Relationship between standards and other publications
Standards are closely related to several European Union legal
acts. Finnish legislature may also contain references to standards. EU legal
acts are regulations, directives or decisions. Regulations are implemented
without modifications in all EU countries. Each member country can enforce
directives in a manner that best suits them. Decisions apply to the enterprises
or member countries at which they have been addressed. In addition, standards
are mentioned in several EU documents (communications, green papers,
resolutions etc.) that are not legally binding.
New Approach directives only define the essential requirements related to health, safety, consumer protection and environmental issues, and the alternatives for attesting conformity. Older directives used to include detailed technical regulations. Most Old Approach directives relate to motor vehicles and food.
The technical details or specifications required for producing and marketing products in accordance with the directive's requirements are now presented in European harmonized standards. These are European standards prepared under a mandate given by the European Commission and/or EFTA and cited in the Official Journal of the European Union.
However, technical specifications prepared in this manner are not mandatory but hold the status of a voluntary standard. National authorities shall, however, recognize that products manufactured according to harmonized standards conform to the safety requirements given in directives. Thus, these products may be marketed and sold across national borders.
Because using standards is voluntary, products are not always manufactured according to standards. In such cases, the manufacturer shall use other means to prove that the product complies with the essential requirements of directives.
New approach directives do not refer to individual standards but to harmonized standards in general. Old approach directives, instead, refer to several individual European standards.
EU General Product Safety Directive applies to products that are not covered by a specific directive. Standards related to the General Product Safety Directive are listed in the Official Journal. No compulsory marking is associated with the General Product Safety Directive.
Finnish regulations on electric work safety state that the work complies with the statutory safety requirements if it is conducted in accordance with standards. The Finnish Safety and Chemicals Agency (Tukes) maintains a list of these standards.
Several national and EU regulations contain references to individual standards. A standard can be made mandatory by a reference, or it can be considered as an example of a solution that fulfils the regulation's requirements.
Products covered by New Approach directives are labelled with a CE marking. There are over 20 New Approach directives. Low Voltage Directive, published in 1973, is also considered to be a New Approach directive, although it was prepared 10 years prior to the decision of the Council of the European Union to introduce New Approach to technical harmonization. In addition, CE marking is used in among other things machinery, medical equipment, toys, pressure equipment, personal protective equipment, radio equipment and telecommunications terminal equipment.
More information on CE marking
ISO and CEN standards may include technology protected by patents,
if this is considered necessary at the time the standards are drafted. However,
the patent holder shall grant a license on the protected technology on a
worldwide (for ISO standards) or European-wide (for CEN standards) basis and
under fair, reasonable, and non-discriminatory (FRAND) terms.
A product protected by a patent may comply with a standard, but the standard may still be freely used. Product protection is defined in the patent.
A certificate indicates that a product or a
system complies with the requirements of a specific standard. Certificates are
granted by certification bodies, some of which are accredited.
SFS sells standards presenting the requirements for a product or a system but does not act as a certification body. Information on accredited certification bodies operating in Finland can be found on the web page of the Finnish Accreditation Service (FINAS).