SAI Guide: European Directives
The European Directives are a set of legislation that is applied across the entire European Union. For some of the Directives, they are used to define and achieve the safety of products bought and sold within the E.U. As a manufacturer, there are about five or six Directives that you need to be aware of if you are going to be CE Marking your product. By understanding why the Directives are used and what their requirements are, you can know how to apply them to your product.
Although there are 100s of Directives, highlighted below are a few that will be important for machine manufacturers and designers.
Machinery Directive 2006/42/EC
Note: In 2023, the Machinery Directive was replaced by the Machinery Regulation 2023/1230, and it will be officially applied in 2027. In order for you to prepare for this change, Swanson Associates, Inc. has created an SAI Guide on the Machinery Regulation and what the key differences are between it and its predecessor, the Machinery Directive.
The Machinery Directive lays down the health and safety requirements for the design and construction of machinery being placed on the European market. Annex I of the Directive lists the requirements needed to adhere with to ensure compliance. The Directive applies to machinery, interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, removable mechanical transmission devices and partly completed machinery. Although you will not need to know all the details of the Annexes, it is good to know what they are:
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Annex I - Essential health and safety requirements relating to the the design and construction of machinery
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Annex II - Declarations
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Annex III - CE marking
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Annex IV - Categories of machinery to which one of the procedures referred to in Article 12(3) and (4) must be applied
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Annex V - Indicative list of the safety components referred to in Article 2(c)
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Annex VI - Assembly instructions for partly completed machinery
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Annex VII - Technical files / technical documentation
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Annex VIII - Assembly instructions for partly completed machinery
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Annex IX - EC type-examination
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Annex X - Full quality assurance
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Annex XI - Minimum criteria to be taken into account by Member States for the notification of bodies
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Annex XII - Correlation table with Directive 98/37/EC
Annex I is the most important segment to understand if you are looking to ensure compliance with your machine. From the Directive itself, Annex I is the “Essential health and safety requirements relating to the design and construction of machinery”. It lists out the safety requirements needed to show compliance. Some of these requirements are:
Risk Assessment:
A Risk Assessment must be carried out on your machine. Using ISO 12100 as a reference, you will follow the iterative process to assess and reduce the risk of your machine. The machine must then be designed with taking the results of the risk assessment into account. For more help on creating a Risk Assessment, follow our Risk Assessment (ISO 12100) guide below.
Annex I lays out the safety framework for the overall design of the machine. It consists of several guidelines to which you need to adhere, such as:
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Materials and Products: The materials used to construct the machine shall be safe and will not endanger a person's safety.
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Lighting: Machinery must be supplied with integral lighting suitable for its operation.
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Handling: Machinery must be capable of being handled and transported safely and be packaged or designed to be stored safely.
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Safety and Reliability of Control Systems: The control systems must be designed to prevent hazardous situations from arising. Some examples include:
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Machinery must not start unexpectedly
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Protective devices must remain fully effective or give a stop command
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No moving part of the machine must fall or be ejected
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Control Devices: Control devices must be clearly visible and identifiable and positioned safely and efficiently around the machine.
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Stopping: Machine must be equipped with a stop function and an emergency stop function.
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Protection Against Mechanical Hazards: Some mechanical hazards must be protected.
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Stability
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Ejected objects
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Sharp edges
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Moving parts
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Uncontrolled movement
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Guards and Protective Devices: The following requirements are provided for guarding on the machine.
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Robust construction
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Securely held in place
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Not be easily bypassed
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Located at an adequate distance from the danger zone
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Protection Against Other Risks:
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Electrical supply
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Static electricity
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Non-electrical energy supply
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Extreme temperatures
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Fire, Explosion
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Noise
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Maintenance: Machinery must be able to be maintained and energy sources must be able to be isolated.
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Marking on Machine: The following markings must be placed on the machine.
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The business name and full address of the manufacturer
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Designation of the machinery
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CE Marking
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Designation of series or type
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Serial number
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Year of construction
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Instructions: Instructions for the machine must accompany it and be written in the official language of the market in which the machine is located.
The above summary is meant to help introduce the requirements of Annex I of the Machinery Directive. For a more detailed review and how it applies to your machine, please check out the official Machinery Directive below or reach out to us directly.
Annex VII lays out the instructions on how to create your Technical Construction File. The Technical Construction File (TCF) serves as a collection of all documents required to demonstrate compliance in the European Union, specifically for the Machinery Directive. If you are looking to put a CE mark on your machine, you will need to create a TCF. It is mandated by the Machinery Directive to create one for your machine.
Now that you have completed the evaluations and created the test reports, you will now compile all required documentation into a folder that will serve as your product’s technical construction file.
The TCF is a collection of the following:
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Design drawings
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Risk assessments
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Test reports
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Component datasheets
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Manuals
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Information on the manufacturing process
These documents demonstrate that the machine complies with all requirements and specifications according to the Machinery Directive. The TCF should be constructed systematically, going down one by one and ensuring all relevant information is added or created. For risk assessments, test reports, and manuals, ensure you are following the requirements laid out in the different machinery standards. For example, the EN 60204-1 standard calls for specific information in the manual and all necessary testing that needs to be done for electrical safety
EMC Directive 2014/30/EU
The Electromagnetic Compatibility Directive ensures that electrical and electronic equipment does not generate, or is not affected by, electromagnetic disturbances. Whether you are designing a large robotic machine or a small 5V electronic module, all electrical equipment must meet the EMC Directive. In order to show compliance, you will need to provide test reports that show evidence that your product meets these EMC requirements. They can be broken down in the following four types:
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Radiated Emissions
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Radiated Immunity
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Conducted Immunity
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Conducted Emissions
By testing to these four EMC requirements, you are showing that your product is not radiating noise, it is not affected by radiated noise in its environment, and it is neither affected by or sending out noise via conduction (supply conductors). Although there are many standards based on the product type and application, the following two standards should be your primary testing standards for most machines. They outline both the immunity and emission requirements needed for you to successfully CE mark your product. Also, these standards define the different levels of immunity and emissions that you will need to state based upon your applicable market requirements.
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EN 61000-6-2 (EMC Immunity requirements)
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EN 61000-6-3 (EMC Emissions requirements)
For further questions on the EMC Directive and its requirements, don't hesitate to reach out below and learn exactly what you need to focus on to ensure your product is compliant.
Low Voltage Directive 2014/30/EU
The Low Voltage Directive (LVD) is for all electrical devices (appliances, cables, power supplies, etc.) that have a voltage rating of 50 – 1000 VAC or 75 – 1500 VDC. This is an important directive of which to be aware if your products are not machines but do fall into the voltage ratings. If your electrical device is not considered a machine but is supplied by the voltage rating listed above, it will fall under this Directive. The LVD is quite similar to the Machinery Directive, but its requirements are a bit more relaxed due to the limited mechanical hazards that are normally present in machines.
Some examples of products that fall into this Directive are:
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Appliance couplers
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Cord extensions
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Outlet travel adapters
In order to show compliance to the Low Voltage Directive, the manufacturer is able to test the devices themselves and prove conformity.
ATEX Directive 2014/34/EU
The ATEX Directive (Equipment for potentially explosive atmospheres) refers to machinery and electronics that will be used in a potentially explosive environment. If an ATEX marking is required, than your product must adhere to the ATEX Directive. Fundamentally, an ATEX mark ensures that your piece of equipment will not serve as a source of ignition in an explosive environment. This comes down to the available energy in your machine or circuit, the available discharge available during faults, and how your components and electrical conductors are isolated from one another and the environment. Special care needs to be taken for the creepage and clearance of PCB boards, wiring terminals, and conductors. Additionally, whether your electrical circuits are fully isolated from the atmosphere or not affects your available route to conformity.
In order to ensure your electrical device or machine is compliant to the ATEX Directive, you first must determine the classification you seek. The following Zones and Categories affect how stringent the design requirements are:
The ATEX Zone refers to the state of the explosive atmosphere:
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Zone 0 / 20: The atmosphere is continuously present
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Zone 1 / 21: Likely to occur during normal operation
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Zone 2 / 22: Not likely to occur during normal operation
The ATEX Category refers to the level of safety the device protects itself from the atmosphere:
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Category 1: The protection can withstand up to two faults simultaneously
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Category 2: The protection can withstand up to one fault
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Category 3: The protection only exists during normal operation
There are a lot of design considerations required in order to ensure your product is compliant with its specific ATEX zone and category. This consists of detailed schematic reviews, an understanding of the available energy within the circuit, physical construction review of the PCBs and components, as well as your protective means to prevent exposure to the environment.
If you and your team are looking to gain ATEX Compliance for your product, please message Swanson Associates, Inc. for a free consultation and review of your product and to gain an understanding for what you will need to focus on to prove your compliance.