GB/T 36066-2025Cleanrooms and associated controlled environments - Technical requirements and application of testing (English PDF)

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 replaces GB/T 36066-2018 "Analysis and Application of Clean Room and Related Controlled Environment Testing Technology" and GB/T 36066- Compared with.2018, in addition to structural adjustments and editorial changes, the main technical changes are as follows:

a) The terms "unidirectional flow", "non-unidirectional flow", "discrete particle counter", "test aerosol", "aerosol generator", "aerosol photometer", etc. have been deleted. Meter", "Installed Filtration System", "Installed Filtration System Leak Detection", "Scanning", "Isokinetic Sampling", "Leakage", "Leakage" (see.2018 edition 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 3.10, 3.11, 3.12);

b) Added the definitions of the terms "clean room and related controlled environment", "warning value" and "intervention value" (see 3.1,

c) Added "The environmental performance test items for clean rooms in different application fields should be determined according to the process and use requirements and meet the current national (See 4.1)

d) Changed "Test items and related application areas" (see 4.2, Chapter 4 of the.2018 edition);

e) Added "other routine testing items for clean rooms and related controlled environments" (see 4.3);

f) Deleted "Technical Preparation" and "Testing Operation Elements" (see

5.5 of the.2018 edition);

g) Added "reagents and consumables", "testing plan" and "monitoring" (see 5.3,

h) Changed the requirements for "testing instruments", "testing conditions" and "testing reports" (see 5.2, 5.5, 5.7, 5.3, 5.1,

5.6 of the.2018 edition);

i) Added "Application of methods" and "Reasons for test data deviation" (see

j) "Test Condition Analysis" has been deleted (see Chapter 7 of the.2018 edition). 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 Standardization of Clean Rooms and Related Controlled Environments (SAC/TC319). This document was drafted by: China Power Investment Engineering Research, Testing and Assessment Center Co., Ltd., Suzhou Suxin Environmental Technology Co., Ltd., Suzhou Antai Air Technology Co., Ltd., Wujiang Huayu Purification Equipment Co., Ltd., Shenzhen Tiansuo Metrology and Testing Co., Ltd., China Association for Standardization, China Electronics Engineering Design Institute Co., Ltd., Beijing Dyna Testing Technology Co., Ltd., Suzhou Yiyou Testing Technology Co., Ltd., Shanghai Ke Xin Testing Technology Co., Ltd., China Academy of Building Research Co., Ltd., Yaxiang System Integration Technology (Suzhou) Co., Ltd., Beijing Zhong Bangxingye Technology Co., Ltd., Wuhan Huakang Century Medical Co., Ltd., Shanghai Kaichun Clean Room Technology Engineering Co., Ltd., Nanjing Tuozhan Technology Co., Ltd., Shanghai Food and Drug Packaging Materials Testing Institute, Bocheng System Technology Co., Ltd., Jiangxi Inspection, Testing and Certification Corporation Institute of Food Inspection and Testing, China Food and Drug Inspection Institute, Zhongkai University of Agriculture and Engineering, Zhejiang Tiantai Pharmaceutical Co., Ltd., Huirui Purification Technology (Jiangsu) Co., Ltd., Changxin Electric (Beijing) Storage Technology Co., Ltd., China Chemical Information Association, Wuxi Evergrande Electronic Technology Co., Ltd., Hefei Jinghe Integrated Circuit Co., Ltd., and MCC Testing and Certification Co., Ltd. The main drafters of this document are. Guo Kai, Zhang Xiuchun, Shi Xia, Wu Zhijian, Tan Jun, Zhao Xia, Gao Zheng, Wei Jiaming, Yu Junlei, Chi Haipeng, Wang Li, Yan Xiaoqing, Jiang Tao, Hui Lufeng, Feng Xin, Ji Jinxing, Chen Yuan, Han Hui, Bai Bing, Ding Lixing, Cui Kaijie, Li Shuai, Wang Jingkai, Zhang Changan, Shen Jinhuan, Yang Chupeng, Yang Dagui, Xie Jianming, Yang Xiaozhang, Zhang Jing. The previous versions of this document and the documents it replaces are as follows:

1 Scope

China's national standard for the technical requirements and application of cleanroom testing. It specifies the terms and definitions, the test items and their fields of application, the technical requirements and the applications, with an informative annex on further test items. A cleanroom is classified by how many particles of a given size are present in a cubic metre of its air, and that single number is what the classification standards fix. What this document addresses is everything else that has to be measured before the number means anything: the air volume and change rate, the pressure differences that keep the room cleaner than its neighbours, the airflow pattern that determines whether contamination is swept away or recirculated, the integrity of the filters and their housings, the recovery time after a disturbance, and the temperature and humidity. A room can meet its particle count while failing any of those, and it will then fail in service - which is why the tests are specified alongside their fields of application.

This document provides the test items and related application areas of clean rooms and related controlled environments, stipulates the test technical requirements, and provides Suggestions on the application of the test method. This document applies to the testing of clean rooms and related controlled environments.

2 Normative references

The contents of the following documents constitute 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.

GB/T 25915.3 Clean rooms and related controlled environments Part

3 Terms and definitions

The terms and definitions defined in GB/T 25915.3 and the following apply to this document.

3.1 A room (clean room) or confined space (clean area) that is controlled and classified according to the concentration of airborne particles, microbial limits, and chemical concentrations. And related limited areas where pollution sources are controlled in accordance with prescribed methods (related controlled environments). [Source: GB/T 29469-2024, 3.2]

3.2 After the clean room is contaminated, the time from when the purification air conditioning system starts to operate to when the clean room returns to the stable specified indoor cleanliness level.

3.3 Warning value alertlevel User-set parameter values can give early warnings when they deviate from normal conditions.

Note. When this value is exceeded, pay close attention or take corrective action. [Source: GB/T 25915.2-2021, 3.4, modified]

3.4 Intervention value action level The parameter value set by the user, when exceeded, requires immediate intervention, identification of the cause and taking corrective measures. [Source: GB/T 25915.2-2021, 3.3]

3.5 Threshold size A minimum particle size selected to measure the concentration of particles greater than or equal to that size.