| Обозначение | Заглавие на русском языке | Статус | Язык документа | Цена (с НДС 20%)
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Aseptic processing of health care products - Part 2: Sterilizing filtration
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На языке оригинала
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Aseptic processing of health care products - Parts 3: Lyophilization
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Aseptic processing of health care products - Part 4: Clean-in-place technologies
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Aseptic processing of health care products - Part 5: Sterilization in place
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Aseptic processing of health care products - Part 6: Isolator systems
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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
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Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices
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Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices
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Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
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Sterilization of health care products - Biological and chemical indicators - Test equipment
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Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
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Sterilization of health care products - Low temperature vaporized hydrogen peroxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
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Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
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На языке оригинала
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Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10в€’6
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