ГОСТ ISO 10993-1-2021. Межгосударственный стандарт. Изделия медицинские. Оценка биологического действия медицинских изделий. Часть 1. Оценка и исследования в процессе менеджмента риска

[1]

ISO 7405

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (Стоматология. Оценка биологической совместимости медицинских изделий, применяемых в стоматологии)

[2]

ISO 9000

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

[3]

ISO 9001

Quality management systems - Requirements (Системы менеджмента качества. Требования)

[4]

ISO 9004

Quality management - Quality of an organization - Guidance to achieve sustained success (Менеджмент качества. Качество организации. Руководство по достижению устойчивого успеха организации)

[5]

ISO/TR 10993-22

Biological evaluation of medical devices - Part 22: Guidance on nanomaterials (Оценка биологического действия медицинских изделий. Руководство по наноматериалам)

[6]

ISO/TR 10993-33

Biological evaluation of medical devices - Part 33: Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3 (Оценка биологического действия медицинских изделий. Руководство по испытаниям на генотоксичность. Дополнение к ISO 10993-3)

[7]

ISO 13485:2016

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

[8]

ISO/IEC 17025

General requirements for the competence of testing and calibration laboratories (Общие требования к компетенции испытательных и калибровочных лабораторий)

[9]

ISO 18562

(все части)

Biocompatibility evaluation of breathing gas pathways in healthcare applications (Оценка биологической совместимости путей для дыхательных газов в здравоохранении)

[10]

Previews B.I.O.S.I.S. Ovid Technologies, Inc, available at: https://www.ovid.com/

[11]

Guideline on the limits of genotoxic impurities, European Medicines Agency Evaluation of Medicines for Human Use (EMEA), available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002903.pdf

[12]

Black, J., Biological Performance of Materials: Fundamentals of Biocompatibility, CRC Press, 2006

[13]

Boutrand J. ed. Biocompatibility and Performance of Medical Devices. Woodhead Publishing, 2012

[14]

Bush R.B. A Bibliography of Monographic Works on Biomaterials and Biocompatibility; Update II. J. Biomed. Mater. Res. 1999, 48 pp. 335 - 341 [Appl Biomater]

[15]

Tinkler J.J.B. Biological Safety and European Medical Device Regulations. Quality First International Press, London, 2000

[16]

Williams D.F. Fundamental aspects of biocompatibility. Biocompatibility. 1 CRC. 1980

[17]

Williams D.F. Definitions in Biomaterials. Progress in Biomedical Engineering. 1987, 4 pp. 1 - 72

[18]

EMBASE. Elsevier B.V., available at: https://www.embase.com/

[19]

IPCS. World Health Organization, available at: https://www.who.int/ipcs/en/

[20]

IRIS. U.S. Environmental Protection Agency, available at: https://www.epa.gov/IRIS/

[21]

PubMed. U.S. National Library of Medicine, available at: https://www.ncbi.nlm.nih.gov/pubmed

[22]

SciFinder, American Chemical Society, available at: https://www.cas.org/SCIFINDER/SCHOLAR/index.html

[23]

- A Cited Reference Science Database, Dialog, LLC, available at: https://library.dialog.com/bluesheets/html/bl0034.html

[24]

Toxnet. U.S. National Library of Medicine, available at: https://toxnet.nlm.nih.gov

[25]

ToxGuides. Agency for Toxic Substances & Disease Registry (ATSDR), available at: https://www.atsdr.cdc.gov/toxguides/index.asp

[26]

OECD Guidelines for the Testing of Chemicals - Section 4: Health Effects

[27]

Japan, Good Laboratory Practice for Preclinical Biological Tests of Medical devices; MHLW Ordinance No. 37 and No. 115 (03-23-2005 and 06-13-2008, respectively)

[28]

Japan (bilingual in Japanese and English): Basic Principles of Biological Safety Evaluation Required for Application for Approval to Market Medical Devices, YAKUJI NIPPO, Ltd. Tokyo, 2012

[29]

USA. Code of Federal Regulations Title 21 Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies

[30]

Use of International Standard. ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process - Guidance for Industry and Food and Drug Administration Staff, June 16, 2016, available at: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm348890.pdf

[31]

ICH Q3A Impurities in New Drug Substances, available at: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3A_R2/Step4/Q3A_R2__Guideline.pdf

[32]

ICH Q3B Impurities in New Drug Products, available at: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3B_R2/Step4/Q3B_R2__Guideline.pdf

[33]

ICH Q3C Impurities: Guideline for Residual Solvents, available at: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3C/Q3C__R6____Step_4.pdf

[34]

ICH Q3D Impurities: Guidelines for Elemental Impurities, available at: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3D/Q3D_Step_4.pdf

[35]

ICH M7 ASSESSMENT AND CONTROL OF DNA REACTIVE (MUTAGENIC) IMPURITIES IN PHARMACEUTICALS TO LIMIT POTENTIAL CARCINOGENIC RISK. Available at: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Multidisciplinary/M7/M7_Step_4.pdf

[36]

ISO/TR 10993-19, Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials (Оценка биологического действия медицинских изделий. Исследования физико-химических, морфологических и топографических свойств материалов)

УДК 615.46:002:006.354

МКС 11.100.20

IDT

Ключевые слова: медицинское изделие, оценка биологического действия, основные положения, общие требования к проведению исследований в процессе менеджмента рисков