11.080.01 消毒和灭菌综合 标准查询与下载

YY/T 1737-2020 医疗器械生物负载控制水平的分析方法

Analytical methods for bioburden control levels of medical devices

YY/T 1733-2020 医疗器械辐射灭菌 辐照装置剂量分布测试指南

Guidelines for Dose Distribution Testing of Radiation Sterilization Irradiation Devices for Medical Devices

ISO 14160:2020 一次性医疗器械的灭菌 包含动物产地的材料 - 液体化学杀菌剂的灭菌验证和常规控制

This document specifies requirements for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin. This document covers the control of risks arising from contamination with bacteria and fungi by application of a liquid chemical sterilization process. Risks associated with other microorganisms can be assessed using other methods (see NOTE 1). This document is not applicable to material of human origin. This document does not describe methods for the validation of the inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (see NOTE 2 and NOTE 3). This document does not describe methods for validation of the inactivation or elimination of protozoa and parasites. The requirements for validation and routine control described in this document are only applicable to the defined sterilization process of a medical device, which is performed after the manufacturing process, and do not take account of the lethal effects of other bioburden reduction steps (see NOTE 4). This document does not specify tests to establish the effects of any chosen sterilization process upon the fitness for use of the medical device (see NOTE 5). This document does not cover the level of residual sterilizing agent within medical devices (see NOTE 6). Guidance for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin is provided in informative Annex A. NOTE 1 The prior application of risk management principles to medical devices utilizing animal tissues, as described in ISO 22442-1 is important. ISO 18362 provides information on control of microbial risks during processing of cell-based health-care products. NOTE 2 Liquid chemical sterilizing agents traditionally employed to sterilize animal tissues in medical devices might not be effective in inactivating the causative agents of TSE such as bovine spongiform encephalopathy (BSE), or scrapie. Satisfactory validation in accordance with this document does not necessarily demonstrate inactivation of infective agents of this type. Risk controls related to sourcing, collection and handling of animal materials are described in ISO 22442-2. NOTE 3 The validation of the inactivation, elimination, or elimination and inactivation of viruses and TSE agents is described in ISO 22442-3. NOTE 4 Manufacturing processes for medical devices containing animal tissues frequently include exposure to chemical agents which can significantly reduce the bioburden on the medical device. Following the manufacturing process, a medical device is exposed to a specified sterilization process. NOTE 5 Such testing is a crucial part of the design and development of a medical device.  NOTE 6 ISO 10993-17 specifies a method to establish allowable limits for residues of sterilizing agents. NOTE 7 Standards for quality management systems (see ISO 13485) can be used in the control of all stages of manufacture including the sterilization process.

Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, developmen

ISO/TS 21387:2020 医疗器械的灭菌 - 使用参数释放对环氧乙烷灭菌过程的验证和常规加工要求的指导

Sterilization of medical devices — Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release

T/ZHCA 601-2020 食品生产企业消毒技术规范

1  范围 2  规范性引用文件 3  术语和定义 4  食品生产企业消毒管理要求 5  消毒效果评估 6  消毒产品使用注意事项 附 录 A(资料性）食品生产企业常用消毒产品的选用

Technical specification for disinfection in food enterprises

DB3701/T 8-2020 疫情防控集中隔离场所污水消毒技术规范

本标准适用于济南市内疫情防控集中隔离场所污水处理设施的建设与运行管理，可作为疫情防控集中隔离场所污水处理设施运行管理的参考依据。

Technical specifications for sewage disinfection in centralized isolation places for epidemic prevention and control

ISO/TS 11137-4:2020 保健产品的灭菌 - 辐射 - 第4部分:过程控制指南

Sterilization of health care products — Radiation — Part 4: Guidance on process control

YY/T 0802-2020 医疗器械的处理 医疗器械制造商提供的信息

Disposal of medical devices Information provided by medical device manufacturers

T/ACEF 004-2020 室内车内环境消毒杀菌服务能力评价规范

本规范规定了室内车内环境消毒杀菌服务能力评价规范的术语和定义、 基本要求、服务资源要求、服务过程要求、消毒效果要求、 服务能力等级。

Specification for evaluation of service capability for disinfection and sterilization of indoor environment in vehicles

T/GDBX 027-2020 车内环境PEM臭氧实时消毒净化装置

本文件规定了车内环境实时PEM臭氧消毒净化装置的技术要求、试验方法、检验规则以及标志、包装、运输和贮存。 本文件适用于由车内电源供电的额定电压不超过36V的车内环境实时PEM臭氧消毒净化装置（以下简称装置）。

Real-time environmental PEM ozone disinfection and purification device in the vehicle 2020-

T/GDBX 028-2020 公共场所室内环境智能PEM臭氧消毒净化系统

本文件规定了公共场所室内环境智能PEM臭氧消毒净化系统的技术要求、智能控制、试验方法、检验规则以及标志、包装、运输和贮存。 本文件适用于公共场所室内环境智能PEM臭氧消毒净化系统的设计、施工、验收、运维和管理。

Intelligent PEM ozone disinfection and purification system for indoor environment in public places

GSO ISO 11737-1:2020 保健品灭菌 微生物学方法 第1部分：产品微生物种群的测定

ISO 11737-1:2018 specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package. NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data. NOTE 2 See Annex A for guidance on Clauses 1 to 9. ISO 11737-1:2018 does not apply to the enumeration or identification of viral, prion or protozoan contaminants. This includes the removal and detection of the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. NOTE 3 Guidance on inactivating viruses and prions can be found in ISO 22442‑3, ICH Q5A(R1) and ISO 13022. ISO 11737-1:2018 does not apply to the microbiological monitoring of the environment in which health care products are manufactured.

Sterilization of health care products -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products

T/BPMA 0001-2020 新型冠状病毒肺炎疫情期间预防性消毒技术要求

各类传染病预防性消毒的原则、范围、方法、消毒效果评价与注意事项，适用于未出现传染病病人时各类场所的预防性消毒，指导开展科学消毒、适时消毒、精准消毒，既保证消毒效果，又避免过度消毒，适用于居民家庭、各类公共场所的预防性消毒及其消毒效果评价。

Technical requirements for preventive disinfection against coronavirus disease 2019

T/HBCC 007-2020 购物中心疫情防控指南

本指南适用于石家庄行政区域内购物中心发生突发公共卫生事件时的紧急防控、应急处置工作；周边地区出现群体性不明原因疾病时的紧急应对工作。

Guidelines for Epidemic Prevention and Control in Shopping Centers

T/SEA 005-2020 公共环境消毒杀菌企业服务资质等级评定准则

企业资质分为四个等级，从低到高依次划分为丙级、乙级、甲级、特级资质企业。 按企业综合实力、人力资源、机构管理、服务质量、服务规范及诚信经营六个方面的情况进行综合评定，根据得分进行等级划分，评定要素和计分方法

The Service Evaluation Standard of Public Environmental Disinfection and Sterilization Enterprises

T/DGASE 001-2020 新型冠状病毒肺炎疫情期间电梯消毒操作规范

    消毒工作实施主体：电梯使用单位负责本辖区内电梯的消毒工作。成立由组长、消毒人员、电梯安全管理员组成的结构，成员分别由满足要求的人员担任。     人员防护：进入电梯消毒现场的人员都应当穿戴工作衣、手套、工作鞋、口罩、帽子，必要时戴护目镜。     轿厢消毒：暂停电梯运行，保证紧急照明和通风设施工作。使用消毒剂对按钮、厢壁、轿厢门、轿厢内扶手等进行消毒，对地面消毒，做好消毒标识。     自动扶梯、自动人行道消毒：关停自动扶梯或自动人行道，对扶手带、侧面防护等部位消毒，使用消毒剂对自动扶梯或自动人行道梯级进行消毒，并做好消毒标识。     消毒后工作：填写电梯消毒记录，恢复电梯运行，处置防护用品，对手部进行清洗消毒。

Regulation of Disinfection for Elevator and Escalator during the Epidemic of COVID-19

DB6101/T 3073.1-2020 学校复课新型冠状病毒肺炎疫情防控消毒 技术指南 第 1 部分：托幼机构 （试行）

本标准规定了托幼机构复课新型冠状病毒肺炎疫情防控消毒的管理要求、消毒要求、消毒人员要 求、常用消毒方法。 本标准适用于招收 0～6 岁儿童的各级各类托儿所、幼儿园（以下简称托幼机构）。

Technical Guidelines for the Prevention and Control of the Novel Coronavirus Pneumonia Epidemic and Disinfection for School Resumption Part 1: Childcare Institutions (Trial)

DB6101/T 3073.3-2020 学校复课新型冠状病毒肺炎疫情防控消毒 技术指南 第 3 部分：普通高等学校（试行）

本标准规定了新型冠状病毒肺炎普通高等学校复课消毒卫生管理要求，复课前消毒方法、预防性消 毒方法、疫源地消毒方法、消毒人员要求、常用消毒方法。 本标准适用于各级各类普通高等学校。党校、社会主义学院、行政学院、中等职业学校、中等专业 学校、中等师范学校、中等技工学校、技师学院、职业中学、成人中专、职业高中、成人高中、高等专 业学院、夜校等在新型冠状病毒肺炎期间的防控消毒可参照本标准执行。

Technical Guidelines for Prevention, Control and Disinfection of the Novel Coronavirus Pneumonia Epidemic in School Resumption Part 3: Ordinary Universities (Trial)

DB6101/T 3074.2-2020 新型冠状病毒肺炎疫情防控消毒技术指南 第 2 部分：建筑工地 （试行）

本标准规定了新型冠状病毒肺炎流行期间建筑工地防控消毒的术语和定义、管理要求、消毒要求、消毒人员要求和常用消毒方法。 本部分适用于新型冠状病毒肺炎流行期间建筑工地的消毒，包括新建、改建、扩建的土木工程、建 筑工程、线路管道工程、设备安装工程、装修装饰工程及拆除工程等施工场所。其它传染病流行适用时 也可以参照执行。

Technical Guidelines for Disinfection and Prevention of Novel Coronavirus Pneumonia Epidemic Part 2: Construction Site (Trial)

DB6101/T 3074.1-2020 新型冠状病毒肺炎疫情防控消毒技术指南 第 1 部分：公共场所（试行）

本部分规定了新型冠状病毒肺炎流行期间公共场所消毒的术语和定义、管理要求、消毒要求、消毒人员要求和常用消毒方法。 本部分适用于新型冠状病毒肺炎流行期间办公场所、酒店宾馆、商场超市、农贸市场等公共场所的 消毒，其它公共场所也可参照执行。

Technical Guidelines for Disinfection and Prevention of Novel Coronavirus Pneumonia Epidemic Part 1: Public Places (Trial)