GB/T 33556.1-2017 (GB/T33556.1-2017, GBT 33556.1-2017, GBT33556.1-2017)
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Application specification for hospital cleanrooms and associated controlled environment -- Part 1: General guidelines
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GB/T 33556.1-2017
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| Standard ID | GB/T 33556.1-2017 (GB/T33556.1-2017) | | 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 | 13.040.20 | | Word Count Estimation | 12,160 | | Date of Issue | 2017-05-12 | | Date of Implementation | 2017-12-01 | | Quoted Standard | GB 15982; GB 19083-2010; GB/T 25915.2-2010; GB/T 25915.3-2010; GB/T 25915.4; GB/T 25916.1; GB/T 25916.2; GB/T 29469-2012; GB 50333-2013; WS/T 368 | | Drafting Organization | Zhongtian Tiancheng (Suzhou) Clean Technology Co., Ltd., Tianjin Longchuan Purification Engineering Co., Ltd., China Standardization Association, PLA General Hospital, Air Force General Hospital, Peking University Third Hospital, Chinese Academy of Medical Sciences Peking Union Medical College Hospital, China Zhongyuan International Engineering Co., Ltd., Lianhe Chengcheng Engineering Co., Ltd., Institute of Health Equipment, Academy of Military Medical Sciences, Beijing Tianzhi Hang Medical Technology Co., Ltd., Shenzhen Lifeng Purification Technology Co., Ltd., Yantai Baoyuan Purification Co., Ltd., Jiangsu Sujing Technology Co., Ltd., Shenzhen Institute of Science and Technology Co., Ltd., Shenzhen City, Granville Medical Systems Engineering Co., Ltd., Beijing Huayang Medical Systems Engineering Co., Ltd., Divine Technology Co., Ltd. | | Administrative Organization | National Clean Room and Related Controlled Environmental Standardization Technical Committee (SAC/TC 319) | | Proposing organization | National Clean Room and Related Controlled Environmental Standardization Technical Committee (SAC/TC 319) | | Issuing agency(ies) | General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, China National Standardization Administration Committee | | Summary | This standard specifies the laboratory clean room and related controlled environment validation, operation management and maintenance and other norms. This standard applies to the hospital clean room and related controlled environment, such as clean operating room, hematopoietic stem cell transplantation ward, reproductive center, burn ward, ICU ward, intravenous infusion preparation center. | GB/T 33556.1-2017
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 13.040.20
C 70
Application Specification for Hospital Cleanrooms
and Associated Controlled Environment –
Part 1. General Guidelines
ISSUED ON. MAY 12, 2017
IMPLEMENTED ON. DECEMBER 1, 2017
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine;
Standardization Administration of PRC.
3. No action is required - Full-copy of this standard will be automatically &
immediately delivered to your EMAIL address in 0~60 minutes.
Table of Contents
Foreword ... 3
Introduction ... 4
1 Scope ... 6
2 Normative References ... 6
3 Terms and Definitions ... 7
4 Requirements ... 8
Appendix A (Informative) Intelligent Monitoring System for Hospital Controlled
Environment Data ... 14
Appendix B (Informative) Comparison List of Various Classifications of
Cleanliness ... 15
Bibliography ... 16
Foreword
GB/T 33556 Application Specification for Hospital Cleanrooms and Associated
Controlled Environment can be divided into the following 4 parts.
--- Part 1. General Guidelines;
--- Part 2. Operating Room, Hematopoietic Stem Cell Transplantation Room, Burn
Ward, etc.;
--- Part 3. Reproduction Center, Cell Therapy and the Like Micro Operation
Environment;
--- Part 4. Others.
This Part belongs to Part 1 of GB/T 33556.
This Part was drafted as per the rules specified in GB/T 1.1-2009.
This Part was proposed by and under the jurisdiction of National Technical Committee
for Standardization of Cleanrooms and Associated Controlled Environment.
Drafting organizations of this Part. Success Way Clean Technology Co., Ltd., Tianjin
Longchuan Purifying Engineering Co., Ltd., China Association for Standardization, PLA
General Hospital, Air Force General Hospital, Peking University Third Hospital, Peking
Union Medical College Hospital of Chinese Academy of Medical Science, China IPPR
International Engineering Co., Ltd., Alliance Contracting Co., Ltd., Institute of Medical
Equipment Academy of Military Medical Science, TINAVI Medical Technologies Co.,
Ltd., Shenzhen Lifeng Cleanroom Technologies Co., Ltd., YANTAIR Co., Ltd., Jiangsu
Suzhou Purification Science and Technology Co., Ltd., Research Institute of Chemical
Defense, Guangzhou Clima Air Purity Equipment Co., Ltd., Shenzhen Jilong
Contamination Control Technology Co., Ltd., Beijing North Tianyu Architectural
Decoration Co., Ltd., Wuxi Hanjia Medical Science & Technology Co., Ltd., Shenzhen
Weida Medical System Engineering Co., Ltd., and Beijing Huayee Shenzhou
Technology Co., Ltd.
Chief drafting staffs of this Part. Yang Ziqiang, Cao Jingui, Yin Xiaodong, Xu Huoju,
Jiang Weikang, Zhang Lihai, Zhao Ameng, Huang Jihui, Yu Ziqiang, Tu You, Lin
Xiangyang, He Li, Guo Li, Zhou Hengjin, Ma Dong, Li Zhiping, Yang Xiaobing, Chen
Hanqing, Zhang Xiaodong, Bing Shaotong, Pan Xuegang, Jiang Haoxia, Tong
Guangcai, and Hou Bin.
Introduction
Hospital cleanroom is one of the auxiliary measures to control the hospital infection. In
1961, Sir John Charnley (1911-1982) known as “Father of Hip Arthroplasty” in the
British Wrightington Hospital pioneered to, by cleaning the air method, improve the
operating room environment; so that reduce surgical infection. However, the literature
on relationship between air environment and surgical infection rate that had the clinical
significance of medical statistics and was widely cited was published by LidewellOM
et al. in 1987, the title of such literature is of “Multiple Studies on Ultra Clean Air and
Antibiotics Used to Prevent Postoperative Infection in 8052 Cases of Joint
Replacement Surgery”; such study recognized, to a certain extent, the role of ultra
clean air.
Internationally, for the role of the hospital cleanroom and associated controlled
environment in reducing the rate of infection, the medical field and engineering
personnel in the cleanroom and associated controlled environment had their own
opinions. The medical field has long been skeptical about the effectiveness of clean
operating room. In recent year, the international medical field proposed more specific
doubts on the laminar flow clean operating room based on statistical analysis on a
large number of clinical case practice. The introduction of the Russian Federation
Standard GOSTR 52539-2006 General Requirements for Air Cleanliness in Hospital
prepared by Russian Association of Micro-Contamination Control Engineers clearly
states that the cleanroom ventilation, air conditioning system and equipment can’t
replace the traditional hospital bacterial control measures, but can only supplement it.
Human’s cognition on medical infection is still in the process of exploration. In the air
attached to the dust of microorganisms (In the relevant information at home and abroad,
the literature has not been found on the exact relationship between the number of dust
and microorganisms. Obviously, animals and plants are more likely to scatter off the
fine dust containing microorganisms, such as pollen, body debris, etc.) have been
recognized at home and abroad one of the objects of prevention; while purifying the
air in the medical space has become one of the measures to prevent the medical
infection.
China’s national serial standards of GB/T 25915 Cleanrooms and Associated
Controlled Environment equivalently adopting ISO 14644 internals serial standards
drew lessons on the international counterparts’ systematic concepts in each links such
as test, design, construction, start operation, etc. To give full play to the role of the
hospital cleanroom, and meet the use requirements, every detail in the operation can’t
be ignored.
The energy consumption for the air conditioning system and ventilation in the hospital
cleanroom and associated controlled environment is about 5tims ~ 10times of that in
the high-grade hotel with the same area. Reasonably determining the matching among
Application Specification for Hospital Cleanrooms
and Associated Controlled Environment –
Part 1. General Guidelines
1 Scope
This Part of GB/T 33556 specifies the specifications on the verification, operation
management, maintenance, and etc. of hospital cleanroom and associated controlled
environment.
This Part is applicable to the hospital cleanroom and associated controlled
environment like clean operating room, hematopoietic stem cell transplantation room,
reproduction center, burn ward, ICU ward, intravenous infusion preparation center.
2 Normative References
The following documents are essential to the application of this document. For the
dated documents, only the versions with the dates indicated are applicable to this
document; for the undated documents, only the latest version (including all the
amendments) are applicable to this document.
GB 15982 Hygienic Standard for Disinfection in Hospitals
GB 19083-2010 Technical Requirements for Protective Face Mask for Medical
Use
GB/T 25915.2-2010 Cleanrooms and Associated Controlled Environments – Part
2. Specifications for Testing and Monitoring to Prove Continued Compliance with
GB/T 25915.1
GB/T 25915.3-2010 Cleanrooms and Associated Controlled Environments – Part
3. Test Methods
GB/T 25915.4 Cleanrooms and Associated Controlled Environments – Part 4.
Design, Construction and Start-Up
GB/T 25916.1 Cleanrooms and Associated Controlled Environments –
Biocontamination Control – Part 1. General Principles and Methods
[GB 50333-2013, definition 2.0.13]
3.6 Operational
Facilities are operated in the specified state; there is specified personnel present; and
work in an agreed state.
3.7 Installation acceptance inspection
Facilities have been built; under the as-built condition, confirm whether the
performance parameters of facilities in the cleanroom and associated controlled
environment meet the requirements of design.
3.8 Function acceptance inspection
Under the at-rest condition, confirm whether the performance of facilities in the
cleanroom and associated controlled environment satisfies (continues to meet) the
requirements of design.
3.9 Operational evaluation
Under the specified operational condition, conform the compliance of performance
parameters of facilities in cleanroom and associated controlled environment.
4 Requirements
4.1 Assessment, acceptance and operational evaluation
4.1.1 Assessment
4.1.1.1 When designing new hospital buildings of cleanroom and associated
controlled environment, it shall be performed after assessing the rationality of
controlled environment, overall layout, etc.
4.1.1.2 Before constructing the cleanroom and associated controlled environment
within the existing building, assess the rationality of the following items like controlled
environment function, requirements, classification of cleanliness, overall layout, indoor...
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