RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of January 13, 2016 No. 94

About approval of the Technical regulation of legislatively regulated means of the measuring equipment

According to part one of article 5 of the Law of Ukraine "About technical regulations and assessment of conformity" the Cabinet of Ministers of Ukraine decides:

1. Approve the Technical regulation of legislatively regulated means of the measuring equipment which is attached.

2. Provide to the Ministry of economic development and trade implementation of the Technical regulation approved by this resolution.

3. This resolution becomes effective in six months from the date of its publication.

Approved by the Resolution of the Cabinet of Ministers of Ukraine of January 13, 2016, No. 94

Technical regulation of legislatively regulated means of the measuring equipment

General part

1. This Technical regulation establishes requirements to which there shall correspond the means of the measuring equipment intended for application in the field of legislatively regulated metrology (further - means of the measuring equipment) when they are presented in the market and/or are put into operation for accomplishment of the tasks connected with measurements.

2. Action of this Technical regulation extends to means of the measuring equipment which list is given in appendix 1.

Action of this Technical regulation does not extend to legislatively regulated means of the measuring equipment, medical products and/or medical products for diagnostics of in vitro.

3. This Technical regulation contains more detailed requirements for resistance of means of the measuring equipment to electromagnetic hindrances, than the Technical regulation for electromagnetic compatibility of the equipment approved by the resolution of the Cabinet of Ministers of Ukraine of December 16, 2015 No. 1077. At the same time requirements of the Technical regulation for electromagnetic compatibility of the equipment concerning means of the measuring equipment also shall be fulfilled.

4. In this Technical regulation the following basic concepts are used:

1) putting into operation - use of means of the measuring equipment to destination the consumer (user) in Ukraine for the first time;

2) response - any action aimed at providing return of means of the measuring equipment which was already provided to the consumer (user)

3) node - the hardware device mentioned as such in national standards and technical specifications for certain means of the measuring equipment functioning independently also forms means of the measuring equipment together with other nodes to which it is compatible, or to compatible means of the measuring equipment;

4) assessment of conformity - process of the proof that essential requirements of this Technical regulation, the concerning means of the measuring equipment, were executed;

5) technical specifications - the documents (including international standards, regulating documents of the International organization of legislative metrology) establishing technical requirements to which there shall correspond means of the measuring equipment.

5. Other terms are used in the value given in the Laws of Ukraine "About general safety of non-food products", "About standardization", "About technical regulations and assessment of conformity" and "About metrology and metrological activities".

Applicability to nodes

6. If national standards and technical specifications for certain means of the measuring equipment establish essential requirements to nodes, provisions of this Technical regulation shall be applied with corresponding changes to such nodes.

7. Nodes and means of the measuring equipment can be estimated independently and separately for the purpose of establishment of compliance.

Essential requirements

8. Measuring instruments shall conform to the essential requirements established in appendix 2 and in the corresponding national standards and technical specifications for certain means of the measuring equipment.

Provision in the market and/or commissioning

9. Provision in the market and/or commissioning in the territory of Ukraine of any means of the measuring equipment which meet the requirements of this Technical regulation cannot be forbidden for the reasons which follow from this Technical regulation.

10. Measuring instruments can be provided in the market and/or are put into operation only in case they conform to requirements of this Technical regulation.

11. Measuring instruments shall correspond to the provisions regulating their commissioning taking into account local climatic conditions. For this purpose it is necessary to choose the corresponding upper and lower borders of temperature from the table 1 of appendix 2 and to determine humidity conditions (with condensation or without condensation), and also to consider openness or closeness of the expected place of use.

12. If for measuring instruments different classes of accuracy are determined:

1) in national standards or technical specifications for certain means of the measuring equipment accuracy classes which should be used for certain scope of such means can be specified;

2) in all other cases accuracy classes which shall be used for certain scope of means of the measuring equipment within certain classes of accuracy are determined provided that use of all classes of accuracy is allowed in the territory of Ukraine.

In the cases specified in subitems 1 or 2 of this Item means of the measuring equipment of more high-class accuracy can be used if the owner makes such choice.

13. Display and/or demonstration of the means of the measuring equipment which are not conforming to requirements of this Technical regulation during fairs, exhibitions, displays or demonstration in a different way are possible under condition if in visible designation it is accurately specified that such means of the measuring equipment cannot be provided in the market and/or are put into operation before their reduction in compliance with requirements of this Technical regulation.

Obligations of producers

14. Producers in case of input of means of the measuring equipment in the address and/or operation guarantee that they were developed and made according to the essential requirements determined in appendix 2, and the requirements specified in the corresponding national standards and technical specifications for certain means of the measuring equipment.

15. Producers constitute the technical documentation specified in Items 48-52 of this Technical regulation and perform the corresponding assessment procedure of compliance given in Item 47 of this Technical regulation or provide its accomplishment.

16. If compliance of measuring instruments to requirements of this Technical regulation which are applied to them was confirmed with the established procedure of assessment of conformity, producers constitute the declaration of conformity according to Items 53 - the 56th this Technical regulation and put mark of conformity and additional metrological markings according to Items 57 - the 70th this Technical regulation.

17. Producers keep technical documentation and the declaration of conformity within 10 years after introduction of means of the measuring equipment in turnover.

18. Producers provide that procedures which are applied in places of serial production of means of the measuring equipment were supported in connection therewith by the Technical regulation. Changes in design of means of the measuring equipment or their characteristics, and also changes in the corresponding national standards and technical specifications for certain means of the measuring equipment by the reference to which compliance of such means is declared, shall be considered.

19. Considering risks which are created by means of the measuring equipment, producers carry out the corresponding selective testings of the means of the measuring equipment placed in the market and in case of need consider claims, keep the register of the claims and means of the measuring equipment which are not conforming to the established requirements and withdrawals of means of the measuring equipment, and also inform distributors on results of carrying out any monitoring.

20. Producers provide that at the expense of the measuring equipment which they introduced into circulation designation of type, batch number or serial number or other element which allows to identify them was put, or if the size or nature of means of the measuring equipment does not allow drawing such data, - to provide necessary information in the accompanying documentation and on packaging if that is available, according to Item 31 appendices 2.

21. Producers note on measuring instruments the name, the registered commercial name or registered trademark (sign for goods and services) and the postal address or if it is impossible, - note such information in the accompanying documentation and on packaging if that is available, respectively to Item 31 of appendix 2. Contact information shall be stated according to the legislation on languages.

22. Producers provide that means of the measuring equipment which they introduce into circulation were followed by the copy of the declaration of conformity, and also instructions and information according to Item 32 applications 2, which are run according to the legislation on languages. Such instructions and information, and also any markings shall be accurate, clear and obvious.

23. Producers which consider or have the reasons to consider that the means of the measuring equipment introduced by them into circulation does not conform to requirements of this Technical regulation, shall immediately (taking into account the level of discrepancy of such means) to take the adjusting measures necessary for its reduction in compliance with the established requirements, retirement or response. If the specified means of the measuring equipment represents risk, producers shall inform immediately bodies of the state market supervision (further - bodies of market supervision), providing detailed data, in particular about discrepancy of such means to requirements of this Technical regulation and any taken adjusting measures.

24. Producers shall provide on reasonable request of body of market supervision to it all information and documents in paper or electronic form, necessary for confirmation of conformity of means of the measuring equipment for requirements of this Technical regulation. Upon the demand of the specified body producers shall cooperate with it concerning any actions directed to elimination of risks which is constituted by the means of the measuring equipment introduced by them into circulation.

Obligations of authorized representatives

25. The producer can determine the authorized representative based on the written order.

The obligations established in Item 14 of this Technical regulation and obligation to constitute technical documentation, established in Item 15 of this Technical regulation, shall not be part of the order received by the authorized representative.

26. The authorized representative carries out the tasks determined in the power of attorney received from the producer. Based on the order the authorized representative shall carry out at least the following:

1) to keep the declaration of conformity and technical documentation for its provision on requests of bodies of market supervision within 10 years after introduction of means of the measuring equipment in the address;

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