13.040.35 清洁室（无菌室）及相关受控环境 标准查询与下载

ISO 14644-10:2013 洁净室和相关控制环境.第10部分:通过化学浓缩进行表面清洁度分类

This part of ISO 14644 defines the classification system for cleanliness of surfaces in cleanrooms with regard to the presence of chemical compounds or elements (including molecules, ions, atoms and particles). This part of ISO 14644 is applicable to all solid surfaces in cleanrooms and associated controlled environments such as walls, ceilings, floors, working environment, tools, equipment and devices. NOTE 1 For the purpose of this part of ISO 14644, consideration is only given to the chemical characteristics of a particle. The physical properties of the particle are not considered and this part of ISO 14644 does not cover the interaction between the contamination and the surface. NOTE 2 This part of ISO 14644 does not include the contamination generation process and any time-dependent influences (deposition, sedimentation, ageing, etc.) 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: Classification of surface cleanliness by chemical concentration

BS EN ISO 14644-8:2013 洁净室和相关受控环境.利用化学浓缩的空气洁净度分类(ACC)

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

EN ISO 14644-8:2013 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 part of ISO 14644 establishes the classification 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 within the specification for classification. This part of ISO 14644 currently considers only concentrations of air chemical contaminants between 100 and 10−12 g/m3 under cleanroom operational conditions.This part of ISO 14644 is not relevant for application in those industries, processes or productions where the presence of airborne chem

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

ISO 14644-8:2013 净化室和相关控制环境.第8部分:空气传播分子污染物(ACC)分类

This part of ISO 14644 establishes the classification 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 within the specification for classification. This part of ISO 14644 currently considers only concentrations of air chemical contaminants between 100 and 10−12 g/m3 under cleanroom operational conditions. This part of ISO 14644 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 part of ISO 14644 to describe the nature of air chemical contaminants. This part of ISO 14644 does not give a classification of surface chemical contamination.

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

GOST R ISO 14644-9-2013 洁净室和相关控制环境. 第9部分. 采用颗粒浓度法对洁净度的分类

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

LST EN ISO 14644-9:2012 洁净室和相关受控环境 第9部分：按颗粒浓度分类表面清洁度（ISO 14644-9:2012）

Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration (ISO 14644-9:2012)

DIN EN ISO 14644-9:2012 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(ISO 14644-9-2012).德文版本EN ISO 14644-9-2012

This part of ISO 14644 establishes the classification of cleanliness levels on solid surfaces by particle concentration 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 part of ISO 14644 applies to all solid surfaces in cleanrooms and associated controlled environments, such as walls, ceilings, floors, working environments, tools, equipment and products. The classification of surface cleanliness by particle concentration (SCP) is limited to particles between 0,05 pm and 500μm.

Cleanrooms and associated controlled environments.Part 9: Classification of surface cleanliness by particle concentration (ISO 14644-9:2012); German version EN ISO 14644-9:2012

DS/EN ISO 14644-9:2012 洁净室和相关受控环境 第9部分：按颗粒浓度对表面清洁度分类

ISO 14644-9:2012 establishes the classification of cleanliness levels on solid surfaces by particle concentration in cleanrooms and associated controlled environment applications. Recommendations on testing and measuring methods, as well as information ab

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

NF X44-101-9*NF EN ISO 14644-9:2012 洁净室和相关控制环境. 第9部分: 采用颗粒浓度法对洁净度的分类.

Cleanrooms and associated controlled environments - Part 9 : classification of surface cleanliness by particle concentration.

BS EN ISO 14644-9:2012 洁净室和相关控制环境. 微粒浓度法进行表面洁净度分类

Cleanrooms and associated controlled environments. Classification of surface cleanliness by particle concentration

EN ISO 14644-9:2012 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 part of ISO 14644 establishes the classification of cleanliness levels on solid surfaces by particleconcentration in cleanrooms and associated controlled environment applications. Recommendations ontesting and measuring methods, as well as information about surface characteristics, are given in Annexes Ato D.

Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration (ISO 14644-9:2012)

ISO 14644-9:2012 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

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

VDI 2083 Blatt 3.1-2012 洁净室技术 洁净室空气中的计量学 监测

This guideline deals with the permanent installation-specific monitoring of individual parameters of controlled environments. The monitoring may be continuous (pressure, temperature, humidity) or sequential (microbiology). The guideline applies to the classical monitoring, i.e. permanent checking of parameters, but not for recurrent measurements for qualification purposes. The guideline does not specify microbiological techniques. It specifies methods the measurements on cleanroom installations and the required instrumentation so as to define a standard. The specifications regarding monitoring measurements aim at aiding the user in selecting methods allowing to determine installation- and process-related deviations from requirements during operation. The guideline does not apply to data loggers which store data to be read out at intervals. Data loggers, on the other hand, which immediately hand over data to a master system, i.e. loggers which are used merely as sensors, aare not excluded.

Cleanroom technology - Metrology in cleanroom air - Monitoring

ASTM E2217-12 航空洁净室和污染控制区设计与施工标准实践

This practice describes and defines factors to be taken into consideration when designing and fabricating a cleanroom or controlled area that is used for aerospace operations and fabrication. Following the suggestions herein should provide a facility that is more capable of meeting performance requirements and that will offer protection against contamination for objects fabricated and processed in such a facility.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......

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

VDI 2083 Blatt 18-2012 洁净室技术 生物污染控制

This guideline describes the origins and potential consequences of microbiological contamination in the air and on surfaces in cleanrooms as well as the detectin, quantitative determination, avoidance and control of biocontaminatin. The guideline describes the general principles for the treatment, handling, avoidance and reduction of microbiological contamination in cleanrooms. The guideline is intended to aid the user of hygienic production processes under controlled clean conditions in choosing options for establishing optmised control concepts for microbiological contamination in accordance with the state of the art.

Cleanroom technology - Biocontamination control

JIS B 9917-7:2011 净化室和相关控制环境.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)

This Standard 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 JIS B 9919 and JIS B 9917-5. The application of this Standard takes into account the following limitations. User requirements are as agreed by the customer and the 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.

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

ISO/CD 14644-5:2011 洁净室和相关受控环境 第 5 部分：操作

Cleanrooms and associated controlled environments — Part 5: Operations

ASTM E2312-11 清结室材料测试的标准操作规程

This practice is not intended to advocate or discourage use of any particular test method. It is intended for information only, and to provide a useful guide for further detailed study, test, and evaluation of cleanroom materials and products.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 and health practices and determine the applicability of regulatory limitations prior to use.

Standard Practice for Tests of Cleanroom Materials

VDI 2083 Blatt 13.3-2010 洁净室技术 超纯水的质量、生产和分配 制药和其他生命科学应用

This guideline describes the quality, production and supply of purified and ultrapure water for processes with particular cleanliness requirements. Similar processes are used in power stations and nuclear technology; these, however, are not specified in this guideline, being the subject of other publications.

Cleanroom technology - Quality, production, and distribution of ultrapure water - Pharmacy and other life-science applications

VDI 2083 Blatt 16.1-2010 洁净室技术 屏障系统（隔离器、微环境、隔离装置） 有效性和认证

This guideline provides guidance for the planning, manufacture/installation, commissioning and operation of barrier systems in contamination control. Planer, manufacturer and user of clean environments must define, and lay down in writing, the requirements to be met by the product and its environment. The scope of this guideline includes any type of barrier between the room and the process environment, which serves for contamination control, expressly including dynamic (flow) as well as solid barriers. All types of contamination (particulate, chemical/molecular, biological) are included. The guideline supplements DIN EN ISO 14644-7 in practical aspects.

Cleanroom technology - Barier systems (isolators, mini-environments, separative devices) - Effectiveness and certification