The second article in a six part series on CE marking
Directives and Standards, a Product Example
In the first part of our CE marking series, Unlocking the European Market: A Step-by-Step Guide to CE Marking, we introduced CE marking as the way to access the European Union, one of the largest single free trade markets in the world.
The key to CE marking is understanding applicable EU directives that establish common requirements for health, safety, and environmental protection and the application of harmonized standards to show conformity. In this article we will give a practical example of choosing directives and applying standards for a simple product.
Product Example
Consider a simple laboratory fume hood, like the one shown below.
Assume the the following product description:
The product is an enclosed fume hood for laboratory use
Power is from the wall outlet
There is a blower motor used to extract fumes
There are some low-voltage electronics for monitoring air flow and controlling blower motor speed
The AI Challenge
Before continuing, take the product description above and give it to your favorite AI. Ask the AI to provide you with the appropriate European directives and standards to use for product CE marking.
Drop a line in the comments section (bottom of the page) with your results and the name of the AI. I am very interested in seeing the results -and how they may change over time.
Applicable Directives
As detailed in Unlocking the European Market: A Step-by-Step Guide to CE Marking, the first step to CE marking is to identify the EU directives for health, safety, and environmental protection that are applicable to your product. Given the product description above, we can determine that, the following directives apply.
Machinery Directive (2006/42/EC):
This is the overarching directive for most machinery sold in the EU. It covers essential safety requirements for design, manufacturing, and conformity assessment procedures. This directive defines machinery as 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. Since the fume hood contains a rotating blower mechanism, it falls within this broad category of machinery.
Low Voltage Directive (2014/35/EU):
This directive applies to electrical equipment operating between 50 and 1000 volts AC, to ensure that electrical equipment on the market fulfils the requirements providing for a high level of protection of health and safety of persons, and of domestic animals and property. Since the fume hood is powered from the mains and has control electronics, it falls under the scope of this directive.
Electromagnetic Compatibility (EMC) Directive (2014/30/EU):
This directive ensures the fume hood doesn't generate excessive electromagnetic interference that could disrupt other equipment. It aims to ensure the functioning of the internal market by requiring equipment to comply with an adequate level of electromagnetic compatibility. Because the product contains control electronics that produce electromagnetic interference, it needs to comply with this directive.
Restriction of Hazardous Substances (RoHS) Directive (2011/65/EU):
This directive lays down rules on the restriction of the use of hazardous substances in electrical and electronic equipment (EEE) with a view to contributing to the protection of human health and the environment, including the environmentally sound recovery and disposal of waste EEE. Since the fume hood contains electronics, it is necessary that the product complies with these limitations.
Applicable Standards
As detailed in Unlocking the European Market: A Step-by-Step Guide to CE Marking, the second step to CE marking is to identify the applicable harmonized standards that provide the product requirements necessary to show compliance with the directives.
If Only it Was That Simple:
The legal requirement for CE marking is to meet the technical requirements for health, safety, and environmental protection, as set forth in the directives. Unfortunately, there may be several harmonized standards that can be applied to show compliance.
Even for a relatively simple product as the fume hood described above, the application of standards to show compliance can be complicated and depend on specific aspects of the product design or use. The two major safety directives chosen for the product are the Machinery Directive (2006/42/EC) and the Low Voltage Directive (2014/35/EU), both of these directives require that a risk assessment be carried out and documented. Selection of appropriate standards for safety compliance will depend on the risk identified in the product risk assessment.
Safety Standards:
The following standards can be applied to show compliance for safety:
EN 60204-1:2018 - Safety of machinery - Electrical equipment of machines - Part 1: General requirements. This is a general standard referenced in the Machinery Directive applying to the electrical portion of a machine. EN 60204-1 is used along with specific standards that are considered applicable to components or features of the machine. The additional standards are used to confirm the safe intended use of the machine based on the risk assessment.
EN 61010-1:2010 - Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements. This is a specific standard for electrical safety of laboratory equipment referenced in the Low Voltage Directive. This standard will address specific electrical construction and safety aspects for laboratory equipment.
EN 14175:2003 - Fume cupboards- Safety requirements and performance tests. This standard is not directly referenced in any directive, however it is the primary harmonized standard for a laboratory fume extractor, covering safety and performance aspects like containment, construction, airflow, materials, and labeling. This standard is divided into eight parts, the applicable parts of the standard will depend on the exact usage of the fume hood.
So, to cover safety, you would first apply EN 14175:2003, then apply EN 61010-1:2010, then apply EN 60204-1:2018 to any remaining risk.
Electro-Magnetic Compatibility Standards:
The following standards can be applied to show compliance for electro-magnetic compatibility:
EN 61000-6-3:2007 - Electromagnetic compatibility (EMC) - Part 6-3: Emission standards - Emission limits for residential, commercial and light-industrial environments can be used to show compliance for emissions.
EN 61000-6-1:2015 - Electromagnetic compatibility (EMC) - Part 6-1: Generic standards - Immunity for residential, commercial and light-industrial environments can be used to show compliance for immunity.
Environmental Standards:
There aren't any specific standards directly focused on RoHS compliance for a fume hood, so you need to rely on general compliance of component manufacturers to ensure compliance.
Key Considerations for RoHS Compliance:
Material Declarations: Obtain and record detailed material declarations from your component suppliers to verify the absence of restricted substances for all components.
Internal Testing: Conduct material analysis and testing to verify compliance of components without declarations.
Documentation: Maintain thorough documentation of material composition, supplier declarations, and testing results.
Where to Start
As you can see, even for a relatively simple product, such as a basic fume hood, the steps needed for CE marking can be very complex. If you need help and guidance understanding the rules for your product, consider the following:
Consult a Notified Body:
Notified Bodies are conformity assessment organizations authorized by EU member states to assess product compliance with relevant directives. Consulting a Notified Body experienced with your product type can provide specific guidance on applicable directives and standards. The New Approach Notified and Designated Organizations (NANDO) website can be used to search for appropriate Notified Body in your area.
Seek Help from a Consultant:
A product regulatory consultant can assist you in navigating the complexities of EU regulations and help to identify the directives associated with your product and the applicable standards for assessing compliance.
Striper Solutions LLC, Your Regulatory Partner
With over 30 years development experience and more than a decade providing consulting services, Striper Solutions has demonstrated a commitment to excellence and integrity in developing new products. Embracing a shift to regulatory compliance allows us to focus on a critical area of product development with the dedication and quality our customers need.
See more at www.striperllc.com
You might think that large language model AIs would be perfect for regulatory compliance work because it's all built on written rules. That doesn't seem to be the case (yet). I think it may have to do with standards being copyrighted and not freely available for AI training purposes.
This example is based on a product I worked with in the past, so I already knew the appropriate directives and applicable standards. However, I tried to use Google Gemini to get the same results using the above product description. It did a pretty good job on the directives but I spent an entire afternoon directing it through minor issues such as selecting a generic electrical safety standard when a more…