For the successful implementation of the conformity assessment process, certain technical documentation shall be provided to the notified bodies. They are the prerequisite for an EAC Certificate or EAC Declaration. Some technical regulations of the Eurasian Economic Union, such as TR CU 10/2011 On safety of machinery and equipment or TR CU 032/2013 On safety of pressure equipment require certain technical documentation proving the conformity of the product with the requirements of the technical regulations. The documents must be carried out in Russian or in the official language of the Member State where the conformity assessment takes place.
The necessary technical documentation shall include:
- technical passport
- safety justification
- risk assessment
- instruction manual
- SDS safety data sheet
- ignition hazard assessment
- installation, assembly and commissioning instructions
- test methodology
Technical passport is the most important basis for product identification. The technical passport must be drawn up for each machine, equipment, printing unit or part of the equipment. The technical passport must be available throughout the product lifecycle. The passport is made by the manufacturer. When compiling technical passports, the requirements of GOST-R 2.601-2013 "Unified System of Design and Operating Documents" and GOST-R 2.610-2006 "Unified System of Design Documents" shall apply. Rules for the preparation of the operating documents "as well as the requirements of the relevant technical regulations of the EAEU.
Each pass contains information on the manufacturing guarantee, the values of the most important parameters, product properties, as well as information on certification and disposal. The technical passport will be stamped with the company stamp and the exhibition date.
The TR CU 032/2013 On safety of pressure equipment precisely sets how a technical passport, for example, for pipelines, gas cylinders, fittings, pressure vessels or for a boiler should look like.
The content of safety justification is described in Article 2 of TR 010/2011 On safety of machinery and equipment and TR CU 032/2013 On safety of pressure equipment as follows:
Security justification is a document that contains risk assessment, information on the minimum required safety measures from the design and operating documents as well as technical documentation. The document accompanies the machine at all stages of its life cycle. The document is expanded with the results of risk assessment during operation and after repairs.
Art. 7 TR CU 010/2011 On safety of machinery and equipment and Art. 25 TR CU 032/2013 On safety of pressure equipment is designed by the manufacturer regarding the safety of pressure equipment. The original remains with the manufacturer, the copy goes to the operator.
The content and structure of the safety justification is defined by a harmonized standard GOST-R 54122-2010. The GOST-R standard 54122-2010 has been developed in accordance with the Machinery Directive 2006/42/EC and serves to harmonize national Russian standards with those of the European Community.
The GOST-R standard 54122-2010 knows two forms of safety assessment - full and shortened.
The shortened form is declarative and requires no proof. The full form requires examinations and proofs. The shortened form is used to prove conformity with the technical requirements. It contains all measurement and test results and a written safety concept.
It is permissible to use references to other standards and documents as far as they can be clearly identified in the safety justification. It is not necessary to enter everything that has already been written elsewhere.
The risk assessment is an integral part of the safety assessment. It is recommended that the risk assessment is prepared as a separate document and attached to the safety assessment. The aim is to ensure safe machine operation.
Risk assessment is carried out according to ISO 12100-1, ISO 12100-2, ISO 13849-1 and GOST-R 51344-99 and has many similarities with the European Machinery Directive 2006/42/EC.
The risk assessment comprises the following steps:
- identification of hazards
- risk evaluation
- development of recommendations on risk reduction
Risk assessment is carried out during the development, construction, assembly, repair, maintenance, repair and disposal of machines.
The instruction manual contains information on the design, functioning and composition of the product, its characteristics and its operation, as well as information on proper and safe use, maintenance, storage, transport and disposal of the product.
It is essential that the operating instructions contain the necessary safety precautions for the application and maintenance of the product. The text with the safety measures must always be highlighted and show clearly to the consumer that this is a warning. It is recommended to use a graphic warning sign.
The following standards prescribe how an instruction manual should look like: GOST-R 2.601-2013 "Unified System of Design and Operating Documents", GOST-R 2.610-2006 "Unified System of Design Documents. The rules for the production of the operating documents ". Individual technical regulations such as TR CU 010/2011 On safety of machinery and equipment or TR CU 012/2011 On safety of the equipment for operation in explosive atmospheres add further requirements to the operating instructions.
Our experienced experts develop high-quality technical documentation for the conformity assessment: EAC Certificate, EAC Declaration, state registration, fire safety certification, etc. If necessary, we can translate your documents into Russian.
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Costs for the preparation of the instruction manual
The cost for preparation of the instruction manual depends on various factors. We always find an individual concept and offer a variety of payment options to meet the needs of our customers.