| Course Unit Code | 040-0156/01 |
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| Number of ECTS Credits Allocated | 4 ECTS credits |
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| Type of Course Unit * | Compulsory |
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| Level of Course Unit * | Second Cycle |
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| Year of Study * | First Year |
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| Semester when the Course Unit is delivered | Summer Semester |
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| Mode of Delivery | Face-to-face |
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| Language of Instruction | Czech |
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| Prerequisites and Co-Requisites | Course succeeds to compulsory courses of previous semester |
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| Name of Lecturer(s) | Personal ID | Name |
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| VEZ01 | Ing. Hana Věžníková, Ph.D. |
| DRA156 | Ing. et Ing. Vendula Laciok, Ph.D. |
| Summary |
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| The subject deals with the certification system as a tool for assessing a safe product and the role of legal entities involved, including the activities of control organizations. The course introduces the process of analyzing conditions that affect the safe functioning of the product when used in professional conditions. Provides an overview of sources of information such as technical regulations and technical documentation of the manufacturer. The course introduces the system of classification of products and the conditions in which they are used with regard to the potential danger. |
| Learning Outcomes of the Course Unit |
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| Gaining knowledge about methods of ensuring the safety of products placed on the market and put into operation in the EU and in the Czech Republic. Analysis of technical regulations requirements for products used professionally, with regard to conditions of use, especially when working in potentially explosive atmospheres. Application of technical documentation data to determine the safe operation of the product with respect to safety and health and environmental protection. |
| Course Contents |
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1. INTRODUCTION TO THE PROBLEM
Objectives of EU policy focusing on the creation of a single internal market and a system of regulations to ensure the safety of non-food products when they are placed on the market. Product safety assessment methods - definition of basic terms, consumer and user protection, connections with environmental protection and health and safety
2.LEGAL REGULATIONS RELATING TO PRODUCT SAFETY
An overview of harmonized EU regulations in relation to a safe product when it is placed on the market, individual phases of the regulation of the free movement of goods and their importance for the modernization of market surveillance, the creation of CR regulations for product safety
3. REGULATIONS OF THE CZECH REPUBLIC ON GENERAL PRODUCT SAFETY
Purpose of the regulation, basic definitions, assessment procedure for products from regulated and unregulated areas, legal entities responsible for the safety of the product when it is placed on the market, monitored criteria for safety assessment and accompanying documentation for the product, obligations of state administration bodies and local self-government bodies, supervisory authorities and their authorization during product safety control, notification obligation, Safety Gate system
4. REGULATIONS OF THE CZECH REPUBLIC FOR THE SAFETY OF CERTAIN PRODUCTS
Technical requirements for a safe product, laws and implementing regulations issued for conformity assessment of specified products, regulated and unregulated sphere, harmonization of regulations, comparison of technical regulations and standards
5. TECHNICAL STANDARDS AND THEIR USE
The process of standardization and the importance of standards for the unification of requirements for products, types of standards and their application in the evaluation of product safety, technical standardization commissions, technical standards as a source of information for determining the safe function of the product, the subject and methods of product inspections
6. PARTICIPANTS IN THE SUPPLY CHAIN AND THEIR OBLIGATIONS
Definition of economic entities that have responsibility for the safety of products placed on the market, measures to ensure that the production process ensures compliance of products with the requirements of technical regulations, the obligation to transfer information about detected non-compliance to internal supervisory authorities.
7. REQUIREMENTS FOR PRODUCTS
Basic requirements in regulations and standards, requirements for traceability, technical documentation, specific requirements for instructions for use, EU declaration of conformity, product labeling
8. ASSESSMENT OF COMPLIANCE OF PRODUCT PROPERTIES WITH THE REQUIREMENTS OF THE REGULATIONS
Modules for conformity assessment and their meaning and application and selection, entities performing conformity assessment, their types and duties, the administrative authority for conformity assessment, its tasks and powers,
9. ACCREDITATION AND AUTHORIZATION OF CONFORMITY ASSESSMENT ENTITIES
The legal framework for accreditation at the national and EU level, its principles and practical application, the system of national accrediting bodies within the EU and the national accreditation organization in the Czech Republic, mutual evaluation and labeling of protocols, the authorization system, notified bodies and their European NANDO database
10. METHODS OF PROVING CONFORMITY WITH REQUIREMENTS FOR A SAFE PRODUCT
An overview of the procedure of the manufacturer or his authorized representative in demonstrating conformity, sources of information for the assessment procedure, including the ÚNMZ Bulletin, amendments to regulations and standards.
11. REQUIREMENTS FOR SAFETY OF MACHINE EQUIPMENT
Overview of legislation, analysis of the structure of the government regulation as a typical regulation for product safety assessment, basic definitions, overview of product groups to which the regulation applies, basic requirements and their connection with the wording of standards, hierarchy of standards
12. SAFETY REQUIREMENTS FOR EQUIPMENT AND PROTECTIVE SYSTEMS INTENDED FOR ENVIRONMENTS WITH A DANGER OF EXPLOSION
Legislative regulations, their structure and subject of regulation, entities performing conformity assessment, classification of products intended for explosive atmospheres, connection with environmental classification
13. SPECIFIC TYPES OF HAZARDS FOR SELECTED PRODUCTS
Products as sources of initiation of explosion and fire, influence of the environment on products, classification of products and design of their use with respect to the environment, properties threatening the environment and protection against them, liability for damage caused by the product
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| Recommended or Required Reading |
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| Required Reading: |
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1. Evropská komise. Sdělení komise „Modrá příručka“ k provádění pravidel EU pro výrobky 2016 (Text s významem pro EHP). [online] Úřední věstník Evropské unie, OJ C 2016/272. [cit. 21. 9. 2017] Český překlad. http://eur-lex.europa.eu/legal-content/CS/TXT/PDF/?uri=OJ:C:2016:272:FULL&from=EN
2. Evropská unie. Směrnice Evropského parlamentu a Rady 2001/95/ES, ze dne 3. 12. 2001, o obecné bezpečnosti výrobků (Text s významem pro EHP). [online] (Úř. věst. L 11, 15. 1. 2002, s. 4) Konsolidované znění, český překlad. [cit. 21. 8. 2017]. http://eur-lex.europa.eu/legal-content/CS/TXT/PDF/?uri=CELEX:02001L0095-20100101&from=EN
3. Evropská Unie. Nařízení Evropského parlamentu a Rady (EC) 765/2008 ze dne 9. července 2008, kterým se stanoví požadavky na akreditaci a dozor nad trhem týkající se uvádění výrobků na trh a kterým se zrušuje nařízení (EHS) č. 339/93 (Text s významem pro EHP). [online] (Úř. Věst. EU L 2008/218, 9. 7. 2008, s. 30) český překlad. [cit. 12. 9. 2017]. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:218:0030:0047:cs:PDF
ÚNMZ. ŘÍRUČKA KE SMĚRNICI ATEX (druhé vydání – překlad), ÚNMZ: Praha, 2006
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1. Evropská komise. Sdělení komise „Modrá příručka“ k provádění pravidel EU pro výrobky 2016 (Text s významem pro EHP). [online] Úřední věstník Evropské unie, OJ C 2016/272. [cit. 21. 9. 2017] Český překlad. http://eur-lex.europa.eu/legal-content/CS/TXT/PDF/?uri=OJ:C:2016:272:FULL&from=EN
2. Evropská unie. Směrnice Evropského parlamentu a Rady 2001/95/ES, ze dne 3. 12. 2001, o obecné bezpečnosti výrobků (Text s významem pro EHP). [online] (Úř. věst. L 11, 15. 1. 2002, s. 4) Konsolidované znění, český překlad. [cit. 21. 8. 2017]. http://eur-lex.europa.eu/legal-content/CS/TXT/PDF/?uri=CELEX:02001L0095-20100101&from=EN
3. Evropská Unie. Nařízení Evropského parlamentu a Rady (EC) 765/2008 ze dne 9. července 2008, kterým se stanoví požadavky na akreditaci a dozor nad trhem týkající se uvádění výrobků na trh a kterým se zrušuje nařízení (EHS) č. 339/93 (Text s významem pro EHP). [online] (Úř. Věst. EU L 2008/218, 9. 7. 2008, s. 30) český překlad. [cit. 12. 9. 2017]. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:218:0030:0047:cs:PDF
ÚNMZ. ŘÍRUČKA KE SMĚRNICI ATEX (druhé vydání – překlad), ÚNMZ: Praha, 2006
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| Recommended Reading: |
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1. Nařízení vlády č. 406/2004 Sb. o bližších požadavcích na zajištění bezpečnosti a ochrany zdraví při práci v prostředí s nebezpečím výbuchu
2. ÚNMZ. Technické normy a Vaše podnikání. Jak profitovat z užívání technických norem při Vašem podnikání a jak se zapojit do aktivit technické normalizace.[online] Přeložil a doplnil P. KUBEŠ. Sborníky technické harmonizace 2014. .[cit. 21. 7. 2017] Praha: ÚNMZ, 2014
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1. Nařízení vlády č. 406/2004 Sb. o bližších požadavcích na zajištění bezpečnosti a ochrany zdraví při práci v prostředí s nebezpečím výbuchu
2. ÚNMZ. Technické normy a Vaše podnikání. Jak profitovat z užívání technických norem při Vašem podnikání a jak se zapojit do aktivit technické normalizace.[online] Přeložil a doplnil P. KUBEŠ. Sborníky technické harmonizace 2014. .[cit. 21. 7. 2017] Praha: ÚNMZ, 2014
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| Planned learning activities and teaching methods |
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| Lectures, Tutorials |
| Assesment methods and criteria |
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| Task Title | Task Type | Maximum Number of Points
(Act. for Subtasks) | Minimum Number of Points for Task Passing |
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| Credit and Examination | Credit and Examination | 100 (100) | 51 |
| Credit | Credit | 30 | 16 |
| Examination | Examination | 70 | 35 |