Technical Regulations
Description: Training of qualified specialists with legal, theoretical knowledge and practical skills in the field of technical regulation of medical equipment. Legal and regulatory regulation of relations related to the definition, establishment, application and execution of mandatory requirements for telecommunications and measuring equipment, including activities for metrological certification of measuring instruments, accreditation of testing laboratories and state metrological control and supervision of compliance with established requirements.
Amount of credits: 5
Course Workload:
| Types of classes | hours |
|---|---|
| Lectures | 15 |
| Practical works | 30 |
| Laboratory works | |
| SAWTG (Student Autonomous Work under Teacher Guidance) | 30 |
| SAW (Student autonomous work) | 75 |
| Form of final control | Exam |
| Final assessment method | writing exam |
Component: Component by selection
Cycle: Base disciplines
Goal
- The purpose of studying the discipline is to train qualified specialists with legal, theoretical knowledge and practical skills in the field of technical regulation of medical equipment.
Objective
- Acquisition of knowledge, understanding, skills and abilities to apply technical regulation methods to improve the efficiency of production of products and services.
Learning outcome: knowledge and understanding
- Special knowledge in the field of technical regulation
Learning outcome: applying knowledge and understanding
- Ability to apply basic and specialized knowledge in the field of standardization, conformity assessment and accreditation
Learning outcome: formation of judgments
- The ability to independently apply methods and means of knowledge, training and self-control, to realize the prospects of intellectual, cultural, moral, physical and professional self-development and self-improvement, to be able to critically evaluate their advantages and disadvantages.
Learning outcome: communicative abilities
- Ability to work effectively individually and as a team member, demonstrating leadership skills of individual groups of performers, including on interdisciplinary projects, to be able to show personal responsibility, commitment to professional ethics and standards of conduct of professional activities.
Learning outcome: learning skills or learning abilities
- Carry out communications in the professional environment and in society as a whole, including in a foreign language; analyze existing technical documentation and develop it yourself; clearly state and protect the results of complex engineering activities in the field of automation and management.
Teaching methods
When conducting training sessions, the following educational technologies are provided: - interactive lecture (using the following active forms of training: guided (controlled) discussion or conversation; moderation; demonstration of slides or educational films; brainstorming; motivational speech); - building scenarios for the development of various situations based on the specified conditions; - information and communication (for example, classes in a computer class using professional application packages); - search and research (independent research activities of students in the learning process); - solving educational problems.
Assessment of the student's knowledge
Teacher oversees various tasks related to ongoing assessment and determines students' current performance twice during each academic period. Ratings 1 and 2 are formulated based on the outcomes of this ongoing assessment. The student's learning achievements are assessed using a 100-point scale, and the final grades P1 and P2 are calculated as the average of their ongoing performance evaluations. The teacher evaluates the student's work throughout the academic period in alignment with the assignment submission schedule for the discipline. The assessment system may incorporate a mix of written and oral, group and individual formats.
| Period | Type of task | Total |
|---|---|---|
| 1 rating | Practice work 1 | 0-100 |
| Practice work 2 | ||
| Testing | ||
| 2 rating | Practice work 3 | 0-100 |
| Practice work 4 | ||
| Testing | ||
| Total control | Exam | 0-100 |
The evaluating policy of learning outcomes by work type
| Type of task | 90-100 | 70-89 | 50-69 | 0-49 |
|---|---|---|---|---|
| Excellent | Good | Satisfactory | Unsatisfactory |
Evaluation form
The student's final grade in the course is calculated on a 100 point grading scale, it includes:
- 40% of the examination result;
- 60% of current control result.
The final grade is calculated by the formula:
| FG = 0,6 | MT1+MT2 | +0,4E |
| 2 |
Where Midterm 1, Midterm 2are digital equivalents of the grades of Midterm 1 and 2;
E is a digital equivalent of the exam grade.
Final alphabetical grade and its equivalent in points:
The letter grading system for students' academic achievements, corresponding to the numerical equivalent on a four-point scale:
| Alphabetical grade | Numerical value | Points (%) | Traditional grade |
|---|---|---|---|
| A | 4.0 | 95-100 | Excellent |
| A- | 3.67 | 90-94 | |
| B+ | 3.33 | 85-89 | Good |
| B | 3.0 | 80-84 | |
| B- | 2.67 | 75-79 | |
| C+ | 2.33 | 70-74 | |
| C | 2.0 | 65-69 | Satisfactory |
| C- | 1.67 | 60-64 | |
| D+ | 1.33 | 55-59 | |
| D | 1.0 | 50-54 | |
| FX | 0.5 | 25-49 | Unsatisfactory |
| F | 0 | 0-24 |
Topics of lectures
- Technical regulation
- Standardization
- Types of work in the field of standardization
- Activities of technical committees for standardization
- Normative documents on standardization: state standards, qualifiers of technical and economic information; standards organizations and recommendations for standardization in the Republic of Kazakhstan; implementation of international, regional, national standards and normative documents on standardization of foreign States; categories and types of regulatory documents
- Methods of standardization
- Information support for standardization work
- Confirmation of compliance of products and processes with the established requirements
- Certificate of conformity
- Accreditation
- Fundamentals of Metrology
- Units of values, standards of units of values, ways to Express the accuracy and reliability of measurement results
- Средства измерительной техники, Классификация, характеристики
- Погрешности средств измерений, их нормирование, классы точности
- Метрологическая прослеживаемость
Key reading
- Osnovy standartizatsii, metrologii, sertifikatsii i menedjmenta kachestva. Uchebnoe posobie. - Almaty: Kazahstanskaıa assotsiatsiıa marketinga, 2012.
- Fridman A.. Osnovy metrologii. Sovremennyi kurs. –SPb.: NPO «Professional», 2013.
- Alekseev V.V. Metrologiıa, standartizatsiıa i sertifikatsiıa. –M.: Izdatelskii tsentr «Akademiıa», 2010.
- GSI ST RK 2.1-2018 Metrologiıa. Terminy i opredeleniıa.
Further reading
- Zakon Respubliki Kazahstan «O tehnicheskom regulirovanii» ot 9 noıabrıa 2004 g.(s izmeneniıami).
- Zakon Respubliki Kazahstan «O standartizatsii» ot 15 oktıabrıa 2018 g.
