ГОСТ Р ИСО 18562-1-2022. Национальный стандарт Российской Федерации. Оценка биосовместимости каналов дыхательных газов в медицинских изделиях. Часть 1. Оценка и проведение испытания в процессе менеджмента риска

[1]

ISO 10993-9

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products

[2]

ISO 10993-13

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices

[3]

ISO 10993-14

Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics

[4]

ISO 10993-15

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys

[5]

ISO 13485:2016

Medical devices - Quality management systems - Requirements for regulatory purposes

[6]

ISO 16142-1:2016

Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards

[7]

ISO/IEC 17025

General requirements for the competence of testing and calibration laboratories

[8]

IEC 60601-1:2005+AMD1:2012

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

[9]

BS 5724-3.12

Medical electrical equipment - Particular requirements for performance - Method of declaring parameters for lung ventilators

[10]

Glossary, Scientific Committees of the EU. [accessed 2 May 2016]. Available from: http://ihcp.jrc.ec.europa.eu/glossary?search_letter=e

[11]

US FDA 510(k) Memorandum #K97-1, January 10, 1997

[12]

Godfrey S. Growth and development of the respiratory system. In: Scientific Foundations of Paediatrics (Davis J.A., & Dobbing J. eds.). Heinemann, London, Second Edition, 1981, pp. 432 - 450

[13]

Stocks J. The functional growth and development of the lung during the first year of life. Early Hum. Dev. 1977, 1 pp. 285 - 309

[14]

Fraunhofer RepDose Database. The database for the analysis of relationship between chemical function groups/categories and target organs in repeated dose studies. [accessed 28 June 2016]. Available from: http://fraunhofer-repdose.de/

[15]

International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use, Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk ICH M7 Step 4 version, dated 23 June 2014

[16]

Miller F.J., Schlosser P.M., Janszen D.B. Haber's rule: a special case in a family of curves relating concentration and duration of exposure to a fixed level of response for a given endpoint. Toxicology. 2000, pp. 21 - 34

УДК 615.47:006.354

ОКС 11.040.10

Ключевые слова: медицинские изделия, биосовместимость, газовый канал, оценка, испытания, процесс менеджмента риска