Machine Translation of "RS 941.210.4 DFJP order of 30 January 2015 on expired air alcohol measuring instruments (OIAA)" (Switzerland)

Art. 1 Purpose

This Order governs:

A.: Requirements for alcohol measurement devices in expired air;
B.: The procedures for placing these measuring instruments on the market;
C.: Procedures to maintain the stability of measurement of these measuring instruments.

Art. 2 Scope of application

The following are subject to the provisions of this order:

A.

The ethylotests that are used to determine:

1.: A violation of the prohibition on the consumption of alcohol referred to in s. 63, para. 1, of the order of 11 February 2004 on military traffic (CMO) ¹ And the prohibition on driving under the right-of-way of alcohol referred to in s. 63, para. 2, OCM
2.: The bribe referred to in s. 1 of the Order of the Federal Assembly of 21 March 2003 concerning blood alcohol limits allowed for road traffic ²,
3.: The violation of the driving prohibition under the right-of-way of the alcohol referred to in s. 2 A The order of 13 November 1962 on the rules of road traffic ³,
4.: The inability to serve the alcohol referred to in s. 14 of the order of 4 November 2009 on the decisive activities for safety in the railway sector ⁴,
5.: A violation of the prohibition on the consumption of alcohol referred to in s. 45, para. 4, of the Cable Facilities Order ⁵,
6.: Inability to drive due to the influence of the alcohol referred to in s. 24 A The Federal Act of 3 October 1975 on inland navigation ⁶,
7.: Exceeding the permitted alcohol level or the concentration of alcohol in the expired air in accordance with s. 6.01, para. 3, of the Regulation of 17 March 1976 on the navigation of Lake Constance ⁷,
8.: Driving under the right of way of an alcohol referred to in s. 90 ^Bis Federal Aviation Act of 21 December 1948 ⁸;

B.

Ethylometers to be used to determine driving under the influence of alcohol in accordance with the amendment of June 15, 2012 ⁹ Federal Law of 19 December 1958 on Road Traffic ¹⁰;

C.

Anti-staring gauges which are to be used to determine whether a person who cannot drive, in accordance with the amendment of the Federal Act of 19 December 1958 on Road Traffic Act of 19 December 2012, that vehicles fitted with a Anti-startup ethyometer, is under the influence of alcohol.

¹ RS 510.710
² RS 741.13
³ RS 741.11
⁴ RS 742.141.2
⁵ RS 743.011
⁶ RS 747.201
⁷ RS 747.223.1
⁸ RS 748.0
⁹ RO 2012 6291
¹⁰ RS 7 41.01

Art. 3 Definitions

For the purposes of this order:

A.: Alcohol: Ethanol;
B.: Alcohol measurement instrument in expired air: Ethylotest, Ethylometer, or Anti-Marketer Ethylometer
C.: Ethylotest : a measuring instrument that determines the mass concentration of ethanol in the expired air and converts it to an alcohol level in the blood expressed in g/kg or per cent (per mile) through a conversion factor;
D.: Ethylgauge : A measuring instrument that determines and displays, in a redundant manner and under controlled sampling conditions, the mass concentration of alcohol in the expired air;
E.: Anti-startup ethyometer: Measuring instrument that determines the mass concentration of alcohol in the expired air in order to prevent the vehicle from starting the vehicle when the prescribed mass concentration is exceeded;
F.: Alcohol concentration in expired air: Volume of alcohol by volume of air expired, expressed in mg/l.

Art. 4 Essential requirements

The ethylotests shall meet the essential requirements set out in Annex 1 OIMes and Annex 1 to this order.

Art. 5 Procedure for placing on the market

Ethylotests shall be subject to regular approval by the Federal Institute of Metrology (METAS) and an initial verification in accordance with Annex 5 OIMes and Annex 2, c. 1, of this order, carried out by METAS or by an authorized verification laboratory.

Art. 6 Procedure for maintaining measurement stability

Ethylotests shall 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 2, c. 1, of this order, carried out annually by METAS or by an authorized audit laboratory;
B.: Maintenance in accordance with Annex 7, c. 7, OIMes and Annex 2, c. 2, of this order, made at least every year by a competent person; and
C.: Fitting in accordance with Annex 7, c. 8, OIMes and Annex 2, c. 3, of this order, carried out at least semi-annually by a competent person.

Art. 7 Maximum Tolerable Errors During Controls

In the case of disputes within the meaning of s. 29, para. 1, OIMes or subsequent control, the maximum permissible errors set out in Annex 1, c. 4, of this Order shall apply.

Art. 8 Essential requirements

Ethylometers must meet the essential requirements set out in Schedule 1 OIMes and Schedule 3 of this order.

Art. Procedure for placing on the market

Ethylometers are subject to regular approval by METAS and an initial verification in accordance with Annex 5 OIMes and Annex 4, c. 1, of this order, carried out by METAS or an authorized verification laboratory.

Art. 10 Procedure for maintaining measurement stability

Ethylometers shall be subject to the following procedures to ensure the maintenance of measurement stability:

A.: Subsequent verification in accordance with Annex 7, c. 1, OIMes and Annex 4, c. 1, of this order, carried out each year by METAS or by an authorized audit laboratory;
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; and
C.: Fitting in accordance with Annex 7, c. 8, OIMes and Annex 4, c. 3, of this order, carried out at least once a year by a competent person.

Art. 11 Maximum Tolerable Errors During Controls

In the case of disputes within the meaning of s. 29, para. 1, OIMes or in the subsequent control the maximum permissible errors set out in Annex 3, c. 4, of this Order shall apply.

Art. 12 Essential requirements

Anti-starters must meet the essential requirements set out in Schedule 1 OIMes and Schedule 5 of this order.

Art. 13 Procedure for placing on the market

Start-up ethylometers are subject to regular approval by METAS and an initial verification in accordance with Annex 5 OIMes and Annex 6, c. 1, of this order, carried out by METAS or an authorized verification laboratory.

Art. 14 Procedure for maintaining measurement stability

Anti-starters shall be subjected to the following procedures 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; and
B.: Fitting in accordance with Annex 7, c. 8, OIMes and Annex 6, c. 3, of this order, carried out at least semi-annually by a competent person.

Art. 15 Maximum Tolerable Errors During Controls

In the case of disputes within the meaning of s. 29, para. 1, OIMes or subsequent control, the maximum permissible errors set out in Annex 1, c. 4, of this Order shall apply.

Art. 16

METAS may reduce or extend the time limits for the maintenance of the stability of measurement procedure for certain models of a specific manufacturer where the metrological characteristics of the measuring instruments used allow or request it.

Art. 17 Repeal of another act

The DFJP order of May 28, 2011, on instruments for measuring alcohol in expired air ¹ Is repealed.

¹ [ RO 2011 3275 , 2012 7183 ch. I 5, 2014 475]

Art. 18 Transitional provisions

¹ Certifications of conformity for ethylotests issued in accordance with the provisions of the decree of the DFJP of 28 May 2011 on instruments for measuring alcohol in expired air ¹ Remain valid until expiration.

² After expiry of the validity of the certificates of conformity referred to in para. 1, ethylotests must be returned to the marketplace in accordance with s. 5.

¹ [ RO 2011 3275 , 2012 7183 ch. I 5, 2014 475]

Art. 19 Entry into force

This order shall enter into force on 1 ^Er March 2015.

(art. 4 and 7)

Specific requirements for ethylotest

1 Construction and Metrological Requirements

Ethylotests must meet the requirements of the SN EN 15964 standard. ¹ And the metrological and manufacturing requirements of this Annex.

2 Measure Extents

2.1

The minimum measurement range for ethylotests is shown in Table 1.

Table 1

	Unit of Measure	Measurement Scope
	Expired air alcohol concentration	(0.025 ... 1.50) mg/l at 34 °C and ambient pressure
	Rate of alcohol (calculated) in blood	(0.05 ... 3.00) g/kg or %

2.2: The rate of alcohol in the blood results from the conversion of the alcohol concentration into the expired air with a factor of 2000 l/kg, in accordance with art. 11, para. 2, of the order of 28 March 2007 on traffic control ², and is expressed in g/kg or % (pour-mile)

3 Nominal Operating Conditions

The values of the nominal operating conditions shall be specified by the manufacturer as follows:

3.1

For climatic and mechanical influences:

-: A temperature range of at least -5 ° C to 40 ° C for the climate environment;
-: The M1 mechanical environment class is applicable;
-: Electromagnetic environment class E1 is applicable.

3.2

For the influence factors of electric power:

-: The voltage and frequency range for AC power supply;
-: The limits of the dc power supply.

3.3

For ambient pressure:

Minimum and maximum ambient pressure: p _Min ≤ 860 hPa, p _Max ≥ 1060 hPa.

4 Maximum Tolerable Errors

4.1

The following maximum permissible errors shall apply in the nominal operating conditions laid down in the c. 3:

-: Alcohol concentration in expired air ≤0.20 mg/l: maximum tolerance of 0.02 mg/l;
-: Alcohol concentration in expired air > 0.20 mg/l: 10 % of the value of the alcohol concentration in the expired air.

4.2

This corresponds to a blood alcohol level (calculated) of 0.04 g/kg or % in the range ≤0.4 g/kg or %, and 10 % of the value in the range > 0.4 g/kg or %.

¹ European standard SN EN 15964: 2011, Ethylotests other than single use devices-Requirements and test methods. The standard can be obtained from the Swiss Association for Standardization (SNV), 8400 Winterthur (www.snv.ch) or obtained free of charge from the Federal Institute of Metrology, 3003 Berne.
² RS 741.013

(art. 5 and 6)

Initial verification and procedures for maintaining the stability of measurement of ethylotests

1 Initial and subsequent audits

1.1: Ethylotests are tested under laboratory conditions. Maximum tolerated errors equivalent to one-half of the maximum tolerated errors in the nominal operating conditions set out in Annex 1, c. 4. METAS determines the subsequent verification procedure on a case-by-case basis according to the type of instrument.
1.2: Dubowski's method as described in OIML R 126 ¹ Must be used to create alcohol mixtures.

2 Maintenance

2.1: Information on the operation of the ethylotests in Annex 1, c. 9.3, OIMes shall contain in particular detailed information on the maintenance obligation of the user, on all maintenance work and on the interval and proof of the performance of the maintenance.
2.2: All maintenance work provided for in the operation information shall be performed correctly. On the other hand, both the scope and the deadlines must be respected.
2.3: All maintenance work must be documented in a maintenance document. This includes in particular the identification of the instrument, the date, the work carried out, the signature of the person who carried out the interview and the instruments of measurement and verification.
2.4: The special measurement and examination instruments to be used for the maintenance of ethylotests shall be connected to the national standards.

3 Adjust

3.1: The adjustment of the ethylotests should be carried out using a mixture of alcohol corresponding to an alcohol (calculated) rate in the blood of 0.8 g/kg or %.
A certified water-alcohol mixture with 1.03 g/l of alcohol in the water must be used if the mixture of alcohol is carried out according to the ch method. 1.2.
3.2: A gas standard mixture certified by an accredited reference gas manufacturer of 225 ìmol/mol 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 ethylotest. This influence shall, where appropriate, be taken into account and corrected automatically by the ethylotest.

¹ International Recommendation OIML R 126, Ethylometers, 2012 Edition. The French or English version of the standard can be obtained against payment from the Federal Institute of Metrology, 3003 Berne, consulted free of charge, or downloaded at the following address: www.oiml.org/fr/publications/recommandations

(art. 8 and 11)

Specific Requirements for Ethylometers

1 Construction and Metrological Requirements

Ethylometers must meet the requirements of the OIML R 126 recommendation ¹ And this annex relating to the construction and the metrological characteristics.

2 Measure Extents

The minimum measurement range for ethylometers is shown in Table 2.

Table 2

	Unit of Measure	Measurement Scope
	Expired air alcohol concentration	(0.00 ... 2.00) mg/L at 34 °C and ambient pressure

3 Nominal Operating Conditions

The values of the nominal operating conditions shall be specified by the manufacturer as follows:

3.1

For climatic and mechanical influences:

-: A temperature range of at least -10 ° C to 40 ° C for the climate environment;
-: The M1 mechanical environment class is applicable;
-: Electromagnetic environment class E1 is applicable.

3.2

For the influence factors of electric power:

-: The voltage and frequency range for AC power supply;
-: The limits of the dc power supply.

3.3

For ambient pressure:

Minimum and maximum ambient pressure: pmin ≤ 860 hPa, pmax ≥ 1060 hPa.

4 Maximum Tolerable Errors

4.1

The following maximum permissible errors shall apply in the nominal operating conditions laid down in the c. 3:

-: Alcohol concentration in expired air ≤0.40 mg/l: maximum tolerance of 0.03 mg/l;
-: Alcohol concentration in expired air > 0.40 mg/l: 7.5 % of the value of the alcohol concentration in the expired air.

5 Other requirements

5.1

Redundancy

Each measured value must be confirmed directly by an appropriate independent measurement process when determined.

This confirmation is provided in particular if:

-: The difference between the values measured by two independent processes for the same expired air sample does not exceed two-thirds of the maximum permissible errors in accordance with c. 4, the lowest value being decisive; or
-: The value measured by a process is verified within two minutes by the measurement of a gas standard mixture certified by an accredited reference gas manufacturer, in which case the difference in the value measured in relation to the value of The reference sample shall not exceed two-thirds of the maximum permissible errors in accordance with c. 4.

5.2

Security Margin

If an automatic margin of security is applied, it must be able to be set by the user.

5.3

Flow of Measure

The measuring apparatus and its order by the software must allow the measurement to be carried out in accordance with the order of 28 March 2007 on traffic control ² And the order of the OFROU of 22 May 2008 concerning the order on traffic control ³.

5.4

Alcohol in breath

The measuring apparatus shall detect alcohol in the upper respiratory tract in accordance with the c. 6.3.4 of the OIML R 126 recommendation, report it and discontinue the measure.

5.5

Round-up

The measurement result shall be rounded once the possible safety margin set out in the c. 5.3 of recommendation OIML R 126.

5.6

Software Security

The software must meet the security requirements as defined in the WELMEC 7.2 software guide ⁴ For the type P case and risk class B.

5.7

Viewing and storing data

The display of the measurement results shall meet the requirements set out in Annex 1, c. 10, OIMes.

The measurement results before and after a possible application of the margin of safety and the possible margin of safety must be able to be displayed, attributed unequivocally and sustainably.

The relevant data to determine the outcome of the measurement, including all measured values, must also be recorded.

The results of measurement which are recorded in the measuring apparatus and which can be attributed to a person who has been tested must be able to be permanently deleted.

¹ International Recommendation OIML R 126, Ethylometers, 2012 Edition. The French or English version of the standard can be obtained against payment from the Federal Institute of Metrology, 3003 Berne, consulted free of charge, or downloaded at the following address: www.oiml.org/fr/publications/recommandations
² RS 741.013
³ RS 741.013.1
⁴ WELMEC Software Guide 7.2 Issue 5, 2012 Edition. The English or German version of the guide can be obtained from the Federal Institute of Metrology, 3003 Berne, consulted free of charge or downloaded at the following address: www.welmec.org/latest/guides/72.html

(art. 9 and 10)

Initial verification and procedures for maintaining the measurement stability of the ethylometers

1 Initial and subsequent audits

1.1: Ethylometers are tested under laboratory conditions. The maximum permissible errors during the subsequent verification shall be equivalent to two-thirds of the maximum permissible errors in the nominal operating conditions set out in Annex 3, c. 4. METAS determines the subsequent verification procedure on a case-by-case basis according to the type of instrument.
1.2: Dubowski's method as described in OIML R 126 ¹ Must be used to create alcohol mixtures.

2 Maintenance

2.1: Information on the operation of the ethylometers in Annex 1, c. 9.3, OIMes shall contain in particular detailed information on the maintenance obligation of the user, on all maintenance work and on the interval and proof of the performance of the maintenance.
2.2: All maintenance work provided for in the operation information shall be performed correctly. On the other hand, both the scope and the deadlines must be respected.
2.3: All maintenance work must be documented in a maintenance document. This includes in particular the identification of the instrument, the date, the work carried out, the signature of the person who carried out the interview and the instruments of measurement and verification.
2.4: The special measurement and examination instruments to be used for the maintenance of the ethylometers shall be connected to the national standards.

3 Adjust

3.1: The adjustment of the ethylometers shall be made using a mixture of alcohol corresponding to a mass concentration of alcohol in the expired air of 0.4 mg/l.
3.2: A certified water-alcohol mixture with 1.03 g/l of alcohol in the water must be used if the mixture of alcohol is carried out according to the ch method. 1.2.
3.3: A gas standard mixture certified by an accredited reference gas manufacturer of 225 ìmol/mol alcohol in nitrogen can be used as an alternative. The use of this dry method requires consideration of the influence of water on the measurement principle of the ethylometer. This influence shall, where appropriate, be taken into account and corrected automatically by the ethylometer.

¹ International Recommendation OIML R 126, Ethylometers, 2012 Edition. The French or English version of the standard can be obtained against payment from the Federal Institute of Metrology, 3003 Berne, consulted free of charge, or downloaded at the following address: www.oiml.org/fr/publications/recommandations

(art. 12 and 15)

Specific Requirements for Anti-Start-up Ethylometers

1 Construction and Metrological Requirements

Anti-starters must meet the requirements of SN EN 50436-1 ¹ And this annex relating to the construction and the metrological characteristics.

2 Measure Extents

The minimum measurement range for anti-starters is shown in Table 3.

Table 3

	Unit of Measure	Measurement Scope
	Expired air alcohol concentration	(0.00 ... 1.50) mg/l at 34 °C and ambient pressure

3 Nominal Operating Conditions

The values of the nominal operating conditions shall be specified by the manufacturer as follows:

3.1

For climatic and mechanical influences:

-: A temperature range of at least -5 ° C to 40 ° C for the climate environment;
-: The M1 mechanical environment class is applicable;
-: Electromagnetic environment class E1 is applicable.

3.2

For the influence factors of electric power:

-: The voltage and frequency range for AC power supply;
-: The limits of the dc power supply.

3.3

For ambient pressure:

Minimum and maximum ambient pressure: pmin ≤ 860 hPa, pmax ≥ 1060 hPa.

4 Maximum Tolerable Errors

The following maximum permissible errors shall apply in the nominal operating conditions laid down in the c. 3:

-: Alcohol concentration in expired air ≤0.20 mg/l: maximum tolerance of 0.02 mg/l;
-: Alcohol concentration in expired air > 0.20 mg/l: 10 % of the value of the alcohol concentration in the expired air.

¹ European standard SN EN 50436-1: 2014, Alcohol interlocks-Test methods and performance requirements-Part 1: Apparatus for drunken driver programs. The standard can be obtained from the Swiss Association for Standardization (SNV), 8400 Winterthur (www.snv.ch) or obtained free of charge from the Federal Institute of Metrology, 3003 Berne.

(art. 13 and 14)

Initial verification and maintenance of measurement stability procedures for anti-starters

1 Initial check

1.1: Anti-starters are tested under laboratory conditions. Maximum tolerated errors equivalent to one-half of the maximum tolerated errors in the nominal operating conditions as defined in Annex 5, c. 4. METAS determines the subsequent verification procedure on a case-by-case basis according to the type of instrument.
1.2: Dubowski's method as described in OIML R 126 ¹ Must be used to create alcohol mixtures.

2 Maintenance

2.1: Information on the operation of the ethylometers in Annex 1, c. 9.3, OIMes shall contain in particular detailed information on the maintenance obligation of the user, on all maintenance work and on the interval and proof of the performance of the maintenance.
2.2: All maintenance work provided for in the operation information shall be performed correctly. On the other hand, both the scope and the deadlines must be respected.
2.3: All maintenance work must be recorded in a maintenance document. This includes the identification of the device, the date, the work performed, the signature of the person who performed the interview, and the measurement and verification instruments.
2.4: The special measurement and examination instruments to be used for the maintenance of the ethylometers shall be connected to the national standards.

3 Adjust

3.1: The adjustment of the ethylometers shall be made using a mixture of alcohol corresponding to a mass concentration of alcohol in the expired air of 0.4 mg/l.
A certified water-alcohol mixture with 1.03 g/l of alcohol in the water must be used if the mixture of alcohol is carried out according to the ch method. 1.2.
3.2: A gas standard mixture certified by an accredited reference gas manufacturer of 225 ìmol/mol alcohol in nitrogen can be used as an alternative. The use of this dry method requires consideration of the influence of water on the measurement principle of the ethylometer. This influence shall, where appropriate, be taken into account and corrected automatically by the measuring instrument.

¹ International Recommendation OIML R 126, Ethylometers, 2012 Edition. The French or English version of the standard can be obtained against payment from the Federal Institute of Metrology, 3003 Berne, consulted free of charge, or downloaded at the following address: www.oiml.org/fr/publications/recommandations

RS 941.210.4 DFJP order of 30 January 2015 on expired air alcohol measuring instruments (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

DFJP Ordinance on expired air alcohol measurement devices

(OIAA)

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