Module B: European Technical Legislation and Infrastructure

Subject description

Introduction to basics of European technical infrastructure and definitions;

Directives and legislation (transposition, implementation, legislation system);

Standardization (standardization infrastructure, how to develop a standard, types, renewal, standard understanding);

Accreditation (infrastructure, preparations for accreditation, assessments, corrective actions);

Metrology (infrastructure, calibration, testing, legal metrology);

Conformity assessment (philosophy of new and global approach, CE marking of products, technical documentation for product);

Discussing generic (infrastructural) groups of standards (directives for documentation for quality systems and conformity assessment, etc.);

Assessment and quality management system certification;

European technical legislation in different fields (production, laboratory, services, environment, safety, health, etc.) and important EU technical directives, safety of electrical products, LVD (Low Voltage Directive), safety of medical technical systems (basics of electromagnetic compatibility – EMC in health, development of products according to EMC, EMC in hospitals, electromagnetic interference), etc.

The subject is taught in programs

Objectives and competences

The aim of the course is to get acquainted with basic technical requirements concerning European legislation that enables products and services to be placed on the common European and global market and at the same time free transfer of goods in all directions. Characteristic and the aim of the European technical legislation is to enable effective common market under the same conditions for all member states and at the same time presents protection from technically non-conform products and services. Knowledge on European technical legislation is indispensable part of modern engineering knowledge in EU studies. This includes learning on whole technical infrastructure from standardization, accreditation, metrology, total quality systems, assessments and certification of systems for achieving the best success. Student gets knowledge on legislation, technical requirements safety and European directives. A great emphasis is also put on environmental problematic connected to quality. The aim of the subject is to present activities and procedures, that manufacturer need to follow to be able to put CE mark (European directives conformity safety mark) on the product. Theoretical knowledge is consolidated with practical examples. Presented is EU practice and connection between legislation, quality and consumer protection.

Teaching and learning methods

Lectures, exercises, seminar work, excursion

Expected study results

After successful completion of the course students should be able to:

– use domestic and foreign literature, standards, directives and legal documents

– interpret technical procedures

– use technical documents in real projects

– interpret and evaluate test results

– analyze problems with different methods and address them structurally with the goal of improvement

– interpret the fundamental principles of EU technical legislation in real conditions

Basic sources and literature

  2. Drnovšek, J.; Pušnik, I.; Bojkovski, J.; Begeš, G.; Kakovost sistemov. Ljubljana: Fakulteta za elektrotehniko 2007
  3. J.M.Juran, F.M.Gryna, Quality planning and analysis, Mc Graw-Hill ISBN 0-07-112992-8
    • European Union Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (Medical Device Directive), Official Journal L 169
    • The Active Implantable Medical Devices Directive, (AIMDD) 90/385/EEC
    • In Vitro Diagnostic Directive, (IVD) 98/79/EC
  4. Lou Chen: Quality Function Deployment, Addison Wesley Longman, 1995
  5. A.J.Marlow: Quality control for Technical Documentation, Amazon, 2005
  6. VIM – International Vocabulary of Terms in Legal Metrology (OIML, 2000)
  7. Slovenski inštitut za standardizacijo: SIST EN 45020 – Standardizacija in z njo povezane dejavnosti – Splošni slovar, 2007

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