Фильтр :
Стандарт и/или проект находящийся в компетенции ISO/TC 198 Секретариата Этап ICS
Guidance on quality of water for sterilizers, sterilization and washer-disinfectors for health care products
50.00
Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
95.99
Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
95.99
Sterilization of health care products — Ethylene oxide — Part 2: Guidance on the application of ISO 11135-1
95.99
Sterilization of health care products — Ethylene oxide — Part 2: Guidance on the application of ISO 11135-1 — Technical Corrigendum 1
95.99
Medical devices — Validation and routine control of ethylene oxide sterilization
95.99
Medical devices — Validation and routine control of ethylene oxide sterilization — Technical Corrigendum 1
95.99
Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
90.92
Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices — Amendment 1: Revision of Annex E, Single batch release
60.60
Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
30.20
Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
90.92
Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 1
60.60
Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 2: Revision to 4.3.4 and 11.2
60.60
Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
30.20
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
95.99
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Technical Corrigendum 1
95.99
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
95.99
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
90.93
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1
60.60
Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects
95.99
Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
90.60
Sterilization of health care products — Radiation — Part 4: Guidance on process control
60.60
Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization
95.99
Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization — Amendment 1: Selection of items for dose setting
95.99
Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization — Technical Corrigendum 1
95.99
Sterilization of health care products — Biological indicators — Part 1: General
95.99
Sterilization of health care products — Biological indicators — Part 1: General requirements
95.99
Sterilization of health care products — Biological indicators — Part 1: General requirements
90.20
Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization
95.99
Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
95.99
Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
90.20
Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization
95.99
Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
95.99
Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
90.60
Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes
95.99
Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes
90.60
Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
95.99
Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
90.60
Sterilization of health care products — Biological indicators — Part 6: Biological indicators for hydrogen peroxide sterilization processes
20.00
Sterilization of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of results
60.60
Sterilization of health care products — Biological indicators — Part 8: Method for validation of a reduced incubation time for a biological indicator
60.60
Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards
60.60
Sterilization of health care products — Vocabulary
95.99
Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards — Amendment 1
30.60
Sterilization of health care products — Vocabulary
95.99
Sterilization of health care products — Chemical indicators — Part 1: General requirements
95.99
Sterilization of health care products — Chemical indicators — Part 1: General requirements — Amendment 1
95.99
Sterilization of health care products — Chemical indicators — Part 1: General requirements
95.99
Sterilization of health care products — Chemical indicators — Part 1: General requirements
90.93
Sterilization of health care products — Chemical indicators — Part 2: Test equipment and methods
95.99
Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicators for steam penetration test sheets
95.99
Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
90.92
Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test — Technical Corrigendum 1
60.60
Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
30.00
Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators for steam penetration test packs
95.99
Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
90.92
Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
30.00
Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for air removal test sheets and packs
95.99
Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
90.92
Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
30.00
Sterilization of health care products — Chemical indicators — Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers
50.20
Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
95.99
Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1
95.99
Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
60.60
Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1
40.20
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
95.99
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1
95.99
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
60.60
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1
40.20
Packaging for terminally sterilized medical devices
95.99
Packaging for terminally sterilized medical devices
95.99
Sterilization of medical devices — Microbiological methods — Part 1: Estimation of population of microorganisms on products
95.99
Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products
95.99
Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products — Technical Corrigendum 1
95.99
Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products
60.60
Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products — Amendment 1
60.60
Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the validation of a sterilization process
95.99
Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
95.99
Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
60.60
Sterilization of medical devices — Microbiological methods — Part 3: Guidance on evaluation and interpretation of bioburden data
95.99
Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing
40.99
Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
60.60
Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
95.99
Aseptic processing of health care products — Part 1: General requirements
95.99
Aseptic processing of health care products — Part 1: General requirements
90.92
Aseptic processing of health care products — Part 1: General requirements — Amendment 1
60.60
Aseptic processing of health care products — Part 1: General requirements
50.00
Aseptic processing of health care products — Part 2: Filtration
95.99
Aseptic processing of health care products — Part 2: Sterilizing filtration
60.60
Aseptic processing of health care products — Part 3: Lyophilization
90.93
Aseptic processing of health care products — Part 4: Clean-in-place technologies
90.93
Aseptic processing of health care products — Part 5: Sterilization in place
90.93
Aseptic processing of health care products — Part 6: Isolator systems
95.99
Aseptic processing of health care products — Part 6: Isolator systems — Amendment 1
95.99
Aseptic processing of health care products — Part 6: Isolator systems
60.60
Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products
90.93
Sterilization of health care products — Radiation sterilization — Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
95.99
Sterilization of health care products — Radiation sterilization — Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
95.99
Sterilization of health care products — Requirements for validation and routine control of moist heat sterilization in health care facilities
95.99
Sterilization of single-use medical devices incorporating materials of animal origin — Validation and routine control of sterilization by liquid chemical sterilants
95.99
Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
95.99
Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
60.60
Sterilization of health care products — Biological indicators — Guidance for the selection, use and interpretation of results
95.99
Sterilization of health care products — Biological indicators — Guidance for the selection, use and interpretation of results
95.99
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
95.99
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 — Technical Corrigendum 1
95.99
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
90.93
Sterilization of health care products — Radiation sterilization — Product families and sampling plans for verification dose experiments and sterilization dose audits, and frequency of sterilization dose audits
95.99
Sterilization of health care products — Radiation sterilization — Selection of sterilization dose for a single production batch
95.99
Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
95.99
Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
90.93
Washer-disinfectors — Part 1: General requirements, terms and definitions and tests
90.92
Washer-disinfectors — Part 1: General requirements, terms and definitions and tests — Amendment 1
60.60
Washer-disinfectors — Part 1: General requirements, terms and definitions and tests
50.00
Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
90.92
Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
30.20
Washer-disinfectors — Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
90.92
Washer-disinfectors — Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
30.20
Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
95.99
Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
60.60
Washer-disinfectors — Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy
60.60
Washer-disinfectors — Part 5: Test soils and methods for demonstrating cleaning efficacy
95.99
Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment
90.60
Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment
90.92
Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment
30.00
Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2
95.99
Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2
60.60
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
60.60
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
60.60
Sterilization of medical devices — Information to be provided by the manufacturer for the processing of resterilizable medical devices
95.99
Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices
95.99
Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
90.92
Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1
90.92
Sterilization of health care products — Moist heat — Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization
90.92
Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
40.20
Manufacture of cell-based health care products — Control of microbial risks during processing
90.93
Manufacture of cell-based health care products — Control of microbial risks during processing — Amendment 1
60.60
Sterilization of health care products — Biological and chemical indicators — Test equipment
95.99
Sterilization of health care products — Biological and chemical indicators — Test equipment
60.60
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 10-6
90.93
Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
90.93
Sterilization of medical devices — Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
60.60
Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
60.60
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
60.60
Sterilization of healthcare products — Microbiological methods— Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
60.60
Sterilization of medical devices — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices
95.99
Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices
60.60
Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 1
60.60

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