Rs 941.210.4 Order Of Fdjp's January 30, 2015 On The Instruments Of Measurement Of Alcohol In Exhaled Air (Oiaa)

Original Language Title: RS 941.210.4 Ordonnance du DFJP du 30 janvier 2015 sur les instruments de mesure d’alcool dans l’air expiré (OIAA)

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941.210.4 order of FDJP on instruments of measurement of alcohol in exhaled air (OIAA) of January 30, 2015 (status March 1, 2015) the federal Department of justice and police (FDJP), having regard to the art. 5, al. 2, 8, al. 2, 16, al. 2, 24, al. 3, and 33 of the Ordinance of 15 February 2006 on measuring instruments (OIMes), stop: Section 1 provisions general article 1 purpose this order regulates: a. the requirements pertaining to instruments of measurement of alcohol in the air expired; b. the procedures for placing on the market of these measuring instruments; c. the procedures designed to maintain the stability of measurement of these measuring instruments.

S. 2 scope are subject to the provisions of this order: a. testers that are used to determine: 1. the violation of the prohibition of alcohol referred to in art. 63, al. 1 by order of 11 February 2004 on the military air traffic (CMO) and the prohibition of driving under the influence of alcohol referred to in art. 63, al. 2, CMO, 2. the impairment referred to in art. 1 of the Ordinance of the Federal Assembly of 21 March 2003 on the blood alcohol limits accepted traffic, 3. the violation of the prohibition of driving under the influence of alcohol referred to in art. 2a of order of November 13, 1962, on the rules of road traffic, 4. the inability of service due to alcohol referred to in art. 14 of the Ordinance of 4 November 2009 on the critical activities for safety in the railway field, 5. the violation of the prohibition of alcohol referred to in art. 45, al. 4 of the Ordinance on installations with cables, 6. the inability of lead due to the influence of alcohol referred to in art. 24A of the Federal Act of 3 October 1975 on inland navigation, 7. the rate over the permitted alcohol or the concentration of alcohol in exhaled air authorized pursuant to art. 6.01, al. 3, of regulation of 17 March 1976 of navigation on Lake Constance, 8. driving under the influence of alcohol referred to in art. 90 of the Federal Act of 21 December 1948 on aviation;

b. breathalysers are to be used for driving under the influence of alcohol in accordance with the amendment of June 15, 2012, of the Federal Act of 19 December 1958 on road traffic; c. anti-starting breathalysers which should be used to see if a person who can lead, in accordance with the amendment of June 15, 2012, of the Federal Act of 19 December 1958 on road traffic that of vehicles equipped with an immobilizer device, is under the influence of alcohol.

RS 510.710 RS 741.13 RS 741.11 RS 742.141.2 RS 743.011 RS 747.201 RS 747.223.1 RS 748.0 2012 6291 RS 741.01 s. RO 3 definitions for the purposes of this order, means: a. alcohol: ethanol; b. measure of alcohol in exhaled air: breathalyzer, alcohol or breathalyzer anti-starting; c. breathalyzer: measuring instrument that determines the mass concentration of ethanol in exhaled air and which converts it to alcohol in the blood expressed in g/kg or ‰ (per-mile) through a conversion factor; d. breathalyzer : measuring instrument which determines and displays, redundantly and controlled sampling conditions, the mass concentration of alcohol in the air expired; e. breathalyzer anti-starting: measuring instrument that determines the mass concentration of alcohol in exhaled air in order to prevent the starting of the vehicle which is equipped with overflow of the prescribed mass concentration; f. concentration of alcohol in the air exhaled : mass of alcohol per volume of air exhaled in mg/l.

Section 2 testers s. 4 essential requirements the RBT shall comply with the essential requirements laid down in annex 1 OIMes and schedule 1 to this order.

S. 5 procedure for placing on the market the products must undergo approval ordinary by the federal Institute of Metrology (METAS) and initial in accordance with annex 5 OIMes and annex 2 verification, ch. 1 of this order, performed by METAS or by an authorized testing laboratory.

S. 6 maintenance of stability of measurement procedure the RBT shall be subjected to the following procedures designed to ensure the maintenance of the stability of measurement: a. subsequent verification in accordance with Annex 7, c. 1, OIMes and annex 2, c. 1 of this order, performed annually by METAS or by a verification laboratory authorised; b. maintenance in accordance with Annex 7 , c. 7, OIMes and annex 2, c. 2, of this order, performed at least annually by a competent person; etc. fitting in accordance with Annex 7, ch. 8, OIMes and annex 2, ch. 3 of this order, performed at least semi-annually by a competent person.

S. 7 maximum permissible errors during checks in the event of disputes within the meaning of art. 29, al. 1, OIMes or during subsequent testing, the maximum permissible errors laid down in annex 1, c. 4, of the present order shall apply.

Section 3 breathalysers s. 8 essential requirements breathalysers should meet the essential requirements laid down in annex 1 OIMes and annex 3 to this order.

S. 9 procedure for placing on the market breathalysers are subject to approval ordinary by METAS and initial in accordance with annex 5 OIMes and Appendix 4 verification, ch. 1, this order, carried out by METAS or an authorized testing laboratory.

S. 10 maintenance of stability of measurement procedure breathalysers should be subject to the following procedures designed to ensure the maintenance of the stability of measurement: a. subsequent verification in accordance with Annex 7, c. 1, OIMes and annex 4, ch. 1, this order, carried out annually by METAS or by a verification laboratory authorised; b. maintenance in accordance with Annex 7 , c. 7, OIMes and annex 4, c. 2, of this order, carried out at least once a year by a competent person; etc. fitting in accordance with Annex 7, ch. 8, OIMes and annex 4, c. 3, of this order, carried out at least once a year by a competent person.

S. 11 maximum permissible errors during checks in the event of disputes within the meaning of art. 29, al. 1, OIMes or during subsequent testing the maximum permissible errors laid down in annex 3, ch. 4, of this order are applicable.

Section 4 breathalysers anti-starting s. 12 essential requirements breathalysers anti-starting must meet the essential requirements laid down in annex 1 OIMes and Appendix 5 of this order.

S. 13 procedure for placing on the market anti-starting breathalysers are subject to approval ordinary by METAS and initial in accordance with annex 5 OIMes and annex 6 verification, ch. 1, this order, carried out by METAS or an authorized testing laboratory.

S. 14 maintenance of stability of measurement process breathalysers immobilizer shall be subjected to the following procedures designed to ensure the maintenance of the stability of measurement: a. maintenance in accordance with Annex 7, c. 7, OIMes and annex 6, c. 2, of this order, carried out at least once a year by a competent person; ETB. adjustment in accordance with Annex 7, ch. 8, OIMes and annex 6, ch. 3 of this order, performed at least semi-annually by a competent person.

S. 15 maximum permissible errors during checks in the event of disputes within the meaning of art. 29, al. 1, OIMes or during subsequent testing, the maximum permissible errors laid down in annex 1, c. 4, of the present order shall apply.

Section 5 extension or reduction of the deadlines for procedures to maintain the stability of measurement article 16 METAS can reduce or extend the deadlines of the procedure for maintenance of stability of measurement for certain models of a specific manufacturer where the metrological characteristics of measuring instruments used allow or request it.

Section 6 provisions finals s. 17 of another act order of the FDJP's May 28, 2011 on the instruments of measurement of alcohol in exhaled air is repealed.

[RO 2011 3275, 2012 7183 c. 5, 2014 475]

S. 18 transitional certificates of compliance for products issued in accordance with the provisions of the Ordinance of the FDJP's May 28, 2011 on the instruments of measurement of alcohol in exhaled air shall remain valid until their expiry.
After expiry of the validity of certificates of compliance referred to in para. 1, the testers must be placed on the market pursuant to art. 5. [RO 2011 3275, 2012 7183 c. 5, 2014 475] art. 19 entry into force this order comes into force on March 1, 2015.

Annex 1 (art. 4 and 7) specific requirements pertaining to the testers 1 requirements pertaining to construction and metrological characteristics the testers must meet the requirements of standard SN EN 15964 and metrological requirements and manufacturing of this annex.

2 measuring ranges 2.1 minimum span for the products is shown in table 1.
Table 1 unit of measurement measuring range Concentration of alcohol in exhaled air (0.025... 1.50) mg/l at 34 ° C and ambient pressure (calculated) alcohol in the blood (0.05... 3.00) g/kg or ‰ 2.2 the rate of alcohol in the blood results from the conversion of the concentration of alcohol in expired air with a factor of 2000 l/kg, in accordance with art. 11, al. 2, of the Ordinance of 28 March 2007 on the control of road traffic, and is expressed in g/kg or ‰ (per thousand)


3 operating conditions nominal values of the nominal operating conditions shall be specified by the manufacturer as follows: 3.1 for the climatic and mechanical influence factors:-a temperature range of at least - 5 ° C to 40 ° C for the climatic environment -; the mechanical environment class that M1 is applicable; - the electromagnetic environment E1 class is applicable.

3.2 for the factors of influence of power:-the extent of voltage and frequency for the power current alternative;-the limits of the power current continuous.

3.3. for the ambient pressure: minimum and maximum ambient pressure values: pmin ≤ 860 hPa, pmax ≥ 1060 hPa.

4 maximum permissible errors 4.1 the following maximum tolerances apply in nominal operating conditions laid down in Chapter 3: - concentration of alcohol in the air exhaled ≤0, 20 mg/l: maximum deviation tolerated 0.02 mg/l; - concentration of alcohol in exhaled air > 0.20 mg/l: 10% of the value of the concentration of alcohol in the air expired.

4.2 cela corresponds to a rate of alcohol in the blood (calculated) 0.04 g/kg or ‰ extent ≤0, 4 g/kg or ‰, and 10% of the value in the scope > 0.4 g/kg or ‰.

European standard SN EN 15964: 2011, products other than devices for single use - requirements and test methods. The standard can be obtained from the Association Switzerland of Standardization (SNV), 8400 Winterthur (www.snv.ch) or accessed for free with the federal Institute of metrology, 3003 Berne.
RS 741.013 annex 2 (arts. 5 and 6) initial Verification and procedures for maintaining stability of measurement of breath 1 initial and subsequent checks 1.1 the testers are verified in laboratory conditions. The maximum permissible errors equivalent to half of the maximum permissible errors in nominal operating conditions laid down in annex 1, c. 4. METAS determines the verification procedure subsequent to case by case depending on the type of instrument mesureur.1.2 Dubowski method as it is described in the OIML Recommendation R 126 should be used to create mixes of alcohol.

2 maintenance 2.1 information on the functioning of the products set out in annex 1 c. 9.3, OIMes must contain in particular details of maintenance which is the responsibility of the user on all the maintenance work as well as the interval and proof of the execution of these. 2.2 all work planned in the information on the functioning maintenance must be performed correctly. Furthermore, both the extent that periods must be respectes.2.3 the performance of all maintenance work must be proven in a maintenance document. It contains in particular the identification of the instrument, the date, the work performed, the signature of the person who performed the maintenance and measuring instruments and verification.2.4 Special measurement and review instruments to be used for the maintenance of the testers must be connected to the national standards.

3 adjusting 3.1 fitting the RBT shall be carried out using a mixture of alcohol at a rate of alcohol in the blood of 0.8 g/kg or ‰ (calculated). Certified water-alcohol mixture with 1.03 g/l of alcohol in water should be used if the mixture of alcohol is carried out according to the method of the EA 1.2.
3.2 a standard mixture of gas certified by a manufacturer of reference gas certified 225 imol/mol of alcohol in nitrogen can be used as an alternative. The use of this dry method requires knowledge of the influence of water on the principle of measurement of the breath. This influence should, where appropriate, be taken into account and corrected automatically by the breathalyzer.

Recommendation international OIML R 126, breathalyzer, 2012 edition. The standard English or French version can be obtained against payment with the federal Institute of metrology, 3003 Berne, viewed free of charge, or downloaded from the following address: www.oiml.org/fr/publications/recommandations Appendix 3 (arts. 8 and 11) specific requirements pertaining to breathalysers 1 requirements pertaining to construction and metrological characteristics breathalysers must meet the requirements of recommendation OIML R 126 and the annex relating to the construction and metrological characteristics.

2 measuring ranges minimum span for breathalysers is indicated in table 2.
Table 2 unit of measurement measuring range Concentration of alcohol in exhaled air (0.00... 2.00) mg/l at 34 ° C and ambient pressure 3 operating Conditions nominal values of the nominal operating conditions shall be specified by the manufacturer as follows: 3.1 for the climatic and mechanical influence factors:-a temperature range of at least - 10 ° C to 40 ° C for the climatic environment -; the mechanical environment class that M1 is applicable; - the electromagnetic environment E1 class is applicable.

3.2 for the factors of influence of power:-the extent of voltage and frequency for the power current alternative;-the limits of the power current continuous.

3.3. for the ambient pressure: minimum and maximum ambient pressure values: pmin ≤ 860 hPa, pmax ≥ 1060 hPa.

4 maximum permissible errors 4.1 the following maximum tolerances apply in nominal operating conditions laid down in Chapter 3: - concentration of alcohol in the air exhaled ≤0, 40 mg/l: maximum deviation tolerated 0.03 mg/l; - concentration of alcohol in exhaled air > 0.40 mg/l: 7.5% of the value of the concentration of alcohol in the air expired.

5. other requirements 5.1 RedondanceChaque measured value must be confirmed directly by a proper independent measurement process in its determination.
This confirmation is provided if particularly:-the difference between the values measured by two independent methods for the same sample of exhaled air does not exceed two thirds of the maximum permissible errors in accordance with ch. 4, the lowest value being decisive. or if - the value measured by a process is checked in within two minutes by the measurement of a standard mixture of gas certified by a manufacturer of reference gas certified, that the difference of the measured value from the value of the reference sample should not exceed two thirds of the maximum permissible in accordance with ch. 4 errors.

5.2 securityIf margin an automatic safety margin is applied, it must be set by the user.
5.3 running of the Measurementthe ' measuring device and its control by the software must allow a course of the measure of order of 28 March 2007 on the control of road traffic and order of FEDRO of 22 May 2008 on the Ordinance on the control of road traffic.
5.4 alcohol in the haleineL' measuring device should detect alcohol in the upper respiratory tract in accordance with recommendation OIML R 126 6.3.4 ch., report it and stop the measure.
5.5 arrondissageLe measurement result is rounded once applied the eventual margin of safety laid down in Chapter 5.3 of recommendation OIML R 126.
5.6 security software software must meet the security requirements defined in WELMEC guide 7.2 on software for the case of P-type and the class of risk b. 5.7 display and storage of the data ' display of measurement results shall fulfil the requirements in annex 1, c. 10, OIMes.
The results of measurement before and after a possible application of the margin of safety so that the eventual margin of safety must be displayed, given unequivocal and permanently registered.
Relevant data to determine the result of the measurement, including all the measured values, must also be recorded.
The measurement results are registered in the measuring device and that can be attributed to a person a test must be permanently erased.

Recommendation international OIML R 126, breathalyzer, 2012 edition. The standard English or French version can be obtained against payment with the federal Institute of metrology, 3003 Berne, viewed free of charge, or downloaded from the following address: www.oiml.org/fr/publications/recommandations RS 741.013 RS 741.013.1 Software WELMEC Guide 7.2 Issue 5, 2012 edition. The English or German version of guide can be obtained from the federal Institute of metrology, 3003 Berne, consulted for free or downloaded at the following address: www.welmec.org/latest/guides/72.html Appendix 4 (arts. 9 and 10) initial Verification and procedures for maintaining stability of measurement of breathalysers 1 initial and subsequent audits 1.1 breathalysers are checked in laboratory conditions. The maximum permissible on the subsequent verification errors equivalent to two-thirds of the maximum permissible errors in nominal operating conditions defined in annex 3, ch. 4. METAS determines the verification procedure subsequent to case by case depending on the type of instrument mesureur.1.2 Dubowski method as it is described in the OIML Recommendation R 126 should be used to create mixes of alcohol.

2 maintenance


2.1 information on the functioning of the breathalyzer in annex 1 c. 9.3, OIMes must contain in particular details of maintenance which is the responsibility of the user on all the maintenance work as well as the interval and proof of the execution of these. 2.2 all work planned in the information on the functioning maintenance must be performed correctly. Furthermore, both the extent that periods must be respectes.2.3 the performance of all maintenance work must be proven in a maintenance document. It contains in particular the identification of the instrument, the date, the work performed, the signature of the person who performed the maintenance and measuring instruments and verification.2.4 Special measurement and review instruments to be used for the maintenance of breathalysers should be connected to the national standards.

3 adjusting 3.1 breathalysers fitting must be carried out using a mixture of alcohol corresponding to a mass concentration of alcohol in exhaled air of 0.4 mg/l.3.2 certified water-alcohol mixture with 1.03 g/l of alcohol in water must be used if the mixture of alcohol is carried out according to the method of ch. 1.2.3.3 a standard mixture of gas certified by a manufacturer of reference gas certified 225 imol/mol of alcohol in nitrogen can be used as an alternative. The use of this dry method requires taking account of the influence of water on the principle of measurement of the breathalyzer. This influence should, where appropriate, be taken into account and corrected automatically by the breathalyzer.

Recommendation international OIML R 126, breathalyzer, 2012 edition. The standard English or French version can be obtained against payment with the federal Institute of metrology, 3003 Berne, viewed free of charge, or downloaded from the following address: www.oiml.org/fr/publications/recommandations Appendix 5 (arts. 12 and 15) specific requirements pertaining to breathalysers anti-starting 1 requirements pertaining to construction and metrological characteristics breathalysers anti-starting must meet the requirements of standard SN EN 50436-1 and the annex relating to the construction and metrological characteristics.

2 measuring ranges minimum span for breathalysers immobilizer is indicated in table 3.
Table 3 unit of measurement measuring range Concentration of alcohol in exhaled air (0.00... 1.50) mg/l at 34 ° C and ambient pressure 3 operating Conditions nominal values of the nominal operating conditions shall be specified by the manufacturer as follows: 3.1 for the climatic and mechanical influence factors:-a temperature range of at least - 5 ° C to 40 ° C for the climatic environment -; the mechanical environment class that M1 is applicable; - the electromagnetic environment E1 class is applicable.

3.2 for the factors of influence of power:-the extent of voltage and frequency for the power current alternative;-the limits of the power current continuous.

3.3. for the ambient pressure: minimum and maximum ambient pressure values: pmin ≤ 860 hPa, pmax ≥ 1060 hPa.

4 maximum permissible errors the following maximum tolerances apply in nominal operating conditions laid down in Chapter 3: - concentration of alcohol in the air exhaled ≤0, 20 mg/l: maximum deviation tolerated 0.02 mg/l; - concentration of alcohol in exhaled air > 0.20 mg/l: 10% of the value of the concentration of alcohol in the air expired.

European standard SN EN 50436-1: 2014, alcohol interlocks - test methods and performance requirements — Part 1: apparatus for programs for drunk drivers. The standard can be obtained from the Association Switzerland of Standardization (SNV), 8400 Winterthur (www.snv.ch) or accessed for free with the federal Institute of metrology, 3003 Berne.

Annex 6 (arts. 13 and 14) initial Verification and procedures for maintaining stability of measurement for breathalysers anti-starting 1 initial Verification 1.1 anti-starting breathalysers are checked in laboratory conditions. The maximum permissible errors equivalent to half of the maximum permissible errors in nominal operating conditions defined in annex 5, ch. 4. METAS determines the verification procedure subsequent to case by case depending on the type of instrument mesureur.1.2 Dubowski method as it is described in the OIML Recommendation R 126 should be used to create mixes of alcohol.

2 maintenance 2.1 information on the functioning of the breathalyzer in annex 1 c. 9.3, OIMes must contain in particular details of maintenance which is the responsibility of the user on all the maintenance work as well as the interval and proof of the execution of these. 2.2 all work planned in the information on the functioning maintenance must be performed correctly. Furthermore, both the extent that periods must be respectes.2.3 the performance of all maintenance work should be recorded in a document of maintenance. It contains, inter alia, the identification of the instrument, the date, the work performed, the signature of the person who performed the maintenance and measuring instruments and verification.2.4 Special measurement and review instruments to be used for the maintenance of breathalysers should be connected to the national standards.

3 adjusting 3.1 breathalysers fitting must be carried out using a mixture of alcohol corresponding to a mass concentration of alcohol in exhaled air of 0.4 mg/one certified water-alcohol mixture with 1.03 g/l of alcohol in water must be used if the mixture of alcohol is carried out according to the method of the EA 1.2.
3.2 a standard mixture of gas certified by a manufacturer of reference gas certified 225 imol/mol of alcohol in nitrogen can be used as an alternative. The use of this dry method requires taking account of the influence of water on the principle of measurement of the breathalyzer. This influence should, where appropriate, be taken into account and corrected automatically by the measuring instrument.

Recommendation international OIML R 126, breathalyzer, 2012 edition. The standard English or French version can be obtained against payment with the federal Institute of metrology, 3003 Berne, viewed free of charge, or downloaded from the following address: www.oiml.org/fr/publications/recommandations

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