CE Marking: Know your standards
LSR’s Test Services Division commonly answers questions regarding selecting the appropriate standards for demonstrating conformity to the essential requirements of the EC Directives when CE Marking a product. So, we thought we’d put together a quick blog to identify some terminology and provide a basic explanation to the hierarchy of requirements. For these examples, we’ll use the EMC Directive 2004/108/EC, but the steps are similar regardless.
First, It is important to understand CE marking and how it relates to conformity. Directive 93/68/EEC establishes the scope, structure, and application for CE Marking, which is the official terminology as specified by the EU (in lieu of the term “CE Mark”); and signifies Declaration of Conformity by the manufacturer. By CE Marking a product, the manufacturer is declaring conformity with the Essential Requirements of all relevant European health, safety, and environmental protection legislation; as outlined in the EC Directives; however, it is up to the manufacturer to determine which Directives are applicable. The terminology used for this is Self-certification and is part of the New Approach method of standardization.
Currently, there are 32 countries that participate in the New Approach, perform market surveillance, and require CE marking. Though manufacturers may receive assistance when determining which directives (and subsequent standards) are best suited for a conformity assessment, it is ultimately the responsibility of the manufacturer to construct the Declaration of Conformity and provide a subsequent record supporting these declarations, if requested by market surveillance authorities. Consequently, it is important that once a directive is determined as applicable to the product being considered for conformity assessment (such as the EMC Directive, for example, in this blog); the essential requirements can then be identified.
Second, let’s review a basic understanding of the classifications and hierarchy of requirements. Article 6 of 2004/108/EC paragraph 2 identifies using the Official Journal of the European Union (OJEU) to identify all relevant harmonized standards, which upon application would satisfy the essential requirements of Annex 1 of the EMC Directive. The EC Directives comprise the legislative requirements that conformity must be declared to, and the OJEU is a listing of harmonized standards that’s accepted by the member states as satisfying all of these essential requirements.
These Harmonized Standards are Product, Product Family, or Generic; and provide the Technical Specifications relevant to the device being tested. Product Standards are specific to the product being tested, think: electrocardiographs; whereas Product Family Standards are specific to the type or class of product, think: medical electrical equipment; and Generic Standards are based on the applicable product environments (such as Residential or Industrial) rather than product type, and are to be utilized when no applicable product family standards are available.
Third, Basic Standards provide test methodology and arrangement; they don’t specify requirements. Because there are no technical requirements in a basic standard, they do not appear in the OJEU. As a result, it’s important to note that making declarations of conformity to Basic standards are unnecessary.
So, the legislative requisites are contained in the EC Directives in the form of essential requirements, and reference a list of harmonized product, product family, and generic standards that provide recognized technical specifications used for demonstrating conformity in the 32 member-states of the EU; some technical specification will contain specific methodologies, or they may reference basic standards which outline the test arrangement and general methods to be used. The image below is a visual outline of this hierarchy:
It is also important to note that compliance to the harmonized standards is not compulsory. There are alternative for demonstrating compliance beyond using the harmonized standards contained in the OJEU. This process, for example for the EMC Directive 2004/108/EC it’s outlined in Annex III, consists of constructing technical documentation submitted to a Notified Body (as defined in Article 12 of 2004/108/EC) for a conformity assessment.
In closing, proper conformity assessment for a product according to the requirements put forth by the European Union and member states would include identifying all of the applicable directives outlined in the New Approach. As an example, when applicable, the EMC Directive 2004/108/EC requires that the essential requirements of Annex 1 are observed: either through compliance to the generic, product family, or product specific standards specified in the Official Journal of the European Union, or via an assessment of a manufacturer’s technical file by a notified body which demonstrates an equivalency. In the event that the harmonized standards of the OJEU are utilized for the Declaration of Conformity, member states do agree to a presumption of compliance.
Understanding the different types of standards and relationships between them is an essential component in understanding which requirements will be applicable for conformity to the EMC Directive, and only upon demonstrating compliance with ALL the applicable directives of the New Approach can a product be subject to CE marking.
LSR has an accredited test facility, and has provided guidance in design services and European conformity assessment for over 30 years. LSR is also recognized as a Conformity Assessment Body, and as such can provide Notified Body services to any of our customers for both the EMC (2004/108/EC) and R&TTE (1995/5/EC) Directives.