WS/T 367-2012 PDF in English
WS/T 367-2012 (WS/T367-2012, WST 367-2012, WST367-2012)
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Regulation of disinfection technique in healthcare settings
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WS/T 367-2012: PDF in English (WST 367-2012) WS/T 367-2012
WS
HEALTHCARE INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.020
C 05
Regulation of disinfection technique
in healthcare settings
ISSUED ON. APRIL 05, 2012
IMPLEMENTED ON. AUGUST 01, 2012
Issued by. Ministry of Health of the PRC
Table of contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 5
4 Management requirements... 11
5 Basic principles of disinfection and sterilization ... 12
6 Washing and cleaning ... 15
7 Common disinfection and sterilization methods ... 16
8 Sterilization of critical items ... 16
9 Disinfection of semi-critical items ... 18
10 Disinfection of non-critical items ... 19
11 Disinfection of item and environment contaminated by prion, gas
gangrene and sudden unexplained infectious disease ... 20
12 Disinfection of skin and mucosa ... 23
13 Cleaning and disinfection of ground and item surface ... 26
14 Disinfection of cleaning supplies ... 27
Appendix A (Normative) Cleaning, disinfection and sterilization effects
monitoring ... 28
Appendix B (Informative) Disinfection test reagents and medium formulations
... 40
Appendix C (Normative) Commonly used disinfection and sterilization methods
... 45
Foreword
This standard was drafted in accordance with the rules given in GB/T
1.1-2009.
This standard was formulated in accordance with the Law of the People's
Republic of China on the Prevention and Treatment of Infectious Diseases.
This standard was proposed by the Hospital Infection Control Standard
Professional Committee of the Ministry of Health.
The drafting organizations of this standard. Peking University First Hospital,
China Disease Control and Prevention Center, Academy of Military Medical
Sciences - Institute of Disease Control, Hubei Provincial Health Department
Health Supervision Bureau, Zhejiang Provincial Disease Control and
Prevention Center, Ministry of Health - Hospital Management Institute,
Zhejiang University Medical Hospital Affiliated Second Hospital, Shanghai
Ruijin Hospital, Capital Medical University - Beijing Chaoyang Hospital,
Xiamen University First Affiliated Hospital.
The main drafters of this standard. Li Liuyi, Zhang Liubo, Yao Chushui, Chen
Shunlan, Ban Haiqun, Hu Guoqing, Zhang Yu, Ding Yanming, Lu Qun, Qian
Liming, Liu Kun, Xing Shuxia, Ren Wuai, Huang Jingxiong, Jia Huixue, Yao
Hui, Huang Huiping.
Regulation of disinfection technique
in healthcare settings
1 Scope
This standard specifies the management requirements for disinfection of
medical institutions; the basic principles of disinfection and sterilization;
washing and cleaning, disinfection and sterilization methods; cleaning,
disinfection and sterilization effect monitoring, etc.
This standard applies to all types of medical institutions of all levels and all
types.
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 Standard.
GB/T 16886.7 Biological evaluation of medical devices - Part 7. Ethylene
oxide sterilization residuals
GB 19258 Ultraviolet germicidal lamp
GB/T 19633 Packaging for terminally sterilized medical devices
GB 50333 Architectural technical code for hospital clean operating
department
WS 310.1 Central sterile supply department (CSSD) - Part 1. Management
standard
WS 310.2 Central sterile supply department (CSSD) - Part 2. Standard for
operating procedure of cleaning, disinfection and sterilization
WS 310.3 Central sterile supply department (CSSD) - Part 3. Surveillance
standard for cleaning, disinfection and sterilization
WS/T 311 Technique standard for isolation in hospitals
WS/T 313 Standard for hand hygiene for healthcare workers in healthcare
settings
YY/T 0506.1 Surgical drapes gowns and clean air suits for patient clinical
staff and equipment - Part 1. General requirements for manufacturers
processors and products
YY/T 0698.2 Packaging materials for terminal sterilized medical devices -
Part 2. Sterilization wrap - Requirements and test methods
YY/T 0698.4 Packaging materials for terminal sterilized medical devices -
Part 4. Paper bags - Requirements and test methods
YY/T 0698.5 Packaging materials for terminal sterilized medical devices -
Part 5. Heat and self-sealable pouches and reels of paper and plastic film
construction - Requirements and test methods
YY/T 0698.8 Packaging materials for terminal sterilized medical devices -
Part 8. Reusable sterilization containers for steam sterilizers - Requirements
and test methods
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Cleaning
It refers to the process of removing the organic matter, inorganic matter and
visible pollutants from the surface of an object.
3.2
Washing
It refers to the whole process of removing the containments from the
treatment instrument, appliance, and items, including washing, cleaning,
rinsing and final rinsing.
3.3
Detergent
3.15
Non-critical items
It refers to the items contacting with the complete skin BUT not contacting
with mucosa, such as stethoscope, sphygmomanometer cuff; bed fence,
bed and bedside cabinet, bedding; wall, ground; spittoon (cup) and toilet.
3.16
Sterilization level
It refers to the sterility assurance level which is reached by killing all
microorganisms including bacterial spores. Methods to achieve sterilization
levels normally include such physical sterilization methods as heat
sterilization and radiation sterilization AND the sterilization methods of using
such chemical sterilizers as ethylene oxide, hydrogen peroxide,
formaldehyde, glutaraldehyde, peracetic acid and so on to conduct
sterilization at the specified conditions with appropriate concentration and
effective time of action.
3.17
High level disinfection
It refers to killing of all bacterial propagules including mycobacteria, viruses,
fungi and their spores, and the vast majority of bacterial spores. The
normally used methods to reach to high level disinfection include using the
chemical disinfectant such as chlorine preparations, chlorine dioxide,
o-phthalaldehyde, peracetic acid, hydrogen peroxide, ozone, iodine tincture
and so on, which can achieve sterilization effects, to conduct disinfection at
the specified conditions with appropriate concentration and effective time of
action.
3.18
Middle level disinfection
It refers to the killing of a variety of pathogenic microorganisms other than
bacterial spores, including mycobacteria. The methods normally used to
achieve to the middle level disinfection include using of iodine disinfectants
(iodophor, chlorhexidine iodine, etc.), alcohols and chlorhexidine compound,
compound of alcohols and quaternary ammonium compounds, phenols and
other disinfectants, to conduct disinfection at the specified conditions with
appropriate concentration and effective time of action.
aggregate on a solid culture medium, which is used to express the number
of viable bacteria.
4 Management requirements
4.1 The medical institutions shall, in accordance with the requirements of this
regulation AND combining with the actual situation of the unit, establish the
scientific and practical disinfection & sterilization system and standard
operating procedures, AND make them implemented.
4.2 The medical institutions shall enhance the training of the medical staff and
disinfection & sterilization staff. Training shall include the significance of
disinfection and sterilization work on the prevention and control of the
nosocomial infection, the requirements of relevant laws and regulations, the
basic principles and knowledge of disinfection and sterilization, and the
occupational protection in disinfection and sterilization work.
4.3 The diagnosis and treatment instrument, appliances and items used by the
medical institutions shall comply with the following requirements.
a) The diagnosis and treatment instrument, appliances and items entering
into human body’s aseptic tissue, organs, lacunae, OR contacting with
the damaged skin, damaged mucosa, and tissue shall be sterilized;
b) The diagnosis and treatment instrument, appliances and items contacting
with complete skin and intact mucosa shall be disinfected.
4.4 The disinfected products used by the medical institutions shall comply with
...
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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