13.040.35 清洁室（无菌室）及相关受控环境 标准查询与下载

PNS ISO 14644-12:2021 洁净室和相关受控环境.第12部分：用纳米颗粒浓度监测空气清洁度的规范

Cleanrooms and associated controlled environments - Part 12: Specifications for monitoring air cleanliness by nanoscale particle concentration

PNS ISO 14644-15:2021 洁净室和相关受控环境.第15部分：通过气载化学浓度评估设备和材料的适用性

This Standard provides requirements and guidelines for assessing the chemical airborne cleanliness of equipment and materials which are foreseen to be used in cleanrooms and associated controlled environments which are linked to the ISO standard for cleanliness classes by chemica

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

PNS ISO 14644-14:2021 洁净室和相关受控环境.第14部分：通过空气颗粒浓度评估设备的适用性

This part of PNS ISO 14644 specifies a methodology to assess the suitability of equipment (e.g. machinery, measuring equipment, process equipment, components and tools) for use in cleanrooms and associated controlled environments, with respect to airborne particle cleanliness as

Cleanrooms and associated controlled environments - Part 14: Assessment of suitability for use of equipment by airborne particle concentration

PNS ISO 14698-2:2021 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

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

PNS ISO 14698-1:2021 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

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

PNS ISO 14644-10:2021 洁净室和相关受控环境.第10部分：按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 14644-7-2020 洁净室和相关的受控环境 - 第7部分:分离设备（清洁空气罩 手套箱 隔离器和迷你环境）

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

KS I ISO 14644-5-2020 洁净室和相关控制环境 - 第5部分:操作

Cleanrooms and associated controlled environments —Part 5: Operations

KS I ISO 14644-7:2020 洁净室和相关的受控环境 - 第7部分:分离设备（清洁空气罩 手套箱 隔离器和迷你环境）

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

KS I ISO 14644-5:2020 洁净室和相关控制环境 - 第5部分:操作

Cleanrooms and associated controlled environments —Part 5: Operations

LST EN 17141-2020 洁净室和相关的受控环境 生物污染控制

Cleanrooms and associated controlled environments - Biocontamination control

KS I ISO 14644-12:2020 洁净室和相关的受控环境.第12部分:用纳米级颗粒浓度监测空气清洁度的规范

Cleanrooms and associated controlled environments —Part 12: Specifications for monitoring air cleanliness by nanoscale particle concentration

KS I ISO 14644-12-2020 洁净室和相关的受控环境.第12部分:用纳米级颗粒浓度监测空气清洁度的规范

Cleanrooms and associated controlled environments —Part 12: Specifications for monitoring air cleanliness by nanoscale particle concentration

BS EN ISO 14644-3:2019 洁净室和相关受控环境 测试方法

What is ISO 14644-3 – C leanroom testing about? ISO 14644 discusses cleanrooms and associated controlled environments. ISO 14644-3 is the third part of the multi-series on cleanrooms and associated controlled environments, and 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. Note: Not all cleanroom parameter test procedures are shown in this document. The procedure and apparatus for the test carried out for the air cleanliness classes by particle concentration and for macroparticles are provided in  BS EN   ISO 14644-1  and specifications for monitoring air cleanliness by nanoscale particle concentrations are provided in  BS EN ISO 14644-12 . The procedures and apparatus to characterize other parameters, of concern in cleanrooms and clean zones used for specific products or processes, are discussed elsewhere in other documents, for example, procedures for control and measurement of viable materials ( BS EN   ISO 14698  series), testing cleanroom functionality ( BS EN   ISO 14644-4 ), and testing of separative devices ( BS EN   ISO 14644-7 ). In addition, other standards can be considered to be applicable. Other cleanliness attribute levels can be determined using  BS EN   ISO 14644-8  (levels of air cleanliness by chemicals),  BS EN   ISO 14644-9  (levels of surface cleanliness by particle concentration) and  BS EN...

Cleanrooms and associated controlled environments - Test methods

ASTM E2614-15(2020)e1 洁净消毒剂评估标准指南

1.1 This guide identifies important factors to consider when selecting a disinfectant for use in a cleanroom or similar controlled environment and recommends test methods suitable for evaluating disinfectants. The proper selection of disinfecting agent combined with qualification testing is a key element of a successful disinfection program. Regulatory guidance such as United States Pharmacopoeia Chapter , “Disinfectants and Antiseptics” and the FDA Guidance for Industry, “Sterile Drug Products Produced by Aseptic Processing–Current Good Manufacturing Practice” address the necessity of disinfectant effectiveness testing but do not clearly define acceptable test methods. 1.2 An understanding of microbiology and microbiological techniques is essential. Knowledge in the following areas is recommended: microorganisms, antimicrobial products (disinfectants, sporicides, and decontamination agents), the chemistry of disinfection, mechanism of activity of disinfectants on cells, application procedures, cleanroom surfaces, and environmental conditions within a cleanroom. This information is available in several published texts listed in the bibliography. 1.3 The theoretical basis for disinfectant activity is not addressed in this guide. An understanding of the effect of disinfectant concentration on microbial reduction (concentration exponent) and kinetics is desirable in determining the use-dilution of different disinfectants and in using dilution to neutralize a disinfectant for efficacy testing. USP chapter provides further information on this topic. 1.4 This guide is written for the cleanroom environment, although many of the principles outlined in this standard are applicable to manufacturing and processing environments outside of the cleanroom. 1.5 Evaluation of disinfectants for biofilm control is outside the scope of this document. 1.6 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 Guide for Evaluation of Cleanroom Disinfectants

ASTM E2090-12(2020) 使用光学和扫描电子显微镜从洁净室刮水器释放的颗粒和纤维的尺寸分化计数的标准测试方法

1.1 This test method covers testing all wipers used in cleanrooms and other controlled environments for characteristics related to particulate cleanliness. 1.2 This test method includes the use of computer-based image analysis and counting hardware and software for the counting of densely particle-laden filters (see 7.7 – 7.9). While the use of this equipment is not absolutely necessary, it is strongly recommended to enhance the accuracy, speed, and consistency of counting. 1.3 The values stated in SI units are to be regarded as the 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.5 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 Test Method for Size-Differentiated Counting of Particles and Fibers Released from Cleanroom Wipers Using Optical and Scanning Electron Microscopy

T/GACT 0001-2020 医用防护口罩生产车间洁净环境控制技术要求

医用防护口罩生产车间洁净环境控制要求、工艺与设计、系统与设备、控制与监测。

Technical Regulation?for Clean Environment of Workshop for Medical Protective Face Mask

T/APE 001-2020 安徽省净化工程专业承包企业能力资质等级

净化工程：在保证房屋建筑主体结构安全的基础上，为了满足社会生产活动所要求的对相关受控环境空气中物理微粒、气溶胶等目标物的一系列控制手段，将受控环境内一系列物理状态（温、湿度，洁净度，菌落数，压差，气流速度与气流分布，噪音，微振，照度，静电等）控制在工艺需求范围内的工程。 净化工程专业承包企业按其企业资信、技术条件、技术装备及管理水平、承包工程能力四方面情况，划分一级、二级、三级三个等级，一级为最高等级。新设立三年以内企业只能申请三级，对业绩方面不作要求。 安徽省净化工程专业承包企业评级基本条件： a)具有独立法人资格，有良好的社会信誉及与经营业务和服务规模相适应的注册资金； b)具有相关经验或职称的企业经理及一定数量的专业技术人员和技术工人，特殊工种的持证上岗证率符合相关要求； c)具有与承包工程范围相适应的设备和能力、完善的质量管理体系及专职安全生产管理人员（有住建部门核发安全员证不作要求）； d)具有承担相应单项合同额的净化工程（设计或施工或设计施工一体）的能力。

Ability Qualification Level of Purification Engineering Professional Contracting Enterprises in Anhui Province

KS I ISO 14698-1-2019 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

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

KS I ISO 14698-2-2019 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

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