Securing Compliance with Sertifike: The 2006/42/EU Machinery Directive and Certification Services
2006/42/EC Machinery Safety Directive, 2014/30/EC EMC (Electromagnetic Compatibility) Directive and 2014/35/EC LVD (Low Voltage) Directive are important legislations that determine the regulations regarding the safety of machines and electrical devices in the European Union. Here is detailed information about these regulations:
What is the purpose and scope of the Machinery Safety Directive 2006/42/EC?
This regulation aims to ensure the safety of users and employees by determining basic health and safety requirements in the design and manufacturing of machines.
All machinery, replaceable equipment, safety components, lifting accessories, chains, ropes, belts and partially completed machinery are covered by this regulation.
What is the definition of machinery?
According to the 2006/42/EC directive ‘machinery’ means:
— an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application,
— an assembly referred to in the first indent, missing only the components to connect it on site or to sources of energy and motion,
— an assembly referred to in the first and second indents, ready to be installed and able to function as it stands only if mounted on a means of transport, or installed in a building or a structure,
— an assembly of linked parts or components, at least one of which moves and which are joined together, intended for lifting loads and whose only power source is directly applied human effort;
What standards shall machinery manufacturers use?
The standards used in the design and testing of machines are as follows. These standards are applied to ensure machine safety and conformity.
EN ISO 12100: Safety of machinery - Safety-related parts of control systems - Part 1: General principles for design.
EN 60204-1: Safety of machinery - Electrical equipment.
EN ISO 13849-1, EN ISO 13849-2: Safety of machinery - Safety-related parts of control systems
EN ISO 13850: Safety in machinery - Emergency stopping equipment - Design principles.
EN 62061: Machinery safety - Functional safety of safety-related control systems.
EN ISO 4413: Hydraulic fluid power - General rules and safety requirements for systems and components.
EN ISO 4413: Pneumatic fluid power - Safety rules and general rules for systems and components.
How to obtain CE certificate for machinery?
All machinery manufacturers shall document technical file for their products (including description of all models) and issue a Declaration of Conformity. The technical file shall contain product information and test results.
If the machine is included in Annex IV of the 2006/42/EC Machinery Safety Directive, it is classified as 'high risk machine' and are subject to mandatory CE Certification. CE certificates are issued as a result of testing and technical file review carried out by notified body.
Obtaining the CE certificate for other products is voluntary. Companies that have completed all the requirements of the directive are entitled to use the CE mark on their products. Products that are classified as risky products are required to carry the number of the Notified Body in addition to the CE mark. Procedures for using the CE mark are awailable on the websites of the Notified Bodies.
As a Sertifike company with our expert staff, we provide technical file creation and certification services to manufacturers of machinery.
- Circular saws (single- or multi-blade) for working with wood and material with similar physical characteristics or for working with meat and material with similar physical characteristics, of the following types:
1.1. sawing machinery with fixed blade(s) during cutting, having a fixed bed or support with manual feed of the workpiece or with a demountable power feed;
1.2. sawing machinery with fixed blade(s) during cutting, having a manually operated reciprocating saw-bench or
carriage;
1.3 sawing machinery with fixed blade(s) during cutting, having a built-in mechanical feed device for the workpieces, with manual loading and/or unloading;
1.4. sawing machinery with movable blade(s) during cutting, having mechanical movement of the blade, with manual loading and/or unloading.
- Hand-fed surface planing machinery for woodworking.
- Thicknessers for one-side dressing having a built-in mechanical feed device, with manual loading and/or unloading for woodworking.
- Band-saws with manual loading and/or unloading for working with wood and material with similar physical characteristics or for working with meat and material with similar physical characteristics, of the following types:
4.1. sawing machinery with fixed blade(s) during cutting, having a fixed or reciprocating-movement bed or support for the workpiece;
4.2. sawing machinery with blade(s) assembled on a carriage with reciprocating motion.
- Combined machinery of the types referred to in points 1 to 4 and in point 7 for working with wood and material with similar physical characteristics.
- Hand-fed tenoning machinery with several tool holders for woodworking.
- Hand-fed vertical spindle moulding machinery for working with wood and material with similar physical characteristics.
- Portable chainsaws for woodworking.
- Presses, including press-brakes, for the cold working of metals, with manual loading and/or unloading, whose movable working parts may have a travel exceeding 6 mm and a speed exceeding 30 mm/s.
- Injection or compression plastics-moulding machinery with manual loading or unloading.
- Injection or compression rubber-moulding machinery with manual loading or unloading.
- Machinery for underground working of the following types:
12.1. locomotives and brake-vans;
12.2. hydraulic-powered roof supports.
- Manually loaded trucks for the collection of household refuse incorporating a compression mechanism.
- Removable mechanical transmission devices including their guards.
- Guards for removable mechanical transmission devices.
- Vehicle servicing lifts.
- Devices for the lifting of persons or of persons and goods involving a hazard of falling from a vertical height of
more than three metres.
- Portable cartridge-operated fixing and other impact machinery.
- Protective devices designed to detect the presence of persons.
- Power-operated interlocking movable guards designed to be used as safeguards in machinery referred to in points 9, 10 and 11.
- Logic units to ensure safety functions.
- Roll-over protective structures (ROPS).
- Falling-object protective structures (FOPS).
The Electromagnetic Compatibility (EMC) Directive 2014/30/EC is a legislation that regulates the placing on the market of products related to electromagnetic compatibility within the European Union. The purpose and scope of this regulation is as follows:
The main purpose of the 2014/30/EC EMC Directive is to ensure the compatible operation of electrical and electronic devices with other devices, systems and networks in the electromagnetic environment. Thus, unwanted electromagnetic interactions between these devices are minimized.
EMC Directive 2014/30/EC aims to regulate the electromagnetic compatibility conditions of electrical and electronic devices, ensuring the safe and effective operation of these devices and their free circulation in the European market. The main goal of the regulation is to ensure the safe operation of devices and to prevent damages that may be caused by electromagnetic disturbances.
EN 60947 series: Low voltage switchgear and control arrangement
EN 60730 series: Automatic control arrangements
EN 50065 series: Signaling in the frequency range from 3 kHz to 148.5 kHz in low voltage electrical installations
EN 50121 series: Railway applications - Electromagnetic compatibility
EN 61000 series: Electromagnetic compatibility (emu) - Testing and measurement techniques
EN 61008 series: Residual current operated circuit breakers - Without integral overcurrent protection - For use in households and similar places (RCCB)
EN 61009: Residual current operated circuit breakers - Used in homes and similar places with integral overcurrent protection (rcbo)
EN 61326: Electrical equipment for measurement, control and laboratory use - EMC requirements
EN 61439: Low voltage switchgear and control equipment
EN 62026: Low voltage switchgear and control gear - Controlling device interfaces (CDI)
EN 62053: Electrical measuring equipment - Special rules
These standards are used to ensure that products within the scope of the EMC Directive 2014/30/EC meet the electromagnetic compatibility requirements. These standards specify requirements both in terms of emission (electromagnetic noise emitted by the product) and immunity (the resistance of the product to electromagnetic noise).
The minimum information that should be included in the technical file created for products within the scope of the 2006/42/EC Machinery Safety Directive is as following:
Manufacturer information
Machine name, general description, model list, differences between models
Operating principle of the machine and calculations
Technical drawings and electrical diagrams
User manual
Label sample
Parts list, if available
Risk analysis
Standards used
Performed tests and relevant reports
Declaration of Conformity
- Active medical implants
- Products related to the aviation and space industry
- Radio and telecommunication terminal equipment
- Devices used in laboratories for experimental and research purposes (under certain conditions)
What is the purpose and scope of the 2014/35/EC LVD (Low Voltage) Directive?
This regulation aims to protect users by determining the health and safety requirements of electrical equipment operating at low voltage. Electrical equipment operating in the range of 50-1000 V AC and 75-1500 V DC falls within the scope of this regulation.
Manufacturers of electrical equipment operating at low voltage shall document technical file for their products and issue a Declaration of Conformity. The technical file shall contain product information and test results.
Obtaining the CE certificate for electrical equipment operating at low voltage is voluntary. Companies that have completed all the requirements are allowed to use the CE mark on their products.
EN 60335-1: Electrical devices used in homes and similar places – General rules
EN 60950-1: Information technology equipment - General rules
EN 60598-1: Luminaires- General rules and tests
EN 61010-1: Electrical equipment for measurement, control and laboratory use – General Rules
EN 61204: Low voltage power supplies with DC output - Performance characteristics and safety regulations
The minimum information that must be included in the technical file created for products within the scope of the 2014/35/EC Low Voltage Directive is as follows:
Manufacturer information
Equipment name, general description, model list, differences between models
Technical drawings and electrical diagrams
User manual
Label sample
List of standards used
Performed tests and relevant reports
Declaration of Conformity
- Electrical Equipment Used in Explosive Environments
- Devices designed for Radiology and Medical purposes
- Electrical parts designed for freight and passenger elevators
- Electricity meters
- Plugs and sockets for domestic use
- Electric Fence Control Devices
- Radioelectrical interference
- Electrical equipment designed for use on ships, aircraft or railways
- Electrical equipment designed for use in research and development facilities
These products are covered by other specific directives and regulations.
Can a product fall under the scope of two or three different Regulations?
Yes, a product may simultaneously fall within the scope of the Safety of Machinery Directive 2006/42/EC, the Electromagnetic Compatibility (EMC) Directive 2014/30/EC and the Low Voltage (LVD) Directive 2014/35/EC. Such products are generally machines with a wide range of uses and must meet the requirements of different regulations. In this case, it is necessary to document that the product complies with all three regulations and to test it according to these regulations. The CE marking can be used for the products that meet all the requirements of these regulations.