Harmonized Regulations and Standards in the EU

Harmonized Regulations and Standards in the EU

Harmonizing in the EU Harmonizing in the EU means adjusting the regulations for the individual EU countries so that they match. For technical products, the requirements of the products are standardized to prevent problems with trade. To harmonize the technical requirements, EU guidelines are created to adjust the regulations so that they match. These guidelines define basic requirements that products must meet if they are going to be traded within the EU.

EU Guidelines

The EU guidelines are not regulations because regulations cannot be made at EU level. But this is only a formality because the EU country is required to add the contents of the EU guidelines to the national regulations. Therefore the requirements defined in the EU guidelines – sooner or later – will be regulations throughout the EU. Examples of EU guidelines are: Machine guidelines, low voltage guidelines, EMC guidelines, guidelines for toys, etc.

Local regulations must be observed! NOTE: Inform yourself about local regulations and valid standards in addition to the information provided in this manual. This manual only provides an overview.

Relevant Guidelines for PLC Users The following guidelines are valid for EMC and the safety of electrical equipment  Low voltage directive Guideline 73/23/EEC from the directive of February 19th 1973 to adjust the regulations of the EU countries concerning electrical equipment for use within certain voltage limits  Machine directives Guideline 98/37/EC from the European Parliament and the directive on June 22nd 1998 to adjust the regulations and administrative directives of the EU countries concerning machines  EMC guidelines Guideline 89/336/EEC from the directive on May 3rd 1989 to adjust the regulations of the EU countries concerning electromagnetic compatibility

Conformity Statement and CE Mark The manufacturer, or whoever trades the product in the EU, must confirm that the requirements of the respective guideline are met in a conformity statement. A CE mark is also required for the products. NOTE: The conformity is normally tested and confirmed by the manufacturer. The CE mark is applied to the product by the manufacturer. For certain products with a high potential for danger, the tests must be carried out by an external test lab (e.g. for presses or woodworking systems).

Harmonized Standards

Harmonized European standards are standards created by the European standardization organizations CEN and CENELEC and are recognized by the EU as being harmonized standards. These standards define how the conformity to the requirements of the EU guidelines can be achieved. Each guideline has a group of harmonized standards.

Role of harmonized standards

If these standards are used, it can be assumed that conformity is guaranteed. However, the standards do not have to be met according to law. If the requirements of the guidelines or the corresponding national regulations are met in other ways, this is also allowed. Using the standards has the advantage that it is easier create a conformity statement and to confirm conformity in a court of law.

NOTE: However, using the standards is not enough. The standards are only the minimum requirements. They only represent the level of technology compared to the far reaching state of science and technology

Types of Standards There are three types of European standard documents:  European standard (EN...) A European standard is the basic goal. An EN is a European technical regulation created by CEN or CENELEC in cooperation and with the consent of the parties concerned from the EU countries. European standards must be added to the national standards without being changed. National standards which do not match are to be withdrawn.  Harmonizing document (HD...) Harmonizing documents can be created in place of European standards if integration identical national standards is unnecessary, or if the only way to achieve agreement is by permitting national differences.  European preliminary standard (ENV...) The European preliminary standard (ENV) was created by CEN and CENELEC to allow definitions to be made quickly which can be used immediately, especially in areas with a high degree of innovation (e.g. IT). The standards are classified in the following types according to the area of application:  Type A (general standards) They contain technical regulations which are not product specific.  Type B (group standards)  Type C (product standards) They contain technical regulations for certain products or product families. Product standards may only complement - and not override - general standards.

Product Standards Product standards are valid for certain product groups. A product standard also contains references to the general standards which are valid to the product. Grouping requirements of various types in a document for a certain product group reduces the overhead for the manufacturer.

NOTE: Requirements from product standards take precedence over requirements from general standards.

Example: The product standard for programmable controllers and peripheral devices is EN 61131.