GB/T 33556.1-2025 English PDF

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GB/T 33556.1-2025	279	Add to Cart	3 days	Application specification for hospital cleanrooms and associated controlled environment - Part 1: General guidelines
GB/T 33556.1-2017	150	Add to Cart	Auto, < 3 mins	Application Specification for Hospital Cleanrooms and Associated Controlled Environment - Part 1: General Guidelines	Valid

Basic data

Standard ID: GB/T 33556.1-2025 (GB/T33556.1-2025)
Description (Translated English): Application specification for hospital cleanrooms and associated controlled environment - Part 1: General guidelines
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C70
Classification of International Standard: 13.040.35
Word Count Estimation: 14,147
Date of Issue: 2025-10-31
Date of Implementation: 2026-05-01
Older Standard (superseded by this standard): GB/T 33556.1-2017
Issuing agency(ies): State Administration for Market Regulation and Standardization Administration of China

GB/T 33556.1-2025: Application specification for hospital cleanrooms and associated controlled environment - Part 1: General guidelines

---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 the People's Republic of China Replaces GB/T 33556.1-2017 Application Standards for Hospital Cleanrooms and Related Controlled Environments Part 1.General Provisions environment-Part 1.General guidelines Implemented on May 1, 2026 State Administration for Market Regulation The State Administration for Standardization issued a statement.

Table of contents

Preface III Introduction IV 1.Scope 1 2 Normative References 1 3.Terms and Definitions 1 4.Basic Requirements 2 5.Technology 3 6.Acceptance, Operation, Maintenance and Evaluation 4 Appendix A (Informative) Intelligent Monitoring System for Hospital Cleanrooms and Related Controlled Environment Data 6 References 7

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents". Drafting. This document is Part 1 of GB/T 33556 "Application Specifications for Cleanrooms and Related Controlled Environments in Hospitals". GB/T 33556 has been issued. The following parts were laid out. ---Part 1.General Provisions This document supersedes GB/T 33556.1-2017 "Application Specifications for Hospital Cleanrooms and Related Controlled Environments Part 1.General Principles" and is consistent with... Compared with GB/T 33556.1-2017, apart from structural adjustments and editorial changes, the main technical changes are as follows. a) The terms and definitions for airborne particles, cleanliness level, project acceptance, static acceptance, and dynamic evaluation have been removed (see.2017 edition). (3.2, 3.3, 3.7, 3.8 and 3.9) b) The definitions of terms such as hospital cleanroom, empty state, static, and dynamic have been revised (see 3.1, 3.2, 3.3, and 3.4; 3.1 in the.2017 edition). 3.4, 3.5 and 3.6); c) Change "Requirements" to "Basic Requirements," "Technical," and "Acceptance, Operation, Maintenance, and Evaluation" (see Chapters 4, 5, and 6,.2017). Chapter 4 of the edition); d) Increased requirements for energy conservation, information technology, and intelligentization of hospital cleanrooms and related controlled environments (see Chapter 5). Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents. This document was proposed and is under the jurisdiction of the National Technical Committee on Standardization of Cleanrooms and Related Controlled Environments (SAC/TC319). This document was drafted by. China Zhongyuan International Engineering Co., Ltd., China Association for Standardization, and Wei Qin, Research Institute of Systems Engineering, Academy of Military Sciences. Protection Technology Research Institute, China Power Investment Engineering Research, Testing and Evaluation Center Co., Ltd., Air Force Special Medical Center, Wuhan Huakang Century Clean Technology Joint-stock company, Xi'an Siteng Environmental Technology Co., Ltd., Peking University Third Hospital, Xiangya Second Hospital of Central South University, Shanghai Installation Engineering Group Co., Ltd., China Academy of Building Research Co., Ltd., First Medical Center of PLA General Hospital, Beijing Jiji Affiliated to Capital Medical University Shuitan Hospital, Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Peking University Cancer Hospital, Beijing Dyna Experimental Technology Co., Ltd. Company, Sinopharm Beijing Medical Technology Co., Ltd., The First Affiliated Hospital of Bengbu Medical University, Jiangsu Qiaoanchen Medical Technology Co., Ltd., Shanghai Shangjing Environmental Technology Co., Ltd., Shenzhen Zhongce Measurement and Testing Technology Co., Ltd., Ningbo Onic Technology Co., Ltd., Ningbo University Affiliated The First Hospital, Peking University School of Stomatology, Beijing Zhongbang Xingye Technology Co., Ltd., Shanghai Indoor Environment Purification Industry Association, Armstrong (China) Investment Co., Ltd., Wuhan Institute of Disease Control and Prevention of China Railway Wuhan Bureau Group Co., Ltd., Guangdong Yizhong Clean Technology Co., Ltd. Company, Aimeike Air Filter (Suzhou) Co., Ltd., The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Peking University Medical Center Marine Petroleum Hospital, Zhongkai Agricultural... College of Industrial Engineering, Zhengzhou Air Purification Association, Shenzhen Jiegong Technology Co., Ltd., Suzhou Huihan Medical Technology Development Co., Ltd., Zhengzhou Saint Mary's Maternity Hospital Co., Ltd., and Dongguan Pengchi Intelligent Equipment Technology Co., Ltd. The main drafters of this document are. Zhang Xiuchun, Huang Zhong, Cao Jingui, Cao Guoqing, Zhang Zongxing, He Shan, Guo Li, Chen Hong, Lu Ming, Xi Xiaopeng, and Gui Fangyu. Zhu Yujiao, Yang Juncheng, Li Li, Tan Sichen, Ouyang Na, Li Shuai, Ge Lanying, Xie Huahui, Wang Donglai, Han Hui, He Tao, Wang Fang, He Li, Zhang Zhijian Xu Guolin, Zeng Yanfeng, Lei Jie, Ding Xuefeng, Wu Luming, Li Qiuci, Zhang Zhaohong, Wang Zhenjie, Zheng Hui, Dong Xiaoyan, Liu Junhang, Ding Lixing, Shi Wenting Wang Xiaoqiao, Feng Yongliang, Yang Yang, Hu Guopeng. The release history of this document and the document it replaces is as follows. ---First published in.2017 as GB/T 33556.1-2017; ---This is the first revision.

Introduction

Hospital cleanrooms and related controlled environments, as spaces vital to life safety in the medical process, have a significant impact on medical care. The quality of treatment plays a crucial role. Air purification technology is an important measure for infection control in hospital cleanrooms; as a comprehensive measure, it can... Effective control of the medical environment and effective avoidance of side effects and harmful substances. Since the world's first clean operating room in a hospital in the 1960s... Since its construction, research on hospital cleanrooms and related controlled environments has continued in various countries. my country has explored a path led by hygiene technology... A medical purification technology route that meets hygiene standards. Although our understanding of hospital-acquired infections is still in the exploratory stage, the existence of airborne microorganisms attached to dust has been recognized both domestically and internationally. They are important targets for prevention. Therefore, hospital clean rooms and related controlled environments that employ air purification have become a crucial aspect of hospital infection control. This document draws on systematic concepts from both domestic and international sources regarding cleanroom design, construction, commissioning, testing, and operation, and is based on GB/T 25915. Based on the "Cleanrooms and Related Controlled Environments" series of standards, relevant requirements are proposed for hospital cleanrooms as a specific object. The design and construction of hospital cleanrooms and related controlled environments are fundamental conditions for their application, and their rationality directly affects the application effect. Therefore, it is crucial to... A comprehensive evaluation of hospital cleanrooms and related controlled environments is an extremely important step. GB/T 33556 is proposed to consist of four parts. ---Part 1.General Principles. The purpose is to provide a basic framework and principles for the development of standards for hospital cleanrooms and related controlled environments. and general requirements. ---Part 2.Clean Operating Rooms, Clean Nursing Units, and Isolation Units, etc. The purpose is to clearly define the clean operating rooms, clean nursing units, and isolation units in hospitals. The basic requirements, technical aspects, acceptance procedures, operation, maintenance, and evaluation requirements for the management unit and isolation unit environment, etc. ---Part 3.Medical Laboratories. The purpose is to clarify the basic requirements, technologies, acceptance procedures, operation, maintenance, and evaluation of medical laboratories. Relevant requirements. ---Part 4.Other. The purpose is to clarify the basic requirements, technologies, acceptance procedures, and operation of cleanrooms and related controlled environments in other hospitals. Maintenance and evaluation requirements, etc. Application Specifications for Hospital Cleanrooms and Related Controlled Environments Part 1.General Provisions

1 Scope

This document specifies the basic requirements, technical requirements, acceptance, operation, maintenance and evaluation requirements for hospital cleanrooms and related controlled environments. This document applies to the general requirements for hospital cleanrooms and related controlled environments.

2 Normative references

The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included. For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies. This document. GB 15982 Hospital Disinfection and Hygiene Standard GB 19083 Medical Protective Masks GB/T 25915.4 Cleanrooms and related controlled environments – Part 4.Design, construction and commissioning GB/T 25915.5 Cleanrooms and related controlled environments – Part 5.Operation GB/T 25915.16 Cleanrooms and related controlled environments – Part 16.Improving the energy efficiency of cleanrooms and air purification systems GB/T 29469 Performance and rationality evaluation of cleanrooms and related controlled environments GB/T 36527 Guidelines for Energy Conservation in Cleanrooms and Related Controlled Environments GB 50333 Technical Specification for Clean Operating Room Buildings in Hospitals GB 50591 Cleanroom Construction and Acceptance Standard GB/T 51454 Technical Standard for Operation and Maintenance of Hospital Buildings GB/T 51457 Technical Standard for Cleanroom and Isolation Unit Buildings in Hospitals WS/T 368 Hospital Air Purification Management Standard YY0469 Medical Surgical Mask YY/T 0506 (All Parts) Surgical drapes, gowns and cleanroom garments for patients, healthcare workers and instruments

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 Hospital cleanroom Hospitals employ air purification technologies and management measures to eliminate pathogenic microorganisms and airborne particles that may cause infection or affect medical outcomes. A room where ions and harmful gases are controlled within permissible levels and where all major performance indicators are under control. Note. Such as clean operating rooms, clean nursing units and isolation units, medical laboratories and other clean rooms, etc. 3.2 empty state as-built The cleanroom or clean area has all service facilities in place and operational, but no equipment, furniture, materials, or personnel. [Source. GB/T 25915.1-2021, 3.3.1] ......

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