Medical standards

Lecturer:

Tutor:

Supervisor:

Department of Biomedical Technology

Synopsis:

The principle and the principles of health legislation. Act on Public Health. The law on competence to perform the medical profession and continuing education in health care (Law on the Professions) and its implementing regulations. EC Directive relating to the means of medical technology. Law on technical requirements for products. Government Regulation on the Law on technical requirements for products. The Atomic Act and its application in health care. Creation of technical standardization in the world, in Europe and in CR. The structure of institutions in the field of technical standards in healthcare. Technical standards relating to the means of medical technology. Practical application of laws, regulations and standards in clinical practice. Procedures for the introduction of new medical devices on the market. Clinical testing equipment. The role of the test. Some facts and experiences from abroad. Importance, principles and rules of so-called good manufacturing, laboratory and clinical practice (GMP, GLP and GCP). Industrial property and its protection (patents, designs). Legal protection of intellectual property. Technology centers, parks, spin: offs.

Binding regulations and electrical regulations. Risks and causes of accidents in electrical engineering. Professional qualifications in electrical engineering: Decree No. 50/78 Coll. Eligibility of persons by level of electrical skills, revision and control installations and electrical appliances. Standards relating to the above issues in question.

Requirements:

Syllabus of lectures:

Principles of formation of health legislation.

The law on professional qualifications.

EU directives.

Law on technical requirements for products.

Creation of technical standardization.

Procedures for placing medical devices on the market.

Clinical testing equipment.

The so-called. good manufacturing, laboratory and clinical practice.

Technology Center.

Injuries in electrical engineering.

Eligibility of persons by level of electrical expertise.

The Atomic Act and its applications.

Industrial property and its protection.

PoslechFonetický přepis

Syllabus of tutorials:

See themes: Following the lecture topics will be discussed in the form of exercise.

Study Objective:

The goal is to give students a basic overview of the principles and the principles of making health care legislation.

Another part of the course will be devoted to the issue of legal ties and electrical regulations. Students will be also acquainted with the risks and addressing the causes of accidents in electrical engineering.

Study materials:

SÁDOVSKÝ, S.: Základy práva. Praha: Karolinum, 2003.

VONDRÁČEK, L.: Základy zdravotnického práva pro posluchače 2. LF UK. Praha: Karolinum, 2004.

http://osz.cmkos.cz/CZ/Pravo/zdr_predpis.html: výběr nejdůležitějších předpisů pro potřeby zdravotnických odborových organizací k listopadu 2007.

http://forum.czechmed.cz/nove/?q=node/34 : přehled základních zákonných předpisů ČR a evropských regulátorů, týkajících se oblasti zdravotnických pomůcek.

http://www.mvcr.cz/sbirka/ : sbírka zákonů ČR.

http://europa.eu.int/eur:lex/en/search/search_lif.html: legislativa EU.

VEJROSTA, V.: Konstrukce zdravotnických elektrických přístrojů: aplikace požadavků mezinárodních a evropských norem. Praha: Česká společnost pro zdravotnickou techniku, 2001.

Note:

Further information:

No time-table has been prepared for this course

The course is a part of the following study plans:

• Bakalářský studijní obor Zdravotnický záchranář - prezenční (compulsory course)