11.080.01 消毒和灭菌综合 标准查询与下载

ASTM E1173-23 术前、导管化或注射前皮肤制剂评估的标准实施规程

1.1 The practice is designed to measure the reduction of the microflora of the skin. 1.2 A knowledge of microbiological techniques is required for these procedures. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.3.1 Exception—In this practice, metric units are used for all applications except for linear measure, in which case inches are used, and metric units follow in parentheses. 1.4 Performance of this procedure requires a knowledge of regulations pertaining to the protection of human subjects (1).2 NOTE 1—Importantly, it must be noted that the FDA currently does not accept data resulting from procedures in this Method for testing products for approval as Vascular Precatheterization Skin Preparations. 1.5 This standard does not purport to address all of the safety problems, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard Practice for Evaluation of Preoperative, Precatheterization, or Preinjection Skin Preparations

YY 0970-2023 医疗保健产品灭菌 一次性使用动物源性医疗器械的液体化学灭菌剂 医疗器械灭菌过程的特征、开发、确认和常规控制的要求

本文件规定了对全部或部分来源于动物材料的一次性使用医疗器械进行灭菌的液体化学灭菌剂的特征，以及灭菌开发、确认、过程控制和监控的要求。本文件适用于液体化学灭菌过程中细菌和真菌污染的风险控制，与其它微生物相关的风险可使用其他方法进行评估。本文件不适用于：人体来源的材料；病毒和传染性海绵状脑病（TSE）灭活的确认；原生动物和寄生虫灭活或消除的确认；生产过程中降低生物负载的处理过程；灭菌过程对医疗器械使用适宜性的测试评估；医疗器械中灭菌剂残留水平的制定。

Sterilization of healthcare products Liquid chemical sterilants for single-use medical devices of animal origin Characterization, development, validation and routine control requirements for medical device sterilization processes

YY/T 1268-2023 环氧乙烷灭菌的产品追加和过程等效

本文件规定了医疗器械环氧乙烷灭菌过程中新产品或变更的产品追加到已经确认的灭菌过程的要求，并为使用不同灭菌设备时评估灭菌过程等效性提供方法。本文件适用于经环氧乙烷灭菌处理、采用传统放行或参数放行的医疗器械。本文件适用的医疗器械环氧乙烷灭菌情况包括：a) 在已经确认的环氧乙烷灭菌过程中增加新产品；b) 评估已确认产品的变更；c) 已确认的过程转移到不同的场地或设备；d) 评估灭菌过程的等效性。

Product additions and process equivalence for ethylene oxide sterilization

T/LNIQA 009-2023 冷链货物外包装消毒作业规程

本文件规定了冷链货物外包装及其装载工具的消毒作业方式、药剂、个人防护用品的选择，作业过程、效果评价方法及注意事项等。　　

Specification for outer packaging disinfection of cold chain cargo

BS ISO 18362:2016+A1:2022 细胞保健产品的制造 加工过程中微生物风险的控制

1   Scope This International Standard 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'. This International Standard 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 fatt...

Manufacture of cell-based health care products. Control of microbial risks during processing

T/WSJD 40-2023 口腔综合治疗台水路清洗消毒技术规范

本文件规定了口腔综合治疗台水路的管理要求、清洗消毒、监测及维护。 本文件适用于开展口腔疾病预防、诊断、治疗服务的医疗机构。

Technical specifications for waterway cleaning and disinfection of oral comprehensive treatment table

T/WSJD 38-2023 抗菌和抑菌制剂良好生产规范

本文件规定了抗菌和抑菌制剂生产企业的基本要求、组织机构和人员、厂房与设备、物料、生产管理、验证、质量管理、卫生管理、产品销售及服务、投诉与报告。 本文件适用于直接接触人体完整皮肤、手、口腔黏膜、阴道黏膜的抗菌和抑菌制剂的生产（含分装）企业。

Good Manufacturing Practice for Antimicrobial and Bacteriostatic Preparations

T/WSJD 39-2023 医疗机构消毒供应中心物品信息追溯系统要求

本文件规定了医疗机构消毒供应中心物品信息追溯系统（以下简称“物品信息追溯系统”）的基本要求、管理模块设计及要求、物品流程追溯模块设计及要求、硬件配置参数要求、信息安全要求等。 本文件适用于二级（含二级）以上医疗机构消毒供应中心。基层医疗机构和物品信息追溯系统开发设计单位可参照执行。

Requirements for the item information traceability system of the disinfection supply center of medical institutions

T/THSX 401-2023 食品小作坊消毒技术规范

食品小作坊消毒技术的范围、规范性引用文件、术语和定义、消毒管理要求、消毒产品使用注意事项等

Technical specification for disinfection of small food workshop

T/CASME 319-2023 医药工业洁净厂房运行维护技术规范

本文件规定了医药工业洁净厂房运行维护技术规范的总则、生产区域、设备、无菌药品生产区域、特殊性质药品生产区域、无菌室的消毒要求、监测、检测与评价。

Technical specification for operation and maintenance of clean workshop in pharmaceutical industry

23/30457240 DC BS EN 556-2 医疗器械的灭菌 标记为“无菌”的医疗器械的要求 第 2 部分：无菌加工医疗器械的要求

BS EN 556-2. Sterilization of medical devices. Requirements for medical devices to be designated ''STERILE" - Part 2. requirements for aseptically processed medical devices

23/30457243 DC BS EN 556-1 医疗器械的灭菌 指定为“无菌”的医疗器械的要求 第 1 部分：最终灭菌医疗器械的要求

BS EN 556-1. Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Part 1. Requirements for terminally sterilized medical devices

KS P ISO 13408-6-2022 卫生保健产品的无菌加工.第6部分:隔离系统

Aseptic processing of health care products — Part 6: Isolator systems

KS P ISO 13408-1-2022 保健品的无菌加工.第1部分:一般要求

Aseptic processing of health care products — Part 1: General requirements

KS P ISO 17664-2-2022 医疗保健产品加工.医疗器械制造商为医疗器械加工提供的信息.第2部分:非关键医疗器械

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

KS P ISO 11137-1-2022 保健品灭菌─ 辐射─ 第1部分:医疗器械灭菌过程的开发、验证和常规控制要求

Sterilization of health care products ─ Radiation ─ Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

KS P ISO 11135-2022 保健品灭菌─ 环氧乙烷─ 医疗器械灭菌过程的开发、验证和常规控制要求

Sterilization of health-care products ─ Ethylene oxide ─ Requirements for the development, validation and routine control of a sterilization process for medical devices

KS P ISO 9999-2022 残疾人辅助产品.分类和术语

Assistive products for persons with disability — Classification and terminology

T/SICCA 016-2022 社区预防性消毒志愿服务规范

4 基本要求 4.1 组织管理 4.2 志愿者管理 5 服务要求 5.1 服务规范 5.2 服务流程 6 服务评价与改进 6.1 服务评价 6.2 服务改进 附录 A（规范性） 居民楼道（含电梯）消毒指南 附录 B（规范性） 居家消毒简易指南 附录 C（规范性） 预防性消毒过程记录表

Community Preventive Disinfection Volunteer Service Specification

ISO/TS 5111:2022 卫生保健产品用消毒器、消毒器和清洗消毒器的水质指南

Guidance on quality of water for sterilizers, sterilization and washer-disinfectors for health care products