Medical Metrology

In most cases medical equipment and devices have standardized metrological characteristics, and therefore they are measurement instruments.

That is why medical measurement instruments, as well as industrial gages shall be subject to a thorough metrological study, i.e. testing, certification and calibration after production thereof.

The main purpose of any metrological service is to provide the uniform measurement.

The uniform measurement is a state of a measurement process when the results of all measurements are expressed in the same legalized units of measurements, and their accuracy assessed with the ensured confidence probability.

The works to ensure uniform measurements in Kazakhstan are regulated by the Law "On ensuring the unity of measurements" of the Republic of Kazakhstan. The law prohibits to market, use, sale and advertise any measurement instruments not tested for the type approval or for metrological certification. For this reason all medical measurement instruments imported into the territory of Kazakhstan shall now be registered in the State System for Ensuring Uniform

Measurement of the Republic of Kazakhstan.
On the basis of the approved RK standards any measurement instruments intended for batch manufacture or import into the territory of Kazakhstan in batch quantities shall be subject to testing with the later type approval; any measurement instruments produced or imported in single quantities and subject to state metrological control shall be certified.

Measurement instruments manufactured in the CIS countries that are parties to the Agreement for mutual recognition of state testing results and type approval, metrological certification, control and calibration of measurement instruments as well as results of laboratories accreditation testing, controlling and calibrating measurement instruments shall be subject to the procedure of recognition of state testing results and type approval of the measurement instruments.

The state activities to ensure the uniform measurements are managed by the authorized standardization, metrology and certification authority of the Republic of Kazakhstan.

The State System for Ensuring Uniform Measurement shall cover the following objects: measurement units, state standards of measurement units, standards of measurement units, measurement instruments, and measurement instrument calibration methods, requirements to the measurement instruments, methods and results, methods of measurements, metrological service activities of the state administration bodies, individuals and entities for ensuring uniform measurement.

Metrology. Registration in the State System for Ensuring Uniform Measurement of the Republic of Kazakhstan

According to Cl. 1 of Article 17 of the Law "On ensuring the unity of measurements" of the Republic of Kazakhstan any measurement instruments intended for batch manufacture or import into the territory of Kazakhstan in batch quantities shall be subject to testing with the later type approval.

The procedure for measurement instrument testing for type approval:
An application for testing for type approval of measurement instruments shall be submitted to the Committee for Technical Regulation and Metrology of the Ministry of Industry and Trade of the Republic of Kazakhstan.

The following documents shall be attached to this application by an applicant:

  • testing program plan or plan of amendments and/or additions to a standard program;
  • manufacturer's document package containing the complete technical and metrological characteristics;
  • verification procedure plan in compliance with the State Standard of the RK 2.63 when the section regulating verification means and methods is not provided;
  • type description methods draft in the form according to Annex D to the ST of the RK 2.21-2007 with general view photos 13x18 or 18x24 in duplicate;
  • the applicant's letter with permission to publish the type description in mass media;
  • information on availability of calibration instruments for measurement instruments during their operation in the Republic of Kazakhstan, as well as information on the companies and organizations for service maintenance and repair work;
  • documents justifying the recommended calibration interval.

 

All documents of a foreign manufacturer shall be submitted together the version of the text translated into the official and/or Russian language.

The application with the document package shall be submitted to RSE ''KazInMetr” for execution. RSE "KazInMetr” concludes an agreement for measurement instrument experimental testing for type approval with the organization submitting the application.

Testing of measurement instruments for type approval shall be carried out according to the testing program developed in compliance with requirements of the RK ST 2.6-2003 "Testing programs for type approval of measurement instruments. Main requirements”” agreed with the applicant and approved by the authorized body or a state scientific metrological center or under the standard testing program as supplemented or amended as provided for by the established procedure.

The authorized body (Committee) for Technical Regulation and Metrology shall make a decision about the measurement instrument type approval on the basis of the measurement instrument test results to approve the type and to confirm the compliance with the approved type. This decision shall be supported with a type approval certificate for measurement instruments in the form specified in the Annex A to the RK ST 2.21 -2007 with the validity terms not exceeding 5 years.

Metrological certification of measurement instruments

Measurement instruments produced or imported in singular quantity and subject to the state metrological control shall be metrologically certified. The decision about metrological certification of measurement instruments shall be supported by a standard metrological certificate issued for measurement instruments with the validity defined upon issuance.

Testing of measurement instruments for type approval and confirmation of the compliance with the approved type, as well as metrological certification of measurement instruments shall be carried out by a state metrological service.

Approved type of measurement instruments and measurement instruments having passed the metrological certification shall be entered into the register of the state system for ensuring uniform measurement.

Measurement instruments operated and stored after the expiry date of the type approval certificate can be used until complete depreciation

Recognition of test results
Test results and type approval shall be recognized in compliance with the requirements of the Rules of International Certification 06-2001 "The Procedure for Mutual Recognition of Test Results, Type Approval, Calibration and Metrological Certification of Measurement instruments”.

Measurement instruments manufactured in the CIS countries shall be subject to the Procedure for recognition of test results and type approval.

To follow this procedure it is necessary to submit an application to the State Committee for Standardization and Metrology and provide the following documents package:

  • a copy of the type approval certificate for measurement instruments legalized by the manufacturing plant;
  • a copy of the type description
  • operating documents;
  • calibration procedure;
  • a form of the verification certificate for measurement instruments after production and (or) a reprint of a verification mark.