Key Benefits:
Law 3/1985, of March 18, of Metrology, establishes the legal regime of the metrological activity in Spain, to which they must submit in defense of the safety, the protection of the health and the economic interests of the consumers and users, the measuring instruments under the conditions which they regulate are laid down. This Law was subsequently developed by various norms of metrological content, among which is the Royal Decree 1616/1985, of 11 September, establishing the metrological control carried out by the State Administration.
The General Regulation of Circulation, approved by Royal Decree 13/1992 of 17 January, provides in Article 21 that all drivers of vehicles are obliged to submit to the tests to be established for the purpose of the arrest of potential alcohol poisonings, in addition to Article 22, in the wording of Royal Decree 1333/1994 of 20 June 1994, that these tests will normally consist of the verification of the air spiralled by means of ethylometers which, officially approved, shall determine the degree of alcoholic impregnation of the those concerned.
It follows from the above the need to enact the corresponding metrological standard, in order to establish the requirements to be met by the instruments intended to measure, with the appropriate precision, the concentration of the alcohol in the air spirated.
On the other hand, the special circumstances of a technical order which are in these measuring instruments, their use by the agents of the authority for the imposition of sanctions, the geographical mobility inherent in the function of Monitoring of road traffic is rife with the need to establish mandatory metrological requirements for instruments intended to measure the concentration of alcohol in the air.
In its virtue, the processing of information to the Commission of the European Community established by Royal Decree 568/1989, of 12 May, has:
CHAPTER I
Application, merchandising, and free movement field
Article 1. Field of application.
This Order is intended to regulate the metrological control of the State established by Law 3/1985 of 18 March of Metrology and Royal Decree 1616/1985 of 11 September on the instruments, hereinafter referred to as " the
Article 2. Metrological control phases.
The State's metrological control over the Ethylometers, to be carried out in accordance with the provisions of Law 3/1985, of 18 March, of Metrology; in Royal Decree 1616/1985, of 11 September, and in this Order, will consist of the following phases: Model approval, primitive verification, verification after repair or modification and periodic verification.
Article 3. Placing on the market and putting into service.
From the date of entry into force of this Order only the ethylometers referred to in Article 1 may be marketed and put into service that comply with the provisions of this Order, provided that they are installed and maintained. and are used in accordance with their purpose.
Article 4. Free movement.
1. For the purposes of the foregoing Article, compliance with the requirements laid down in UNE 26,443 for those ethylometers from other European Union Member States which comply with the rules is presumed to be in conformity with the requirements laid down in the previous Article. techniques, standards or procedures legally established in these States, have been tested in laboratories or approved bodies or have received a certificate from these bodies, provided the levels of accuracy, safety, adequacy and suitability are equivalent to those required in this Order.
2. The competent public authority may request the necessary documentation to establish the equivalence referred to in the previous paragraph. Where the non-compliance with the essential requirements laid down in UNE 26,443 is established, the competent public authority may withdraw the market's ethylometers.
CHAPTER II
Model Approval
Article 5. Request.
Manufacturers, importers or any person who may fulfil the obligations arising from the approval of a model may apply for it in accordance with the provisions of Royal Decree 1616/1985 of 11 September 1985 and in the Order.
Article 6. Execution.
Model approval shall be carried out by the authorised bodies of the competent public administrations, which have the laboratories and the technically qualified personnel required to carry out the tasks which they have are set out in this Order.
Article 7. Requirements.
Model approval will be granted once the formal requirements set out in the first Title of Royal Decree 1616/1985 of 11 September, establishing the metrological control carried out by the State administration, as well as the metrologicals fixed by the UNE 26,443 standard, and after successful completion of the tests provided for in paragraphs 6, 7 and 8 of the UNE 26,443 standard.
Article 8. Tolerances.
The maximum errors tolerated in the tests inherent in the model approval shall be those set out in paragraph 5.1.1 of the UNE 26,443 standard.
Article 9. Model approval sign.
All instruments manufactured in accordance with an approved model shall bear the model approval mark set out in Annex I to Royal Decree 1616/1985 of 11 September.
Article 10. Nameplate.
Each ethylometer manufactured in accordance with an approved model must be fitted with a nameplate containing the information referred to in paragraph 9 of the UNE 26,443 standard, as well as the conditions laid down in this Regulation. {\cs6\f1\cf6\lang
CHAPTER III
primitive verification
Article 11. Subjects obliged.
Beneficiaries of model approvals are required to present to the primitive verification all instruments manufactured according to them, prior to their placing on the market or putting into service.
Article 12. Execution.
The primitive verification shall be carried out by the authorised bodies of the competent public administrations or, under its control, by the officially approved metrological verification laboratories.
Article 13. Tests.
Primitive verification, which shall be intended to check the conformity of the instrument with the approved model, shall be carried out in accordance with the specifications of the UNE 26,443 standard, with at least 10 measurements of the following tests of the above standard:
Accuracy: Section 6.3.1.
Fidelity: Paragraphs 6.3.1 and 5.2.
Influence factors: Paragraphs 7.1.1, 7.1.2, and 7.1.3.
Article 14. A primitive check mark.
The instruments that have successfully passed the primitive verification checks will be duly sealed, placing on them the mark set out in Annex II to Royal Decree 1616/1985 of 11 September.
Article 15. Effects.
Exceeded the primitive verification, the instrument shall be declared as per document issued by the corresponding authorized body. The primitive verification will have periodic verification effects.
CHAPTER IV
Verification after repair or modification
Article 16. Authorized repairers.
The repair or modification of the ethylometers can only be carried out by an authorized repairer and registered in the Register of Metrological Control, in accordance with the rules established by Royal Decree 1618/1985, of 11 of September.
Article 17. Subjects obliged.
When an ethylometer has been repaired or modified, its holder or user shall request from the competent Public Administration for verification after repair or modification, prior to the placing in service of that one.
Article 18. Execution.
The tests relating to verifications after repair or modification shall be carried out by the approved bodies of the competent public administrations.
Article 19. Tests.
The tests to be performed on the verification after repair or modification will be the same as for the primitive verification.
Article 20. Tolerances.
The maximum errors tolerated in the verification after repair or modification shall be those indicated in paragraph 5.1.1 of the UNE 26,443 standard.
Article 21. Effects.
After the verification after repair or modification, the instrument shall be declared in conformity for its purpose by document issued by the corresponding authorized body, followed by its sealing. Verification after repair or modification shall have periodic verification effects.
CHAPTER V
Periodic Verification
Article 22. Establishment.
All in-service ethylometers shall annually exceed the metrological control of periodic verification. The period of validity of such verification shall be one year.
Article 23. Subjects obliged.
Holders of Ethylometers in service will be required to apply for periodic verification before the competent Public Administration.
Article 24. Execution.
The tests relating to the periodic verification shall be carried out by the authorised bodies of the competent public administrations.
Article 25. Tests.
The tests to be carried out on the periodic verification shall be those indicated in the following paragraphs of the UNE 26,443 standard, with at least five measures to be carried out for each test.
Accuracy: Section 6.3.1.
Fidelity: Paragraphs 6.3.1 and 5.2.
Influence factors: Paragraphs 7.1.1, 7.1.2, and 7.1.3.
Article 26. Tolerances.
The maximum errors tolerated in the periodic verification shall be those set out in paragraph 5.1.2 of the UNE 26,443 standard.
Article 27. Effects.
Exceeded the periodic verification, the instrument shall be declared in conformity for its purpose by document issued by the corresponding authorized body, followed by its sealing when it has been necessary to lift the seals to carry out the verification.
Transitional disposition. Ethylometers in service.
Ethylometers which are already in service to the entry into force of this Order and whose models comply with the technical rules, standards or procedures referred to in Article 4, may continue to be used provided that have successfully completed the stage of metrological control under Chapter V.
Final disposition. Entry into force.
This Order shall enter into force on the day following that of its publication in the Official Journal of the State.
Madrid, July 27, 1994.
BORRELL FONTELLES
Ilmo. Mr President of the Spanish Metrology Centre.
