Phare SL Implementation of Technical Regulations on Company Level Breakout session EMC DIRECTIVE Expert: Heinz Wanda Chamber of Commerce and Industry, Ljubljana

Phare SL EMC Directive Council directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility amended by Directives 91/263/EEC, 92/31/EEC,93/68/EEC, 93/97/EEC EMC Directive

Phare SL first published in 1989 it had to be transposed into national law by 1. July 1991 its provisions have applied since 1. January 1992 however a longer transition period was necessary the Council adopted Directive 92/31/EEC with a view to allowing a transitional period until 1995 as of 1. January 1996, Member States have abolished national regulations still in force the EMC Directive is a total harmonization Directive EMC Directive History

Phare SL Objective of the Directive  to ensure that the electromagnetic disturbances produced by electrical and electronic apparatus do not affect the correct functioning of other apparatus  to ensure that the apparatus has an adequate level of immunity to electromagnetic disturbances to enable it to operate as intended  this reflects the essential requirements as indicated in Article 4 EMC Directive

Phare SL  the Directive applies to apparatus liable to cause electromagnetic disturbances or the performance of which is liable to be affected by such disturbances  when EMC provisions are specified for certain products in other directives these directives shall apply  equipment of radio amateurs is excluded unless the apparatus is available commercially EMC Directive Scope

Phare SL Definitions EMC Directive apparatus all electrical and electronical appliances together with equipment and installations containing electrical and/or electronic components finished product any device that has a direct function, its own enclosure and - if applicable - ports and connections intended for enduser

Phare SL direct function any function which fullfills the intended use specified by the manufacturer in the instructions for the enduser. This function can be available without further adjustment or connections other then simple one passive EMC equipment equipment when used as intended does not create or produce any switching or oscillation of current or voltage and is not effected by electromagnetic disturbances (no active parts) Definitions EMC Directive

Phare SL Guide to the application of Directive 89/336/EEC  manual for all parties affected by the EMC Directive  aid for the interpretation of the Directive  not replacing the Directive which is the only legally binding text  agreement by consensus of Member States Governments experts will ensure free movement of goods. main issues:  scope  application to components, systems installations  application to used, repaired products, spare parts  conformity assessment procedures  competent authorities  application of the Directive in specific cases EMC Directive

Phare SL EMC Directive Scope with some restrictions nearly all electrical or electronic devices fall into the scope of the EMC Directive explicitly listed (but not restrictive) are: household appliances fluorescent lighting luminaires fluorescent lamps industrial manufacturing equipment information technology equipment domestic radio and television receivers (radio and television broadcast transmitters) aeronautic and marine radio equipment educational electronic equipment (telecommunication apparatus) etc.

Phare SL Exclusion by " practical criteria"  the emission level is by the inherent physical characteristic below the most stringent limits  immunity: experience shows that there is no influence when used in the intended electromagnetic environmentExamples  protection equipment which only produces transitory disturbances of short duration and which does not include electronic components (fuses, circuit breakers)  manual switches  high voltage inductors, transformers  capacitors  induction motors  quartz wrist watches  filament lamps (bulbs) EMC Directive

Phare SL Apparatus totally excluded  not commercially available radio equipment for radio amateurs  motor vehicles  active implantable medical devices  medical devices (now completely)  in vitro diagnostic devices  equipment intended for aircraft in flight  marine equipment (after 31 December 1998 completely) EMC Directive

Phare SL special provisions for certain types of equipment  components  finished products  systems  installations elements to select the right procedure  direct function  intention to put the product on the market as a "Single Commercial Unit" (SCU) EMC Directive Conformity Assessment

Phare SL applicableHarm.Standards transmitter technical documenttation type examination Declaration of conformity type approuval certificate cert.of a competend bdy technical construction file CE Marking Declaration of conformity D. n stop y n y n Conformity Assessment EMC Directive

Phare SL Components with direct function  the direct function is available without further adjustment, It may be placed on the market as an SCU  if further adjustment is necessary the component must not be placed on the market for end user examples plug in cards for computers programmable logic controllers lift controls electric motors computer disc drives power supply units fully subject to all provisions of the EMC Directive EMC Directive

Phare SL Components with direct function  If there is no intention to put the components on the market for final use or distribution  the manufacturer has only to deliver the relevant instruction to enable the operation within the apparatus in which they will be incorporated  no other element of the EMC Directive is mandatory EMC Directive

Phare SL Components without direct function examples resistors, capacitors, coils diodes, transistors, thyristors, triacs etc. integrated circuits cables and cable accessories all or nothing relays plugs, sockets, terminal blocks etc. light emitting diodes, liquid crystals etc. simple electromechanical thermostats the EMC Directive does not apply at all EMC Directive

Phare SL Finished Products When intended to be put on the market for final use and distribution fully subject to all provisions of the EMC Directive When not intended to be put on the market for final use and distribution only the relevant instructions have to be delivered to enable the operation within the apparatus in which they will be incorporated none of the other provisions are mandatory EMC Directive

Phare SL Systems for the purpose of the EMC Directive system is defined as a combination of several types of equipment, finished products and/or components combined, designed and put together by the same person (system manufacturer) intended to be placed on the market for distribution as a single functional unit for an end user and intended to be installed and operated to perform a specific task EMC Directive

Phare SL System assembled only of CE marked apparatus  Declaration of conformity for the whole system  instruction for the whole system  no CE Marking for the whole system System assembled also from apparatus without CE marking  Declaration of conformity for the whole system  instructions as well  one additional CE Marking on the main part is sufficient EMC Directive

Phare SL  combination of types of equipment, systems... assembled and/or erected by an assembler/installer at a given place to operate together in an expected environment but not to be placed as a SCU on the market the installation must comply with the Essential Requirements as defined in Article 4  such installation cannot enjoy free physical movement and in respect to the EMC Directive there is no need for CE Marking, Declaration of conformity or the intervention of a competent body  the manufacturer must provide clear instructions EMC Directive Fixed Installations

Phare SL description of the apparatus to which it refers reference to the specification under which conformity is declared and where appropriate to the internal measures implemented to ensure the conformity with the provisions of the Directive identification of the signatory where appropriate reference to the EC type-examination certificate issued by a notified body EMC Directive EC Declaration of Conformity

Phare SL Instructions for use they must accompany the apparatus content intended conditions for use assembly adjustment bringing into service maintenance where necessary, warning about limitation of use EMC Directive

Phare SL Technical construction file Part A  name and address of the manufacturer and the identification of the product  the list of harmonized standards followed by the manufacturer and/or the solutions adopted to satisfy the essential requirements  a description of the product  the operating instructions if any  the overall plan if any Part B  full file containing all test reports, information concerning the quality manual, plans, descriptions of the products and processes, standards applied etc. EMC Directive

Phare SL Criteria for competent and notified bodies (Annex II) availability of personnel and the necessary means and equipment technical competence and professional integrity of personnel independence in carrying out the tests etc. of staff and technical personnel in relation to all concerned with the product in question maintenance of professional secrecy by personnel possession of civil liability insurance unless such liability is covered by the State under national law EMC Directive

Phare SL Competent Body  fulfils the criteria of Annex II  presents a certificate by an accreditation body or an other documentary proof  to fulfil EN45000 series gives presumption of conformity  the recognition comes –either from an accreditation body recognized by the authority of a Member State –or from a body representing the supervisory authority of a Member State of the EEA  a manufacturers laboratory may become a competent body too EMC Directive

Phare SL Notified Bodies  have to fulfil the criteria of Annex II  are notified by the Member States under their own responsibility  are published in the Official Journal  are only entitled to issue EC type examination certificates concerning Article 10(5) EMC Directive

Phare SL Application to machines the EMC Directive is to be applied in parallel with the Directive on machinery  If manufacturer uses only CE marked electrotechnical products and strictly follows instructions, the finished machine may be considered in compliance with the EMC Directive and no further verifications will be needed  Declaration of conformity and instructions for the whole machine must be provided.  no extra CE Marking is mandatory if the manufacturer of the machine uses non-CE- marked products he has to follow the procedures for systems or installations EMC Directive

Phare SL Harmonized Standards  drafted under mandate by CENELEC  published in the Official Journal  give presumption of conformity Types  Basic Standards (mainly by IEC) dealing with methods to measure the phenomena  Generic Standards  Product Family Standards  Product Standards EMC Directive

Phare SL Implementation of Technical Regulations on Company Level Breakout session Low Voltage Directive (LVD) Expert: Heinz Wanda Chamber of Commerce and Industry, Ljubljana

Phare SL ELECTRICAL EQUIPMENT DESIGNED FOR USE WITHIN CERTAIN VOLTAGE LIMITS Directive 73/23/EEC Low Voltage Directive Low Voltage Directive (LVD)

Phare SL History:  Adopted 19 February 1973 to harmonize the laws of the Member States in the field of safety for electrotechnical products.  Amended in 1993 by Directive 93/68/EEC to align it better with the New Approach philosophy Kind of directive:  LVD is a "total" harmonization directive, it superseded existing national regulations Objective:  Member State may not impede free circulation of conforming equipment Low Voltage Directive

Phare SL Scope all electrical equipment designed for the use with a voltage rating between 50 V to 1000 V ac or75 V to 1500 V dc (input or output voltages) Exclusions (covered by other Directives) Electrical equipment for use in potentially explosive athmospheres Electrical equipment for radiology and medical purposes Electrical parts for lifts Electrical meters Radio and Telecommunication terminals equipment Low Voltage Directive

Phare SL Exclusions (not covered by other Directives)  Plugs and socket outlets for domestic use  Electric fence controller  Specialized equipment for the use on ships, aircrafts and railways compliant with special international standards. Low Voltage Directive

Phare SL (consumer and capital goods) particular electrical appliances hand held tools lighting equipment switch gear control gear electric wiring appliance couplers cord sets electrical installation equipment cable mangement systems Low Voltage Directive Examples of equipment

Phare SL Essential requirements:  Equipment when constructed in accordance with good engineering practice in safety matters endorsed in the Community shall not endanger the safety of  persons domestic animals or property  when properly installed and maintained and used in applications for which it was made The principal safety objectives are listed in Annex I. Low Voltage Directive

Phare SL Annex I :Principal Elements of Safety Objectives  General conditions (e.a. information to be affixed to the product)  Protection against hazards arising from the elctrical product against danger of physical injury or harm caused by electrical contact to prevent dangerous temperatures, arcs or radiations against non-electrotechnical dangers to ensure that the insulation is adequate for all foreseeable conditions Low Voltage Directive

Phare SL Annex I: Principal Elements of Safety Objectives  Protection against hazards which may be caused by external influences external mechanical shock against non-mechanical influences against overload Low Voltage Directive

Phare SL Safety Aspects Summary A L L risks arising from the use of electrotechnical products are covered N O T J U S T E L E C T R I C A L ones, but also  mechanical  chemical  health aspects of noise and vibrations  ergonomic requirements to protect against hazards of the Directive  and all other safety risks Low Voltage Directive

Phare SL Conformity of products to the LVD  products are presumed to conform if the equipment was manufactured in accordance with technical standards in the order laid down as follows: (1) European Standards;( EN or HD by CENELEC) (2) International standards (by IEC) (3) National standards of the Member State of the manufacturer  The presumption of conformity provided by harmonized Standards arises at the moment of national publication of the standard Low Voltage Directive

Phare SL Coformity Assessment Procedure (Art.8,Annex IV) –Only the manufacturer or his authorized representative can ensure and declare the conformity with the LVD  Harmonized Standards used –technical documentation –internal production control –(report of a notified body) voluntary –Declaration of conformity –CE Marking  Harmonized Standards not used no presumption of conformity –technical documentation must include the description of the solutions to satisfy the ES Low Voltage Directive

Phare SL Conformity Assessment Procedure  technical documentation general description design and manufacturing drawings description and explanation needed to understand the drawings and the operation of the equipment the results of design calculations and of checks carried out etc. test reports (may be made available by the manufacturer or by a third party)  the technical documentation must be kept within the Community by the manufacturer, his authorized representative or the "importer" Low Voltage Directive

Phare SL Report by a notified body (Art.8/2)  In case of challenge by the authorities or before placing on the market a report by a notified body is considered as an element of proof  the notified bodies are published in the Oficial Journal  the main purpose is to provide favourable conditions for innovative products where no Harmonized Standards exist. Low Voltage Directive

Phare SL Declaration of conformity  name and address of the manufacturer or his authorized representative  description of the technical equipment  reference to harmonized standards  where appropirate reference to the specification on which conformity is declared  identification of the signatory  the last two digits of the year in which the CE marking was affixed for the first time Low Voltage Directive

Phare SL National and European Marks  VDE, NF,S,ÖVE etc. continue to exist in the market place Before the amendment of the LVD in 1995 these marks where mentioned in the LVD as one of the possibilities to prove to the authorities the compliance of the product with the LVD now the marks have lost all legal value !  they are only voluntary marks the added value of the marks is still  guarantee of third party type examination  production surveillance by neutral experts Big retail-chains e.g. continue to ask for those marks in addition to the legally required CE Marking Low Voltage Directive

Phare SL Relationship to the Directive on "Machinery"  in article 1(5) of that Directive certain electrical equipment is excluded, if the risks are mainly of electrical origin  the manufacturer has to carry out the usual risk assessment (e.a. EN 1050)  Assistance in this decision is given by the publication of harmonized standards for the product in question under the LVD only Low Voltage Directive

Phare SL Relationship with the Directive on "Machinery"  Where a machine has an electrical supply (within the voltages of the LVD) the LVD has to be fulfilled by the machine concerning the electrical risks, including the assessment procedures (Manufacturer Declaration e.a.)  For the non-electrical risks the conformity assessment procedures of article 8 of the "Machinery Directive" apply Low Voltage Directive

Phare SL Guidelines on the Application of Council Directive 72/23/EEC  to facilitate the application  not legally binding but consistent interpretation  complementary to the "Guide to the implementation of Community Harmonization Directives" published in 1994 main issues covered  scope of the LVD  safety requirements applicable  conformity assessment procedures applicable  relationship with certain other Directives Low Voltage Directive