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
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 17664-1:2021)
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- 11.080.01
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- 发布
- 2021-09-10
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- 2021-09-10
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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- 11.080.01
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- 2021-09-10
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- 2021-09-10
前言 1 范围 2 规范性引用文件 3 术语和定义 4 消毒管理要求 5 消毒技术要求 附录 Ａ （资料性） 化妆品生产企业清洁消毒对象及推荐的操作频次 附录Ｂ（资料性） 消毒操作记录表 参考文献
Technical specification for disinfection in cosmetics production enterprises
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- 11.080.01
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- 2021-09-01
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- 2021-10-01
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 17664-1:2021)
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- 11.080.01
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- 发布
- 2021-09-00
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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 (ISO 11138-8:2021)
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- 11.080.01
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- 发布
- 2021-08-03
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- 2021-08-03
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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- 2021-08-03
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- 2021-08-03
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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- 2021-08-01
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- 2021-08-01
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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- 11.080.01
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- 发布
- 2021-08-00
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- 2021-08-01
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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- 发布
- 2021-08-00
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- 2021-08-01
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)
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- 11.080.01
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- 2021-07-30
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- 2021-07-30
本文件规定了非一次性使用消化内镜再处理的基本原则、总体要求、操作流程。 本文件适用于开展消化内镜再处理的各级各类医疗机构， 注：本文件中的“内镜，内镜附件和诊疗附件”均系指非一次性使用的。
Protocol of non-disposable use gastrointe stinal endoscope reprocess
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- 11.080.01
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- Q841
- 发布
- 2021-07-15
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- 2021-10-12
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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- 发布
- 2021-07-06
- 实施
- 2021-07-06
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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- 发布
- 2021-07-06
- 实施
- 2021-07-06
This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of critical or semi-critical medical devices (i.e. a medical device that enters normally sterile parts of the human body or a medical device that comes into contact with mucous membranes or non-intact skin) or medical devices that are intended to be sterilized. This includes information for processing prior to use or reuse of the medical device. Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable: a) initial treatment at the point of use; b) preparation before cleaning; c) cleaning; d) disinfection; e) drying; f) inspection and maintenance; g) packaging; h) sterilization; i) storage; j) transportation. This document excludes processing of the following: — non-critical medical devices unless they are intended to be sterilized; — textile devices used in patient draping systems or surgical clothing; — medical devices specified by the manufacturer for single use only and supplied ready for use. NOTE See ISO 17664-2:2021, Annex E, for further guidance on the application of the ISO 17664 series to a medical device.
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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- 11.080.01
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- 2021-07-06
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ISO 11138-1:2017 specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes. ISO 11138-1:2017 specifies basic and common requirements that are applicable to all parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO 11138. If no specific subsequent part is provided, this document applies. NOTE National or regional regulations can apply. ISO 11138-1:2017 does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e.g. filtration processes or processes that combine physical and/or mechanical removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming of pipelines. This document, however, can contain elements relevant to such microbiological test systems.
Sterilization of health care products — Biological indicators — Part 1: General requirements
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- 11.080.01
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- 2021-07-01
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ISO 11138-2:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 °C to 65 °C. NOTE 1 Requirements for validation and control of ethylene oxide sterilization processes are provided by ISO 11135 and ISO 14937. NOTE 2 National or regional regulations can provide requirements for work place safety.
Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
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- 11.080.01
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- 2021-07-01
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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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- 11.080.01
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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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- 11.080.01
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- 2021-07-01
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ISO 18362:2016 specifies the minimum requirements for, and provides guidance on, a risk-based approach for the processing of cell-based health care products (CBHPs) requiring control of viable and non-viable microbial contamination. It is applicable both to CBHPs labelled 'sterile' and to CBHPs not labelled 'sterile'. ISO 18362:2016 is not applicable to: - procurement and transport of cell-based starting material used in processing of a CBHP, - cell banking, - control of genetic material, - control of non-microbial product contamination, - in vitro diagnostics (IVDs), or - natural medicines. EXAMPLE Vitamins and minerals, herbal remedies, homoeopathic medicines, traditional medicines such as traditional Chinese medicines, probiotics, other products such as amino acids and essential fatty acids. ISO 18362:2016 does not define biosafety containment requirements. ISO 18362:2016 does not replace national or regional regulations that apply to the manufacture and quality control of a CBHP.
Manufacture of cell-based health care products — Control of microbial risks during processing
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- 2021-07-01
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ISO 11138-3:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent. NOTE 1 Requirements for validation and control of moist heat sterilization processes are provided by the ISO 17665 series. NOTE 2 National or regional regulations can provide requirements for work place safety.
Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
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- 11.080.01
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- 2021-07-01
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