The document - risk analysis (safety justification) is required when confirming compliance with the requirements of the technical regulations of the EAEU

In order to comply with the requirements of the EAU technical regulations.

 

The EEC approves a list of international and regional (interstate) standards, and in their absence, national (state) standards, as a result of which compliance with the requirements of the technical regulations of the Union (hereinafter referred to as harmonized standards) is ensured on a voluntary basis.

 

In the event of non-application of the standards included in list of standards , may be conformity assessment is carried out on the basis of a risk analysis, where "risk" is a combination of the likelihood of harm and the consequences of this harm on human life or health, property, the environment, life or health of animals and plants.

 

Conducting risk analysis allows regulators to focus limited resources on those risks that pose the greatest danger of human health.

 

The risk analysis (safety justification) is document required when confirming compliance with the requirements of the following technical regulations of the Eurasian Economic Union:

  • TR CU 001/2011 "On the safety of railway rolling stock"

 

  • TR CU 002/2011 "On the safety of high-speed rail transport"

 

  • TR CU 003/2011 "On the safety of railway transport infrastructure"

 

  • TR CU 008/2011 "On the safety of toys"

 

  • TR CU 010/2011 "On the safety of machinery and equipment"

 

  • TR CU 011/2011 "Safety of elevators"

 

  • TR CU 012/2011 "On the safety of equipment for operation in explosive atmospheres"

 

  • TR CU 014/2011 "Road Safety"

 

  • TR CU 026/2012 "On the safety of small vessels"

 

  • TR CU 029/2012 "Safety requirements for food additives, flavors and technological aids"

 

  • TR EAEU 037/2016 "On Limiting the Use of Hazardous Substances in Electrical Engineering and Radioelectronics Products"

 

The safety justification developed by the manufacturer shall include a risk analysis which assumes that:

 

  • the hazards must be identified;

 

 

  • for each hazard, a risk assessment shall be carried out by calculation, experiment, expert or based on the operation of analysis of similar machinery and/or equipment.

 

 

Risk assessment methods may be established in the standards and other technical regulations.

 

Definitions:

 

  • risk - is a combination of the likelihood of harm and the consequences of this harm on human life or health, property, the environment, life or health of animals and plants;

 

  • acceptable risk - the value of the risk from the use of the machine and (or) equipment, based on the technical and economic capabilities of the manufacturer, corresponding to the level of safety that must be ensured at all stages of the product life cycle;

 

  • residual risk - the risk remaining after the adoption of protective measures;

 

  • risk analysis – study of technical requirements for the machine in terms of limitations, hazard identification and calculation of the degree of risk;

 

  • risk calculation - determining the severity of possible harm to health and the likelihood that such harm will be caused;

 

  • risk assessment - an assessment of the possibility of reducing the degree of risk, obtained on the basis of the analysis.

 

Based on the definition, risk analysis is carried out at all stages of the life cycle of the machine, equipment, including:

 

  • design;

 

  • manufacturing;

 

  • storage;

 

  • installation;

 

  • adjustment;

 

  • operation, including modernization, repair, maintenance and after-sales service, utilization.

 

 

The main purpose of risk analysis is to substantiate technical solutions for the implementation of established safety requirements. Risk analysis provides a basis for risk assessment, risk reduction measures and risk acceptance.

 

Decisions can be made as part of a larger risk management process by comparing the results of the risk analysis with the acceptable risk criteria.

 

The acceptable risk to the machine and/or equipment must be determined and established during development (design).

 

At the same time, the level of security corresponding to the established risk is ensured:

 

 

  • completeness of research and development work;

 

 

  • carrying out a set of necessary calculations and tests based on methods verified in accordance with the established procedure;

 

 

  • the choice of materials and substances used in certain types of machines and (or) equipment, depending on the parameters and operating conditions;

 

 

  • establishment by the developer (designer) of criteria for limit states;

 

 

  • establishment by the developer (designer) of the assigned service life, assigned resources, maintenance, repair and disposal periods.

 

 

  • identification of all hazards associated with possible foreseeable misuse of the machine and/or equipment;

 

 

  • restrictions on the use of machinery and/or equipment.

 

 

In the event that the assessed risk is higher than the permissible one, the design of the machine and (or) equipment must be changed to reduce it. In this case, the intervention of personnel in all operating modes of the machine and (or) equipment not provided for in the operating manual should be excluded.

 

On the basis of the risk analysis, protective and safety devices used to protect against hazards caused by moving parts of machinery and/or equipment shall be selected.

 

If it is impossible to ensure an acceptable risk or in case of economic inexpediency, the operating manual (instructions) shall contain information restricting the conditions of use of this machine and (or) equipment or warning of the need to take safety measures.

 

Before being put into circulation, the manufacturer must carry out a risk assessment of the machinery and/or equipment.

 

After the overhaul of the machine and (or) equipment, a risk assessment should be carried out, the value of which should not be higher than permissible. If necessary, technical and organizational measures are developed to achieve risk tolerance values.

 

Risk analysis contains the information required to quantify risk, which allows you to assess the safety of the machine.

 

If the manufacturer does not have a risk analysis document (safety justification), the engineers of PROMERY Ltd., on the basis of the manufacturer's documentation, will prepare the necessary documents in order to assess risk and confirm the compliance of products with the requirements of the technical regulations

of the Eurasian Economic Union.