Regulatory Use of Essential Performance Characteristics of Medical Devices for In Vitro Diagnostics
https://doi.org/10.47619/2713-2617.zm.2024.v.5i4p1;142-161
Abstract
The article covers the performance characteristics of in vitro diagnostics (IVD) medical devices, the systematic approaches to specify the performance characteristics of IVD medical devices, the review of regulations with specified performance characteristics, and the methods of validation and conformity assessment of performance characteristics.
About the Author
V. V. Maslennikov
Research Institute for Healthcare Organization and Medical Management of Moscow Healthcare Department
Russian Federation
Russian Federation
Vladimir V. Maslennikov – Researcher
9, Sharikopodshipnikovskaya ul., 115088, Moscow
References
1. ISO 9000:2015 Quality management systems –Fundamentals and vocabulary.
2. ISO/IEC 17000:2020 Conformity assessment – Vocabulary and general principles.
3. 2014, The Fitness for Purpose of Analytical Methods, EURACHEM Guide), пер с англ. 3-го изд. (2011, Quantifying Uncertainty in Analytical Measurement, EURACHEM/CITAC Guide.
4. ISO/IEC Guide 98-1:2009, Uncertainty of measurement – Part 1: Introduction to the expression of uncertainty in measurement.
5. ISO 18113-1:2009 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 1. Terms, definitions and general requirements.
6. ISO 18113-1:2022 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 1. Terms, definitions, and general requirements.
7. ГОСТ Р 51352-2013 In vitro diagnostic medical devices. Test methods.
8. РМГ 29-2013 State system for ensuring the uniformity of measurements. Metrology. Basic terms and definitions.
9. ISO 3534-1:2006, Statistics – Vocabulary and symbols – Part 1: General statistical terms and terms used in probability.
10. ISO 3534-2:2006, Statistics – Vocabulary and symbols – Part 2: Applied statistics.
11. JCGM 200:2008 International vocabulary of basic and general terms in metrology (VIM).
12. ISO 5725-1:1994 Accuracy (trueness and precision) of measurement methods and results. Part 1. General principles and definitions.
13. NCCLS. Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline. NCCLS document EP21-A [ISBN 1-56238-502-X]. NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2003.)
14. ISO 3534-2:2006 Statistics –Vocabulary and symbols. Part 2. Applied statistics.
15. Maslennikov V. V. The use of measurement uncertainty in conformity assessment of medical devices for in vitro diagnostics. AMTECH Bulletin. 2023:(1):5-15. (in Russ.).
16. NCCLS. Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. NCCLS document EP6-A (ISBN 1-56238-498-8). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2003.
17. ISO 17511:2020, In vitro diagnostic medical devices – Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples.
Review
For citations:
Maslennikov V.V. Regulatory Use of Essential Performance Characteristics of Medical Devices for In Vitro Diagnostics. City Healthcare. 2024;5(4):142-161. (In Russ.) https://doi.org/10.47619/2713-2617.zm.2024.v.5i4p1;142-161
Views:
152
Email this article 