GB/T 33556.1-2017Application Specification for Hospital Cleanrooms and Associated Controlled Environment - Part 1: General Guidelines (English PDF)

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]

4 Requirements