13.040.35 清洁室（无菌室）及相关受控环境 标准查询与下载

GB/T 29469-2012 洁净室及相关受控环境.性能及合理性评价

本标准规定了对洁净室及相关受控环境的性能及合理性评价的程序和内容。 本标准适用于对洁净室及相关受控环境的性能及合理性评价”

Cleanrooms and associated controlled environments.Evaluation of performance and rationality

GB/T 25915.8-2010 洁净室及相关受控环境 第8部分：空气分子污染分级

GB/T 25915的本部分依据洁净室及相关受控环境空气中具体化学物质(种、组、类)的浓度,对空气分子污染(AMC)进行分级。同时,本部分在分级技术要求中,给出了包括检测方法、分析方法和时间加权系数的规程。 本部分目前只考虑洁净室运行工况下10g/m～10g/m的AMC浓度。 本部分不涉及那些虽有空气分子物质存在、但不认为对产品或工艺有风险的行业、工艺和生产。 本部分无意探讨空气分子污染物的特性。 本部分不包含对表面分子污染的分级。

Cleanrooms and associated controlled environments.Part 8:Classification of airborne molecular contamination

GB/T 25915.5-2010 洁净室及相关受控环境 第5部分：运行

GB/T 25915的本部分规定了洁净室运行的基本要求，供准备使用并运行洁净室的人员使用。本部分内容未涉及与污染控制有直接关联的安全问题，相关问题应遵守国家和地方的安全法规。本部分涉及生产各类产品的各个级别的洁净室。应用范围广泛，但未涉及各个行业的特定要求。本部分未包括洁净室的常规监测方法和规划的细节，关于粒子的监测参见GB/T 25915.2和GB/T 25915.3，微生物的监测参见GB/T 25916.1和GB/T 25916.2。

Cleanrooms and associated controlled environments.Part 5:Operations

GB/T 25915.3-2010 洁净室及相关受控环境.第3部分：检测方法

警告——GB/T 25915的本部分的应用可能涉及有害材料、作业和设备。GB/T 25915的本部分未提及与应用有关的所有安全性问题。使用前，GB/T 25915本部分的用户有责任制定适当的安全和卫生措施，并遵守各种强制性规定。 GB/T 25915的本部分规定了洁净室和洁净区空气悬浮粒子洁净度等级的检测方法，以及洁净室和洁净区性能的检测方法。性能检测针对是空态、静态和动态3种可能的占用状态下的单向流和非单向流型式洁净室和洁净区。本文件推荐了测定性能参数用检测仪器和检测规程。某些检测方法受限于洁净室或洁净区类型，为此，本文件推荐了若干代替方法。为了满足不同用户的要求，对于某些检测项目，本文件推荐了几种不同的方法和仪器。若需方与供方协商同意，也可以使用本部分未介绍的其他替代方法。替代方法未必给出相同的测量结果。 本部分不适用于测量洁净室或隔离装置内的产品或工艺。

Cleanrooms and associated controlled environments.Part 3: Test methods

GB/T 25916.2-2010 洁净室及相关受控环境 生物污染控制 第2部分：生物污染数据的评估与分析

GB/T 25916的本部分给出评估微生物数据的一般方法及估计风险区活粒子采样结果的一般方法。适用时，本部分应与本标准第1部分一起使用。

Cleanrooms and associated controlled environments.Biocontamination control.Part 2:Evaluation and interpretation of biocontamination data

GB/T 25915.1-2010 洁净室及相关受控环境 第1部分：空气洁净度等级

GB/T 25915的本部分划分洁净室及相关受控环境的空气洁净度等级仅依据其内的空气悬浮粒子浓度,该浓度系指粒径大于或等于阈值(低限)粒径的粒子总数,规定的阈值(低限)粒径为0.1μm～5μm。 本部分未设立0.1μm～5μm 规定粒径以外粒子总数的洁净度等级。但可以用U 描述符和M 描述符,分别表述超微粒子(＜0.1μm)和大粒子(＞5μm)的总数。 本部分不能用于描述空气悬浮粒子的物理、化学、放射性或存活特性。

Cleanrooms and associated controlled environments.Part 1:Classification of air cleanliness

GB/T 25915.7-2010 洁净室及相关受控环境 第7部分：隔离装置（洁净风罩、手套箱、隔离器、微环境）

GB/T 25915的本部分规定了设计、建造、安装、检测和批准隔离装置的最低要求，这些要求有别于GB/T 25915.4和GB/T 25915.5对洁净室的规定。 本部分的应用，考虑有下述限定条件： -需方与供方商定的用户要求； -本部分未说明的具体应用要求； -本部分未规定隔离装置内将要进行的具体工艺； -本部分并未特别关注消防、安全等强制性规定，这些问题应遵守适用的国家和地方法规。

Cleanrooms and associated controlled environments.Part 7:Separative devices (clean air hoods,gloveboxes,isolators and minienvironments)

GB/T 25915.2-2010 洁净室及相关受控环境.第2部分：证明持续符合GB/T 25915.1的检测与监测技术条件

GB/T 25915的本部分规定了对洁净室或洁净区进行定期检测的要求，以证明其持续符合GB/T 25915.1中规定的空气悬浮粒子浓度等级。 这些要求包括GB/T 25915.1说明的洁净室或洁净区的分级检测。此外，还规定了按本部分要求实施的其他检测项目。可按用户要求实施的可选检测项目，本部分也做了说明。 本部分还规定了对洁净室或洁净区（以下简称“设施”）进行监测的要求，以提供其持续符合GB/T 25915.1中规定的空气悬浮粒子浓度等级的证据。

Cleanrooms and associated controlled environments.Part 2: Specifications for testing and monitoring to prove continued compliance with GB/T 25915.1

GB/T 25915.4-2010 洁净室及相关受控环境 第4部分：设计、建造、启动

GB/T 25915的本部分规定了洁净室设施的设计和建造要求，但并未规定满足那些要求所需的具体技术或契约手段。本部分还给出了一份重要性能参数的目录，一并供洁净室设施的需方、供方和设计方使用。本部分给出的包括启动和确认要求的建造指南。在考虑运行和维护的相关事项时，明确了保证持续、满意运行的设计和建造的基本要素。 本部分的应用有如下限定： 用户要求由需方或规定方提出； 对洁净室设施内的具体工艺未做规定； 对消防和安全未做专门规定，消防和安全方面应遵守适用的国家和地方法规； 仅涉及了不同洁净度区域内及之间工艺介质和公用设施的路径； 仅涉及了与洁净室建造有关的初始运行和维护的具体要求。

Cleanrooms and associated controlled environments.Part 4:Design,construction and start-up

GB/T 25916.1-2010 洁净室及相关受控环境 生物污染控制 第1部分：一般原理和方法

GB/T25916 的本部分给出了采用洁净室技术控制生物污染时,对生物污染进行评价与控制的综合计划的原理和基本方法。 本部分规定了监测风险区的统一的方法,规定了与风险程度相应的控制措施。 低风险区域的生物污染控制也可借鉴本部分的规定。 本部分并未给出具体应用要求。 本部分未提及消防和安全方面的问题,此类问题应遵守相关法规以及国家或地方的文件要求。

Cleanrooms and associated controlled enviroments.Biocontamination Control.Part 1:General principles and methods

T/ZMDS 50004-2023 医疗器械 洁净室及相关受控环境监测系统的确认

本标准内容主要包含洁净室及相关受控环境监测系统确认目的、确认原则、确认要求、确认范围、确认程序以及资料性附录示例，指导医疗器械企业进行洁净室及相关受控环境监测系统确认。

Medical device - validation for cleanroom and related controlled environments monitoring system

T/QGCML 2505-2023 煤层气压缩机冷却装置除垢工艺规范

本文件规定了煤层气压缩机冷却装置除垢工艺的术语和定义、压缩机要求、压缩机操作流程、水垢去除剂的使用、除垢、清洗工艺流程、除垢率和洗净率测试方法、注意事项。 本文件适用于煤层气压缩机冷却装置除垢工艺的推广和应用。

Specification for descaling process of coalbed methane compressor cooling device

T/QGCML 1741-2023 洁净室除湿新风系统技术规范

本文件规定了洁净室除湿新风系统技术规范的术语与定义、设计要求、设计规范、结构原理、设备要求、系统施工要求、运行和维护要求、特殊要求、检验方法。 本文件适用于洁净室除湿新风系统技术规范。

Technical specifications for clean room dehumidification and fresh air systems

ISO/CD TS 14644-19:2023 洁净室和相关受控环境 第19部分：紧急医疗用模块化隔离装置的通用技术要求

Cleanrooms and associated controlled environments — Part 19: General technical requirements of modular isolation units for emergency medical use

ISO 14644-18:2023 洁净室和相关受控环境 - 第 18 部分：消耗品适用性评估

Cleanrooms and associated controlled environments — Part 18: Assessment of suitability of consumables

ISO/DTR 14644-21:2023 洁净室和相关受控环境 第 21 部分：空气颗粒采样技术

Cleanrooms and associated controlled environments — Part 21: Airborne particle sampling techniques

ISO/TR 14644-21:2023 洁净室和相关受控环境 - 第 21 部分：空气颗粒采样技术

Cleanrooms and associated controlled environments — Part 21: Airborne particle sampling techniques

ISO/DIS 14644-18 洁净室和相关受控环境 第18部分：耗材适用性评估

Cleanrooms and associated controlled environments — Part 18: Assessment of suitability of consumables

ISO DIS 14644-18:2022 洁净室和相关受控环境 第18部分：消耗品适用性评估

This document gives guidance for assessing personal and non-personal consumables for their appropriate use in cleanrooms, clean zones or controlled zones, based on product and process requirements, cleanliness attributes and functional performance properties. The cleanliness attributes addressed are particles or chemicals in air or on surfaces. Biocontamination (viable particles/ microorganisms) is considered as a special property of consumables. Identification of associated risks are considered. This document complements cleanroom operation as outlined in ISO 14644-5. This document gives guidance concerning: — determination of cleanroom suitability of consumables in general; — specification of requirements for an intended use of a candidate consumable by the customer with respect to functional performance, cleanliness attributes and special properties; — specification of properties for a designed use of a candidate consumable by supplier; — assessment of a candidate consumable for an appropriate use; — documentation. Informative annexes are used to list examples for personal and non-personal consumables, verification methods for cleanliness attributes testing as well as the potential impact of consumables on a cleanroom. Cleaning agents, disinfectants and lubricants are considered as cleanroom consumables with respect to their packaging, as their packaging is likely to have cleanliness requirements in common with all cleanroom consumables. This document does not apply to: — design details of consumables, — testing of functional performance of materials, e.g., barrier properties of gloves, wear and slip resistance of flooring; — health and safety requirements; legal documents of a specific country shall be considered; — cleanability; — (raw) materials which are added within the production process as ingredient; — performance or function testing; — transport containers; — process media such as gases or liquids; — the functional performance of cleaning agents, disinfectants and lubricants. 1

Cleanrooms and associated controlled environments — Part 18: Assessment of suitability of consumables

EN ISO 14644-4:2022 洁净室和相关控制环境.第4部分:设计,建造和启用

This document specifies the process for creating a cleanroom from requirements through to its design, construction and start-up. It applies to new, refurbished and modified cleanroom installations. It does not prescribe specific technological or contractual means of achieving these requirements. It is intended for use by users, specifiers, designers, purchasers, suppliers, builders and performance verifiers of cleanroom installations. The primary cleanliness consideration is airborne particle concentration. Detailed checklists are provided for the requirements, design, construction and start-up, which include important performance parameters to be considered. Energy management design approaches are identified to support an energy-efficient cleanroom design. Construction guidance is provided, including requirements for start-up and verification. A basic element of this document is consideration of aspects, including maintenance, that will help to ensure continued satisfactory operation for the entire life cycle of the cleanroom. NOTE Further guidance is given in Annexes A to D. ISO 14644-1, ISO 14644-2, ISO 14644-8, ISO 14644-9, ISO 14644-10, ISO 14644-12 and ISO 14644-17 provide complementary information. ISO 14644-7 offers guidance on design, construction and requirements for separative devices (clean air hoods, glove boxes, isolators and mini-environments). The following subjects are mentioned but not addressed in this document: — specific operational activities, processes to be accommodated and process equipment in the cleanroom installation; — fire and safety regulations; — ongoing operation, cleaning and maintenance activities, which are covered by ISO 14644-5.

Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2022)