13.040.35 清洁室（无菌室）及相关受控环境 标准查询与下载

ASTM E2217-12(2019) 航空洁净室和污染控制区设计与施工标准实践

1.1 The purpose of this practice is to provide design and construction guidelines for contamination controlled facilities used in the assembly and integration of aerospace hardware. The guidelines herein are intended to ensure that the facilities, when used properly, will meet the cleanliness requirements of aerospace hardware and processes. The objective is to limit contamination due to the deposition of particulate and molecular contaminants on flight hardware surfaces. 1.2 One cleanliness classification of a facility is the airborne particle concentrations in accordance with ISO 14644-1 and 14644-2. Airborne particle concentrations in accordance with FED-STD-209E are included for reference. This simple classification is inadequate to describe a facility that will support the assembly and integration of spacecraft. The extended duration of hardware exposure during fabrication and testing, the sensitivity of the hardware to hydrocarbons and other molecular contaminants, and the changing requirements during assembly and integration must be considered in addition to the airborne particle concentrations. 1.3 The guidelines specified herein are intended to provide facilities that will effectively restrict contaminants from entering the facility, limit contamination generated by and within the facility, and continuously remove airborne contaminants generated during normal operations. Some items of support hardware, such as lifting equipment, stands, and shoe cleaners, are addressed since these items are often purchased and installed with the facility and may require accommodation in the design of the facility. 1.4 Active filtration of molecular contaminants (such as hydrocarbons, silicones, and other chemicals) is discussed. Such active filtration of molecular contaminants may be required for the processing of highly sensitive optical devices, especially infrared and cryogenic sensors. Control of microbiological contamination is not included although HEPA (High Efficiency Particulate Air) filtration will provide some control of airborne bacteria, spores, and other viable contaminants that are typically carried on particles of sizes 0.3 µm and larger. Control of radioactive contamination and accommodation of very hazardous materials such as propellants, strong acids or caustics, or carcinogens are not addressed. 1.5 No facility will compensate for excessive contamination generated inside the facility. In addition to an effective facility design, the user must also institute a routine maintenance program (see Practice E2042) for the facility, and personnel and operational disciplines that limit the transfer of contaminants through entry doors and contaminant generation inside the facility. 1.6 This practice only addresses guidelines for contamination control in facility design. It must be implemented in compliance with all mandatory government and regulatory building and safety codes. References to related cleanroom standards and U.S. building codes and standards may be found in IEST-RP-CC012. 1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.7.1 The values given in parentheses are provided for information only and are not considered standard. 1.8 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. 1.9 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. 1 This practice is under the jurisdiction of ASTM Committee E21 on Space Simulation and Applications of Space Technology and is the direct responsibility of Subcommittee E21.05 on Contamination. Current edition approved Dec. 1, 2019. Published January 2020. Originally approved in 2002. Last previous edition approved in 2012 as E2217 – 12. DOI: 10.1520/E2217-12R19. Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States 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. 2. Referenced Documents

Standard Practice for Design and Construction of Aerospace Cleanrooms and Contamination Controlled Areas

ISO 14644-3:2019 洁净室和相关的受控环境 - 第3部分:测试方法

This document provides test methods in support of the operation for cleanrooms and clean zones to meet air cleanliness classification, other cleanliness attributes and related controlled conditions. Performance tests are specified for two types of cleanrooms and clean zones: those with unidirectional airflow and those with non-unidirectional airflow, in three possible occupancy states: as-built, at-rest and operational. The test methods, recommended test apparatus and test procedures for determining performance parameters are provided. Where the test method is affected by the type of cleanroom or clean zone, alternative procedures are suggested. For some of the tests, several different methods and apparatus are recommended to accommodate different end-use considerations. Alternative methods not included in this document can be used by agreement between customer and supplier. Alternative methods do not necessarily provide equivalent measurements. This document is not applicable to the measurement of products or of processes in cleanrooms, clean zones or separative devices. NOTE This document does not purport to address safety considerations associated with its use (for example, when using hazardous materials, operations and equipment). It is the responsibility of the user of this document to establish appropriate safety and health practices and to determine the applicability of regulatory limitations prior to use.

Cleanrooms and associated controlled environments — Part 3: Test methods

ASTM E2312-11(2019) 洁净室材料试验的标准实施规程

1.1 This practice identifies test methods used to evaluate the properties of various materials and products used in cleanrooms and for cleanroom construction. 1.2 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. 1.3 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 Tests of Cleanroom Materials

BS EN ISO 14644-16:2019 洁净室和相关受控环境 洁净室和独立设备的能源效率

What is this ISO 14644 ‑ 16 – Energy efficiency in cleanrooms about? ISO 14644 ‑ 16 is the 16 th part of the multi-series on cleanrooms and associated controlled environments. ISO 14644 ‑ 16 gives best practices recommendations for optimizing energy usage and maintaining energy efficiency in new and existing cleanrooms, clean zones, and separative devices. ISO 14644 ‑ 16 provides guidance for the design, construction, commissioning, and operation of cleanrooms. ISO 14644 ‑ 16 covers all cleanroom-specific features and can be used in different areas to optimize energy use in electronic, aerospace, nuclear, pharmaceutical, hospital, medical device, food industries, and other clean air applications. ISO 14644 ‑ 16 also introduces the concept of benchmarking for the performance assessment and comparison of cleanroom energy efficiencies, while maintaining performance levels to ISO 14644 requirements. Who is

Cleanrooms and associated controlled environments - Energy efficiency in cleanrooms and separative devices

EN ISO 14644-16:2019 洁净室和相关的受控环境.第16部分:洁净室和分离装置的能源效率

This document gives guidance and recommendations for optimizing energy usage and maintaining energy efficiency in new and existing cleanrooms, clean zones and separative devices. It provides guidance for the design, construction, commissioning and operation of cleanrooms. This document covers all cleanroom-specific features and can be used in different areas to optimize energy use in electronic, aerospace, nuclear, pharmaceutical, hospital, medical device, food industries and other clean air applications. It also introduces the concept of benchmarking for the performance assessment and comparison of cleanroom energy efficiencies, while maintaining performance levels to ISO 14644 requirements[2][3].

Cleanrooms and associated controlled environments - Part 16: Energy efficiency in cleanrooms and separative devices (ISO 14644-16:2019)

KS I ISO 14644-13-2019 洁净室和相关控制环境第13部分:根据颗粒和化学分类达到规定清洁度的表面清洁

Cleanrooms and associated controlled environments — Part 13: Cleaning of surface to achieve defined levels of cleanliness in terms of particle and chemical classifications

KS I ISO 14644-13:2019 洁净室和相关控制环境第13部分:根据颗粒和化学分类达到规定清洁度的表面清洁

Cleanrooms and associated controlled environments — Part 13: Cleaning of surface to achieve defined levels of cleanliness in terms of particle and chemical classifications

KS I ISO 14644-15:2019 洁净室和相关的受控环境.第15部分:用空气中的化学浓度评估设备和材料的适用性

Cleanrooms and associated controlled environments — Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration

KS I ISO 14644-15-2019 洁净室和相关的受控环境.第15部分:用空气中的化学浓度评估设备和材料的适用性

Cleanrooms and associated controlled environments — Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration

ISO/FDIS 14644-18:2019 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 14644-16:2019 洁净室和相关的受控环境.第16部分:洁净室和分离装置的能源效率

This document gives guidance and recommendations for optimizing energy usage and maintaining energy efficiency in new and existing cleanrooms, clean zones and separative devices. It provides guidance for the design, construction, commissioning and operation of cleanrooms. This document covers all cleanroom-specific features and can be used in different areas to optimize energy use in electronic, aerospace, nuclear, pharmaceutical, hospital, medical device, food industries and other clean air applications. It also introduces the concept of benchmarking for the performance assessment and comparison of cleanroom energy efficiencies, while maintaining performance levels to ISO 14644 requirements[2][3].

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

ASTM E2352-19 航空航天洁净室和相关受控环境的标准实施规程&x2014；洁净室操作

1.1 This practice specifies basic requirements, procedures, and practices for operating aerospace cleanrooms and controlled environments and precautions associated with the facility and equipment used. 1.2 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. 1.3 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 Aerospace Cleanrooms and Associated Controlled Environments—Cleanroom Operations

JIS B 9920-1:2019 洁净室和相关受控环境 第1部分：按颗粒浓度对空气洁净度进行分类

Cleanrooms and associated controlled environments -- Part 1: Classification of air cleanliness by particle concentration

JIS B 9920-2:2019 洁净室和相关的受控环境 第2部分：监测以提供与颗粒浓度相关的空气洁净度相关的洁净室性能证据

Cleanrooms and associated controlled environments -- Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration

KS I ISO 14644-9-2019 洁净室和相关控制环境 - 第9部分:颗粒浓度对表面清洁度的分类

Cleanrooms and associated controlled environments — Part 9:Classification of surface cleanliness by particle concentration

KS I ISO 14644-10:2019 洁净室和相关控制环境 - 第10部分:化学浓度对表面清洁度的分类

Cleanrooms and associated controlled environments — Part 10:Classification of surface cleanliness by chemical concentration

KS I ISO 14644-10-2019 洁净室和相关控制环境 - 第10部分:化学浓度对表面清洁度的分类

Cleanrooms and associated controlled environments — Part 10:Classification of surface cleanliness by chemical concentration

KS I ISO 14644-8:2019 洁净室和相关控制环境 - 第8部分:通过化学浓度（Acc）对空气清洁度的分类

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

KS I ISO 14644-9:2019 洁净室和相关控制环境 - 第9部分:颗粒浓度对表面清洁度的分类

Cleanrooms and associated controlled environments — Part 9:Classification of surface cleanliness by particle concentration

KS I ISO 14644-8-2019 洁净室和相关控制环境 - 第8部分:通过化学浓度（Acc）对空气清洁度的分类

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