ГОСТ Р ИСО 20916-2022. Национальный стандарт Российской Федерации. Медицинские изделия для диагностики in vitro. Исследование клиническое функциональных характеристик с использованием образцов биологических материалов человека. Надлежащая исследовательская практика

[1]

ISO 15190:2003

Medical laboratories - Requirements for safety

[2]

ISO 13131:2014

Health informatics - Telehealth services - Quality planning guidelines

[3]

ISO 13485

Medical devices - Quality management systems - Requirements for regulatory purposes

[4]

ISO 14971

Medical devices - Application of risk management to medical devices

[5]

ISO 14155

Clinical investigation of medical devices for human subjects - Good clinical practice

[6]

ISO 15193:2009

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures

[7]

ISO 16142-2:2017

Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards

[8]

ISO 18113-1:2009

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements

[9]

ISO/TR 24971

Medical devices - Guidance on the application of ISO 14971

[10]

ISO/IEC Guide 51:2014

Safety aspects - Guidelines for their inclusion in standards

[11]

Global Harmonization Task Force. Definition of the Terms "Medical Device" and "In Vitro Diagnostic (IVD) Medical Device" [GHTF/SG1/N071:2012] available at: http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n071-2012-definition-of-terms-120516.pdf

[12]

CLSI. Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline - Fourth Edition. CLSI document M29-A4. Wayne, PA: Clinical and Laboratory Standards Institute; 2014

[13]

United States Department of Labor. Occupational Safety and Health Administration. Part 1910.1030 - Bloodborne pathogens. (Codified at 29 CFR § 1910.1030). US Government Printing Office; published annually, available at: https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_id=10051&p_table=STANDARDS

[14]

Declaration of Helsinki, available at: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects

[15]

Global Harmonization Task Force, Principles of In Vitro Diagnostic (IVD) Medical Devices Classification [GHTF/SG1/N077:2012], available at: http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n071-2012-definition-of-terms-120516.docx

[16]

Global Harmonization Task Force, Essential Principles of Safety and Performance of Medical Devices [GHTF/SG1/N68:2012], available at: http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n68-2012-safety-performance-medical-devices-121102.pdf

[17]

Global Harmonization Task Force. Clinical Evidence for IVD medical devices - Key Definitions and Concepts [GHTF/SG5/N6:2012], available at: http://www.imdrf.org/docs/ghtf/final/sg5/technical-docs/ghtf-sg5-n6-2012-clinical-evidence-ivd-medical-devices-121102.pdf

[18]

Global Harmonization Task Force. Clinical Evidence for IVD medical devices - Scientific Validity Determination and Performance Evaluation [GHTF/SG5/N7:2012], available at: http://www.imdrf.org/docs/ghtf/final/sg5/technical-docs/ghtf-sg5-n7-2012-scientific-validity-determination-evaluation-121102.pdf

[19]

Global Harmonization Task Force. Clinical Evidence for IVD Medical Devices - Clinical Performance Studies for In Vitro Diagnostic Medical Devices [GHTF/SG5/N8:2012], available at: http://www.imdrf.org/docs/ghtf/final/sg5/technical-docs/ghtf-sg5-n8-2012-clinical-performance-studies-ivd-medical-devices-121102.pdfmay

[20]

Global Harmonization Task Force. Quality Management Systems - Process Validation Guidance [GHTF/SG3/N99-10:2004], available at: http://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf

[21]

European Commission Guidelines on Medical Devices. Clinical Evaluation: A Guide For Manufacturers And Notified Bodies Under Directives 93/42/EEC and 90/385/EEC [MEDDEV 2.7/1 revision 4, June 2016], available at: http://ec.europa.eu/DocsRoom/documents/17522/attachments/1/translations/

УДК 57.085.2:006.354

ОКС 11.100.10

Ключевые слова: клинические испытания, наборы реагентов для IVD диагностики, функциональные характеристики, образец, информированное согласие