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
本标准规定对化学指示物的性能要求，该指示物暴露于灭菌工艺后，以显示物质发生物理和（或）化学变化来指示灭菌过程。 本标准还包括用于测定指示物是否符合本标准的验收规范。
Sterilization of health care products--Chemical indicators--Part 1: General requirements
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2000-12-18
- 实施
- 2001-05-01
本标准规定了湿热灭菌工艺的设定、确认及常规灭菌的监控要求。 本标准涉及所有应用的湿热灭菌工艺，包括饱和蒸汽及空气一蒸汽混合气体，适用于所有工业生产厂和从事湿热灭菌工作者。虽然本标准末将非工业医疗保健部门的湿热灭菌明确地包括在内，但所列出的原则对其湿热灭菌大部分亦是有用的。 注1：若本标准的通则适用于药品灭菌时，则其他技术要求或管理要求亦可能适用。 本标准不包括质量保证体系，该体系必须控制所有生产阶段（包括灭菌工艺）。
Sterilization of health care products--Requirements for validation and routine control--Industrial moist heat sterilization
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2000-12-13
- 实施
- 2001-05-01
Sterilization of health care products. Moist heat. Requirements for the development, validation and routine control of a sterilization process for medical devices
- ICS
- 11.080.01
- CCS
- 发布
- 2024-05-31
- 实施
- 2024-05-31
本文件规定了一次性使用卫生用品中溶血性链球菌的实时荧光PCR检测方法。 本文件适用于一次性使用卫生用品中溶血性链球菌的定性检测。
Testing of hemolytic streptococci in disposable sanitary products by real-time fluorescence PCR method
- ICS
- 11.080.01
- CCS
- C2770
- 发布
- 2024-05-17
- 实施
- 2024-05-30
1 Scope This document specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of aseptic processing of health care products . This document includes requirements and guidance relative to the overall topic of aseptic processing . Specific requirements and guidance on various specialized processes and methods related to sterilizing filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in the other parts of the ISO 13408 series.
Aseptic processing of health care products - General requirements
- ICS
- 11.080.01
- CCS
- 发布
- 2024-04-30
- 实施
- 2024-04-30
1.1 Inclusions 1.1.1 This document provides requirements for the development, validation and routine monitoring and control of a low temperature sterilization process for medical devices using vaporized hydrogen peroxide (VH2O2) as the sterilizing agent. 1.1.2 This document is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized, organizations performing process validation of VH2O2 sterilization, and organizations responsible for sterilizing medical devices. NOTE VH2O2 sterilizers can be used in both health care and industrial facilities, and this document acknowledges the similarities and differences between the two applications. 1.2 Exclusions 1.2.1 Processes that use other sterilizing agents, or hydrogen peroxide solution in combination with other chemicals as the sterilizing agent are not addressed in this document. NOTE See ISO 14937 for guidance on validation of such processes. 1.2.2 This document does not specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies, e.g. scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents. NOTE Some VH2O2 sterilizers have processes that demonstrate some level of inactivation of the causative agents of spongiform encephalopathies, e.g. scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob Disease. However, this inactivation is process, cycle, and test protocol specific, therefore this inactivation is outside the scope of this document, and no specific test methods are provided (see [14], [26], and [30] for more information). 1.2.3 This document does not specify requirements for designating a medical device as sterile. NOTE See for example EN 556–1 or ANSI/AAMI ST67. 1.2.4 This document does not specify requirements for occupational safety associated with the design and operation of VH2O2 sterilization equipment. NOTE For further information on safety, see examples in the Bibliography. National or regional regulations can also exist. 1.2.5 This document does not apply to the contents of contained product, i.e. product for which the environment within the sterilizer chamber during any stage of the sterilization process does not come into direct contact with the product, such as a solution in a sealed bottle. 1.2.6 This document does not cover hydrogen peroxide decontamination systems for use in rooms, enclosures or environmental spaces. NOTE These decontamination systems operate at ambient conditions (e.g. temperature and pressure) and in general utilise an approach that is different to that of VH2O2 sterilization processes addressed in this document.
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
- ICS
- 11.080.01
- CCS
- 发布
- 2024-04-25
- 实施
本文件规定了医疗机构医用织物洗涤服务的评价指标、评价方法、评价分级等。
Specification for evaluation of medical textiles washing services in medical institutions
- ICS
- 11.080.01
- CCS
- Q849
- 发布
- 2024-03-29
- 实施
- 2024-04-01
本文件规定了医疗机构医用织物洗涤服务的评价指标、评价方法、评价分级等。
Specification for evaluation of medical textiles washing services in medical institutions
- ICS
- 11.080.01
- CCS
- Q849
- 发布
- 2024-03-29
- 实施
- 2024-04-01
本文件规定了以汽化过氧化氢为灭菌介质的低温灭菌器的技术要求、卫生要求、灭菌适用对象与使用注意事项、检验方法、标志、包装与产品说明书、运输和贮存。 本文件适用于低温汽化过氧化氢灭菌器。
Hygienic requirements for low-temperature vaporized hydrogen peroxide sterilizers
- ICS
- 11.080.01
- CCS
- Q849
- 发布
- 2024-03-11
- 实施
- 2024-03-26
本文件规定了消毒湿巾的管理与使用要求、清洁消毒操作规程、注意事项。 本文件适用于各级各类医疗机构，用于手部、完整皮肤、医疗设施设备表面、诊疗用品表面、一般物体表面及污物的清洁消毒。 其他卫生机构、养老机构、医学隔离观察场所（点）等单位可参照执行。
Guidelines for use of disinfectant wipes in healthcare facilities
- ICS
- 11.080.01
- CCS
- Q849
- 发布
- 2024-03-11
- 实施
- 2024-03-26
本文件规定了移动式紫外线消毒器的原材料要求、技术要求、使用范围、使用方法、检验方法、包装、运输和贮存及标识要求。 本文件适用于 GB 28235-2020 紫外线消毒器卫生要求范围以外的以 C 波段紫外线（波长范围为 200nm~280 nm）为杀菌因子直接照射消毒的移动式紫外线消毒器。
Hygiene requirements for mobile UV sterilizers
- ICS
- 11.080.01
- CCS
- Q849
- 发布
- 2024-03-11
- 实施
- 2024-03-26
本文件界定了低温消毒产品的术语和定义，规定了原材料要求、技术要求、检验方法、使用范围、使用方法、包装、运输与贮存、标识要求和注意事项。 本文件适用于低温条件下消毒的消毒产品。 本文件不适用于灭菌处理的灭菌剂和灭菌器械。
Hygiene requirements for low-temperature disinfection products
- ICS
- 11.080.01
- CCS
- Q849
- 发布
- 2024-03-11
- 实施
- 2024-03-26
Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
- ICS
- 11.080.01
- CCS
- 发布
- 2024-03-01
- 实施
BS EN ISO 11135 Sterilization of health care products - Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices
- ICS
- 11.080.01
- CCS
- 发布
- 2024-01-11
- 实施
- 2024-01-11
4 技术要求 工作条件 材料要求 结构及外观要求 稳固性要求 密封性要求 环境适应性要求 机械性能要求 电磁兼容性 电气安全 杀菌效果 有效寿命/连续使用寿命 5 试验方法 试验条件 材料试验 结构性能测试 外观试验 稳固性试验 密封性试验 环境性能试验 机械性能试验 电磁兼容性试验 电气安全试验 杀菌率试验 寿命试验 可靠性和耐用性试验 6 检验规则 出厂检验 抽样方法和抽样数量 型式检验
General technical specification for UVC-LED sterilization module for overflow drinking water
- ICS
- 11.080.01
- CCS
- C397
- 发布
- 2023-12-29
- 实施
- 2023-12-29
4 技术要求 4.1 结构组成及外观要求 4.2 工作条件 4.3 紫外线 4.4 有效寿命 4.5 结构稳固性和牢固性要求 4.6 环境适应性要求 4.7 机械性能要求 4.8 电磁兼容性 4.9 泄漏电流和电气强度 4.10 杀菌效果 5 试验方法 5.1 试验条件 5.2 外观试验 5.3 紫外线试验 5.4 寿命试验 5.5 结构试验 5.6 环境性能试验 5.7 机械性能试验 5.8 电磁兼容性 5.9 泄漏电流和电气强度 5.10 杀菌率试验 6 检验规则 6.1 出厂检验 6.2 抽样方法和抽样数量 6.3 型式检验 7 标志、包装、运输、贮存 7.1 标志 7.2 包装 7.3 运输 7.4 贮存
General technical specification for UVC-LED sterilization module for air conditioner
- ICS
- 11.080.01
- CCS
- C397
- 发布
- 2023-12-29
- 实施
- 2023-12-29
Technical Specifications for Waterway Disinfection of Oral Comprehensive Treatment Units
- ICS
- 11.080.01
- CCS
- C 33
- 发布
- 2023-10-30
- 实施
- 2023-11-30
本文件规定了一次性使用便携式输注泵-非电驱动（以下简称输注泵）的基本要求和相应的试验方法。本文件适用于神经、血管内或皮下应用的可持续（固定的或可调节）给液和/或自控给液的输注泵。本文件不适用于：GB 9706.224所涵盖的电动或电控输注泵；供单个患者使用的，用于输送YY/T 1768系列所涵盖的离散（丸剂）药液的装置；植入器械；肠给养泵；经皮给液装置；输液动力不是由装置本身提供或由患者主动干预获得动力的装置（例如，仅由重力作为动力的装置）。
Single use portable infusion pump non-electrically driven
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2023-09-05
- 实施
- 2026-09-15
Sterilization of health care products. Radiation. Substantiation of selected sterilization dose. Method VDmaxSD
- ICS
- 11.080.01
- CCS
- 发布
- 2023-07-31
- 实施
- 2023-07-31
本文件规定了普通物体表面和空气消毒用二氧化氯消毒片的术语和定义、基本要求、技术要求、试验方法、检验规则、使用方法、标识、包装、使用说明、运输和贮存、质量承诺。 本文件适用于普通物体表面和空气消毒用的二氧化氯消毒片，应用时状态为水溶液。
Chlorine dioxide disinfectant tablets for object surface and air disinfection
- ICS
- 11.080.01
- CCS
- C268
- 发布
- 2023-06-30
- 实施
- 2023-07-30
