European standard EN 15964: 2011 (DSTU EN 15964: 2014) is valid in Ukraine

In accordance with the European Standard EN 15964: 2011 «Breath alcohol test devices other than single use devices - Requirements and test methods», which was adopted as the national standard DSTU EN 15964: 2014 «Reusable devices for the control of exhaust air. Requirements and test methods» (EN 15964: 2011, IDT) by Order of the Ministry of Economic Development and Trade No. 1494 from December 30, 2014, gas analyzers for measuring the alcohol content of exhaled air Dräger Alcotest® in Ukraine are used according to the rules of the given standard from 01.01.2016.

Instruments for measuring the content of alcohol in exhaled air are widely used in Europe for professional purposes, for example, in law enforcement, in order to promote road safety and safety. Test results can have serious consequences for anyone who has been involved. Therefore, test results should be reliable and acceptable.

The standard:

• contains a description of the minimum technical requirements that must be met when testing for the use of repetitive devices for detecting alcohol in exhaled air;
• contains detailed information on the test of conformity and performance requirements of these instruments, the conformity of which is a prerequisite for approval;
• applies to devices for detecting alcohol in exhaled air, that measure the concentration of alcohol contained in the sample of exhaled air and are intended for use during a preliminary examination or control;
• sets requirements for basic safety and performance characteristics and test methods and requirements for marking, marking shields and operating instructions;
• contains guidance on a type approval procedure that is a sequence of technical specifications (with the exception of in vivo testing) subjected to the devices provided by the manufacturer;
• does not apply to OIML R 126: 1998 (Proven Exhaust Air Analyzer) and single-use control devices;
• devices intended for use in law enforcement activities.
   

We recommend paying attention to some important points.

According to DSTU EN 15964:2014 gas analyzers for measuring the content of alcohol in exhaled air using breath test samplers.
Point 3.11 of the Standard states that the mouthpiece is a hygienically packaged part intended for single use, which is attached to the device for detecting alcohol in the exhaled air and through which the person In accordance with the provisions of point 5.2 of the Standard, the device must exclude the possibility of inhalation of contaminated air from previous users. The mouthpiece is intended for single use only. It must be possible to take these mouthpieces without touching the part that has contact with the lips of the person being examined. The mouthpieces should be in an individual sealed package that can be easily opened.
Failure to comply with the above requirements may lead to both epidemiological risks and the risk of improper operation of measuring instruments (gas analyzers) and actual biased tests and, as a result, violate the constitutional rights and interests of the person.
Dräger Alcotest®3000, Dräger Alcotest®5510, Dräger Alcotest®5820, Dräger Alcotest®6510,Dräger Alcotest®6810, Dräger Alcotest®6820, Dräger Alcotest®7510 OIML gas analyzers should use the original Dräger Alcotest® Mouthpieces Standard mouthpieces that have a corresponding quality certificate and are officially legally supplied from the manufacturer through an authorized representative.

The use of second-hand mouthpieces and analogues or substitutes for original mouthpieces that did not undergo an official metrological and medical certification process together with Dräger Alcotest® as the only common measurement system “mouthpiece-device”, can lead to systematic errors and the false test result (due to various gaps in the non-standard attachment of the mouthpiece to the nipple, another flow rate and other conditions for obtaining a test sample, etc.).

Subparagraph 6.1 of EN 15964:2011 provides that the means by which a device is calibrated (grading) or regulated should only be available to authorized persons.

These standards indicate that the "Service maintenance" and "Calibration" of the Dräger Alcotest® gas analyzers are complicated and responsible technical actions that affect the quality of work and service life of the devices, and include the following procedures:
 

• diagnostics and control of functioning,
• testing of all components of the device and software,
• analysis of fault messages (if available) and error correction,
• repairing minor faults that do not require the replacement of elements and nodes,
• checking and adjusting (if necessary) flow sensors, temperatures in order to obtain an acceptable measurement error Dräger Alcotest®,
• preliminary verification of the accuracy of the Dräger Alcotest® measurement,
• in case of detecting significant malfunctions, acts are drawn up and proposals for repairs and their value are issued.

The "Gradation" procedure is the setting of the Dräger Sensor electrochemical sensor to obtain an acceptable measurement error of the Dräger Alcotest® devices.
The "Service maintenance" and "Grading" procedures are possible only by the authorized manufacturer, the official representative having the appropriate certificate, using:

• the special original equipment Dräger Safety AG & Co. KGaA, Germany or its analogue manufacturer-approved manufacturer,
• the necessary service documentation from Dräger Safety AG & Co. KGaA (maintenance and repair procedures, etc.),
• the licensed service software - provided by the manufacturer Dräger Safety AG & Co. KGaA under a separate agreement,
• is carried out exclusively by qualified personnel trained by the manufacturer in Germany and has the appropriate certificates from the manufacturer Dräger Safety AG & Co. KGaA.

If the "Service maintenance" and "Grading" (calibration) of the Dräger Alcotest® 6510 and Dräger Alcotest® 6810 gas analyzers are not performed on time (at least 1 time in 12 months), then due to contamination of the measuring paths (through condensation of micro particles of fat from the vapor of human exhalation, the ingress of micro particles of dust, etc.) and the drift of parameters (including short-term and long-term drifts due to temperature difference, humidity, changes in sensitivity /aging time/ electrochemical sensor, etc.) test results can exceeding the permissible error (the data will be incorrect) with the probability level and within the limits, depending on such factors as: state, age and wear of the sensor, storage conditions of the device and conditions of measurement (temperature, humidity), intensity of use of the device, etc.

In accordance with the international practice of the manufacturer, each device is completed with an individual service (service-guarantee) book, in which according to the results of the operations "Servicing maintenance", "Grading", "Verification" records are made (marks, for example, personal signature, stamp, stamp ) in the service (service-guarantee) book of devices.

Links:

Dräger Alcotest® and Dräger Interlock® comply with the Technical Regulation of Legally Regulated Measuring Devices in Ukraine

Alkotesters (gas-analyzers) Dräger Alcotest® are responsible to the requirements of the Technical Regulation on medical products