ГОСТ Р ИСО 11737-1-2022. Национальный стандарт Российской Федерации. Стерилизация медицинской продукции. Микробиологические методы. Часть 1. Определение популяции микроорганизмов на продукции

[1]

ISO 7870-2

Control charts - Part 2: Shewhart control charts

[2]

ISO 7870-4

Control charts - Part 4: Cumulative sum charts

[3]

ISO 9000:2015

Quality management systems - Fundamentals and vocabulary

[4]

ISO 9001

Quality management systems - Requirements

[5]

ISO 11135

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

[6]

ISO 11137

Sterilization of health care products - Radiation

[7]

ISO 11138-2

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

[8]

ISO 11139:2018

Sterilization of health care products - Vocabulary

[9]

ISO 11737-2

Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

[10]

ISO 13022

Medical products containing viable human cells - Application of risk management and requirements for processing practices

[11]

ISO 14160

Sterilization of health care products - Liquid chemical sterilizing agents for singleuse medical devices utilizing animal tissues and their derivatives. Requirements for characterization, development, validation and routine control of a sterilization process for medical devices

[12]

ISO 14937

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

[13]

ISO 17665 (все части)

Sterilization of health care products - Moist heat

[14]

ISO 20857

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

[15]

ISO 22442-3

Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents

[16]

ISO/IEC 90003

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

[17]

AAMI TIR37

Sterilization of health care products - Radiation - Guidance on sterilization of biologics and tissue-based products

[18]

ASTM D4855-97

Standard practice for comparing test methods

[19]

ICH Q5A(R1), Viral Safety Evaluation Of Biotechnology Products Derived From Cell Lines Of Human Or Animal Origin

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Bryans, T, Hansen, J. The Bioburden Estimate: Not Just Math, But Microbiology. AAMI Industrial Sterilization Research from the Field. 2013

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Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent and Procedure, Budapest 28th April, 1977, amended 26th September, 1980

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Bushar, H.F., Kowalski, J.B., Mosley, G. Estimation of average bioburden values for low-bioburden products, MD+DI. July 2011, 33 (7)

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Collins, C.H., Lyne, P.M., Grange, J.M. Collins and Lyne's Microbiological Methods. 7th Edition. Butterworth- Heinemann Ltd, Oxford. 1995

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DeMan, J.C. M.P.N. Tables Corrected. European J. Appl. Microbiol. 1983, 17, 301-305

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Bacteriological Analytical Manual, Annex 2, October 2010

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Halls, N.A. et al. The Occurrence of Atypically High Presterilization Microbial Counts ("Spikes") on Hypodermic Products. Radiat. Phys. Chem. 1983, 22 (3 - 5), 663 - 666

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Hitchens, A.D., Mishra-Szymanski, A. AOAC International Qualitative and Quantitative Microbiology Guidelines for Methods Validation. Journal of AOAC International. 1999, 82 (2), 402 - 415

[30]

International Conference on Harmonization (ICH) Validation of Analytical Methods: Definitions and Terminology (CPMP/ICH/381/95)

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International Conference on Harmonization (ICH) Validation of Analytical Methods: Methodology (CPMP/ICH/281 /95)

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Lundholm, M. Comparison of Methods of Quantitative Determinations of Airborne bacteria and evaluation of total viable counts. Appl. Environ. Microbiol. 1982, 44 (1), 179 - 183

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PDA Bioburden Recovery Validation Task Force. Technical Report: Bioburden Recovery Validation. Journal of Parenteral Science & Technology. 1990, 44 (6), 324 - 331

[34]

PDA Technical Report No 33. Evaluation, Validation and Implementation of Alternate and Rapid Microbiological Testing Methods. 2013

[35]

European Pharmacopoeia, Chapter 5.1.6 Alternative Methods for Control of Microbiological Quality. European Directorate for the Quality of Medicines & HealthCare. 2015, 27.1:8

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Puleo, J.R., Favero, M.S., Peterson, J.J. Use of ultrasonic energy in assessing microbial contamination on surfaces. Appl. Microbiol. 1967, 15 (6), 1345 - 51

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Rice, E.W., Baird, R.B., Eaton, A.D., Clesceri, L.S. (Eds). Standard Methods for the Examination of Water and Wastewater. 22nd ed. American Public Health Association, American Water Works Association, Water Environment Federation, 2012

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Shirtz, J.T. Sterility Testing. Pharmaceutical Engineering. November/December 1987, 35 - 37

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Sokolski, W.T., Chidester, C.G. Improved Viable Counting Method for Petroleum-Based Ointments. J. Pharm. Sci. 1964, 53, 103 - 107

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US Pharmacopoeia, USP 40/NF 35 2017, <1223> Validation of Alternative Microbiological methods, United States Pharmacopeial Convention Inc.: Rockville, MD. 2017

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US Pharmacopoeia, USP 40/NF 35 2017, <1225> Validation of Compendial Procedures and <1226> Verification of Compendial Procedures. United States Pharmacopeial Convention Inc., Rockville, MD. 2017

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US Pharmacopoeia, USP 40/NF 35 2017, <1225> Validation of Compendial Procedures and <1226> Verification of Compendial Procedures. United States Pharmacopeial Convention Inc., Rockville, MD. 2017

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Cochran W. Estimation of Bacterial Densities by Means of the Most Probable Number, Biometrics. 6:105-116, 1950 (Изменение N 1, 2021)

УДК 637.133.4:006.354

ОКС 11.080.01

07.100.10

Ключевые слова: стерилизация медицинской продукции, микробиологические методы, определение популяции микроорганизмов на продукте, валидация, процесс стерилизации, микробиологические испытания