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GB/T 25915.3-2024 English PDF

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GB/T 25915.3-2024: Cleanrooms and associated controlled environments - Part 3: Test methods
Status: Valid

GB/T 25915.3: Historical versions

Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
GB/T 25915.3-20241014 Add to Cart 7 days Cleanrooms and associated controlled environments - Part 3: Test methods Valid
GB/T 25915.3-2010RFQ ASK 7 days Cleanrooms and associated controlled environments -- Part 3: Test methods Obsolete

Similar standards

GB/T 25915.14   GB/T 25915.1   GB/T 25915.2   GB/T 25915.16   GB/T 25915.8   GB/T 25915.10   

Basic data

Standard ID: GB/T 25915.3-2024 (GB/T25915.3-2024)
Description (Translated English): Cleanrooms and associated controlled environments - Part 3: Test methods
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C70
Classification of International Standard: 13.040.35
Word Count Estimation: 50,523
Date of Issue: 2024-03-15
Date of Implementation: 2024-10-01
Older Standard (superseded by this standard): GB/T 25915.3-2010
Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration

GB/T 25915.3-2024: Cleanrooms and associated controlled environments - Part 3: Test methods

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 13.040.35 CCSC70 National Standards of People's Republic of China Replaces GB/T 25915.3-2010 Cleanrooms and related controlled environments Part 3.Detection methods Part 3.Test methods (ISO 14644-3.2019,IDT) Released on 2024-03-15 2024-10-01 Implementation State Administration for Market Regulation The National Standardization Administration issued

Table of Contents

Preface I Introduction II 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 3.1 General terms 1 3.2 Terms related to airborne particles 2 3.3 Terms related to air filters and filtration systems 3 3.4 Terms related to airflow and other physical conditions 4 3.5 Terminology related to electrostatic measurement 4 3.6 Terms related to measuring instruments and measurement conditions 5 3.7 Terms related to occupancy status 5 4 Testing procedures 5 4.1 Clean room inspection 5 4.2 Principle 6 5 Test report 8 Appendix A (Informative) Selection of Supporting Tests and Checklists 9 Appendix B (Informative) Supporting Test Methods 13 Appendix C (Informative) Testing Instruments 35 Reference 43

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents" Drafting. This document is part 3 of GB/T 25915 Cleanrooms and Related Controlled Environments. GB/T 25915 has been published in the following parts. --- Part 1.Classification of air cleanliness levels according to particle concentration; --- Part 2.Monitoring of particle concentration in clean room air; --- Part 3.Detection methods; --- Part 4.Design, construction and start-up; --- Part 5.Operation; --- Part 6.Vocabulary; --- Part 7.Isolation devices (clean air hoods, glove boxes, isolators, microenvironments); --- Part 8.Classification of air cleanliness (ACC) by chemical concentration; --- Part 9.Classification of surface cleanliness levels according to particle concentration; --- Part 10.Classification of surface cleanliness levels according to chemical concentration; --- Part 12.Technical requirements for monitoring the concentration of nanoparticles in the air; --- Part 13.Surface cleaning to meet particle and chemical cleanliness requirements; --- Part 14.Assessment of equipment suitability according to particle concentration; --- Part 15.Assessment of the suitability of equipment and materials according to the concentration of gaseous chemicals; --- Part 16.Improving the energy efficiency of clean rooms and air purification equipment. This document replaces GB/T 25915.3-2010 "Clean rooms and related controlled environments Part 3.Test methods" and GB/T 25915.3- Compared with.2010, in addition to structural adjustments and editorial changes, the main technical changes are as follows. a) Chapter 3 Terms and Definitions. --- Change the term "discrete particle counter" to "light scattering particle counter" (see 3.6.4, 3.6.8 of the.2010 edition); --- Added "resolution" (see 3.1.5), "sensitivity" (see 3.1.6) and "air volume hood equipped with flow meter" (see 3.6.3); --- Deleted "large particles", "M descriptor", "U descriptor", "ultrafine particles", "standard leakage transmittance", "average air volume", "non-equal Dynamic sampling, cascade impact sampler, condensation nucleus counter, counting efficiency, differential mobility analyzer, diffusion element "Pseudo-counting", "Volume hood", "Coaxial sampling", "Isokinetic sampling", "Particle size limiter", "Threshold particle size", "Time of flight particle size" Measurement” and “Virtual Impactor” (see 3.2.4, 3.2.5, 3.2.11, 3.2.12, 3.3.10, 3.4.2, 3.6.2, 3.6.3, 3.6.4, 3.6.5, 3.6.6, 3.6.7, 3.6.9, 3.6.10, 3.6.11, 3.6.12, 3.6.13, 3.6.14, 3.6.15, 3.6.16); b) Changed “Required Test Items” to “General Tests” and updated the specific content (see 4.1.1, 4.1.1 of the.2010 edition); c) Changed “optional test items” to “supportive tests” and updated the test items (see Table 2, Table 2 of the.2010 edition); d) Change "airflow detection" to "wind speed and air volume detection", "airflow direction detection and visual inspection" to "airflow direction detection and visual inspection" "Isolation leak detection" is "Enclosure structure tightness detection" (see Table 2, Table 2 of the.2010 edition); e) The pressure difference detection (see 4.2.1, 4.2.3 of the.2010 edition), wind speed and air volume detection (see 4.2.2, 4.2.2 of the.2010 edition), Airflow direction detection and visualization (see 4.2.3, 4.2.5 of the.2010 edition), self-cleaning detection (see 4.2.4, 4.2.9 of the.2010 edition), temperature Temperature test (see 4.2.5, 4.2.6 of the.2010 edition), humidity test (see 4.2.6, 4.2.6 of the.2010 edition), leakage test of installed filter system Leakage detection (see 4.2.7, 4.2.4 of the.2010 edition), enclosure tightness detection (see 4.2.8, 4.2.10 of the.2010 edition), static Electricity and ionizer testing (see 4.2.9, 4.2.7 of the.2010 edition), particle deposition testing (see 4.2.10, 4.2.8); f) Deleted the airborne particle count (see 4.2.1 of the.2010 edition); g) Added isolation detection (see 4.2.11). This document is equivalent to ISO 14644-3.2019 "Cleanrooms and associated controlled environments Part 3.Test methods". The following minimal editorial changes were made to this document. ---Test items "air supply speed (unidirectional flow)" and "average wind speed in clean room or clean area" in Table A.1 of ISO 14644-3.2019 "Uniformity (unidirectional flow)" does not correspond to the test procedure reference clauses B.2.2.2 and B.2.3.This document has been adjusted accordingly. Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document was proposed and coordinated by the National Technical Committee for Cleanrooms and Related Controlled Environments (SAC/TC319). This document was drafted by. Wujiang Huayu Purification Equipment Co., Ltd., Shanghai Kexin Testing Technology Co., Ltd., Ximai (Shanghai) Testing Technology Co., Ltd. Technology Services Co., Ltd., China Electronics Engineering Design Institute Co., Ltd., China Power Investment Engineering Research, Testing and Evaluation Center Co., Ltd., China Electronics Tong Engineering Second Construction Co., Ltd., Beijing Zhongrui High-tech Industry Service Co., Ltd., Shenzhen Tiansuo Metrology and Testing Co., Ltd., China Standardization Association, Tangyi Holdings (Shenzhen) Co., Ltd., China Electronics System Engineering Third Construction Co., Ltd., Shanghai Indoor Environment Purification Industry Co., Ltd. Industry Association, Beijing Medical Device Inspection Institute (Beijing Medical Bioprotection Equipment Inspection and Research Center), China Food and Drug Inspection Institute Institute, Shanghai Food and Drug Packaging Materials Testing Institute, China Electronics Precision Electronic Engineering Co., Ltd., Beijing Zhongbang Xingye Technology Co., Ltd., Suzhou Hong Jijing Technology Co., Ltd., Shanghai Weiya Technology Development Co., Ltd., Paionier Environmental Purification Engineering (Beijing) Co., Ltd., Beijing Keyuan Shunda Construction Engineering Co., Ltd., Zhizheng Testing (Shandong) Co., Ltd., Shanghai Installation Engineering Group Co., Ltd., Hunan Ruibang Medical Technology Development Co., Ltd., Suzhou Kangqi Environmental Technology Co., Ltd., Jiangsu Shuoshi Biotechnology Co., Ltd., Shenzhen Yancheng Industrial Technology Co., Ltd. TECHNOLOGY LIMITED. The main drafters of this document are. Chen Siyuan, Tan Jun, Hao Yinbo, Wang Li, Gao Zheng, Tan Zhijian, Yang Huiying, Yang Ziqiang, Guo Kai, Wang Bingxin, Wei Jiaming, Su Jiancheng, Song Jinhui, Kong Shanping, Shi Xia, Xu Shaokun, Tan Liping, Han Hui, Zeng Shiqing, Luo Guanxiang, Peng Yongchang, Wang Kun, Liu Zhonghua, He Yifeng, Cao Xiaocheng, Wei Lan, Hao Cheng, Qu Mingqing, Wan Guibo, Xiao Qiugui. The previous versions of this document and the documents it replaces are as follows. ---First published in.2010 as GB/T 25915.3-2010; ---This is the first revision.

Introduction

GB/T 25915 adopts the ISO 14644 series of national standards, and the settings of each part are consistent with international standards. It is planned to consist of 16 parts. constitute. --- Part 1.Classification of air cleanliness levels by particle concentration. The purpose is to distinguish particle pollution concentration. --- Part 2.Monitoring of particle concentration in clean room air. The purpose is to guide the monitoring of particle contamination to avoid possible contamination risk. --- Part 3.Detection methods. The purpose is to guide the detection of various pollution and related environmental factors in clean rooms. --- Part 4.Design, construction and startup. The purpose is to guide the design, construction and startup of clean rooms. --- Part 5.Operation. The purpose is to guide the operation of the clean room. --- Part 6.Vocabulary. The purpose is to unify and standardize technical terms. --- Part 7.Isolation devices (clean hoods, glove boxes, isolators, microenvironments). The purpose is to propose basic This requirement. --- Part 8.Classification of air cleanliness (ACC) levels by chemical concentration. The purpose is to distinguish the degree of chemical pollution in the air. --- Part 9.Classification of surface cleanliness levels according to particle concentration. The purpose is to distinguish the degree of surface particle contamination. --- Part 10.Classification of surface cleanliness levels according to chemical concentration. The purpose is to distinguish the degree of chemical contamination on the surface. --- Part 12.Technical requirements for monitoring the concentration of nanoparticles in the air. The purpose is to propose the detection of nano-scale particle pollution Require. --- Part 13.Surface cleaning to achieve particle and chemical cleanliness requirements. The purpose is to provide cleaning requirements for surfaces within clean rooms to Avoid possible risks of particle and chemical contamination. --- Part 14.Assessment of equipment suitability by particle concentration. The purpose is to assess the possible particle contamination that may be generated in the clean room by the relevant equipment. Tests to determine the suitability of the equipment. --- Part 15.Assessment of the suitability of equipment and materials according to the concentration of gaseous chemicals. The purpose is to assess the suitability of equipment and materials by assessing... Tests that generate gaseous chemical contamination in clean rooms to determine the suitability of equipment and materials. --- Part 16.Improving the energy efficiency of clean rooms and air purification equipment. The purpose is to save energy consumption in clean room operation. --- Part 17.Application of particle deposition rate. The purpose is to determine the deposition rate of particles into the clean room by measuring the particle deposition rate of the clean room. Acceptable risk to vulnerable surfaces in the room. Cleanrooms and related controlled environments keep contaminants at appropriate levels to complete contamination-sensitive work. Products and processes in industries such as pharmaceuticals, medical devices, food, and healthcare benefit from the control of air pollution. This document does not contain the testing procedures for all clean room parameters. GB/T 25915.1 provides the classification of air cleanliness by particles, etc. GB/T 25915.12 provides the technical requirements for monitoring the concentration of nanoparticles in the air. Cleanrooms and clean areas for specific processes and the testing procedures and instruments used for related parameters are included in other documents prepared by ISO /TC209 Discussion [e.g. microbial control and detection procedures (GB/T 25916 series), clean room functional testing (GB/T 25915.4), and isolation Device testing (GB/T 25915.7)]. In addition, other applicable standards can also be considered in the clean room testing activities. The level of air cleanliness can be classified by GB/T 25915.8 (classification of air cleanliness by chemical concentration), GB/T 25915.9 (classification by particle concentration). The surface cleanliness level is determined by GB/T 25915.10 (surface cleanliness level according to chemical concentration). Cleanrooms and related controlled environments Part 3.Detection methods

1 Scope

This document specifies test methods to support cleanroom and clean zone operations to meet air cleanliness levels, other cleanliness attributes and related control requirements. Control conditions. Performance testing is performed on cleanrooms with unidirectional and non-unidirectional flow in any of the three occupied states. empty, static and dynamic. Clean area. This document recommends test instruments and test procedures for determining performance parameters. Some test methods are limited to the type of clean room or clean area. For this reason, this document recommends several alternative approaches. In order to meet the requirements of different users, this document recommends several different methods and instruments for certain test items. Other alternative methods not described in this document may be used by mutual agreement. Alternative methods do not necessarily give the same measurement results. This document is not intended for use in measuring products or processes within cleanrooms or isolators. Note. This document does not mention safety precautions related to its use (such as when hazardous materials, operations, equipment are involved). Users of this document are responsible for using Establish appropriate safety and health measures before use and determine the applicability of regulatory restrictions.

2 Normative references

The contents of the following documents constitute the essential clauses of this document through normative references in this document. For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to This document. ISO 14644-1 Cleanrooms and related controlled environments Part 1.Classification of air cleanliness by particle concentration tion) Note. GB/T 25915.1-2021 Clean rooms and related controlled environments Part 1.Classification of air cleanliness levels by particle concentration (ISO 14644-1. 2015,MOD)

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 General terms 3.1.1 Clean room Rooms where the concentration of airborne particles is controlled and graded are designed, constructed, and operated in such a way that the particles that enter, are generated, and are retained in the room are controlled. Note 1.Specifies the levels based on the concentration of airborne particles. Note 2.Other factors that affect the cleanliness level, such as the concentration of chemicals, microorganisms or nano-sized particles in the air, and the influence of the surface cleanliness level Other factors such as concentrations of particles, nanoparticles, chemicals or microorganisms can also be specified and controlled.
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