European Technical Legislation and Infrastructure (Modul B)

Higher education teachers: Begeš Gaber

Higher education teachers: , Drnovšek Janko
Credits: 6
Semester: summer
Subject code: 64260



Subject description

Prerequisits:

  • selection of course

Content (Syllabus outline):

  • Introduction (basics of European technical infrastructure)
  • Basic definitions (quality, standardization, accreditation, etc.)
  • 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.

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.

Intended learning outcomes:

skills of useing domestic and foreign literature and standards, directives and legal documents, collecting and interpreting technical procedures, implementation of technical documents in real projects, use a variety of methods for solving technical problems, interpretation and evaluation of test results, a broad knowledge of problem analysis and solving them structured with the aim of improvements

Learning and teaching methods:

  • Lectures, exercises, seminar work.





Study materials

  • www.sist.si, www.iso.org, www.iec.ch, www.iecee.org, www.cenelec.org, www.itu.int, www.cenorm.be, www.gov.si/sa, www.ilac.org, www.mirs.si, www.euramet.eu, www.wto.org, www.ansi.org, http://ts.nist.gov, www.conformityassessment.org, www.wssn.net, www.oiml.org, www.asq.org, http://ec.europa.eu/enterprise/newapproach/
  • http://ec.europa.eu/enterprise/newapproach/index_en.htm
  • Drnovšek, J.; Pušnik, I.; Bojkovski, J.; Begeš, G.; Kakovost sistemov. Ljubljana: Fakulteta za elektrotehniko 2007
  • 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
  • Lou Chen: Quality Function Deployment, Addison Wesley Longman, 1995
  • A.J.Marlow: Quality control for Technical Documentation, Amazon, 2005
  • VIM - International Vocabulary of Terms in Legal Metrology (OIML, 2000)
  • Slovenski inštitut za standardizacijo: SIST EN 45020 - Standardizacija in z njo povezane dejavnosti - Splošni slovar, 2007



Study in which the course is carried out

  • 1 year - 2nd cycle - Electrical Engineering - Electronics
  • 1 year - 2nd cycle - Electrical Engineering - Electrical Power Engineering
  • 1 year - 2nd cycle - Electrical Engineering - Biomedical Engineering
  • 1 year - 2nd cycle - Electrical Engineering - Control Systems and Computer Engineering
  • 1 year - 2nd cycle - Electrical Engineering - Mechatronics
  • 1 year - 2nd cycle - Electrical Engineering - Robotics
  • 1 year - 2nd cycle - Electrical Engineering - Information and Communication Technologies