11.080.01 消毒和灭菌综合 标准查询与下载
共找到 871 条与 消毒和灭菌综合 相关的标准，共 59 页
ISO 11137-3:2017 gives guidance on meeting the requirements in ISO 11137-1 and ISO 11137-2 and in ISO/TS 13004 relating to dosimetry and its use in development, validation and routine control of a radiation sterilization process.
Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
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- 2021-07-01
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ISO/TR 20520:2018 specifies aspects to be considered for infection control for acupuncture treatment. Clinical practice in acupuncture treatment is outside the scope of this document.
Traditional Chinese medicine — Infection control for acupuncture treatment
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- 2021-07-01
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ISO 11138-4:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing dry heat as the sterilizing agent at sterilizing temperatures within the range of 120 °C to 180 °C. NOTE 1 Requirements for validation and control of dry heat sterilization processes are provided by ISO 20857. NOTE 2 Requirements for work place safety can be provided by national or regional regulations.
Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes
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- 2021-07-01
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1.1 This test method is intended to describe a procedure for testing the effectiveness of a disinfection process for reprocessing reusable medical devices when it is tested with a challenge of vegetative cells including mycobacteria. Disinfection normally deals with testing activity against vegetative cells of bacteria, viruses, and fungi. Since this test method is process oriented, the user may wish to examine a variety of test organisms. 1.2 This test method is designed to provide a reproducible procedure to verify the effectiveness of a previously validated disinfectant or disinfection procedure for reusable medical instruments and devices. 1.3 This test method is not meant to define the effectiveness of or validation of the particular disinfection process used or its kinetics, but rather, it is devised to confirm the effectiveness of the disinfection process by simulating use situations with a particular test process using medical devices and instruments. Either manual or machine reprocessing can be tested.
Standard Test Method to Determine Efficacy of Disinfection Processes for Reusable Medical Devices (Simulated Use Test)
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- 2021-07-01
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Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator (ISO 11138-8:2021)
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- 2021-07-00
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Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator
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- 11.080.01
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- 2021-07-00
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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 (ISO/DIS 11140-6:2021)
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- 11.080.01
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- 2021-07-00
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Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)
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- 2021-07-00
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- 2021-07-01
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 pr
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- 11.080.01
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- C47
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- 2021-06-30
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- 2021-09-11
Sterilization of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of results
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- 11.080.01
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- 2021-06-28
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Sterilization of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of results
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- 11.080.01
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- 发布
- 2021-06-28
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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 pr
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- 11.080.01
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- 2021-06-00
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Aseptic processing of health care products – Part 6: Isolator systems
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- 2021-05-27
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- 2021-05-27
Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2021)
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- 发布
- 2021-05-27
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- 2021-05-27
This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related to aseptic processing of health care products and processing of cell-based health care products. This document does not specify requirements for restricted access barrier systems (RABS). This document does not supersede or replace national regulatory requirements such as Good Manufacturing Practices (GMPs) and/or compendia requirements that pertain in particular to national or regional jurisdictions. This document does not specify requirements for isolators used for sterility testing; however, some of the principles and information in this document could be applicable to this application. This document does not define biosafety containment requirements.
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)
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- 2021-05-19
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- 2021-08-31
Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products — Amendment 1
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- 2021-05-19
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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 (ISO 25424:2018/DAM 1:2021) (Amendment)
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- 2021-05-01
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- 2021-05-01
Sterilization of health care products - Radiation - Part 4: Guidance on process control (Adopted ISO technical specification 11137-4:2020, first edition, 2020-06)
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- 2021-05-01
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This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related to aseptic processing of health care products and processing of cell-based health care products. This document does not specify requirements for restricted access barrier systems (RABS). This document does not supersede or replace national regulatory requirements such as Good Manufacturing Practices (GMPs) and/or compendia requirements that pertain in particular to national or regional jurisdictions. This document does not specify requirements for isolators used for sterility testing; however, some of the principles and information in this document could be applicable to this application. This document does not define biosafety containment requirements.
Aseptic processing of health care products — Part 6: Isolator systems
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- 11.080.01
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- 发布
- 2021-04-13
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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 (ISO/FDIS 17664-1:2021)
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- 11.080.01
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- 发布
- 2021-04-01
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- 2021-04-01
