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Order Itc / 3707/2006 Of 22 November, Which The State Metrological Control Of Instruments Designed To Measure The Alcohol Concentration In Exhaled Air Is Regulated.

Original Language Title: Orden ITC/3707/2006, de 22 de noviembre, por la que se regula el control metrológico del Estado de los instrumentos destinados a medir la concentración de alcohol en el aire espirado.

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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 primitive model and verification, in the instruments subject to national specific regulations, to the system of conformity assessment which is regulated in the said Directive, and also to the development of the the metrological control phases corresponding to the periodic verification and after repair, stages which are not covered by Community legislation.

According to all this, this order has the purpose of regulating the metrological control of the State of the instruments intended to measure the mass concentration of alcohol in the air, in all the phases that are regulated in the This Royal Decree 889/2006 of 21 July 2006, that is to say, both those corresponding to the placing on the market and putting into service as well as the controls of the instruments in service comprising those for 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 in the field of technical standards and regulations, provided for in Directive 98 /34/EC of the European Parliament and of the Council of 22 June a procedure for the provision of information in the field of technical standards and regulations, as amended by Directive 98 /48/EC of 20 July amending Directive 98 /34/EC laying down a procedure for the provision of information in the field of standards and technical regulations, as well as in Royal Decree 1337/1999 of 31 July, for which the regulates the referral of information in the field of technical standards and regulations and regulations relating to the services of the information society, 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 concentration of alcohol in the air spirated, hereinafter referred to as ethylometers, used as (a) means for the imposition of sanctions, the conduct of judicial tests or the application of rules or regulations requiring their use.

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 21 July, which regulates the metrological control of the State on measuring instruments, which refer to, respectively, to the marketing and commissioning stages and to the instruments in service of the measuring instruments referred to in Article 1 of this order.

2. The control referred to in Chapter II of this order 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. 3. The controls of the instruments in service shall include both the verification after repair or modification and the periodic verification of those instruments.

CHAPTER II

Marketing and commissioning phase

Article 3. Metrological and technical requirements.

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

Article 4. Modules for conformity assessment.

1. The modules to be used to carry out the conformity assessment of the instruments referred to in Article 1 shall be module B, model examination, plus module F, declaration of conformity with the model based on the verification of the product, as determined in Article 6 (2) and Annex III to Royal Decree 889/2006 of 21 July 2006.

2. Conformity with the essential metrological and technical requirements laid down in Article 4 of those ethylometers from other Member States of the European Union and of Turkey or originating in other signatory States shall be assumed. the Agreement on the European Economic Area, which complies with the technical standards, standards or procedures legally established in these States, or has received a certificate from these bodies, provided that the levels of accuracy, security, adequacy and suitability are equivalent to those required in this order.

3. 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 ethylometers.

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 an ethylometer in service maintains, after a repair or modification requiring the breaking of seals, the characteristics the metrological nature of the application, in particular as regards the maximum permissible errors, as well as works according to its design and is in accordance with its specific regulations and the approved model.

Article 6. Performances of the repairers.

1. The repair or modification of the ethylometers may only be carried out 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 of the ethylometer, both at the disposal of the competent authority and of the approved inspection bodies for a minimum period of two years. years since the intervention was performed.

3. The nature of the repair, the replaced elements, the date of 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 an ethylometer, after checking its correct operation, shall adjust the errors to zero with the least possible tolerance of its equipment and instruments.

Article 7. Bound subjects and requests.

1. The holder of the ethylometer shall communicate to the competent public authority or, where appropriate, the authorised metrological verification body, its repair or modification, indicating the object of the measure and specifying the elements of the replaced, where appropriate, and the adjustments and controls made. Verification of the same shall be carried out prior to its entry into service.

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

Article 8. Testing and execution.

1. The ethylometer shall pass an administrative examination, consisting of the complete identification of the instrument and the verification that it meets the requirements required to be legally in service. It shall be carried out on the basis of the information in the identification Bulletin set out in Annex I of this order. It shall be determined, in particular, that the instrument has the declaration of conformity or, where appropriate, the approval of the model, and the corresponding markings in accordance with the rules applicable to it and that the nameplate complies with the requirements indicated in each case.

2. The tests to be performed on the verification after repair or modification shall be as set out in Annex II of 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 ethylometer to perform its function shall be indicated by 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 type of instrument concerned. The corresponding certificate of verification shall also be issued. 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 an ethylometer 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 indicated 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 an ethylometer has maintained since its last verification the metrological characteristics applicable to it, in particular as regards the maximum errors permitted, as well as operating in accordance with their design and in accordance with their specific regulations and the approved model.

Article 13. Bound subjects and requests.

1. The holders of ethylometers in service shall be obliged to request, before the year of the preceding year, the periodic verification of the same, their use being prohibited in the event that this phase of metrological control is not exceeded.

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

Article 14. Testing and execution.

1. The ethylometer shall pass an administrative examination, consisting of the complete identification of the instrument and the verification that it 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 determined in particular that the instrument has the declaration of conformity or, where appropriate, the approval of the model, and the corresponding markings in accordance with the applicable regulations.

2. The tests to be carried out on periodic verification shall be as set out in Annex II to this order.

Article 15. Maximum errors allowed.

The maximum errors allowed in the periodic verification will be those indicated as maximum errors allowed in Annex II of this order.

Article 16. Compliance.

The periodic verification phase shall be exceeded, the conformity of the ethylometer shall be recorded 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 type of instrument concerned. The corresponding certificate of verification shall also be issued.

Article 17. Not exceeding verification.

When an ethylometer 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.

Ethylometers that are in service to the entry into force of this order may continue to be used while they exceed the periodic verification in the terms established therein.

Single repeal provision. Regulatory repeal.

The Order of the Ministry of Public Works, Transport and the Environment, of 27 July 1994, is hereby repealed, regulating the State's metrological control for the instruments intended to measure the concentration of alcohol in expired air.

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 in Royal Decree 889/2006 of 21 July 2006, the administrative procedures to which the actions regulated in this order will take place will be governed by the provisions of Law 30/1992, of 26 November, of the Legal Regime of the Public Administrations and of the Common Administrative Procedure, and in 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 in the Annexes to this order, by means of a resolution and a report of the High Council of Metrology, any amendments of a technical nature to the 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 Gazette.

Madrid, 22 November 2006. -Minister for Industry, Tourism and Trade, Joan Clos i Matheu.

ANNEX I

Etilometer Identification Bulletin

Imagen: img/disp/2006/292/21358_001.png

ANNEX II

Verification procedure

The verification procedure for an ethylometer shall be as set out in this Annex.

1. Administrative examination.

The administrative examination shall consist of the complete identification of the ethylometer and the verification that it 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 bulletin set out in Annex I of this order.

If the required data is found to be anomalies or deficiencies, the holder of the ethylometer will be notified to be subsated. However, this circumstance will not interrupt the requested verification process.

2. Metrological examination. General requirements of the tests.

2.1 Reference conditions.

Room temperature: 20 ° C ± 5 ° C.

Relative Humidity: 60% ± 15%.

Atmospheric pressure: 86 kPa at 106 kPa.

Power Voltage: nominal voltage (Vnom).

Power Frequency: Nominal Frequency (Fnom).

Total Hydrocarbon Fraction in Environment (methane equivalent): 2.10-6.

2.2 Reference values characteristic of the test gas.

The test gas injected continuously in the ethylometer to be verified must have the following parameters:

Released Volume: 3 L ± 0.3 L.

Total injection duration: 5 s ± 1 s.

Relative humidity of gas: at least 95%.

Gas temperature: 34 ° C ± 0.5 ° C.

Carrier gas: pure air with a fraction of CO2 of 5% ± 1%.

2.3 Maximum errors allowed.

The maximum allowable errors for the in-service ethylometers are:

0.030 mg/L for all concentrations less than or equal to 0.400 mg/L;

7.5% of the true concentration value for any concentration greater than 0.400 mg/L and less than or equal to 1 mg/L;

20% of the true concentration value for any concentration greater than 1 mg/L.

2.4 Repetibility.

The experimental standard deviation is calculated using the following formula

Imagen: img/disp/2006/292/21358_002.png

where:

n = number measured at a given mass concentration,

Andj = each of the measurements made at a given mass concentration,

= arithmetic mean of the n measurements taken at a given mass concentration.

Compliance requirements.

the experimental standard deviation for any concentration less than or equal to 1 mg/L should be less than 0.007 mg/L,

the experimental standard deviation for any concentration greater than 1 mg/L must be less than 1.75% of the true value of the mass concentration.

2.5 Test Equipment.

The means used for the verification of the ethylometers must provide a test gas with the appropriate mass concentration of ethanol, with a flow rate of between 0.2 L/s and 1 L/s, for a minimum time of 5 s, as well as allow to determine the true value of the concentration with an expanded uncertainty (k = 2) less than or equal to one-third of the maximum permissible error.

Taking into account the ethylometer to be verified, the tests must be performed with the maximum frequency of the ethylometer.

2.6 Accuracy and repeatability test.

For the verification of the maximum permitted errors in paragraphs 2.3 and 2.4 of this Annex, the following concentration values must be performed at least:

Test Gas n. º

Concentration (mg/L)

1

0.00 to 0.05

2

3

0.25

4

0.40

5

6

0.95

7

1.50

In the case of periodic verification, five injections of each test gas shall be carried out and 10 injections for verification after repair or modification.

2.7 Factors of influence on the parameters that characterize the test gases.

For these tests the values of the parameters that are not specified must be those set out in paragraph 2.2 of this annex, modifying only the parameter object of the specified test. For each test, five measurements shall be carried out using the test gas n. 4 of paragraph 2.6 of this Annex. Each of these measures should respect the maximum permitted errors set out in paragraph 2.3 of this Annex.

2.7.1 Influence of freed volume.

Volume Released: 1.5 L ± 0.3 L

Volume Released: 4.5 L ± 0.3 L

2.7.2 Influence of duration of exhalation.

Total injection duration: 15 s ± 1 s.

ANNEX III

Metrological and technical requirements for ethylometers

Ethylometers must provide a high level of metrological protection so that all affected parties can have confidence in the result of the measurement, and must be designed and manufactured with a high level of quality with regard to measurement technology and the safety of measurement data.

REQUIREMENTS

The description and metrological, technical and design characteristics of the Ethylometers are found in International Recommendation number 126 of the International Organization of Legal Metrology.