13.040.35 清洁室（无菌室）及相关受控环境 标准查询与下载

ISO 14644-8:2006 净化室和相关控制环境.第8部分:空气传播分子污染物分类

This part of ISO 14644 covers the classification of airborne molecular contamination (AMC) 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 within the specification for classification. This part of ISO 14644 currently considers only concentrations of AMC between 10° and 10-12 g/m3 under cleanroom operational conditions. This part of ISO 14644 is not relevant for application in those industries, processes or production, where the presence of airborne molecular substances is not considered a risk to the product or process. It is not the intention of this part of ISO 14644 to describe the nature of airborne molecular contaminants. This part of ISO 14644 does not give a classification of surface molecular contamination.

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

DS/EN ISO 14698-2/AC:2006 洁净室和相关受控环境 生物污染控制 第2部分：生物污染数据的评估和解释

This standard gives guidance on methods for the evaluation of microbiological data and the estimation of results obtained from sampling for viable particles in risk zones for biocontamination control.

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

LST EN ISO 14644-3:2006 洁净室和相关受控环境 第3部分：测试方法（ISO 14644-3:2005）

Cleanrooms and associated controlled environments - Part 3: Test methods (ISO 14644-3:2005)

ANSI/IEST/ISO 14644-3:2005 洁净室及其相关控制环境.第3部分:试验方法

This part of ISO 14644 specifies test methods for designated classification of airborne particulate cleanliness and for characterizing the performance of cleanrooms and clean zones. Performance tests are specified for two types of cleanrooms and clean zones: those with unidirectional flow and those with non-unidirectional flow, in three possible occupancy states: as-built, at-rest and operational. The test methods recommend test apparatus and test procedures for determining performance parameters.

Cleanrooms and associated controlled environments - Part 3: Test methods

NF X44-103:2006 无菌室和相关控制环境.第3部分:试验方法

Cleanrooms and associated controlled environments - Part 3 : test methods.

DIN EN ISO 14644-3:2006 洁净室和相关控制环境.第3部分:试验方法(ISO 14644-3-2005).德文版本EN ISO 14644-3-2005

This part of ISO 14644 specifies test methods for designated classification of airborne particulate cleanliness and for characterizing the performance of cleanrooms and clean zones. Performance tests are specified for two types of cleanrooms and clean zones: those with unidirectional flow and those with non-unidirectional flow, in three possible occupancy states: as-built, at-rest and operational. The test methods recommend test apparatus and test procedures for determining performance parameters. 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 part of ISO 14644 may be used if based on agreement between customer and supplier. Alternative methods do not necessarily provide equivalent measurements. This part of ISO 14644 is not applicable to the measurement of products or of processes in cleanrooms or separative devices.

Cleanrooms and associated controlled environments - Part 3: Test methods (ISO 14644-3:2005); English version of DIN EN ISO 14644-3:2006-03

ANSI/IEST/ISO 14644-7:2004 洁净室和相关控制环境.第7部分:分离装置(洁净空气罩,手套式操作箱,光电隔离器和微循环设备)

This part of ISO 14644 specifies the minimum requirements for the design, construction, installation, test and approval of separative devices, in those respects where they differ from cleanrooms as described in ISO 14644-4 and 14644-5. The application of this part of ISO 14644 takes into account the following limitations: user requirements are as agreed by customer and supplier; application-specific requirements are not addressed; specific processes to be accommodated in the separative-device installation are not specified; fire, safety and other regulatory matters are not considered specifically; where appropriate, national and local regulations apply. This part of ISO 14644 is not applicable to full-suits.

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

ANSI/IEST/ISO 14644-5:2004 洁净室和相关控制环境.第5部分:操作

This part of ISO 14644 specifies basic requirements for cleanroom operations. It is intended for those planning to use and operate a cleanroom. Aspects of safety that have no direct bearing on contamination control are not considered in this part of ISO 14644 and national and local safety regulations must be observed. This document considers all classes of cleanrooms used to produce all types of products. Therefore, it is broad in application and does not address specific requirements for individual industries. Methods and programmes for routine monitoring within cleanrooms are not covered in detail in this part of ISO 14644 but reference is made to ISO 14644-2 and ISO 14644-3 for monitoring particles and ISO 14698-1 and ISO 14698-2 for monitoring micro-organisms.

Cleanrooms and associated controlled environments-Part 5: Operations

AS/NZS ISO 14644.7:2006 无尘室及相关受控环境．分离装置（清洁空气罩，手套箱，隔离器以及微环境）

Adopts of ISO？14644-7:2004 to specify the minimum requirements for the design, construction, installation, test and approval of separative devices.

Cleanrooms and associated controlled environments - Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)

DS/EN ISO 14644-3:2006 洁净室和相关的受控环境 第3部分：测试方法

This standard specifies test methods for designated classification of airborne particulate cleanliness and for characterizing the performance of cleanrooms and clean zones. Performance tests are specified for two types of cleanrooms and clean zones: those with unidirectional flow and those with non-unidirectional flow, in three possible occupancy states: as-built, at-rest and operational.

Cleanrooms and associated controlled environments - Part 3: Test methods

AS/NZS ISO 14644.5:2006 无尘室及相关受控环境．作业

Adopts of ISO？14644-5:2004 to specify basic requirements for cleanroom operations. It is intended for those planning to use and operate a cleanroom.

Cleanrooms and associated controlled environments - Operations

ASTM E2088-06(2011) 测量清洁室和相关受控环境中粒子沉积物用选择,制备,暴露和分析参考表面的标准操作规程

This practice provides a standard approach to measuring particle deposition, or fallout, in cleanrooms and other controlled environments. It is based on the use of a witness surface to collect particles that deposit from the surrounding environment and subsequently sizing and counting the particles by conventional methods. Several options are introduced, with limitations and guidelines for selecting the best choice for the intended application. This practice is applicable across numerous industries including aerospace, microelectronics, and pharmaceuticals.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 and health practices and determine the applicability of regulatory limitations prior to use.

Standard Practice for Selecting, Preparing, Exposing, and Analyzing Witness Surfaces for Measuring Particle Deposition in Cleanrooms and Associated Controlled Environments

KS I ISO 14644-5:2005 洁净室和相关控制环境.第5部分:操作

이 규격은 청정실의 작업에 관한 기본적인 요구 조건을 설명한다. 이것은 청정실의 사용 및

Cleanrooms and associated controlled environments－Part 5：Operations

KS I ISO 14644-7:2005 洁净室和相关控制环境.第7部分:分离装置(洁净空气罩、手套式操作箱、分离器和微环境)

이 규격은 분리 장치가 KS M ISO 14644-4와 KS M ISO 14644-5에 기

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

BS EN ISO 14644-3:2005 洁净室和相关控制环境.试验方法

ISO 14644-3:2005 specifies test methods for designated classification of airborne particulate cleanliness and for characterizing the performance of cleanrooms and clean zones. Performance tests are specified for two types of cleanrooms and clean zones: those with unidirectional flow and those with non-unidirectional flow, in three possible occupancy states: as-built, at-rest and operational. ISO 14644-3:2005 is not applicable to the measurement of products or of processes in cleanrooms or separative devices.

Cleanrooms and associated controlled environments - Test methods

ISO 14644-3:2005 洁净室和相关控制环境.第3部分:试验方法

This part of ISO 14644 specifies test methods for designated classification of airborne particulate cleanliness and for characterizing the performance of cleanrooms and clean zones. Performance tests are specified for two types of cleanrooms and clean zones: those with unidirectional flow and those with non-unidirectional flow, in three possible occupancy states: as-built, at-rest and operational. The test methods recommend test apparatus and test procedures for determining performance parameters. 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 part of ISO 14644 may be used if based on agreement between customer and supplier. Alternative methods do not necessarily provide equivalent measurements. This part of ISO 14644 is not applicable to the measurement of products or of processes in cleanrooms or separative devices.

Cleanrooms and associated controlled environments - Part 3: Test methods

VDI 2083 Blatt 3-2005 洁净室技术 计量和测试方法

This guideline specifies measurement procedures for cleanrooms, which are applied during handing over, in the context of the qualification of new installations, for routine checks and for continuous monitoring. The methods described here are tailored to the needs of cleanrooms, thus being different from measurement procedures for other technical systems.

Cleanroom technology - Metrology and test methods

VDI 2083 Blatt 1-2005 洁净室技术 微粒空气洁净度等级

The guideline contains the classification of air cleanliness for cleanrooms and associated controlled environments in mathematical, tabular and graphical form. The guideline covers exclusively the maximum concentration of airborne particles at the clean work place. Following the classification according to DIN EN ISO 14644, only particles within the specified size range 0,1 ?m and 5 ?m are considered. This guideline cannot be used to characterize the physical, chemical, radiological, or viable nature of airborne particles.

Cleanroom technology - Particulate air cleanliness classes

DIN EN ISO 14644-5:2005 洁净室和相关控制环境.第5部分:操作

This part of International Standard ISO 14644 specifies basic requirements for operating cleanrooms and associated controlled environments to meet their levels for cleanliness. This cleanroom standard does not specify levels of cleanliness nor the methods or means for attaining the desired level. However, annexes provide further guidance. It is intended for those planning to use and operate a cleanroom.#,,#

Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2004); German version EN ISO 14644-5:2004

DIN EN ISO 14644-7:2005 洁净室和相关控制环境.第7部分:分离设备(洁净空气罩、手套式操作箱、分离器和微环境)

This International Standard specifies the minimum requirements for the design, construction, installation, testing and approval of enhanced clean devices in those respects where they differ from cleanrooms as described in ISO 14644-4 and ISO 14644-5. Enhanced clean devices range from open to closed systems. The following limitations apply: Application Specific requirements are not addressed; user requirements as agreed by customer and supplier; micro-biological safety cabinets are not included; specific processes to be accommodated in the enhanced clean device installation are not specified; fire and safety regulations are not considered - the appropriate national and local requirements shall be respected.#,,#

Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) (ISO 14644-7:2004); German version EN ISO 14644-7:2004