Harmonized standards and European directives for CE marking

What are harmonized technical standards?

Harmonized standards are standards that describe how to verify the requirements set by directives on safety, health and environmental protection.
The wording "harmonized standard" is synonymous with "harmonized standard".

Who develops the harmonized standards?

The harmonized technical standards are developed by the European Standardization Bodies: CENELEC for products in the electrical/electronic sector, ETSI for products in the telecommunications sector, CEN for products from other sectors.

What is determined in the harmonized standards?

Harmonized standards determine the suitability of a certain verification method to presume product conformity with the directive.
These standards are called "harmonized" when their references are published in the Official Journal of the European Communities (GUCE) in relation to a directive.

The complete application of the harmonized standards allows the manufacturer to place the product on the market without previously submitting the technical manufacturing dossier to a notified body.
This allows you to independently carry out the CE certification of the products and the editorial team of EU declaration of conformity.
The manufacturer who is suitably equipped can carry out the tests in his own laboratories, otherwise he can contact a trusted laboratory.

Measurements and calculationsAre the EC Directives mandatory in nature?

Yes, the Directives are mandatory. The manufacturer (if the product is manufactured in the EEA - European Economic Area) or the importer (if the product is manufactured outside the EEA) is obliged to draw up a technical file for the CE marking containing the tests to which the product has been subjected .
The tests are specific for each product category and the technical file must be presented upon request to the national supervisory authorities.

Are CE standards voluntary?

There is still confusion about the term "voluntary".
The EC Directives do not make it mandatory to adopt harmonized standards, however it is always necessary to demonstrate the compliance of the product with the requirements of the directives applicable to the product.
In fact, it is possible to choose other technical and procedural solutions to comply with the essential requirements established by the directives. These solutions typically require more in-depth technical evaluations and the involvement of a Notified Body. Although more demanding, the latter is the only way forward in the case of products which, due to their technical characteristics, cannot be assessed by applying the harmonized standards in full.

When to contact a Notified Body?

The intervention of a notified body is necessary when all applicable harmonized standards are not fully implemented. The costs in this case are higher especially because the non-standard test methods must be previously evaluated, developed and fine-tuned.

What is the fastest route to obtaining the CE mark?

The fastest, least expensive and most protective path for the manufacturer is the full adoption of all the harmonized standards applicable to the product, these in fact are the "recipes" developed and tested over time to verify the conformity of the product with the requirements of the directives.

Sicom Testing offers a complete service for CE certification of the products.

To request further information on this topic, write to info@sicomtesting.com
or call +39 0481 778931.

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28 thoughts on “Norme armonizzate e direttive europee per la marcatura CE”

  1. Good morning,
    As a manufacturer of machinery equipment, do we need to create a technical documentation file according to Directive 2006-42/EC if we have evidence of compliance with EN 60204?

    • Good morning,
      Yes, the manufacturer must prepare a technical documentation file for the machines he produces, the file must contain (Annex VII – part A):
      a) a construction file consisting of:

      —from a general description of the machine,

      —from an overall drawing of the machine and the control circuit diagrams, as well as the related descriptions and explanations necessary to understand the operation of the machine,

      —detailed and complete drawings, possibly accompanied by calculation notes, test results, certificates, etc., which allow verification of the conformity of the machine with the essential safety and health protection requirements,

      —the risk assessment documentation which must demonstrate the procedure followed, including:

      i) a list of the essential safety and health protection requirements applicable to the machine,

      ii) the protective measures implemented to eliminate the identified dangers or to reduce the risks and, where appropriate, the indication of the residual risks associated with the machinery,

      —the standards and other technical specifications applied, which indicate the essential safety and health protection requirements covered by those standards,

      — any technical report providing the results of tests carried out by the manufacturer himself or by a body chosen by the manufacturer or his authorized representative,

      — from a copy of the machine instructions,

      —if applicable, from the declaration of incorporation for the partly completed machinery included and the related assembly instructions,

      —if applicable, a copy of the EC declaration of conformity of the machines or other products incorporated in the machine,

      —a copy of the EC declaration of conformity;

      b)in the case of mass production, the internal provisions that will be applied to maintain the conformity of the machinery with the provisions of this Directive.

      Best regards
      Sicom Test

  2. I was reading the content of this site and truthfully it helped me a lot to understand a little more about this topic. Thanks for the material shared. I am new to this industry and this is my first time doing this type of work. I would like to know if you have any examples or formats of a technical dossier or data sheet and conformity assessment of a product that I can share so that it can act as a basis or support to guide me. Thank you

    • Good morning
      We do not have a sample file because all work for our clients is covered by confidentiality. The contents of the dossier are indicated in the directives (for 2014/53/EU – RED it is indicated in Annex 5).
      The composition itself is quite simple but a certain amount of expertise is required to verify the adequacy of the various documents, which is why many clients prefer to entrust its preparation to us.
      Greetings Sicom Test

  3. Hi, I'm an RSPP in a cleaning service company in a healthcare environment. Given the delicate moment we're living in, I've had a problem with cleaning and sanitizing electro-medical equipment, DEFIBRILLATORS, ECODOPLERS, CARDIOLINS, as they are equipment in direct contact with the patient and emit electrical voltages, given their delicate nature, sanitization should not be the responsibility of personnel authorized to use them

    • Good morning.
      I think you should follow the cleaning instructions in the user manuals for these instruments. Precautions related to the chemical products used must also be applied. Furthermore, the general rules for cleaning electrical and electronic equipment must be applied, as well as for the protection of the materials they are made of.
      Greetings from Sicom Testing

  4. Is the EN54.22 standard a harmonized standard?
    If not, can I still install products that comply with the previous EN54.5 standard?

    • Good morning,
      the EN 54-22 standard is not a harmonized standard.
      The EN 54-5 standard is linked to the European regulation 305/2011 Construction products (CPR/CPD).
      Greetings to Sicom Testing

    • Good morning,
      in the declaration of conformity procedure made by the manufacturer, the directives require the application, in full and with positive results, of the harmonized standards listed in the European Official Journal, which are suitable for the product and cover all the requirements indicated in the directives themselves.

      The application of different standards or versions other than those indicated in the European Official Journal does not give presumption of conformity with the directives.

      Greetings from Sicom Testing

  5. Good morning
    I wanted to ask a question to see if I'm right. I want to carry out the CE marking of a low voltage industrial machine. I have identified the applicable directives which in this case would be machines, electromagnetic compatibility and voltage limits. To ensure compliance with the Machinery Directive, I understand that I need to consult the EN 60204-1 standard that I have already acquired in AENOR but for electromagnetic compatibility compliance, several rules appear that would apply in this directive and I wanted to know if I need to obtain all of them these rules to ensure compliance and whether I am correct in everything I have stated.
    A greeting.

    • Dear Ismael,

      for the machinery directive, a risk assessment must be carried out in accordance with the EN/ISO 12100 standard. All the risks highlighted must be assessed and where possible this is done using harmonized standards such as EN 60204-1.
      For the electromagnetic compatibility directive, tests must be carried out according to harmonized standards to verify immunity and emissions, both radiated and conducted.
      The Low Voltage Directive (LVD) does not apply when the Machinery Directive applies, however its requirements are referenced directly from the Machinery Directive.

      Good job from Sicom Testing

  6. Good morning,
    The EN 16012/2015 standard is a European standard but it is not a harmonized standard as it does not appear in the list of harmonized standards. What does it mean?

    • A standard is developed to create a common understanding of some aspect of the product. For example dimensional aspects, quality aspects or safety aspects.
      These standards can be used to regulate sales contracts or to declare the type or quality of a product to the customer.
      Some standards are assessed as suitable for demonstrating the conformity of a product to the requirements of a European directive, in these cases they are included in the list of harmonized standards of that directive.
      At the current date, the EN 16012 standard is not a harmonized standard, therefore it cannot be used independently to demonstrate the conformity of a product to the requirements of a directive.
      Good work
      Sicom Testing

  7. HI,
    Is it correct to say that a new or updated standard can be considered harmonized once published by an EU member state?
    Is there a reliable statement on this that can be cited?

    • Good morning,
      a harmonized standard can be considered as such once published in the Official Journal of the European Union.
      Best regards
      Sicom Testing Staff

      • HI,

        I agree.
        But do I think it is possible to adopt a new or revised standard once published by a national standardization body in an EU member state even if the standard or its revision is not yet listed in the EU OJ? For innovative products there is a need to design products according to the latest technical developments (state of the art). Can I have problems if I list rules not yet listed in the Official Journal? Basically I am free to demonstrate compliance. I need to be able to explain my approach. A cutting-edge approach is a good point, isn't it?

        • Good morning,
          in this case, in general, a Notified Body must be involved in the certification of the product.
          Best regards
          Sicom Testing Staff

    • Good morning Sergio.
      The involvement of the Notified Body is in fact mandatory in the cases provided for by the Directives. However, for products that fall outside the cases expressly indicated, the intervention of a Notified Body is necessary if the harmonized standards have not been applied in full.
      Best regards
      Staff Sicom testing

  8. I have a special product (socket-plug). But there is no harmonized or local standard for this. The voltage of the product is 220-240 V. If I simply apply Annex I of the LVD Directive, is this sufficient for CE marking?

    • Good morning Serkan,
      Electrical plugs and sockets for domestic use are excluded from the scope of the LVD, as described in Annex II. However, if your product is intended for industrial use and/or powered in some way, it must be tested to verify its compliance with the applicable requirements. For further information, write to us at info@sicomtesting.com
      Best regards
      Sicom Staff

  9. Good morning,

    I wanted to ask for information regarding the updating of the harmonized standards. In particular to the Machinery Directive. How can I check for a possible update to the list? As of today, what was published in the gazette on 03/09/18 should apply. How can I check if there have been any updates to that list?

  10. Good morning,

    Once the directive (or directives) applicable to a product has been identified, how can we trace the harmonized standards relating to the directive?

    • Good morning Alexander,
      thanks for contacting us.
      The harmonized standards relating to the directives are published in a list in the European Official Journal. The lists are available online on the Commission website.
      Sicom testing can help you identify the standards applicable to your product and perform the relevant tests. To receive a quote you can write to us here https://www.sicomtesting.com/richiesta-di-preventivo/.
      Best regards
      Sicom Staff


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