ГОСТ Р ИСО 11737-2-2022. Национальный стандарт Российской Федерации. Стерилизация медицинской продукции. Микробиологические методы. Часть 2. Исследования на стерильность, выполняемые при определении, валидации и техническом обслуживании процесса стерилизации

[1]

ISO 9000:2015

Quality management systems - Fundamentals and vocabulary

[2]

ISO 9001:2015

Quality management systems - Requirements

[3]

ISO 11135

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices

[4]

ISO 11137-1

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

[5]

ISO 11137-2

Sterilization of health careproducts - Radiation - Part 2: Establishing the sterilization dose

[6]

ISO 11138-2

Sterilization of health careproducts - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes

[7]

ISO 11138-7

Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results

[8]

ISO 11139:2018

Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards

[9]

ISO 13485:2016

Medical devices - Quality management systems - Requirements for regulatory purposes

[10]

ISO 14160

Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid chemical sterilants

[11]

ISO 14644 (all parts)

Cleanrooms and associated controlled environments

[12]

ISO 14698 (all parts)

Cleanrooms and associated controlled environments - Biocontamination control

[13]

ISO 14937

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

[14]

ISO 15189

Medical laboratories - Requirements for quality and competence

[15]

ISO 17665-1

Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

[16]

ISO 20857

Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices

[17]

ISO/IEC 90003

Software engineering - Guidelines for the application of ISO 9001:2008 to computer software

[18]

EN 12469

Biotechnology - Performance criteria for microbiological safety cabinets

[19]

Akers J.D. et al., Survey on Sterility Testing Practices, J. Parenteral Sci. Technol., 41, 6, 1987

[20]

Alexander K., Bryans T., Evaluation of the Sterility Test for Detection of Microbial Contaminants of Allografts, Cell and Tissue Banking, 7, 1, pp. 23 - 28, 2006

[21]

Association of Analytical Chemists Official Methods of Analysis. 15th ed., Arlington, AOAC; pp 430 - 437, 1992

[22]

Association of Analytical Chemists Bacteriological Analytical Manual (BAM). 6th ed., Arlington, AOAC; 1984

[23]

Block S.S. Disinfection, Sterilization and Preservation, 5th ed., 2001

[24]

Daniell E. et al. Product Sterility Testing ... To Test or Not to Test? That Is the Question, Biomedical Instrumentation & Technology, 50, s3, pp. 35 - 43, 2016

[25]

Gerhardt P. et al. Manual of Methods for General Bacteriology, American Society for Microbiology, Washington, DC, 1981

[26]

Mathews A.G., Optimal incubation conditions for sterility tests, Develop. Biol. Stand., 23, pp. 94 - 102, 1974

[27]

Meltzer L.L., Ordal Z.J., Thermal Injury and Recovery of Bacillus subtilus, Applied Microbiology, 24, 6, pp. 878 - 884, 1972

[28]

Russell A.D. Principles of Antimicrobial Activity, in Block S.S. (ed.) Disinfection, Sterilization and Preservation, Lea & Febiger, Philadelphia, PA, 4th edition, p. 27, 1991

[29]

Sokolski W.T., Chidestey C.G., Improved viable counting method for petroleum-based ointments, J. Pharm. Sci., 53, pp. 103 - 107, 1964

[30]

Straka R.P., Stokes J.L., Rapid destruction of bacteria in commonly used diluents and its elimination. J. App. Microbiology, 5, p. 21, 1957

[31]

The European Pharmacopoeia 9th ed., European Directorate for the Quality of Medicines (EDQM), Strasbourg, 2017

[32]

The Japanese Pharmacopoeia, 17th ed., Society of Japanese Pharmacopoeia, Tokyo, 2016

[33]

The United States Pharmacopeia, 42nd ed., United States Pharmacopeial Convention (USP), Rockville, MD, 2019

[34]

The Korean Pharmacopoeia, (KP). 11th ed., Ministry of Food and Drug Safety (MFDS), Osong, 2014

[35]

ISO 10012

Measurement management systems - Requirements for measurement processes and measuring equipment

[36]

ISO 11737-1:2018

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products

[37]

ISO/IEC 17025:2017

General requirements for the competence of testing and calibration laboratories

УДК 637.132.4:715.478:658.513:006.354

ОКС 11.080.01

07.100.10

Ключевые слова: стерилизация, медицинская продукция, микробиологические методы, исследования на стерильность, валидация, техническое обслуживание процесса стерилизации