ГОСТ Р ИСО 11737-2—2022
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[
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Библиография
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1
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ISO 9000:2015
2
]
ISO 9001:2015
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3
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ISO 11135
[4]
ISO 11137-1
[5]
ISO 11137-2
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 — Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices
Sterilization of health careproducts — Radiation — Part 2: Establishing the sterilization
dose
6
]
ISO 11138-2
[7]
ISO 11138-7
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8
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ISO 11139:2018
[9]
ISO 13485:2016
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10
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ISO 14160
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11
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ISO 14644 (all parts)
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12
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ISO 14698 (all parts)
[13]
ISO 14937
[14]ISO 15189
[15]ISO 17665-1
[16]ISO 20857
[17]ISO/IEC 90003
Sterilization of health careproducts — Biological indicators — Part 2: Biological indicators
for ethylene oxide sterilization processes
Sterilization of health care products — Biological indicators — Part 7: Guidance for the
selection, use and interpretation of results
Sterilization of health care products — Vocabulary of terms used in sterilization and
related equipment and process standards
Medical devices — Quality management systems — Requirements for regulatory
purposes
Sterilization of single-use medical devices incorporating materials of animal origin —
Validation and routine control of sterilization by liquid chemical sterilants
Cleanrooms and associated controlled environments
Cleanrooms and associated controlled environments — Biocontamination control
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
Medical laboratories — Requirements for quality and competence
Sterilization of health care products — Moist heat — Part 1: Requirements for the
development, validation and routine control of a sterilization process for medical devices
Sterilization of health care products — Dry heat — Requirements for the development,
validation and routine control of a sterilization process for medical devices
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 ofAnalytical Chemists Official Methods ofAnalysis. 15th ed., Arlington, AOAC; pp 430—437, 1992
22
]
Association ofAnalytical Chemists BacteriologicalAnalytical 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 ... ToTest 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 ofAntimicrobial 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
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