What is the Machinery Directive?
The Machinery Directive 2006/42/EC, which replaces Directive 98/37/EC, lays down the requirements for the manufacturer to comply with before he can place his machine or plant on the European market 29 June 2006 and entered into force on 29 December 2009. The Machinery Directive was introduced because "the machinery sector is an important part of the mechanical engineering industry and is one of the industrial mainstays of the Community economy.
"The social costs of the large number of accidents caused by the use of machinery can be reduced by the inherently safe design and construction of machinery, as well as by proper installation and maintenance."
How is the Machinery Directive structured?
The Machinery Directive is divided into the following chapters:
- Annex I Essential health and safety requirements
- Annex II declarations
- Annex III - CE marking
- Indicative list of safety components
- Annex VI - Assembly instructions for incomplete machines
- Annex VII -Technical documentation for machinery
- Annex VIII -Conformity assessment with internal control of the manufacture of machinery
Which machines are covered by the Machinery Directive?
The Machinery Directive does not distinguish between individual machines, so almost everything falls within the scope of the directive. It applies mainly to new machines that are manufactured or to some used machines imported from a non-European country.
For example, if you install a machine for use in your workplace, it must meet all CE requirements of the Machinery Directive. In addition, the user/manufacturer must ensure that the device they purchase is not only CE marked, but also the CE marking is directly attached to the machine. Compliance with the Machinery Directive requires machines to be considered with due diligence in mind.
Does the CE conformity assessment have to be performed again when linking several machines?
When you create a complex assembly by linking a set of existing machines together, you effectively create a new machine. Therefore, the person performing the work must ensure that the entire assembly complies with the directive, regardless of the age of the machines. Responsibility for the CE marking is often specified in the contracts.
Does the CE conformity assessment have to be carried out again after modifying a machine?
In turn, if you change the function or performance of a machine or complex assembly, you create something new and must ensure that the policy is respected, for example, when you take out the intended parameters of a machine, then a CE marking must be created again for this.
These regulations also apply to self-made machines
- If the manufacturer of this machine puts this machine into operation himself
- If you have imported a machine from a country outside the EEA and put that machine into operation (in this case, there are European representatives responsible for CE marking)
So, if you have a proprietary machine and modify or change the function or performance, you should go through a conformity assessment procedure for it and provide it with the CE marking.
Which requirements or obligations must manufacturers comply? Do you comply with the EMC directive so that you can mark your product CE?
For the CE marking of an EMC product, the manufacturer or distributor must comply with 9 different obligations:
- The devices must be designed and manufactured in such a way as to limit the emission of interference, considering the prior art.
- Furthermore, the products must have a reasonable degree of immunity.
- There are additional requirements for fixed installations.
Which products are affected by the Machinery Directive and must bear the CE marking?
Article 2 of the Directive defines the products to which the Directive applies. It should be noted that the Machinery Directive covers all areas where a machine or plant is used, not only in the factory, but also in other areas. In all cases, relevant provisions of other EC directives must be taken into account, if applicable (EMC, ATEX) in order to achieve full compliance with the directive - including the basic health and safety requirements
What is a machine according to the Machinery Directive?
Machines: A machine is an assembly that is equipped with or intended to be equipped with a drive system other than a direct human or animal force. Furthermore, a machine consists of interconnected parts or components that serve a specific purpose. At least one of the connected parts or components must be movable, including:
- Interchangeable equipment
- Safety components
- Lifting equipment
- Lifting accessories
- Chains, ropes and belts
- Removable mechanical transmission devices
- Partly completed machinery
What is replaceable equipment after the machine Directive?
Replaceable equipment is a device assembled by the operator himself after commissioning a machine or tractor to change its function or to give it a new function, provided that this equipment is not a tool. This definition mainly refers to the agricultural sector, for example, to a basic tractor, on which various equipment can be mounted at the rear and front, which can change the safety of the tractor. One example could be the plough equipment on the tractor, which makes it more susceptible to tipping over. Therefore, replaceable equipment must be CE marked to ensure compatibility with the use of this tractor.
What are safety components after the machine Directive?
Safety components can be defined as components:
- which serve to fulfil a safety function,
- placed on the market independently,
- whose failure and/or malfunction endangers the safety of persons, and which
- which are not necessary for the functioning of the machine or can be replaced by normal components to ensure the functioning of the machine.
Annex V contains a provisional list of safety components. It should be noted that these are only examples and not a final listing.
- Extraction systems: If you work in a factory and you must install a small ventilation or extraction system, in the future you must ask your ventilation engineer to affix a CE mark.
- Protection devices and protective devices: This means that you can no longer replace a protection device on a machine, you must ensure that it is provided with a CE marking and a declaration of conformity.
- Command devices for calling hoists and fall protection devices for hoists
- Protective devices for detecting the presence of a person
- Seat belts and seat belts
- Hydraulic check valves when used for fall protection, including pneumatic check valves.
What are lifting accessories after the machine Directive?
Lifting accessories are components that are not directly connected to the machine but are used for lifting loads or equipment. These accessories allow the load to be held and are typically attached between the machine and the load, or directly to the load itself. Lifting accessories can also include slings and their components, such as hangers or similar items.
What are incomplete machines after the machine Directive?
Incomplete machines are a set of machines or incomplete machines that are arranged and controlled to achieve the same purpose in such a way that they function as an integral whole. An example is a robot manufacturer. This cannot provide the robot with the CE marking because it cannot meet all aspects of the directive. What he can do, however, is to make a declaration of incorporation that as much as possible has been fulfilled. Another example is a filling plant in which the machines work together.
Examples of products covered by the directive are commercial microwaves and washing machines.
Which products are explicitly excluded from the Machinery Directive?
A machine driven by animal (including human) power does not fall within the scope of the directive. The exceptions also include:
- Fair/amusement park equipment
- Machines for nuclear purposes
- Motor vehicles and their trailers covered by Directive 70/156/EEC
- 2 or 3-wheel motor vehicles covered by Directive 2002/24/EC of 18 March 2002
- Motor vehicles intended for competition
- Means of transport by air, water or rail
- Seagoing vessels and mobile offshore installations
- Machines intended for military or police purposes
- Conveyor systems for mines
- Machines designed to move performers in artistic performances
- Weapons
- Machines designed and built specifically for research purposes for temporary use in laboratories
What measures does the manufacturer have to take to apply a CE marking?
The manufacturer or distributors must carry out a risk assessment of the machine to determine whether the health and safety requirements applicable to the machine are met. The limit values of the machine shall be established, including the intended use and any reasonably foreseeable misuse of the machine (preparation of technical documentation).
How are basic health and safety requirements tested under the Machinery Directive?
In the first step of the conformity assessment procedure of the Machinery Directive, the manufacturer checks the basic health and safety requirements. They are not prescriptive and are divided into six sections.
- General 1.21 Machines must be safely put into operation
- food, medicine
- mobile machinery
- lifting technology
- Underground machines
- Lifting or moving people
The first EHSR requires a risk assessment, first, all hazards must be identified, that is, everything that can cause damage. Then it is necessary to evaluate the risk, the probability that a person or persons would come into contact with the danger and how much damage it would cause
Stability: The machine and its components must be designed and constructed to be stable enough to be used without the risk of tipping, falling or unexpected movements. This requirement also applies during transport, assembly, disassembly, scrapping and any other activity on the machine (complete life cycle).
The protective devices must be securely fastened. They must protect against ejection or falling of materials and objects. Fixed guards must be secured by systems that can only be opened or removed with tools. Their fastening systems must remain attached to the guards or to the machine when the guards are removed. Where possible, protective guards must not be able to remain in place without their fixings.
Each machine must have an operating manual in the official language or. be accompanied by the official languages of the Member State in which it is placed on the market and/or put into service. The word "original" must appear on the manual
A translation must be provided by the manufacturer or his authorized representative or by the person who brings the machine to this language area. This manual must be marked with the word "translation".
EN standards (Euro-Norm standards): Now that the control measures have been defined, it must be ensured that they comply with the EHSRs.
The EHSR is binding, but the EN standards are not. In the case of machinery manufactured in accordance with certain published harmonized European standards, the references of which have been published in the Official Journal of the European Union, it is assumed that they comply with the essential health and safety requirements covered by those standards.
How is the technical design file created after the machine Directive?
In the second step of the conformity assessment procedure according to the Machinery Directive, the manufacturer creates the technical design file.
This document documents that the device has been correctly marked with the CE marking.
The TCF must be presented by the responsible person if there is reason to doubt the compliance of the machine with the directive.
It can be stored electronically; however, it must be able to be assembled in a time set by the law enforcement authorities. 48 hours are given as a guideline.
The documentation must be kept for a period of 10 years after production of the last machine of the type to which the TCF refers. The TCF is the only way to prove that you have complied with the EHSRs and other provisions of the policy. Technical documentation for the product must be available in the EU.
A technical documentation must contain the following points:
- Description of the device
- Abstract design, manufacturing drawings, diagrams of components, subassemblies, circuits, etc.
- Descriptions and any explanations necessary to understand the drawings and diagrams and the operation of the device
- List of harmonized standards
- Results of design calculations and tests
- Test reports
- Operating instruction
Which harmonized standards are often applied to the Machinery Directive?
Along the three types of standards, you will find examples of commonly used standards:
- Type A applies to all machines, for example 12100 deals with the basic safety design of machines.
- Type B is intended to promote safety and is divided into B1 and B2, for example:
- Emergency stop standard BS EN ISO 13850:2008 Normative references (required to meet this standard) IEC 60204-1:2005
- BS EN 953 refers to the selection and manufacture of protective devices
- BS EN ISO 13857 refers to the arrangement of separating protective devices for the protection of the upper and lower limbs This standard specifies values for safety distances that prevent the upper limbs of persons from three years of age reaching danger zones. Values for safety distances against reaching danger zones with the lower limbs for persons aged 14 and over.
- Type C applies to a specific type of machine, for example:
- BS EN 415 "Safety of packaging machines" in 9 parts: Part 4 applies to palletizers
- BS EN 10218 "Industrial robots - safety recommendations"
- BS EN 12417 "Safety of machine tool machining centers"
Why is the correct implementation of the conformity assessment procedure so important?
If you comply with the Machinery Directive, you have a market of millions of people to whom you can sell your machines.
Since conformity assessment is a legal requirement, non-compliance can lead to your product being withdrawn from the market and the associated poor publicity.
However, it has documented and can prove that the machine complies with the requirements of the directive. This also serves the safety of the manufacturer. Placing on the market because in the event of damage caused by the machine, he can prove that he has properly fulfilled all requirements.
In principle, non-compliance with CE requirements can lead to criminal penalties and fines. Non-compliance may take the form of a lack of technical documentation or operating instructions, a lack of declaration of conformity, incorrect or missing affixing of the CE mark. In Germany, violations of the Product Safety Act can be punished with fines of 3,000 - 30,000 € (full 19) and imprisonment up to 1 year (full 20).
