users, the measuring instruments, under the conditions to be determined. This Law was subsequently developed by various norms of metrological content, among which is the Royal Decree 889/2006, of July 21, which regulates the metrological control of the State on measuring instruments.

This royal decree transposing into national law Directive 2004 /22/EC of the European Parliament and of the Council of 31 March 2004 on measuring instruments, while adapting the metrological control phases concerning the approval of a model and a primitive verification, in the instruments subject to national specific regulations, to the system of conformity assessment which is regulated in the abovementioned directive, also addressing the development of the the metrological control phases corresponding to the periodic verification and after repair, stages which are not covered by Community legislation.

Commission Regulation (EEC) No 2676/90 of 17 September 1990 laying down the Community methods of analysis applicable in the wine sector which, in paragraph 2 of the Annex, provides for the method of Community analysis for the assessment of the sugar content of musts, concentrated musts and rectified concentrated musts, refractometry.

In accordance with all this, this order is intended to regulate the State's metrological control over the instruments intended for the determination of the sugar content of the grape must, concentrated musts and musts In all the stages covered by the said Royal Decree 889/2006 of 21 July 2006, that is to say, both that which corresponds to that of the placing on the market and put into service, and those relating to verification after repair or modification and periodic verification.

For the elaboration of the order, the autonomous communities have been consulted and the mandatory hearing has been carried out for the interested parties. He has also favourably reported the Metrology Board.

This provision has been submitted to the procedure for information on technical standards and regulations provided for in Directive 98 /34/EC of the European Parliament and of the Council of 22 June, as amended by the Directive 98 /48/EC of 20 July, as well as Royal Decree 1337/1999 of 31 July, which incorporates both directives into the Spanish legal order.

In its virtue, I have:

CHAPTER I

General Provisions

Article 1. Object.

The purpose of this order is to regulate the metrological control of the State of the instruments intended to measure the sugar content of grape must, concentrated musts and rectified concentrated musts, hereinafter referred to as refractive.

Article 2. Metrological control phases.

1. The metrological control of the State established in this order is the one that is regulated in Chapters II and III of Royal Decree 889/2006, of July 21, which regulates the metrological control of the State on measuring instruments. These chapters relate respectively to the marketing and commissioning stages and to the instruments in service of the measuring devices referred to in Article 1 of this order.

2. The control referred to in Chapter II shall be carried out in accordance with the conformity assessment procedures laid down in Article 6 and Annex III to Royal Decree 889/2006 of 21 July 2006 and in Article 4 of this order.

3. Controls on instruments that are already in service will include both after-repair or modification verification and the periodic verification of those instruments.

CHAPTER II

Marketing and commissioning phase

Article 3. Essential metrological and technical requirements.

1. The essential, metrological and technical requirements to be met by the refractometers are those set out in Annex II of this order.

2. The conformity of a refractometer with the essential, metrological and technical requirements shall be carried out in accordance with the conformity assessment procedures laid down in Article 4 of this order.

Article 4. Modules for conformity assessment.

The modules to be used to carry out the conformity assessment of the instruments referred to in Article 1 shall be chosen by those responsible for placing them on the market and in the service of those referred to in Article 1. continuation, as provided for in Annex III to Royal Decree 889/2006 of 21 July 2006:

1. Module B, model examination, plus Module D declaration according to the model based on the quality assurance of the manufacturing process.

2. Module B, model examination, plus Module F, declaration of compliance with the model based on product verification.

3. Module G, Compliance statement based on unit verification.

4. Module H1, Declaration of conformity based on the total quality assurance plus the design examination.

The essential requirements of the instruments and the technical standards or documents to be applied are those detailed in Annexes II and III respectively.

The conformity with the essential metrological and technical requirements, as set out in Annex II, of those refractive from any Member State of the European Union, of a Member State of the European Union, is assumed. European Free Trade Association which is a contracting party to the Agreement on the European Economic Area or Turkey, provided that, according to a certificate or similar document issued by a competent body in accordance with the rules of the said Agreement States, comply with the technical standards, rules or procedures legally established in the and the levels of accuracy, safety, adequacy and suitability required are equivalent to those required by the applicable rules in Spain.

The competent public administration may request the necessary documentation to determine the equivalence referred to in the preceding paragraph. Where the non-compliance with the essential, technical and metrological requirements is established, the competent public administration may prevent the placing on the market and service of the refractometers.

CHAPTER III

Verification after repair or modification

Article 5. Definition.

It is understood by verification after repair or modification, in accordance with the provisions of Article 2 (z) of Royal Decree 889/2006, of July 21, the set of administrative, visual and technical examinations which may be carried out in a laboratory or in the place of use, which are intended to check and confirm that a refractory in service maintains, after a repair or modification requiring the breaking of seals, the characteristics (a) the metrological nature of the measures, in particular as regards the maximum errors; permitted, as well as to operate in accordance with its design and in accordance with its specific regulations and, where appropriate, the approved design or model.

Article 6. Authorized repairers.

1. The repair or modification of the refractometers may only be performed by a person or entity registered in the Register of Metrological Control, in accordance with the provisions of Royal Decree 889/2006 of 21 July 2006.

2. All the actions performed by an authorized repairer will be documented in a work part, in a self-copying diptych format. The first sheet of the part shall be held by the repairer and the second sheet, held by the holder, both at the disposal of the competent authority and of the approved bodies at least for a minimum period of two years. since the intervention was performed.

3. The nature of the repair, the substituted elements, the date of the action, the number with which the repairer who has made the repair is registered in the Register of Metrological Control, the identification of the person who has made the repair or modification, his signature and the stamp of the repair entity. The description of the operations carried out shall be sufficiently detailed so that their scope can be assessed by the competent authority.

4. The repairer that has repaired or modified a refractometer, having checked its correct operation, shall adjust its errors to zero with the least tolerance to allow its instrument equipment.

Article 7. Bound subjects and requests.

1. The holder of the refractometer shall communicate to the competent public authority its repair or modification, indicating the object of the repair or modification and specifying the elements which are substituted, where appropriate, and the adjustments and controls carried out. Before you are put into service, you will need to request verification.

2. The application for verification shall be accompanied by the identification bulletin set out in Annex I.

3. Once the application for the verification of a refractometer has been submitted after repair or modification, the competent public administration or the approved body of verification shall have a maximum period of 30 days in which to proceed to its inspection. verification.

Article 8. Testing and execution.

1. The refractometer shall pass an administrative examination, consisting of the complete identification of the instrument and the verification that the instrument meets the requirements required to be legally in service. It shall be carried out on the basis of the information provided by the applicant in the identification bulletin set out in Annex I. It shall be verified, in particular, that the instrument has the declaration of conformity and the corresponding markings, According to the provisions of Royal Decree 889/2006 of 21 July 2006, the nameplate meets the requirements set out in each case.

2. The tests to be carried out on verification after repair or modification shall verify compliance with the essential requirements described in paragraphs 2.1 and 2.2 of Annex II to this order.

Article 9. Maximum errors allowed.

The maximum errors allowed in the verification after repair or modification shall be as indicated in Annex II of this order.

Article 10. Compliance.

1. After the verification phase after repair or modification, the conformity of the refractometer shall be recorded in order to perform its function, by means of the adhesion of a label in a visible place of the verified instrument, which must meet the characteristics and requirements as set out in Annex I to Royal Decree 889/2006 of 21 July 2006 specifying in the same instrument class as that concerned. The relevant verification certificate shall also be issued and the verifier shall reseal the instrument.

2. Verification after repair or modification shall have periodic verification effects with respect to the calculation of the time limit for your application.

Article 11. Not exceeding verification.

When a refractometer does not exceed the verification after repair or modification it must be put out of service until the deficiency that has prevented the improvement is remedied. This circumstance shall be made by means of a label of disablement of use, situated in a visible place of the instrument, the characteristics of which are set out in Annex I to Royal Decree 889/2006 of 21 July 2006, specifying the type of instrument in question. In the event that such a deficiency is not remedied, appropriate measures shall be taken to ensure that it is definitively withdrawn from the service.

CHAPTER IV

Periodic Verification

Article 12. Definition.

It is understood by periodic verification, in accordance with the provisions of Article 2 (aa) of Royal Decree 889/2006, of July 21, the set of administrative, visual and technical examinations that can be carried out in a laboratory or in the place of use, which are intended to check and confirm that a refractory in-service has maintained since its last verification the metrological characteristics applicable to it, in particular as regards the maximum permissible errors, as well as function according to their design and conform to their specific rules and, where applicable, the approved design or model.

Article 13. Bound subjects and requests.

1. The holder of a refractory in-service shall be obliged to apply annually for the periodic verification of the same, and its use shall be prohibited in the event that this stage of metrological control is not exceeded.

2. The application for verification shall be accompanied by the bulletin set out in Annex I.

Article 14. Testing and execution.

1. The refractometer shall pass an administrative examination, consisting of the complete identification of the instrument and the verification that the instrument meets the requirements required to be legally in service. It shall be carried out on the basis of the information provided by the applicant in the identification bulletin set out in Annex I. It shall be verified in particular that the instrument has the declaration of conformity or, where appropriate, the approval of the model, and corresponding markings as indicated in Royal Decree 889/2006, of July 21.

2. The tests to be carried out on the periodic verification shall verify compliance with the essential requirements described in paragraphs 2.1 and 2.2 of Annex II to this order.

Article 15. Maximum errors allowed.

The maximum errors allowed in the periodic verification shall be those indicated in the description of each test, as determined in Annex II of this order.

Article 16. Compliance.

The periodic verification phase shall be exceeded, the compliance of the refractometer shall be recorded in order to perform its function, by means of the adhesion of a label in a visible place of the verified instrument, which shall meet the the characteristics and requirements set out in Annex I to Royal Decree 889/2006 of 21 July 2006, specifying the instrument concerned. The corresponding certificate of verification shall also be issued.

Article 17. Not exceeding verification.

When a refractometer does not exceed the periodic verification, it must be put out of service until the deficiency that has prevented the improvement is remedied. This circumstance shall be made by means of a disable label for use, the characteristics of which are set out in Annex I to Royal Decree 889/2006 of 21 July 2006, specifying the type of instrument concerned. In the event that such a deficiency is not remedied, appropriate measures shall be taken to ensure that it is definitively withdrawn from the service.

Single transient arrangement. Instruments in service.

Refracted in service from the entry into force of this order may continue to be used provided that they have successfully exceeded the requirements for the periodic monitoring metrological control phase, regulated in the preceding Chapter IV, without the application of the provisions laid down in Article 14.1.

Final disposition first. Competence title.

This order is dictated by the provisions of article 149.1.12. of the Constitution, which attributes to the State, as exclusive competence, the legislation of weights and measures.

Final disposition second. Applicable rules.

In this order and Royal Decree 889/2006 of 21 July 2006, the administrative procedures to which the actions regulated in that order will take place, will be governed by the provisions of Law 30/1992, of 26 November, the Legal Regime of Public Administrations and the Common Administrative Procedure and the specific legislation of the competent public administrations.

Final disposition third. Authorization to modify the technical content of the order.

The Secretary-General of Industry is hereby authorized to introduce into the Annexes to this order, by means of a resolution and a report of the Superior Council of Metrology, any amendments of a technical nature to be necessary for keep their content adapted to the technical innovations that occur.

Final disposition fourth. Entry into force.

This order will take effect the day following your publication in the "Official State Bulletin".

Madrid, 17 October 2007. -Minister for Industry, Tourism and Trade, Joan Clos i Matheu.

ANNEX I

Identification Bulletin

Imagen: img/disp/2007/255/18479_001.png

ANNEX II

Essential metrological and technical requirements. Patterns to be used and ratio between refractive index and mass percentage of a sucrose solution

1. Definitions

1.1 Refractometer: instrument measuring the refractive index of grape must, concentrated musts and rectified concentrated musts before fermentation, using the phenomenon of refraction of the light or the total internal reflection of the light.

1.1.1 Type I. -Automatic Refractometer, equipped with:

An automatic temperature compensation device;

An indicator device that is visible at the same time by all stakeholders;

A set-to-zero or tuning device at another point of scale other than zero;

A zero control device;

An automatic cleaning device.

1.1.1 Type II. -Manual Refractometer with automatic indication, equipped with:

An automatic temperature compensation device;

An indicator device that is visible at the same time by all stakeholders;

A set-to-zero or tuning device at another point of scale other than zero;

A zero control device.

1.2 Messing: particular magnitude subjected to measurement.

1.3 Magnitude of influence: magnitude that, not being the measurement, has an effect on the measurement result.

1.4 Influence factor: magnitude of influence of value between the limits specified in the corresponding requirement, but out of the operating specified for the measuring instrument.

1.5 Disturbance: magnitude of influence in which its value is placed within the limits specified in this order, but outside the assigned operating conditions of the measuring instrument.

1.6 Nominal operating conditions: the nominal conditions of use are the values for the measurement and for the magnitudes of influence that shape the normal working conditions of an instrument.

1.7 Reference Conditions: Set of values set for the influence measures set to allow comparison between measurement results.

1.8 Intrinsic error: error of a refractometer used in the reference conditions.

1.9 Significant Defect: The difference between the indication error and the intrinsic error in which the absolute value is greater than one step.

2. Specific essential requirements

The refractory objects in this order must meet the common essential requirements of the applicable measuring instruments of Annex IV to Royal Decree 889/2006 of 21 July 2006. They shall also comply with the following specific requirements concerning the manufacturing characteristics:

2.1 Expression of the result.

The result of the measure can be expressed in one of the following ways:

The value of the refractive index.

The mass percentage of a sucrose solution that will have the same refractive index.

The degree of probable alcohol.

2.1.1 Refractive Index:

The refractive index of a homogeneous substance is defined as the ratio of the speed of light in the vacuum and the speed of light in the substance considered.

The refractive index in the air does not differ from the refractive index in the vacuum by more than 3 x 10-4, so the refractive index of the grape must is expressed in relation to the refractive index in the air.

The refractive index increases with the wave frequency of the light, it is necessary to adopt a reference monochromatic light wave. By convention, the refractive index to which this order refers is the measured index relative to the standard air from the yellow line of sodium (line D of wavelength 589 nm).

They are defined as standard air reference conditions (conditions defined by the International Commission for Uniform Methods of Sugar Analysis):

Temperature: 20 ° C;

Atmospheric pressure: 101,325 kPa;

Relative Humidity: 50%;

CO2 Fraction: 0.03% vol;

Wavelength: 589 nm;

Standard Air Refraction Index: 1,000 271 91.

2.1.2 The mass percentage of a sucrose solution.

The percentage by mass of a solution in distilled water (Wb), also known as Brix grade, is the ratio of the mass of chemically pure sucrose contained in the solution and the total mass of the solution. It is expressed as a percentage (% mass) by the following formula:

Imagen: img/disp/2007/255/18479_002.png

where:

m1 is the sucrose mass contained in the solution, and

m2 is the mass of the solution,

masses m1 and m2 are expressed in the same drive.

By convention, the sugar percentage of a must, expressed in%, is equal to the percentage of a sucrose solution in distilled water, having the same refractive index in the reference conditions.

In paragraph 4 of this annex, the equation is given to calculate the ratio between the mass percentage of a sucrose solution and the refractive index of a sucrose solution, under the reference conditions.

2.2 Deriva from scratch.

In the sliding conditions to those of normal use, the zero drift for four hours must be less than half the step.

2.3 Maximum errors allowed.

2.3.1 Maximum errors allowed for new or repaired refracteters.

The maximum allowed error is equal to ± 1 step. The maximum allowed error applies to unrounded indications.

2.3.2 Maximum errors allowed for in-service refractive.

For in-service refractometers, which have not been subject to pre-verification repair, the absolute value of the maximum permissible error is increased in the middle of the step.

2.4 Measures of influence.

2.4.1 Influence factors.

2.4.1.1 Reference conditions and operating conditions.

Factor

Reference condition

Operating condition

temperature.

20 ° C ± 2 ° C

5 ° C to 40 °

Power Supply by Network (CA).

nominal Tension ± 2%

Power Tension + 10%

Power Tension -15%

Power-to-network power frequency.

nominal frequency ± 0.4%

nominal frequency ± 2%

Note: The manufacturer may choose a higher temperature range in operating conditions.

2.4.1.2 Specifications.

The results of the tests, converted at 20 ° C, must respect the maximum permissible errors for each influence factor studied separately.

The corrections to be applied to the percentage of sucrose according to the temperature are given in Annex B of the International Recommendation of OIML R 124 (between 5 ° C and 10 ° C, the values have been extrapolated by calculation).

2.4.1.3 Electrical Disturbances.

No indication should be significant when the refractometer is subjected to the tests listed in the following table:

Essay

Harmonised Standard

Severity

Tension and short interrupts.

UNE-EN-61000-4-11.

Reduction of 100% for 10 ms.

Reduction for 20 ms for 20 ms.

UNE-EN-61000-4-4.

1 kV crest Tension

Electrostatic Downloads.

UNE-EN-61000-4-2.

8 kV discharge into the air.

6 kV downloads contact.

2.4.2 Mechanical Chokes.

Results converted to 20. The maximum errors allowed before and after a test corresponding to the severity level 2 of paragraph B5 of Document D11 of the International Organization of Legal Metrology (OIML) must be respected.

2.5 Technical requirements.

2.5.1 Materials.

Refractometers must be made in materials that ensure sufficient robustness and stability for use.

In particular, the parts in contact with the grape must must be made of unalterable materials by the grape must.

2.5.2 Escalation.

According to the measurement used for the expression of the measurement result, the step in normal utilization mode is equal to:

2 x 10-4 for refraction index or

0.1% for the mass percentage of a sucrose solution.

2.5.3 Indicator device.

2.5.3.1 Type I Refractometer

The indicator device must contain a numeric indication. In the indicator device the figures must be 2.5 cm high for the luminous characters and 3 cm for the rest.

Rounding should be done to the nearest step. In metrological control operations it should be possible to use a control step of at least a quarter of the refract step. This capability cannot be accessible to the user of the instrument.

2.5.3.2 Type II Refractometer.

The indicator device must respond to the same requirements as for the type I refractometers, except as regards the height of the figures which must be at least 0,5 cm.

2.5.4 Print Device.

Refractometers may be provided with a device that prints the result in the form of aligned figures.

The print must be a replica of the value and the drive presented by the indicator device.

More than one value and one unit can be printed if they are present in the indicator device, provided there is no ambiguity about the reading.

Printing should not be possible before the measurement is complete.

2.5.5 Zero-set and zero-control device.

Zero-set and zero-control devices are mandatory for all types of refracts. These devices must be simple and have practically continuous effect.

A scale that extends from one part and another to zero must allow the verification of the set to zero. This scale must have an extension of one step of one part and another step of zero and must be graded in step quarters. Zero and zero control must be able to be carried out with an uncertainty equal to a quarter of a step. A system must expose any deviation greater than one step.

If the refractometer has an adjustment device at a point of scale that does not correspond to zero, the refract must prevent the measurement in case of malfunction (detection of an error greater than one step). Pure water used for zero control can be replaced by a product in which its refractive index is known and stable.

It should be possible to differentiate between automatic control operations and measurement operations.

2.5.6 Measure Interval.

For the magnitude considered, the minimum measurement range should comprise the range corresponding to the values of 10% and 30% by mass percentage of a sucrose solution.

2.5.7 Temperature compensating device.

The refractometer must be equipped with a device such that the indication of the refractometer corresponds to the indication that would have been obtained at the reference temperature of 20 ° C.

The temperature scale must have a minimum measurement range of 5 ° C to 40 ° C. An automatic device must be in evidence if the expected temperature range for the compensating device is exceeded.

2.5.8 Sampling device.

For Type I refractometers, the sample used for the measure must respond to the following conditions:

Static fluid.

When the must is stationary during the measurement, the receptacle must have a minimum content of 20 cl.

Dynamic fluid.

When the must is in motion during the measurement, the measurement result must be representative of a sample of a volume at least equal to 30 cl.

2.5.9 Reliability device.

2.5.9.1 Cleaning device.

After each measurement, the optical faces of the refractometer in contact with the measured fluid and, if applicable, the fluid passing circuits should be effectively cleaned and without deterioration of the instrument.

For Type I refractometers, cleanup must be automatic.

2.5.9.2 Indication.

When the fluid is not in contact with the optical faces of the refractometer, the instrument must not give a result, except when the sample is dynamic, in which case it cannot be shown more than one minute after the fluid has finished your step.

2.5.10 Inscriptions.

The name of the measurement must be clearly on the front face of the instrument and on the nameplate. This unit of measure or its symbol must appear next to the measurement result.

The feature board must bear the following indications.

Manufacturer's Social Identification or Reason;

Model;

serial number;

measure magnitude;

measure range and

usage temperature limit;

The refractometer must bear the conformity marks in accordance with what is set out in Annex I to Royal Decree 889/2006 of 21 July 2006.

2.5.11 Seal device.

Except for the set-zero device, the adjustment devices that are capable of influencing the measurement must be sealed.

3. Work patterns for the refracting assays.

The laboratories of the competent public administrations or, where appropriate, the bodies authorised by them, which intend to carry out activities within the scope of this order, shall use:

3.1 Heavy-crafted sucrose pattern solutions.

For the elaboration of these solutions, a special accuracy scale class I is used in accordance with the International Recommendation R 76 of the OIML to measure the mass of chemically pure sucrose (purity of at least the 99.9%) and the mass of the solution in the water.

A scale of this class with a 1 mg step allows to obtain solutions with a mass percentage of a sucrose solution with an uncertainty of 0.02% when the mass of the solution is greater than 10 g, when the measurements are they perform under the reference conditions and taking into account the thrust of the air.

These solutions are unstable in time as sucrose is hydrolyzed into glucose and fructose. Their employment is not appropriate for long-term verifications. These solutions must be prepared and used on the same day.

3.2 Pattern solutions whose concentration is determined by a pattern refract.

Stabilized glucose solutions with allyl isothiocyanate, 0.5 mL/L, and tartric acid, 3 g/L solution are employed. These solutions may be stored for several years in watertight containers.

For each standard solution, the mass percentage of a solution is determined from the refractive index determined by the standard refractometer to 20. ° C. This refractory pattern must be calibrated to 20. ° C with chemically pure sucrose solutions prepared gravimetrically. It is necessary to take into account the fact that the corrections according to the temperature of the sucrose and the glucose are not equal. For the latter, Table I (" Correction to be carried out when the percentage of sucrose mass is determined at a temperature other than 20. (C) of paragraph 2 of the Annex to Regulation (EEC) No 2676/90 must be corrected by multiplying by 1,3.

Glucose solutions must have a mass percentage with a relative uncertainty of less than 0.06%.

During the calibration process, the temperature must be between 19 ° C and 21 ° C and the corrections must be applied with linear interpolation of 0.1 ° C.

Stabilized sucrose solutions with 50 mg of sodium nitride per litre of solution or with other stabilizers can be used to ensure their preservation. These solutions can be stored at room temperature for several months.

4. Relationship between the refractive index and the mass percentage of a sucrose solution

The ratio of the mass percentage of a sucrose solution, wB, expressed in% (0% < wB < 85%) and the refractive index in the vacuum of this solution, nV, to a temperature of 20 ° C and for a wavelength of 589 nm is given by the formula:

nV = A0 + A1 × WB + A2 × WB2 + A3 × WB3 + A4 × WB4 + A5 × WB5

where:

A0= + 1,333 348 8

A1= + 1,428 372 × 10-3

A2= + 5,440 473 × 10-6

A3= + 1,306 219 × 10-8

A4= + 1,203 625 × 10-10

A5= -8,977 784 × 10-13

To obtain the correspondence between the percentage by mass and the refractive index in the air, calculated from the value set by B. Edlen for the air index under the reference conditions na= 1,000 271 91, using the formula:

n = nv/na

ANNEX III

Standards and technical documents establishing the presumption of compliance with the essential requirements of the instruments

The conformity of instruments with the essential metrological and technical requirements of those instruments that comply with the International Recommendation of the International Organization of Legal Metrology (OIML) shall be presumed. OIML R 124 and as determined in document D11 of the International Organisation for Legal Metrology (OIML).