Understanding EN standards, or harmonised standards, is an integral part of ensuring compliance when selling products in the European Union. In this article, Ferry Vermeulen of INSTRKTIV explains what an EN standard is, and what you must know to make sure that your products are fully compliant.
1. What is an EN standard?
EN standards are standards that have been developed by a standardisation institute, mandated by the European Commission and are in order to comply with one or more mandatory essential requirements from a specific European directive.
Products that meet the requirements of harmonised standards [applicable in all EU member states] benefit from a presumption of conformity with the corresponding essential requirements.
Generally speaking, harmonised standards contain the following content:
Scope – Describes the field of application of the standard.
Normative reference – Lists the standards that have been used and which are essential for the correct application of the standard.
Terms and definitions – Describes used terms and definitions.
Requirements – Gives detailed requirements on how to meet the more general product requirements from the related directive.
Warnings, markings, and instructions – Describes how to properly instruct users about product risks and inform them about important product characteristics?
Test methods – Describes how to test if a product meets the requirements and how to document this for the technical file.
2. Where can I find EN standards online?
Whereas directives are mandatory and can be freely accessed via the website of the European Commission, standards are voluntary and need to be purchased.
3. Is compliance with all EN standards mandatory?
It is not always necessary to meet with all the requirements from an EU directive and therefore you also may not always need to meet all EN standards.
When conducting the CE marking process, you will first need to identify the directives and standards that apply to your product. Then, you can identify the applicable requirements of both the directives and standards.
And again, standards are not mandatory but complying with them creates a presumption of conformity with the corresponding essential requirements of the directives.
4. How do I know if a certain product (including my own design) is compliant with a certain EN standard?
When you design your own product, the best way to avoid pitfalls is to study on any available relevant harmonised standards first. Standards give, amongst others, requirements on the design and product characteristics.
Knowing what the technical requirements are, will be a good starting point for your design process. In other words: when you want to design or construct a product for compliance, using harmonised standards is the best thing you can do.
If you want to know if your imported product complies with (a requirement from) a standard, you should conduct a conformity assessment. In many cases and for many products you are allowed to conduct the testing and the assessment yourself.
In some cases, the testing needs to be done by a Notified Body. Consult the relevant directives to determine how to conduct the testing.
Even though you might be allowed to do the testing yourself, not everyone has the technical ability for doing the tests. In that case, you can ask a testing institute to support you.
Harmonised standards describe how a test must be conducted.
As an example, the Directive on the Safety of Toys requires that edges must be designed in a way that the risks of physical injury from contact with them are reduced as far as possible.
This requirement can either be a starting point for your design or can be a thing to check (and prove by means of photos in your technical file) in case of an imported [ODM] product.
The directive also requires that toys and their parts and “must have the requisite mechanical strength and, where appropriate, stability to withstand the stresses to which they are subjected during use without breaking or becoming liable to distortion at the risk of causing physical injury.”
To comply with this requirement, the EN 71-1 Standard has been developed. Compliance to this standard can be proved either by self-testing or by having a test institute the product tested.
6. How do I know which EN standards apply to a certain product?
There are an extensive amount of standards out there and they are constantly withdrawn, newly developed or updated. One single clear list of all available standards simply does not exist. To find standards that could be used for the development or testing of your product, try the following resources:
To find out if standards exist, try the following:
1. The website of the European Commission. Select a product group and on the next page see if some relevant standards are listed.
2. Search on the website of normalisation institutes, such as DIN, BS, ISO, IEC, NEN and SIS, by using keywords or numbers.
3. Search standards on Google
4. Search the Official Publication Journal of the European Community.
When you have found a standard that might apply to your product, make sure you check the Scope (chapter 1) to verify if it indeed applies to your product.
7. Is it common that more than one EN standard may apply to a certain product?
An EN standard typically covers one or more essential requirements of a directive and not all.
In order to comply with all essential requirements, always make sure that you have found all relevant standards.
8. What’s the difference between EN and ISO standards?
An ISO standard is a standard developed by the standardisation institute ISO. An EN standard is named as such when a standard has been harmonised by the European Commission.
A standard can be developed by ISO, for example, the ISO 12000-1. When the standard has been submitted and approved by the Member States, the standard will be published by the European Commission.
From then on the standard is harmonised, meaning that the Member States need to adopt these standards and withdraw any conflicting standards.
The standard then is named EN-ISO XXXXX. When a member state translates the standard, it is written for example as DIN EN ISO XXXXX or BS EN ISO XXXXX.
9. What’s the difference between EN standards and EU directives (i.e., the Low Voltage Directive)?
An EN standard is a way to meet the requirements of the EU directives. Directives are mandatory, standards are voluntary.
A standard is a way to use the latest state of the art technology to meet the essential (and more general) requirements of the directives technically.
So, it is not mandatory to comply with standards that are listed under a certain directive. But by doing so, you will create a presumption of conformity.
When you have a different way to comply with the directive’s requirements than by following standards, you are free to do so.
Consider EN standards as a database of solutions to comply with the requirements.
INSTRKTIV supports companies in the CE marking process and helps their clients to create compliant user instructions. As the director, Ferry speaks regularly at conferences and maintains a blog about product safety. Read his latest article about creating compliant user manuals.