ГОСТ Р ИСО 11737-1—2022
Библиография
2
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[
]
6
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ISO 11137
[7]
ISO 11138-2
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8
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ISO 11139:2018
[9]
ISO 11737-2
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10
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ISO 13022
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11ISO 14160
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1
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ISO 7870-2
[ ]
ISO 7870-4
3
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ISO 9000:2015
[4]
ISO 9001
[5]
ISO 11135
Control charts — Part 2: Shewhart control charts
Control charts — Part 4: Cumulative sum charts
Quality management systems — Fundamentals and vocabulary
Quality management systems — Requirements
Sterilization of health care products — Ethylene oxide — Requirements for the
development, validation and routine control of a sterilization process for medical devices
Sterilization of health care products — Radiation
Sterilization of health care products — Biological indicators — Part 2: Biological indicators
for ethylene oxide sterilization processes
Sterilization of health care products — Vocabulary
Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility
performed in the definition, validation and maintenance of a sterilization process
Medical products containing viable human cells — Application of risk management and
requirements for processing practices
Sterilization of health care products — Liquid chemical sterilizing agents for single
use medical devices utilizing animal tissues and their derivatives. Requirements for
[12] ISO 14937
characterization, development, validation and routine control of a sterilization process for
medical devices
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
Sterilization of health care products — Moist heat
Sterilization of health care products — Dry heat — Requirements for the development,
validation and routine control of a sterilization process for medical devices
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
Software engineering — Guidelines for the application of ISO 9001:2008 to computer
software
Sterilization of health care products — Radiation — Guidance on sterilization of biologies
and tissue-based products
Standard practice for comparing test methods
[13] ISO 17665 (все части)
[14] ISO 20857
[15] ISO 22442-3
[16] ISO/IEC 90003
[17] AAMITIR37
[18] ASTM D4855-97
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[
[19] ICH Q5A(R1),
Viral Safety Evaluation Of Biotechnology Products Derived From Cell Lines Of Human Or Animal
Origin
20
]
Bailey, M. Notes on bioburden distribution metrics: The log-normal distribution. Panel on Gamma and Electron
Beam. March 2010
[
21
]
Polansky, J.R. A Model system for testing raw materials for microbial content. Pharm. Technol. 1980, 4(2), 49—51
22
]
Bryans, T., Hansen, J. The Bioburden Estimate: Not Just Math, But Microbiology. AAMI Industrial Sterilization
Research from the Field. 2013
[23] 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
[24] Bushar, H.F., Kowalski, J.B., Mosley, G. Estimation of average bioburden values for low-bioburden products, MD+DI.
July 2011, 33(7)
[25] Collins, C.H., Lyne, P.M., Grange, J.M. Collins and Lyne’s Microbiological Methods. 7th Edition. Butterworth-
Heinemann Ltd, Oxford. 1995
[26] DeMan, J.C. M.P.N. Tables Corrected. European J. Appl. Microbiol. 1983, 17, 301—305
[27] Bacteriological Analytical Manual, Annex 2, October 2010
[28] Halls, NA. et al. The Occurrence of Atypically High Presterilization Microbial Counts («Spikes») on Hypodermic
Products. Radiat. Phys. Chem. 1983, 22(3—5), 663—666
[29] Hitchens, A.D., Mishra-Szymanski, A. AOAC International Qualitative and Quantitative Microbiology Guidelines for
Methods Validation. Journal ofAOAC International. 1999, 82(2), 402—415
[30] International Conference on Harmonization (ICH) Validation of Analytical Methods: Definitions and Terminology
(CPMP/ICH/381/95)
[31]
International Conference on Harmonization (ICH) Validation ofAnalytical Methods: Methodology (CPMP/ICH/281/95)
[32] 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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