How to Obtain CE Certification for Machines in Accordance with the 2006/42/EC Machinery Safety Regulation?
The letters CE stand for “Conformité Européenne” in French, “Conformity of Europe” in English, and “Avrupa Normlarına Uygunluk” in Turkish. The series of problems that every machine manufacturer occasionally faces and cannot resolve begins when their customer requests a Machine CE Certificate in accordance with the 2006/42/EC Machinery Safety Directive for the product they will purchase. The manufacturer realizes that the CE mark is not just a figure affixed to labels when they find the correct conformity assessment method. Although it may seem complicated and difficult, when you entrust the process to reliable addresses that comply with the directive and to experts in the field, you will both learn the process and gain experience in this area.
The Machinery Directive, published in 1993, came into full effect in 1995 after a two-year transition period. Under this directive, every machine must have a label bearing the CE mark and a CE certificate obtained in accordance with the requirements of the relevant regulation. If the regulations are fully implemented and tested in accordance with Annex 1 “Basic Health and Safety Requirements,” machines can obtain a CE certificate and affix the CE mark.
Manufacturers can facilitate the sale of their products by placing them on the market with a CE certificate and test/inspection reports, thereby enabling free movement within the domestic market and the European market. The CE certificate/mark, which acts as a passport for the product in European countries, is of great importance to manufacturers.
The following are the groups of risky machines covered by Annex 4 of the Machine Safety Regulation:
If the manufacturer produces one of the machines covered by this scope, they must obtain an “EC Type Examination Certificate” (EC Type Examination Certificate). After meeting the necessary requirements, the CE mark is affixed to the product along with the approved body number of the organization that issued the Machine CE certificate.
1 Circular saws of the following types (single or multi-blade) used for processing materials with physical properties similar to wood or meat:
1.1 Circular saw machines with fixed blades during cutting, mounted on a fixed bed or support, where the workpiece is fed manually or by a removable power drive,
1.2 Circular saw machines with fixed blades during cutting, equipped with a manually operated reciprocating saw carriage or table,
1.3 Sawing machines with fixed blades during cutting, equipped with a combined mechanical feed mechanism for the workpiece, with manual loading and/or unloading,
1.4 Sawing machines with moving blades during cutting, with mechanical blade movement, and manual loading and/or unloading,
2 For woodworking, manually fed planing benches,
3 Woodworking machines with a mechanical combined feeding mechanism, manually loaded and/or unloaded, single-sided surface planing machines,
4. For processing wood and materials with similar physical properties, or meat and materials with similar physical properties, manually loaded and/or unloaded, the following types of band saw benches:
4.1 Sawing machines with fixed blades during cutting, equipped with a fixed or movable bed or support for the workpiece,
4.2 Sawing machines with blades mounted on a movable carriage,
5 Combined machine types used for processing materials with physical properties similar to wood, as referred to in paragraphs 1 to 4 and paragraph 7 above.
6 Hand-fed tenoning machines with various tool holders for processing wood,
7 Vertical spindle molding machines for processing wood and similar materials with physical properties similar to wood,
8 Portable chain saws for woodworking.
9 Presses, including bending presses, used for the cold working of metal materials, with manual loading and/or unloading, and moving workpieces with a stroke of more than 6 mm and a speed of more than 30 mm/s.
10 Hand-fed or unloaded injection (spray) or compression (press) plastic molding machines.
11 Manually loaded or unloaded, injection (spray) or compression (press) rubber molding machines.
12 Machines used in the following types of underground work:
12.1 Locomotives and dekovils,
12.2 Hydraulically powered roof supports.
13 Manually loaded garbage trucks with compression mechanisms used for collecting domestic waste.
14 Removable mechanical transmission/drive assemblies and housings.
15 Housings for removable mechanical transmission/drive assemblies.
16 Vehicle maintenance lifts.
17 Devices used for lifting persons or persons and objects, posing a risk of falling from a vertical height of more than three meters.
18 Portable cartridge-operated testing benches and other impact machines.
19 Protective devices designed to detect the presence of persons.
20 Power-driven, lockable movable enclosures designed for use as protective devices on the machinery specified in paragraphs 9, 10, and 11.
21 Logic units designed to provide safety functions.
22 Rollover protective structures (ROPS).
23 Falling object protective structures (FOPS).
How to obtain a CE Certificate for machinery?
The manufacturer/importer is responsible for placing machinery on the market with the CE certificate affixed and for affixing the CE mark to the machinery. The following methods are used by the manufacturer to affix the CE mark to the product.
Low-risk products: Many products fall into low-risk product groups in terms of safety. Therefore, after conducting a conformity assessment, the manufacturer publishes a declaration stating that the product complies with the mandatory safety, health, environmental, and consumer protection standards. This declaration must be prepared in accordance with the relevant standard.
High-risk products: For these products, the manufacturer’s declaration is insufficient. In such cases, the products must be tested by notified bodies (notified bodies). Following the notified body’s review, the manufacturer may affix the CE mark to the product. Manufacturers of all systems and units produced for use in the final product must provide the manufacturers responsible for integration with a file and declaration regarding components and parts in accordance with the relevant directive (regulation) conditions. Organizations producing parts or components for integration cannot affix the CE mark to their products.
What tests must be performed under the 2006/42/EC Machinery Safety Regulation?
According to the 2006/42/EC Machinery Safety Regulation, a risk assessment must be performed in accordance with the EN ISO 12100 Standard in order to obtain a CE certificate for a machine. The risk analysis examines many details, from ergonomics to electrical control systems. The 2006/42/EC Machinery Safety Regulation Annex “Preparation of a checklist and inspection in accordance with the basic health and safety requirements” must be prepared and carried out. The main machine tests are as follows;
- EN 60204-1 Electrical Safety Tests
- EN ISO 13857 Clearance checks
- EN ISO 13850 Emergency stop button inspection
- EN ISO 13849-1, EN ISO 13849-2 Inspection of control circuits
- EN ISO 4413, 4414, Inspection of hydraulic and pneumatic systems
If applicable, type examination in accordance with the C-type standard
WHAT HAPPENS IF THERE IS NO CE MARK (CERTIFICATE) ON THE MACHINE?
In machines where the CE Mark (certificate) is mandatory, the export of production lines and equipment intended for industrial use to the European Union, their sale in Turkey, and their import into Turkey from third countries is not possible without the CE Mark (certificate).The validity period of the machine CE certificate is five years, unless otherwise specified, provided that the standards and regulations remain up to date.
How is the CE Mark affixed to the machine?
The 2006/42/EC Machinery Safety Regulation provides detailed information on how the CE mark should be affixed to products. The machine manufacturer must obtain CE certification for the machine in accordance with the 2006/42/EC Machinery Safety Regulation and affix the CE mark. CE Mark:
All new machines entering the market for the first time, regardless of whether the manufacturer is located within or outside the EU
Second-hand machines to be imported into the European Union and Turkish markets
Completely refurbished machinery/equipment offered to the European Union and Turkish markets.
What are the dimensions of the CE mark on machinery?
The CE conformity mark must consist of the initials “CE” in the following format:
CE Mark
The CE Mark may be enlarged or reduced in size according to the shape shown in the figure above.
The various elements of the CE mark must essentially have the same vertical dimension. This dimension must not be less than 5 mm. The minimum dimension may be modified for small-scale machines. The dimensions of the CE mark may vary depending on the size of the label on hand tools.
The CE mark must be affixed in close proximity to the name of the manufacturer or authorized representative using the same technique.
How is the technical file prepared for CE certification of machinery?
Cover
Table of Contents
Information about the manufacturer
General description of the machine
Name of the machine
Models
List of differences and similarities between model types
General machine description
Machine diagram
Calculations related to the machine
General operating principle of the machine
Risk analysis
Technical drawings
Label example
Complete parts list
Safety parts list (electrical and electronic components)
Tests performed
Standards applied
User manual
Appendices
Declaration of Conformity (Declaration of Conformity)
How is the Declaration of Conformity (self-declaration) prepared for machines?
The AT Declaration of Conformity must include at least the following:
1) The trade name and full address of the manufacturer or, if applicable, their authorized representative,
2) The name and address of the person authorized to prepare the technical file, who must be established in Turkey or within the Community,
3) Description and identification of the machinery, including model coding, function, model, type, serial number, and commercial name,
4) A statement directly declaring that the machinery complies with the provisions of Directive 2006/42/EC, and, where applicable, a similar statement declaring compliance with other regulations and/or relevant provisions applicable to the machinery,
5) Where applicable, the name, address, and identification number of the Notified Body that conducted the EC Type Examination as specified in Annex IX, along with the EC Type Examination Certificate number,
6) Where applicable, the name, address, and identification number of the Notified Body that approved the Full Quality Assurance System as specified in Annex X,
7) References to the harmonized standards used,
8) References to other technical standards and specifications,
9) Place and date of the declaration,
10) Identification details and signature of the person authorized to prepare the declaration on behalf of the manufacturer or their authorized representative.
11) A copy of the CE certificate issued by the Notified Body.
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