13.040.35 清洁室（无菌室）及相关受控环境 标准查询与下载

EN ISO 14644-3:2005 清洁室和相关受控环境.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 ISO 14644-3: 2005

GOST R ISO 14644-5-2005 洁净室和相伴控制环境.第5部分:运营

Cleanrooms and associated controlled environments. Part 5. Operations

GOST ISO 14698-2-2005 洁净室和相伴控制环境.生物污染控制.第2部分:生物污染数据评估和判读

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

GOST ISO 14698-1-2005 洁净室和相伴控制环境.生物污染控制.第1部分:基本原则和方法

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

DS/EN ISO 14644-7:2004 洁净室和相关受控环境 第7部分：分离装置（洁净空气罩、手套箱、隔离器和微型环境）

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 ISO 14644-4 and 14644-6.

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

ISO 14698-2:2003/cor 1:2004 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解释.技术勘误1

The standard is Cleanrooms and associated controlled environments — Biocontamination control — Part 2: Evaluation and interpretation of biocontamination data TECHNICAL CORRIGENDUM 1

Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data; Technical Corrigendum 1

LST EN ISO 14644-5:2004 洁净室和相关受控环境 第5部分：操作（ISO 14644-5:2004）

Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2004)

BS EN ISO 14644-7:2004 洁净室和相关的受控环境.分离装置(洁净空气罩、手套式操作箱、分离器和微环境)

ISO 14644-7:2004 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 ISO 14644-7:2004 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. ISO 14644-7:2004 is not applicable to full-suits.

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

DS/EN ISO 14644-5:2004 洁净室和相关的受控环境 第5部分：操作

This standard specifies basic requirements for operating cleanrooms. It is intended for those planning to use and operate cleanrooms.

Cleanrooms and associated controlled environments - Part 5: Operations

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、分离器和微环境)

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 mini-environments)

BS EN ISO 14644-5:2004 洁净室和相关的受控环境.操作

ISO 14644-5:2004 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 should be 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 - Operations

ISO 14644-5:2003 洁净室和相关控制环境.第5部分:操作

Cleanrooms and associated controlled environments - Part 5: Operations

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

Cleanrooms and associated controlled environments - Part 5: Operations

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

DIN EN ISO 14698-1:2004 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

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

JIS B 9919:2004 无菌室的设计、建设和启用

この規格は，クリーンルーム施設の設計施工に要求される事項について規定する。これらの要求を満たすための特別な技術又は契約方法を規定するものではない。

Design, construction and start-up for cleanrooms

NF X44-111:2004 无菌室和相关控制环境.生物污染控制.第2部分:生物污染数据的评价和解释

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

NF X44-110:2004 无菌室和相关控制环境.生物污染控制.第1部分:总则和方法

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

DIN EN ISO 14698-2:2004 洁净室和相关控制环境.生物污染控制.第2部分:生物污染数据的评估和说明

This International Standard gives guidance on basic principles and methodological requirements for all microbiological data evaluation, and the estimation of biocontamination data obtained from sampling for viable particles in zones at risk, as specified by the system selected. This part of ISO 14698 is intended to be used in conjunction with the other standards of the ISO 14698 series and their annexes, where appropriate. This standard is not intended for testing the performance of microbiological counting techniques of determining viable units; e. g., by plate count methods, which should be carried out periodically, and for which ISO E 30 may apply.

Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data (ISO 14698-2:2003); German version EN ISO 14698-2:2003

EN ISO 14644-7:2004 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) ISO 14644-7-2004

Cleanrooms and associated controlled environments - Part 7: Separative enclosures (clean air hoods, gloveboxes, isolators, mini-environments) (ISO 14644-7:2004)