Harmonized standards and European Directives for CE marking

Harmonized standards and European Directives for CE marking

What are harmonized technical rules?

The harmonized standards are standards in which it is described how to verify the requirements laid down by the directives in the field of security, health and environmental safeguard.

Who harmonized standards are developed?

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

What it is determined in the harmonized standards?

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

The full application of harmonized standards allows the manufacturer to place the product on the market without previously subjecting the technical construction file to a notified body.
This allows for, independently, the CE certification of products and the drafting of EU declaration of conformity.
The producer who is suitably equipped can perform the tests in its own laboratories or they will turn to a referral laboratory.

Measurements and calculationsThe EC Directives have compulsory nature?

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

The EC standards are voluntary?

the term “volunteer” there is still confusion.
The EC Directives do not make it mandatory to adopt the harmonized standards, however it is always necessary to prove the compliance of the product with the requirements of the directives applicable to the product.
You can in fact choose other technical and procedural solutions to comply with the essential requirements set out in Directives. These solutions typically require more in-depth technical assessments and the involvement of a Notified Body. Although most challenging, the latter is the only feasible in the case of products which due to their technical characteristics can not be evaluated by applying to the entire harmonized standards.

When you contact a Notified Body?

The intervention of a notified body is required when all the applicable harmonized standards are not executed in full. The costs in this case are more especially because the test methods outside the standard should be evaluated in advance, developing and developed.

What is the fastest route to get the CE mark?

The quickest route, less expensive and more tutelante for the producer is the full adoption of all harmonized standards applicable to the product, in fact these 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 the certificazione CE of products.


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

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28 comments on “Harmonized standards and European directives for CE marking”

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

    • Good morning,
      Yup, the manufacturer must prepare a technical documentation dossier for the machinery he produces, the dossier must contain (Annex VII – part A):
      a)a composite construction file:

      —a general description of the machinery,

      —an overall drawing of the machinery and diagrams of the control circuits, 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., enabling the conformity of the machinery with the essential health and safety requirements to be verified,

      —the risk assessment documentation to demonstrate the procedure followed, Included:

      the)a list of the essential health and safety requirements applicable to the machinery,

      Ii)the protective measures implemented to eliminate the identified hazards or to reduce the risks, and, I know about the case, an indication of the residual risks associated with the machinery,

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

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

      — a copy of the instructions of the machinery,

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

      —where applicable, a copy of the EC declaration of conformity of the machinery or other products incorporated in the machinery,

      —a copy of the EC declaration of conformity;

      b)in the case of series manufacture, the internal provisions which will be applied to maintain the conformity of machinery with the provisions of this Directive.

      Kind regards
      Sicom Test

  2. I was reading the content of this site and it actually 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 example or format of technical dossier or datasheet and conformity assessment of a product that I can share so that it can serve 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 content of the dossier is indicated in the guidelines (for 2014/53 / EU – RED is indicated in the attachment 5).
      The composition itself is quite simple but some expertise is required to verify the adequacy of the various documents, for this reason many customers prefer to entrust its preparation to us.
      Greetings Sicom Test

  3. Howdy, I am RSPP in a cleaning service company in the healthcare environment, given the delicate moment we are living in, I was faced with a problem of cleaning and sanitizing the electromedical equipment, DEFIBRILLATORS, ECODOPLER, CARDIOLINI, being equipment in direct contact with the patient and emitting electrical voltages, given their delicacy, sanitation would not be the responsibility of authorized personnel for use

    • Good morning.
      I think you should follow the cleaning instructions in the user manuals of these tools. Precautions related to the chemicals used should also be applied. In addition, 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

    • Good morning,
      EN standard 54-22 It is not harmonized standard.
      The EN standard 54-5 it 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 application, in full and successfully, of the harmonized standards listed in the European Official Gazette, that are suitable for the product and to 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 the presumption of compliance with the directives.

      Greetings from Sicom Testing

  4. Good morning
    I wanted to ask a question to find out if I'm right. I want to carry the CE marking of a low-voltage industrial machine. I identified the relevant directives which in this case would be machines, Electromagnetic compatibility and voltage limits. To ensure compliance with the Machinery Directive, I understand that I must refer to EN 60204-1 I have already acquired AENOR but for compliance with electromagnetic compatibility, appear different rules that would apply in this Directive and wanted to know if I need to get all these rules to ensure compliance and if I'm correct in everything that I said.
    A greeting.

    • Dear Ismael,

      For the Machinery Directive must carry out a risk assessment in accordance with EN / ISO standards 12100. All the risks identified should be evaluated and where can you do it using harmonized standards such as EN 60204-1.
      For the EMC Directive must perform the tests according to harmonized standards for immunity and emissions test, Radiated and Conducted.
      The low voltage directive (LVD) It does not apply when applying the Machinery Directive, however, its requirements are called directly by the Machinery Directive.

      Good work by Sicom Testing

  5. Good morning,
    The EN standard 16012/2015 It 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 svilupato is to create a common understanding of some aspect of the product. For example dimensional aspects, aspects of quality or safety aspects.
      These standards can be used to adjust for the sale or to declare the type or quality of a product to the customer.
      Some standards are assessed capable of demonstrating the compliance of a product with the requirements of a European directive, in these cases are included in the list of harmonized standards that Directive.
      To date, EN standard 16012 It is not harmonized standard, so it can not be used alone to demonstrate the conformity of a product with the requirements of Directive.
      good job
      Sicom Testing

  6. Hello,

    am I right with the assunption that a new or revised standards can be counted as harmonized once published by one EU member state ?
    Is there a reliable statement about this which can be cited ?

    • Good morning,
      a harmonized standard can be considered as such when published in the EU Official Journal.
      Staff Sicom Testing

      • Hello,

        But I think it is possible to adopt a new or revised standard once published by national standard organisation in one EU member state even if the standard or its revision is not yet listed in the OJ of the EU? Being an early adaptor fulfill the requirement to design products according to latest technical developments (state-of-the-art). Or, theoretically, can I get problems if I list up standards not yet listed in the OJ ? Basically I’m free how to demonstrate compliance. I need to be able to explain my approach. State-of-the-art approach is a good argument, isn’t it ?

    • Hello Sergio.
      The involvement of the Notified Body is indeed mandatory in cases prescribed by the Directives. However, for products that go beyond the cases expressly indicated, the intervention of a Notified Body is necessary if they have not been applied in full harmonized standards.
      Staff Sicom testing

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

    • Good morning Serkan,
      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 should be tested to verify its compliance with the applicable requirements. For more information, write to us at info@sicomtesting.com
      Kind regards
      Staff Sicom

  8. Good morning,

    I wanted to ask a question about the updating of harmonized standards. In particular the Machinery Directive. How can I check a possible update of the list? To date it should apply as published in the Gazette on 09/03/18. How can I check if you have run the updates to that list?

  9. Good morning,

    once identified the Directive (or directives) applicable to a product as can be traced back to the harmonized standards relating to the directive?

    • Good morning Alessandro,
      thanks for contacting us.
      The harmonized standards relating to 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 rules applicable to the product and perform the tests. To receive a quote can write here https://www.sicomtesting.com/richiesta-di-preventivo/.
      Staff Sicom

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