ГОСТ Р ИСО 22367-2022. Национальный стандарт Российской Федерации. Лаборатории медицинские. Применение менеджмента риска в медицинских лабораториях

[1]

ISO 14971:2019

Medical devices - Application of risk management to medical devices (Изделия медицинские. Применение менеджмента риска к медицинским изделиям)

[2]

ISO/TR 24971:2019

Medical devices - Guidance on the application of ISO 14971 (Изделия медицинские. Руководство по применению ИСО 14971)

[3]

ISO 15189:2012

Medical laboratories - Requirements for quality and competence (Медицинские лаборатории. Специальные требования к качеству и компетентности)

[4]

ISO 15190:2003

Medical laboratories - Requirements for safety (Лаборатории медицинские. Требования безопасности)

[5]

ISO 18113:2009

In vitro diagnostic medical devices - Information supplied by the manufacturer (labeling)

[6]

ISO 9000:2015

Quality management systems - Fundamentals and vocabulary (Системы менеджмента качества. Основные положения и словарь)

[7]

ISO 31000:2009

Risk management - Principles and guidelines (Менеджмент рисков. Принципы и руководящие указания)

[8]

ISO 13485:2016

Medical devices - Quality management systems - Requirements for regulatory purposes (Изделия медицинские. Системы менеджмента качества. Требования для целей регулирования)

[9]

ISO 20916:2019

Clinical performance studies for in vitro diagnostic devices (IVDs) using specimens from human subjects - Good study practice (in development by ISO/TC 212/WG 3) (Диагностика in vitro медицинских изделий. Исследование клинических характеристик с использованием образцов, полученных от человека. Надлежащая клиническая практика)

[10]

ISO/TS 22367:2008

Medical laboratories - Reduction of error through risk management and continual improvement

[11]

ISO Guide 73:2009

Risk management - Vocabulary (Менеджмент риска. Термины и определения)

[12]

ISO/IEC Guide 51:1999

Safety aspects - Guidelines for their inclusion in standards (Аспекты безопасности. Руководящие указания по включению их в стандарты)

[13]

ISO/IEC Guide 99:2007

International vocabulary of metrology - Basic and general concepts and associated terms (VIM) (Международный словарь по метрологии. Основные и общие понятия и соответствующие термины (VIM)

[14]

IEC/ISO 31010:2009

Risk management - Risk assessment techniques (Менеджмент рисков. Методы оценки рисков)

[15]

IEC 60601-1:2005

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (Изделия медицинские электрические. Часть 1. Общие требования безопасности с учетом основных функциональных характеристик)

[16]

IEC 60812:2006

Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA) (Техника анализа надежности систем. Метод анализа вида и последствий отказа)

[17]

IEC 61025:2006

Fault tree analysis (FTA) (Анализ диагностического дерева неисправностей)

[18]

IEC 62366-1:2015

Medical devices - Part 1: Application of usability engineering to medical devices (Изделия медицинские. Часть 1. Проектирование медицинских изделий с учетом эксплуатационной пригодности)

[19]

CLSI C24-A3 2006

Statistical Quality Control For Quantitative Measurements Procedures: Principles And Definitions; Approved Guideline, 3rd Ed

[20]

CLSI EP23-A 2011

Laboratory Quality Control Based on Risk Management; Approved Guideline

[21]

Global Harmonization Task Force, Implementation of risk management principles and activities within a Quality Management System (GHTF/SG3/N15R8; May 20, 2005) Available at http://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n15r8-risk-management-principles-qms-050520.pdf

[22]

Global Harmonization Task Force, Design Control Guidance for Medical Device Manufacturers.(GHTF/SG3/N99-9; June 29, 1999) Available at http://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-9-design-control-990629.pdf

[23]

Global Harmonization Task Force, Clinical Evaluation - Final Guidance (GHTF SG5/N2R8; May 2007). Available at http://www.imdrf.org/docs/ghtf/final/sg5/technical-docs/ghtf-sg5-n2r8-2007-clinical-evaluation-070501.pdf

[24]

Global Harmonization Task Force, Medical Devices: Post Market Surveillance: Proposal for Reporting of Use Errors with Medical Devices by their Manufacturer or Authorized Representative (GHTF SG2N31R8: 2003). Available at http://www.imdrf.org/docs/ghtf/final/sg2/technical-docs/ghtf-sg2-fd-99-7-reporting-guidance-990629.pdf

[25]

MEDDEV 2.12.1 Rev. 6, Guidelines on a Medical Devices Vigilance System (December 2009). Available at http://ec.europa.eu/DocsRoom/documents/15506/attachments/1/translations/en/ renditions/native

[26]

MEDDEV2, 7/1 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directives 93/42/EEC and 90/385/EEC (June 2016), available online at https://www.bsigroup.com/meddev/LocalFiles/en-GB/Documents/Dev-2.7.1-Rev-4.pdf

[27]

European Association of Notified Bodies for Medical devices. (October 13, 2014). Consensus Paper for the Interpretation and Application of Annexes Z in EN ИСО 14971:2012. Version 1.1 (Interim NBMed consensus version). Available at http://www.team-nb.org//wp-content/uploads/2015/05/documents2014/NBRG_WG%20RM_Interim_NBmed_Consensus_Version_140812_1_1.pdf

[28]

Cheng Michael Medical device regulations - Global overview and guiding principles: World Health Organization, Geneva (2003)

[29]

Reason J. Human Error. Cambridge, England: Cambridge University Press, 1990

[30]

Schmidt Mike W The Use and Misuse of FMEA in Risk Analysis. MDDI 2004

[31]

Stamatis DH, Failure Mode and Effect Analysis: FMEA from Theory to Execution

[32]

ISO/IEC Guide 63:2012, Guide to the development and inclusion of safety aspects in International Standards for medical devices

[33]

CLSI EP18-A2, 2009, Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline, 2nd Ed

[34]

CDC, CMS, US Department of Health and Human Services. IQCP - Individualized Quality ControlPlan: Developing an IQCP - A Step-by-Step Guide. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/IQCP-Workbook.pdf

УДК 006.83:006.354

ОКС 11.100.01

Ключевые слова: менеджмент риска, исследования, медицинские лаборатории, медицинское изделие, валидация