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SAFETY VS "LAW". Is it legal to use Dräger Alcotest® 6510 and Dräger Alcotest® 6810 in Ukraine? Yes, it is.

15.02.2018
       
   
 

© Saturn® Data International, the use of materials is permitted if the source reference is provided.

 

WARNING! The information you are reading is constantly updated in response to new questions from drivers, lawyers, government agencies, and the media.

 

Dear drivers, lawyers, government officials and media professionals!

We all are traffic participants. There is no driver that is also not a pedestrian. Road safety is an important indicator of the society level of development.

 

Unfortunately, not all of them carry out such important safety rules as the sober driving of a car.

According to the National Police Communications Department of Ukraine in 2017, more than 114,000 cases of drunk driving were documented by police officers. At the same time, due to drunk drivers, 5.8 thousand accidents occurred.

It is precisely for the control and detection of such violators who often carry fatal accidents, for more than 60 years Dräger professional alcohol testers are used. Concern Dräger Safety AG & Co. KGaA, Germany was founded in 1889, is a manufacturer of more than 10,000 items of medical and other purposes and supplies its products to more than 100 countries. Saturn® Data International has been an official representative of Concern Dräger Safety AG & Co. KGaAin Ukraine for more than 20 years on the supply of professional means of alcohol and drugs detection, has a certified service center for the operations "Service maintenance", "Grading", "Verification", providing high-quality guarantee and after-guarantee service.

 

Is it lawful to use Dräger Alcotest® 6510 and Dräger Alcotest® 6810 Alchetesters in Ukraine?

Yes, it's legal. And that's why.

 

According to Concern's Dräger domestic policy, certification issues for each product within a country are resolved in strict accordance with the legislation of that country. The gas analyzers Dräger Alcotest® 6510 and Dräger Alcotest®6810 were supplied to Ukraine in full compliance with the legislation of Ukraine, which operated during the delivery period.

 

Gas analyzers for monitoring the alcohol content of exhaled air Dräger Alcotest® from the concern Dräger Safety AG & Co. KGaA is the world's best portable instrumentation, the precision of which is comparable to that of a gas chromatograph, and is used in police departments of the USA, Canada, Germany, Poland, Ukraine, the Baltic States and many other countries of the world.

 

Gas analyzers Dräger Alcotest® 6510 and Dräger Alcotest®6810 (hereinafter referred to as measuring devices) were officially shipped to Ukraine from 2007 through 2014 through an authorized representative through an authorized representative.

 

During this period, the indicated measuring devices were subject to the requirements of the Law of Ukraine "On Metrology and Metrological Activity" of 11.02.1998 No.113/98-VR (hereinafter - the Law), which expired on 01.01.2016, in accordance with the Law of Ukraine "On Metrology and Metrological Activity» dated 05.06.2014, No.1314-VII and other normative legal acts and normative documents on metrology.

According to this Law, the import of measuring devices to the territory of Ukraine was possible by parties, if the types of these funds were entered in the State Register of Measuring Instruments (item 4 of Article 11 of the Law).

In the meaning of this Law, the type of measuring devices is a collection of measuring devices of the same purpose, having the same principle of operation, the same design and manufactured with the same technical documentation.

In accordance with the requirements of the Procedure for issuing certificates of approval of the type of measuring equipment, certificates of conformity of the measuring instruments of the approved type and certificates of recognition of type approvals for measuring equipment, approved by the order of the State Committee for Standardization, Metrology and Certification of Ukraine No. 100 of 19.02.2002 (in the version valid at the time of issuance of certificates), certificates of approval of the type of measuring equipment and certificates of conformity of the measuring instruments of the approved type was issued by the specially authorized central body of executive power in the field of metrology (hereinafter - CEPM) to foreign manufacturers of measuring instruments or their official representatives of Ukraine for:

- official confirmation of the approval of the type of measuring equipment and the possibility of their introduction into the territory of Ukraine by the parties;

- official confirmation of conformity of the measuring equipment with the approved type and their subsequent import into the territory of Ukraine by batches.

According to this Procedure, the certificates of approval of the type of measuring equipment are valid prior to the withdrawal of the corresponding types of measuring equipment from the State Register.

Validity of certificates of conformity of measuring equipment of an approved type was determined by the period of validity of the results of state control tests of measuring equipment, which was 3 years.

In the event of positive results of the following state control trials and on the basis of the minutes of the meeting of the Metrology Commission, a new certificate of conformity of the measuring equipment was issued in accordance with clauses 2.2., 2.3 of this Procedure.

Consequently, before the introduction into circulation in the Ukrainian market, the above-mentioned type of measuring devices was already approved in Ukraine in accordance with the procedure established by law and entered by the CEPM in the State Register of Measuring Instruments (Registration No. У788-13) and had all the necessary permits (Derzhspozhyvstandart, Ministry of Economic Development and Trade of Ukraine, Ministry of Health of Ukraine, etc.) regarding their introduction into the customs territory, implementation and application in Ukraine, namely:

  • certificate of approval of the type of measuring equipment №UA-MI/1-96-2007 from 10.07.2007;
  • certificate of approval of the type of measuring equipment №UA-MI/1-96-2013from 17.07.2013;
  • certificate of approval of the type of measuring equipment №UA-MI/1-96-2014from 10.07.2014;
  • certificate of conformity of the measuring equipment of the approved type №UA-MI/2-2292-2007 dated 10.07.2007;
  • certificate of conformity of the measuring equipment of the approved type №UA-MI/2-3275-2010 from 18.05.2010;
  • certificate of conformity of the measuring equipment of the approved type №UA-MI/2-4241-2013 from 17.07.2013;
  • certificate of conformity of the measuring equipment of the approved type №UA-MI/2-4574-2014 from 01.09.2014;

   

Thus, the foregoing gives grounds for the conclusion that the above certificates was issued by Dräger Safety AG & Co. KGaA, Germany, in particular, the certificate of conformity of the measuring equipment of the approved type № UA-M/2-4574-2014 from 01.09.2014, which expired on 27.03.2017, was provided by Dräger Safety AG & Co. KGaA and ours Company as the official representative of Dräger Safety AG & Co. KGaA in Ukraine, the right to import this type of measuring devicesinto the customs territory of Ukraine within the validity period of the certificates and in no way created rights or obligations for third parties and did not cause any legal consequences.

 

In addition, this type of measuring deviceswas entered in the State Register of medical equipment and medical devices according to the certificates of state registration №7261/2007 from 23.11.2007 and №7261/2007 from 10.01.2010. Name of VM: Electrodiagnostic devices Alcotest 7410 Plus com, Alcotest 6510, Alcotest 6810. Manufacturer: Dräger Safety AG & Co. KGaA Germany.

 

At that time, the mechanism of state registration of medical equipment and medical products was determined by the Procedure for state registration of medical equipment and medical devices, approved by the Resolution of the Cabinet of Ministers of Ukraine dated 09.11.2004 No. 1497 (hereinafter referred to as the Order), which expired on 01.07.2015.

 

This Order provided that on the basis of the decision on state registration, medical products are included in the State Register of Medical Equipment and Medical Devices (hereinafter referred to as the Registry), which is conducted by the State Medical Service, and the certificate of state registration of medical products is issued to the applicant (item 12 of the Procedure). At the last certificate on the state registration of the Ministry of Health No.07261/2007 of 10.01.2010, when it was issued in 2010, it was stated that the certificate was valid until 10.02.2015.

 

According to the Order of the Ministry of Health of Ukraine No. 533 of 16.07.2012 "On Approval of the Procedure for the Storage of the State Register of Medical Equipment and Medical Devices" (hereinafter - the Order that expired on 02.02.2018), the State Service of Medicines has kept the State Register of Medical Equipment and Medical Devices the appointment and item 11 of this Procedure it was determined that medical products, which were entered in the State Register in accordance with the established procedure as of 30.06.2015, are in the State Register until 30.06.2020.

 

The above confirm:

  • letter of the Ministry of Health No.992 of 11.12.2014 and
  • letter of the State Enterprise "All-Ukrainian State Scientific and Production Center for Standardization, Metrology, Certification and Consumer Protection" No. 28-10/60 of 04.04.2017.

According to them, the Dräger Alcotest® 6810 gas analyzers for measuring the content of alcohol in exhaled air production of the concern Dräger Safety AG & Co. KGaA, which are in service, are in compliance with the requirements of the current legislation and can be maintained in the future provided that the "Service maintenance", "Grading" and "Verification" procedures are timely performed.

 

According to the manufacturer's letter from 06.07.2016, the Dräger Alcotest® 6510 and Dräger Alcotest® 6810 gas analyzers must undergo procedures the "Service maintenance", "Grading" and "Verification" at least once every 12 months.

 

According to the letter of the State Enterprise "Ukrmetrteststandard" from 22.09.2016 № 12-41/42, the maximum interval between operations "Grading" of gas analyzers Dräger Alcotest® 6510 and Dräger Alcotest®6810 is 12 months.

 

According to the European Standard EN 15964: 2011, which was adopted as a national standard by the designation DSTU EN 15964:2014 «Breath alcohol test devices other than single use devices. Requirements and test methods» (EN 15964:2011, IDT) by the order of the Ministry of Economic Development and Trade No. 1494 dated December 30, 2014, gas analyzers for monitoring the alcohol content of exhaled air Dräger Alcotest® in Ukraine are used according to the rules of the specified. 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.

We recommend paying attention to some important points.

According to the DSTU EN 15964:2014, devices for testing alcohol in exhaled air use mouthpieces for breathing samples.

These standards indicate that the "Service maintenance" and "Calibration" of the Dräger Alcotest® 6510 and Dräger Alcotest® 6810 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 Аlcotest® 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® 6510 and Dräger Alcotest® 6810 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.

 

The metrological parameters of the gas analyzers Dräger Alcotest® 6510 and Dräger Alcotest®6810, which are included into the State Register of Measuring Instruments of Ukraine, are determined during the state control trials conducted by the State Enterprise "Ukrmetrteststandard".

According to the results of state control tests conducted by “Ukrmetrteststandart”, 16.04.2014, the description of the type of gas analyzers Alcotest..., Interlock XT has been made, according to which in the column "Basic technical characteristics" it is stated that the limits of the permissible basic error of the Dräger Alcotest® 6810 device are –

in units of air content:

- absolute ± 0,02 mg/dm3 (in the range of measurement from 0 to 0,4 mg/dm3),

- relative ± 5% (in the range of the measurement more than 0.4 mg / dm3);

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.

 

According to Art. 1 of the Law of Ukraine "On Metrology and Metrological Activity" from 05.06.2014, No.1314-VII (as amended), the periodic verification of measuring equipment is used in this sense - the verification carried out during the period of operation of the measuring equipment through a set time interval (intercalation interval).

 

Calibration interval for the category of legally regulated means of measuring equipment "Measuring the content of alcohol in blood and exhaled air" is established by the order of the Ministry of Economic Development and Trade of Ukraine from 13.10.2016 № 1747 is 1 year. For these instruments the maximum interval between "Service maintenance", "Grading" and the calibration interval, including Dräger Alcotest® 6510 and Dräger Alcotest® 6810 devices, is 1 year. The devices memory stores information about the date of the last calibration (calibration).

 

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.

 

According to the DSTU EN 15964:2014, devices for testing alcohol in exhaled air use mouthpieces for breathing samples. 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 who is being inspected submits a sample of exhaled air. The mouthpiece is used to prevent mixing the breath test with ambient air and diluting the concentration of alcohol.

 

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® 6510 and Dräger Alcotest® 6810 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® 6510 and Dräger Alcotest® 6810 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.).

 

The Dräger Alcotest®6510 and DrägerAlcotest®6810 gas analyzers, as a measure of the content of alcohol in the blood and exhaled air, are not subject to the provisions of the Technical Regulation of the regulated measuring devices, approved by the CMU Decree No94 of 13.01.2016, because Alcotest® 6510 and Alcotest®6810 from 2014 are not officially shipped to Ukraine, are already in service and are not put into circulation in the Ukrainian market for the first time.

 

Therefore, according to the legislation currently in force in Ukraine, the Drajger Alcotest® 6510 and Dräger Alcotest® 6810 gas analyzers are not required to comply with the Declaration of Conformity, and in the period from 2007 to 2014 no Dräger Alcotest® 6510 and Dräger Alcotest® 6810 Declaration of Conformity was issued. acting at that time by the legislation of Ukraine.

 

In view of the above, we can conclude that the measuring instruments of the gas analyzers for controlling the alcohol content of the exhaled air Dräger Alcotest® 6510 and Dräger Alcotest® 6810 manufactured by Dräger Safety AG & Co. KGaA, Germany, which were put into circulation in the Ukrainian market and put into operation by the consumer (user) until 10.02.2015, are in compliance with the requirements of the current legislation and can be further exploited, provided that the "Service maintenance" and "Grading" operations are performed in a timely manner in an authorized manufacturer by a certified service center not less than 1 time in 12 months and operations "Verification" not less than 1 time in 12 months, fulfillment of the requirements of the operating documentation for measuring instruments and the use of the Dräger Alcotest® Mouthpieces Standard mouthpieces in accordance with European Standard EN 15964: 2011, which was adopted as a national standard by the designation DSTU EN 15964:2014 «Breath alcohol test devices other than single use devices. Requirements and test methods» (EN 15964:2011, IDT) by the order of the Ministry of Economic Development and Trade No. 1494 of 30.12.2014.

At the same time, an important issue is the speedy implementation of evidence-based alcohol testers, for example, Dräger Alcotest®7510 OIML, whose results are international in accordance with international practice, comply with the international standard OIML R126: 2012, adopted in Ukraine as a state standard.


© Saturn® Data International, the use of materials is permitted provided the source is indicated.

 

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