TR CU 010/2011: documents for machinery and equipment

Equipment differs from consumer goods in that the document of conformity is only the tip of the iceberg. Below it is the safety justification: calculations, a risk analysis and a description of protective measures that the manufacturer must prepare and keep. Importers usually learn about this when the certification body asks for a document that the foreign supplier does not have in the required form.

What counts as machinery and equipment

TR CU 010/2011 applies to machinery and equipment used in industry and at home, and also to their components that affect safety. These are machine tools, pumps, compressors, conveyors, lifting machines, agricultural and construction machinery, woodworking and food processing equipment, and household machines that are not covered by other regulations.

The regulation does not apply to products that have special regulations: lifts, pressure equipment, equipment for explosive atmospheres, measuring instruments, and railway and road transport. The first thing to find out is whether your object has been moved to a separate regulation, because the whole further procedure depends on this.

Certification or declaration

The regulation divides equipment by the degree of risk. Products included in the list in the annex to the regulation must be subject to mandatory certification. Everything else that falls within the scope is subject to declaration.

The list for certification includes machinery with a high potential to cause harm: woodworking equipment, presses, casting machines, lifting machines, equipment for work in mines, centrifuges, industrial tractors, earth-moving machines and other heavy machinery.

Schemes and how to choose the right one

The scheme depends on what you import or make: a series, a batch or a single unit.

Scheme 9c is the most frequent choice for single deliveries of expensive industrial equipment, when it makes no economic sense to test a machine by destructive methods. The basis is the manufacturer’s technical documentation, and the requirements for its completeness are the highest here.

Safety justification: the main document

The regulation requires the manufacturer to prepare a safety justification when it designs the equipment. This is a document that contains a risk analysis and data from the design documentation on the minimum necessary safety measures.

What it must contain:

• A description of the machine and its intended modes of operation. This includes setup, maintenance and emergency stop modes.
• A risk analysis at all stages of the life cycle. Installation, operation, maintenance, repair, transport and disposal.
• Identification of hazards. Mechanical, electrical, thermal, noise, vibration, radiation, hazardous substances and ergonomic factors.
• Risk reduction measures. Design solutions, protective devices and warning labels.
• Residual risks and information about them for the user.
• Calculations and test results that confirm the decisions taken.

The safety justification is kept by the manufacturer and is passed on, together with the equipment, to the person who operates it. For imports this means that you need to obtain the document from the foreign supplier. Often it has to be prepared again, because the European technical file under the Machinery Directive is similar in meaning but is not the same in content.

Operating manual and passport

Operating documents are a mandatory part of the set, and their absence is a violation of the requirements of the regulation in itself. The operating manual must contain information about the design, the principle of operation, the characteristics, the safety measures, the procedure for installation, start-up, adjustment, maintenance and repair, and about critical failures and the actions of personnel in such cases.

The requirement that is violated most often in imports: operating documents must be made in Russian and in the state languages of the member states where such requirements exist. A machine translation of the manual, in which the safety terms are translated at random, is a typical claim during inspection control.

Marking of equipment

A marking is applied to the machine, and it contains:

• Name of the manufacturer or its trademark
• Name or designation of the machine, type and model
• Year of manufacture
• Serial or factory number
• Main technical characteristics that affect safety
• Unified circulation mark of the EAEU (EAC)

The marking must remain for the whole service life. A paper sticker on an industrial machine tool does not meet this requirement. A metal nameplate is usually used.

Used equipment

This is a separate and painful topic. The regulation applies to equipment whether it is new or used, if it is put into circulation in the territory of the Union for the first time. This means that importing a second-hand machine tool from Europe does not remove the need for conformity assessment.

The difficulty is that for machinery made many years ago the seller usually has no technical file, no calculations and no manufacturer ready to confirm anything. The practical way is to issue the documents under the scheme for a single item, with tests and with a safety justification prepared with the help of engineers. This is more expensive and takes longer than the buyer expects, so you should assess the documents before the deal.

Inspection control

A certificate for serial products is accompanied by inspection control: the certification body periodically checks that the products still match the confirmed sample. It checks the state of production, selects samples and analyses complaints.

Avoiding inspection control leads to suspension or termination of the certificate. For an importer this means that the document that was paid for stops being valid at the worst moment, at the time of the next delivery. You can find more about the procedure itself in the article on inspection control.

Standards: what the evidence is built on

Technical regulations state the requirements in a general form: a machine must be safe, and risks must be reduced. How to achieve this is described by the standards that are included in the lists to the regulation.

Using such standards is voluntary, but it gives a presumption of conformity: if the equipment is made to a standard from the list, the requirements of the regulation are considered to be met. Refusing the standard is not forbidden, but then you must prove conformity yourself, by calculations and tests, and this work is much larger.

• Standards for a specific type of equipment. They set separate requirements for presses, machine tools and conveyors.
• Machinery safety standards. General design principles, risk assessment, protective devices and emergency stop.
• Standards for test methods. They define how noise, vibration and forces are measured.

For imported equipment this is also a way to save money: if the manufacturer applied international standards that are harmonized with ours, part of the evidence can be reused. If only internal factory norms were applied, the work must be done again.

Complete lines: one document or several

This question arises when a production line of several machines is delivered. The answer depends on how the machines are connected.

The main trap is a line built from machines of different manufacturers. Each machine may have its own documents, but putting them together into one complex creates new risks: the interaction between units, the common emergency stop system and the zones between the machines. The person who builds the line becomes the manufacturer of the complex and is responsible for the risk assessment of the whole line.

Installation, commissioning and the later life of the machine

Conformity assessment settles the question of putting the product into circulation, but not of its operation. After installation, the equipment is subject to other rules, those of industrial safety, and they have their own requirements.

• Installation is done according to the manufacturer’s instructions; deviations are recorded and justified
• Commissioning is confirmed by a certificate, and the parameters are recorded
• Personnel are trained to work on the specific equipment
• Operating documentation is kept: the passport and the maintenance log
• The maintenance intervals from the manual are observed
• Modernization of the equipment is assessed separately, because it can change its safety

Modernization needs a separate mention. Replacing the control system, installing an additional unit or changing the output can change the characteristics of the machine so much that the documents no longer describe it. In this situation the organization that carried out the modernization in fact creates a new machine, with all the resulting duties.

What to request from the supplier before the contract

This list saves months. It is harder to obtain all these documents after payment than before it.

A separate piece of advice on the contract: include the supplier’s duty to provide the technical documentation in the volume that is needed for conformity assessment in the territory of the Union, and link part of the payment to it. The wording “documents are provided on request” does not work in practice.

Typical mistakes when importing equipment

The first row occurs more often than all the others together: the applicant issues a document under the “main” regulation and considers the matter closed, although the electrical part of the machine needs confirmation under two other regulations.

Noise, vibration and ergonomics

These are three characteristics that importers notice last, although they are regulated in the same way as mechanical safety and must be stated in the documentation.

• Noise. The sound pressure level at the operator’s workplace is stated. If it exceeds the set limit, the manufacturer must describe protective measures, from housings to requirements for personal protective equipment.
• Vibration. It is regulated separately for vibration transmitted to the hands and to the whole body. For hand tools and mobile machines this is a key indicator.
• Ergonomics. The position of the controls, the forces on the levers, the visibility of the work area, the lighting and the operator’s position. This also includes the requirement that emergency stop devices must be reachable from the working position.

Data on noise and vibration are taken from the factory tests. If the supplier did not provide them, the measurements will have to be made here, which means extra cost and time. So include this request in the list of documents in the contract, together with the diagrams and calculations.

Steps for importing equipment

• Determine whether the object is a product that has a special regulation
• Check whether the equipment is on the list that requires certification, or whether a declaration is enough
• Establish the full list of applicable regulations, including 004 and 020 for electrical equipment
• Request from the manufacturer the technical file and the data for the safety justification before the contract
• Choose the scheme according to what is delivered: a series, a batch or a single unit
• Prepare the operating manual and the passport in Russian
• Agree on the method of applying a marking that lasts for the service life
• Plan the inspection control, if a certificate is issued for a series

It is easier to determine the list of regulations if you start with classification: the HS code (TN VED) is the starting point for finding the requirements. This is explained in a separate article. How the scheme affects the set of documents and the terms was explained in the article on conformity assessment schemes.