13.040.35 清洁室（无菌室）及相关受控环境 标准查询与下载

BS EN ISO 14698-2:2003 洁净室和相关控制环境.生物污染控制.生物污染数据的评价和说明

ISO 14698-2:2003 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. It should be used, where appropriate, in conjunction with ISO 14698-1.

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

DS/EN ISO 14698-1:2003 洁净室和相关受控环境 生物污染控制 第1部分：一般原则和方法（ISO 14698-1:2003）

This standard establishes the principles and basic methodology of a formal system of biocontamination control for assessing and controlling biocontamination when cleanroom technology is applied for that purpose.

Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods (ISO 14698-1:2003)

DS/EN ISO 14698-2:2003 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（ISO 14698-2:2003）

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 (ISO 14698-2:2003)

BS EN ISO 14698-1:2003 无菌室及相关控制环境.生物污染控制.一般原则和方法

ISO 14698:2003 establishes the principles and basic methodology of a formal system of biocontamination control (Formal System) for assessing and controlling biocontamination when cleanroom technology is applied for that purpose. It specifies the methods required for monitoring risk zones in a consistent way and for applying control measures appropriate to the degree of risk involved. In zones where risk is low, it can be used for information.

Cleanrooms and associated controlled environments - Biocontamination control - General principles and methods

EN ISO 14698-1:2003 洁净室和相关控制环境.生物污染控制.第1部分:总则和方法 ISO 14698-1-2003

Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods ISO 14698-1:2003

EN ISO 14698-2:2003 洁净室和相关控制环境.生物污染控制.第2部分:生物污染数据的评价和说明 ISO 14698-2-2003

Cleanrooms and associated controlled environments -Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data ISO 14698-2: 2003

ISO 14698-2:2003 洁净室和相关可控环境.生物污染控制.第2部分:生物污染数据的评价和解释

This part of ISO 14698 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. It should be used, where appropriate, in conjunction with ISO 14698-1.

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

ISO 14698-1:2003 洁净室和相关可控环境.生物污染控制.第1部分:一般原理和方法

This part of ISO 14698 establishes the principles and basic methodology of a formal system of biocontamination control (Formal System) for assessing and controlling biocontamination when cleanroom technology is applied for that purpose. This part of ISO 14698 specifies the methods required for monitoring risk zones in a consistent way and for applying control measures appropriate to the degree of risk involved. In zones where risk is low, it can be used as a source of information. Application-specific requirements are not given. Neither are fire and safety issues addressed; for these, see regulatory requirements and other national or local documentation.

Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods

SANS 14644-2:2003 无尘室和有关受控环境．第2部分：确保持续符合ISO 14644－1的测试和监控规范

Specifies requirements for periodic testing of a cleanroom or clean zone to prove its continued compliance with SANS 14644-1/ISO 14644-1 for the designated classification of airborne particulate cleanliness.

Cleanrooms and associated controlled environments Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1

SANS 14644-4:2003 无尘室及相关受控环境．第4部分：设计，施工和启动

Specifies requirements for the design and construction of cleanroom installations but does not prescribe specific technological or contractual means to meet these requirements

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

ANSI/IEST/ISO 14644-2:2000 洁净室和相关控制环境.第2部分:证明持续符合IEST/ISO 14644-1-1999标准要求的试验和监测规范

This part of ISO 14644 specifies requirements for periodic testing of a cleanroom or clean zone to prove its continued compliance with ISO 14644-1 for the designated classification of airborne particulate cleanliness. These requirements invoke the test described in ISO 14644-1 for classification of a cleanroom or clean zone. Additional tests are also specified, to be carried out in accordance with the requirements of this part of ISO 14644. Optional tests, to be applied at the user's discretion, are also identified. This part of ISO 14644 also specifies requirements for monitoring of a cleanroom or clean zone (hereafter referred to as an installation) to provide evidence of its continued compliance with ISO 14644-1 for the designated classification of airborne particulate cleanliness.

Cleanrooms and associated controlled environments--Part 2: Specifications for testing and monitoring to prove continued compliance with IEST/ISO 14644-1:1999

ANSI/IEST/ISO 14644-4:2001 洁净室和相关控制环境.第4部分:设计,建造和启动

This part of ISO 14644 specifies requirements for the design and construction of cleanroom installations but does not prescribe specific technological or contractual means to meet these requirements. It is intended for use by purchasers, suppliers and designers of cleanroom installations and provides a checklist of important parameters of performance. Construction guidance is provided, including requirements for start-up and qualification. Basic elements of design and construction needed to ensure continued satisfactory operation are identified through the consideration of relevant aspects of operation and maintenance. Note: Further guidance in respect of the above requirements is given in annexes A to H. Other parts of ISO 14644 may provide complementary information. Application of this part of ISO 14644 is restricted in the following: user requirements are represented by purchaser or specifier; specific processes to be accommodated in the cleanroom installation are not specified; fire and safety regulations are not considred specifically--the appropriate national and local requirements shoud be respected; process media and utility services are only considered with respect to their routing between and in the different zones of cleanliness; regarding initial operation and maintenance, only cleanroom construction-specific requirements are considered.

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

ANSI/IEST/ISO 14644-1:1999 洁净室和相关控制环境.第1部分:空气清洁度的分级

This part of ISO 14644 covers the classification of air cleanliness in cleanrooms and associated controlled environments exclusively in terms of concentration of airborne particles. Only particle populations having cumulative distributions based on threshold (lower limit) sizes ranging from 0, 1 ?m to 5 ?m are considered for classification purposes. This part of ISO 14644 does not provide for classification of particle populations that are outside of the specified particle size range, 0, 1 ?m to 5 ?m. Concentrations of ultrafine particles (particles smaller than 0, 1 ?m) and macroparticles (particles larger than 5 ?m) may be used to quantify these populations in terms of U descriptors and M descriptors, respectively. This part of ISO 14644 cannot be used to characterize the physical, chemical, radiological, or viable nature of airborne particles. Note: The actual distribution of particle concentrations within incremental size ranges normally is not predictable and typically is variable over time.

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

DIN EN ISO 14644-4:2003 洁净室和相关控制环境.第4部分:设计、建造和运行

Cleanrooms and associated controlled environments - Part 4: Design, construction and start up (ISO 14644-4:2001); German version EN ISO 14644-4:2001

AS 2252.1:2002 生物安全柜．人员和环境保护用生物安全柜（I类）

Specifies requirements for Class I biological safety cabinets which are intended to provide protection from hazardous biological agents for personnel and the environment.

Biological safety cabinets - Biological safety cabinets (Class I) for personnel and environment protection

AS/NZS 14644.2:2002 洁净室及相关受控环境．证明持续符合 ISO 14644.1（ISO 14644．2：2000，MOD）要求的试验和监测规范

Specifies requirements for periodic testing of a cleanroom or cleanzone to prove its continued compliance with ISO 14644-1 for the designation classification of airborne particulate cleanliness. This Standard is modified adoption of ISO 14644-2:2000.

Cleanrooms and associated controlled enviornments - Specifications for testing and monitoring to prove continued compliance with ISO 14644-1 (ISO 14644-2:2000, MOD)

JIS B 9920:2002 洁净室空气洁净度的分类

この規格は，クリーンルーム及びこれに関連する制御された環境(以下，クリーンルーム施設という。)における空気清浄度の浮遊微粒子濃度によるクラス分類及びその評価法について規定する。

Classification of air cleanliness for cleanrooms

ASTM E2217-02 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 recommended 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 m 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 E 2042) 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 recommended 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 the standard. 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 and health practices and determine the applicability of regulatory limitations prior to use.

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

AS/NZS ISO 14644.1:2002 给水用1/2 In.(12 mm)到2 In.(50 mm)聚乙烯-铝-聚乙烯和交联聚乙烯-铝-交联聚乙烯复合压力管

Covers the classification of air cleanliness of cleanrooms and associated controlled environments exclusively in terms of concentrations of airborne particles. This Standard is identical with and has been reproduced from ISO 14644-1:1999.

Cleanrooms and associated controlled environments - Classification and air cleanliness

AS/NZS ISO 14644.4:2002 给水用1/2 In.(12 mm)到2 In.(50 mm)聚乙烯-铝-聚乙烯和交联聚乙烯-铝-交联聚乙烯复合压力管

Specifies requirements to provide control of airborne particulate contamination of levels appropriate for accomplishing contamination-sensitive actives. This Standard is identical with, and has been reproduced from, ISO 14644-4:2001.

Cleanrooms and associated controlled environments - Design, construction and start-up