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Writing and registration of technical conditions

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Technical Specifications (TS) is a document that prescribes technical requirements to be met by a particular product, material, substance, etc., or its group. Furthermore, procedures must be specified by which one can determine whether these requirements are met.

Technical Specifications is a technical document, which is being developed to address the developer (manufacturer) or at the request of the customer (consumer) of the production. Technical Specifications is an integral part of the set design and other technical documentation of the production. TS must include, in the absence of the documentation, a full range of requirements of the production, its manufacturing, inspection and acceptance.

 
Composition, construction and design of the technical conditions must comply with the requirements of DSTU, GOST and other normative documents, acting on the territory of Ukraine.


Example identification of technical specifications: TU U 22.2-24993721-001: 2010, where 22.2 - DKPP code 24993721 – OKPO code.

According to the standards that are in force in Ukraine, technical specifications should include an introductory section and sections located in the following sequence:

  • Technical requirements;
  • Safety requirements;
  • Environmental protection requirements, Recycling;
  • Acceptance rules;
  • Control methods;
  • Transportation and storage;
  • Use guidelines;
  • Manufacturer’s warranty.

Technical specifications may be a regulatory document, which is carried out for compliance with product certification and an obtaining of certificate of conformity.

PE“Consulting service plus” has been working on the market of medical equipment more than fourteen years, has the necessary knowledge, ability to carry out the whole spectrum of development work and writing of the technical specifications.

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