13.040.35 清洁室（无菌室）及相关受控环境 标准查询与下载

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)

ISO 14644-4:2022 洁净室和相关受控环境.第4部分:设计、施工和启动

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

22/30433806 DC BS EN ISO 14644-18 洁净室和相关受控环境 第 18 部分：消耗品适用性评估

BS EN ISO 14644-18. Cleanrooms and associated controlled environments - Part 18. Assessment of suitability of consumables

T/ZAPA 0002-2022 医院洁净用房空气过滤器更换规范

本文件规定了医院洁净用房空气过滤器更换的一般要求、日常维护、更换及自检要求。 本文件适用于医院洁净用房空气过滤器的运行维护和更换

Specification for air filter replacement in hospital clean rooms

BS EN ISO 14644-9:2022 洁净室和相关的受控环境 评估颗粒浓度的表面清洁度

1   Scope This document establishes a procedure for the assessment of particle cleanliness levels on solid surfaces in cleanrooms and associated controlled environment applications. Recommendations on testing and measuring methods, as well as information about surface characteristics, are given in Annexes A to D. This document applies to all solid surfaces in cleanrooms and associated controlled environments, such as walls, ceilings, floors, working environments, tools, equipment and products. The procedure for the assessment of surface cleanliness by particle concentration ( SCP ) is limited to particles of between 0,05 µm and 500 µm. The following issues are not considered in this document: — requirements for the cleanliness and suitability of surfaces for specific processes; — procedures for the cleaning of surfaces; — material characteristics; — references to interactive bonding forces or generation processes that are usually time-dependent and process-dependent; — selection and use of statistical methods for assessment and testing;

Cleanrooms and associated controlled environments. Assessment of surface cleanliness for particle concentration

BS EN ISO 14644-8:2022 洁净室和相关的受控环境 通过化学浓度评估空气清洁度（ACC）

1   Scope This document establishes typical assessment processes to determine grading levels of air chemical cleanliness ( ACC ) in cleanrooms and associated controlled environments, in terms of airborne concentrations of specific chemical substances (individual, group or category), and provides a protocol to include test methods, analysis and time-weighted factors for their determination. This document currently considers only concentrations of air chemical contaminants between 10 0 g/m 3 and 10 −12 g/ m 3 under cleanroom operational conditions. This document is not relevant for application in those industries, processes or productions where the presence of airborne chemical substances is not considered a risk to the product or process. It is not the intention of this document to describe the nature of air chemical contaminants. This document does not give a classification of surface chemical contamination .

Cleanrooms and associated controlled environments. Assessment of air cleanliness by chemical concentration (ACC)

BS EN ISO 14644-10:2022 洁净室和相关受控环境 第10部分：化学污染表面清洁度评估

1   Scope This document establishes appropriate testing processes to determine the cleanliness of surfaces in cleanrooms with regard to the presence of chemical compounds or elements (including molecules, ions, atoms and particles). This document is applicable to all solid surfaces in cleanrooms and associated controlled environments such as walls, ceilings, floors, worksurfaces, tools, equipment and devices. NOTE 1 For the purpose of this document, consideration is only given to the chemical characteristics of a particle. The physical properties of the particle are not considered and this document does not cover the interaction between the contamination and the surface . NOTE 2 This document does not include the contamination generation process or any time-dependent influences (e.g. deposition, sedimentation, ageing) or process-dependent activities such as transportation and handling. Neither does it include guidance on statistical quality-control techniques to ensure compliance.

Cleanrooms and associated controlled environments - Part 10: Assessment of surface cleanliness for chemical contamination

EN ISO 14644-8:2022 洁净室及相关受控环境-第8部分:分类的空气清洁化学浓度(ACC)

This document establishes typical assessment processes to determine grading levels of air chemical cleanliness (ACC) in cleanrooms and associated controlled environments, in terms of airborne concentrations of specific chemical substances (individual, group or category), and provides a protocol to include test methods, analysis and time-weighted factors for their determination. This document currently considers only concentrations of air chemical contaminants between 100 g/m3 and 10−12 g/m3 under cleanroom operational conditions. This document is not relevant for application in those industries, processes or productions where the presence of airborne chemical substances is not considered a risk to the product or process. It is not the intention of this document to describe the nature of air chemical contaminants. This document does not give a classification of surface chemical contamination.

Cleanrooms and associated controlled environments - Part 8: Assessment of air cleanliness by chemical concentration (ACC) (ISO 14644-8:2022)

ISO 14644-8:2022 洁净室和相关受控环境.第8部分:用化学浓度（ACC）评估空气清洁度

This document establishes typical assessment processes to determine grading levels of air chemical cleanliness (ACC) in cleanrooms and associated controlled environments, in terms of airborne concentrations of specific chemical substances (individual, group or category), and provides a protocol to include test methods, analysis and time-weighted factors for their determination. This document currently considers only concentrations of air chemical contaminants between 100 g/m3 and 10−12 g/ m3 under cleanroom operational conditions. This document is not relevant for application in those industries, processes or productions where the presence of airborne chemical substances is not considered a risk to the product or process. It is not the intention of this document to describe the nature of air chemical contaminants. This document does not give a classification of surface chemical contamination.

Cleanrooms and associated controlled environments — Part 8: Assessment of air cleanliness by chemical concentration (ACC)

EN ISO 14644-9:2022 净化室和相关控制环境.第9部分:利用颗粒物浓度对表面洁净度的分类

This document establishes a procedure for the assessment of particle cleanliness levels on solid surfaces in cleanrooms and associated controlled environment applications. Recommendations on testing and measuring methods, as well as information about surface characteristics, are given in Annexes A to D. This document applies to all solid surfaces in cleanrooms and associated controlled environments, such as walls, ceilings, floors, working environments, tools, equipment and products. The procedure for the assessment of surface cleanliness by particle concentration (SCP) is limited to particles of between 0,05 µm and 500 µm. The following issues are not considered in this document: — requirements for the cleanliness and suitability of surfaces for specific processes; — procedures for the cleaning of surfaces; — material characteristics; — references to interactive bonding forces or generation processes that are usually time-dependent and process-dependent; — selection and use of statistical methods for assessment and testing; — other characteristics of particles, such as electrostatic charge, ionic charges and microbiological state.

Cleanrooms and associated controlled environments - Part 9: Assessment of surface cleanliness for particle concentration (ISO 14644-9:2022)

EN ISO 14644-10:2022 洁净室和相关控制环境.第10部分:通过化学浓缩进行表面洁净度分类

This document establishes appropriate testing processes to determine the cleanliness of surfaces in cleanrooms with regard to the presence of chemical compounds or elements (including molecules, ions, atoms and particles). This document is applicable to all solid surfaces in cleanrooms and associated controlled environments such as walls, ceilings, floors, worksurfaces, tools, equipment and devices. NOTE 1 For the purpose of this document, consideration is only given to the chemical characteristics of a particle. The physical properties of the particle are not considered and this document does not cover the interaction between the contamination and the surface. NOTE 2 This document does not include the contamination generation process or any time-dependent influences (e.g. deposition, sedimentation, ageing) or process-dependent activities such as transportation and handling. Neither does it include guidance on statistical quality-control techniques to ensure compliance.

Cleanrooms and associated controlled environments - Part 10: Assessment of surface cleanliness for chemical contamination (ISO 14644-10:2022)

ISO 14644-9:2022 洁净室和相关受控环境.第9部分:颗粒浓度的表面清洁度评定

This document establishes a procedure for the assessment ofparticle cleanliness levels on solid surfaces in cleanrooms and associated controlled environment applications. Recommendations on testing and measuring methods, as well as information about surface characteristics, are given in Annexes A to D. This document applies to all solid surfaces in cleanrooms and associated controlled environments, such as walls, ceilings, floors, working environments, tools, equipment and products. The procedure for the assessment of surface cleanliness by particle concentration (SCP) is limited to particles of between 0,05 µm and 500 µm. The following issues are not considered in this document: — requirements for the cleanliness and suitability of surfaces for specific processes; — procedures for the cleaning of surfaces; — material characteristics; — references to interactive bonding forces or generation processes that are usually time-dependent and process-dependent; — selection and use of statistical methods for assessment and testing; — other characteristics of particles, such as electrostatic charge, ionic charges and microbiological state.

Cleanrooms and associated controlled environments — Part 9: Assessment of surface cleanliness for particle concentration

ISO 14644-10:2022 洁净室和相关受控环境.第10部分:化学污染表面清洁度的评定

This document establishes appropriate testing processes to determine the cleanliness of surfaces in cleanrooms with regard to the presence of chemical compounds or elements (including molecules, ions, atoms and particles). This document is applicable to all solid surfaces in cleanrooms and associated controlled environments such as walls, ceilings, floors, worksurfaces, tools, equipment and devices . NO TE 1 For the purpose of this document, consideration is only given to the chemical characteris tics of a particle. The physical properties of the particle are not considered and this document does not cover the interaction between the contamination and the surface. NO TE 2 This document does not include the contamination generation process or any time- dependent influences (e. g. deposition, sedimentation, ageing) or process- dependent activities such as transportation and handling. Neither does it include guidance on s tatis tical quality- control techniques to ensure compliance.

Cleanrooms and associated controlled environments — Part 10: Assessment of surface cleanliness for chemical contamination

KS I ISO 14644-3-2021 洁净室和相关受控环境.第3部分:试验方法

Cleanrooms and associated controlled environments —Part 3: Test methods

KS I ISO 14644-3:2021 洁净室和相关受控环境.第3部分:试验方法

Cleanrooms and associated controlled environments —Part 3: Test methods

KS I ISO 14644-16:2021 洁净室和相关受控环境.第16部分:洁净室和分离装置的能源效率

Cleanrooms and associated controlled environments —Part 16: Energy efficiency in cleanrooms and separative devices

KS I ISO 14644-16-2021 洁净室和相关受控环境.第16部分:洁净室和分离装置的能源效率

Cleanrooms and associated controlled environments —Part 16: Energy efficiency in cleanrooms and separative devices

prEN ISO 14644-4:2021 洁净室和相关受控环境 第4部分：设计、建造和启动（ISO/DIS 14644:2021）

Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO/DIS 14644:2021)

ASTM E2088-06(2021) 洁净室和相关受控环境中测量颗粒沉积用见证表面的选择、制备、暴露和分析的标准实施规程

1.1 This practice is intended to assist in the selection, preparation, exposure, and analysis of witness surfaces for the purpose of characterizing particle deposition rates in cleanrooms and associated controlled environments, particularly for aerospace applications. 1.2 Requirements may be defined in terms of particle size distribution and count, percent area coverage, or product performance criteria such as optical transmission or scatter. Several choices for witness surfaces are provided. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 This standard does not purport to address all of the safety concerns, 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. 1.5 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 Selecting, Preparing, Exposing, and Analyzing Witness Surfaces for Measuring Particle Deposition in Cleanrooms and Associated Controlled Environments