WS/T 367-2012 PDF English
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WS/T 367-2012: Regulation of disinfection technique in healthcare settings---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/WST367-2012
WS
HEALTHCARE INDUSTRY STANDARD
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
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
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
It refers to the reagent used in the washing process to remove the organic
matter, inorganic matter and microorganisms from the items under
treatment.
3.4
Disinfection
It refers to the treatment of removing or killing pathogenic microorganisms
on the media in order to achieve harmlessness.
3.5
Disinfectant
It refers to the reagent which can kill the microbes on the media AND reach
to the requirements of disinfection.
3.6
High-efficacy disinfectant
It refers to the disinfection reagent which can kill all bacterial propagules
(including mycobacteria), viruses, fungi and spores, etc., AND have a
certain killing effect against the bacterial spores.
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.
4.4 The disinfected products used by the medical institutions shall comply with
the relevant national provisions, AND the relevant certificates of the disinfected
products shall be reviewed and archived for reference.
4.5 The medical institutions shall maintain the clean and dry surface of the
diagnosis and treatment environment, conduct timely and effective disinfection
in the case of pollution; AND conduct regular disinfection against the
departments of high infection risk.
4.6 The medical institutions shall, combining with the actual disinfection and
sterilization work of the unit, provide the corresponding protective equipment
for the workers engaging in the cleaning, disinfection and sterilization of the
treatment instrument, appliance, and item, in order to protect the occupational
safety of medical staff.
4.7 The medical institutions shall regularly check and monitor the disinfection
work, conduct timely analysis and feedback, AND make corrections in time if
finding problems.
4.8 Medical staff shall master the basic knowledge of disinfection and
sterilization and occupational protection skills.
5 Basic principles of disinfection and sterilization
5.1 Basic requirements
5.1.1 The reusable treatment instrument, appliance and items shall, after use,
be firstly cleaned and then disinfected or sterilized.
5.1.5 Disinfection products used in the disinfection of medical institutions shall
be approved by the health administrative department OR comply with the
relevant standard technical specifications, AND shall follow the approved
scope, methods and precautions.
5.2 Selection principles of disinfection and sterilization method
5.2.1 The corresponding disinfection and sterilization method is selected
based on the risk of infection after the item is contaminated.
5.3 Occupational protection
5.3.1 It shall take appropriate occupational protection measures in accordance
with different disinfection and sterilization methods.
5.3.2 Occupational exposure to medical personnel shall be prevented during
the recovery and cleaning of contaminated treatment instruments, appliances,
and items.
5.3.3 Handling sharp instruments and appliances shall take effective protective
measures to avoid or reduce the occurrence of weapon injuries.
6 Washing and cleaning
6.1 Scope of application
Washing is applicable to all the moisture-resistant treatment instruments,
appliances and items; AND cleaning is applicable to all kinds of item surfaces.
6.2 Washing and cleaning methods
6.3 Precautions
6.3.1 The items with chamber or with uneven surface shall, after being soaked
in detergent, be carefully brushed manually or cleaned ultrasonically. The
complex items which can be disassembled shall be cleaned after disassembly.
6.3.2 Cleaning water and detergent shall comply with the provisions of WS
310.1.
6.3.3 The manual cleaning tools such as brushes shall, after daily use, be
cleaned and disinfected.
6.3.4 The cleaning of endoscopic and oral equipment shall follow the relevant
national provisions.
6.3.5 As for the splash containing a small amount of blood or body fluids and
other substances, it may be firstly cleaned and then disinfected; as for the
splash of a large amount, it shall firstly use the moisture-absorbing material to
remove visible contaminants AND then clean and disinfect it.
7 Common disinfection and sterilization methods
Common disinfection and sterilization methods shall be in accordance with the
provisions of Appendix C; AND as for the products used, it shall check the
relevant certificates.
8 Sterilization of critical items
8.1 Sterilization of surgical instruments, appliances and items
8.1.1 Preparation before sterilization
Cleaning, packaging, and loading shall follow the requirements of WS 310.2.
8.1.2 Sterilization method
8.1.2.7 Power tools. They are divided in pneumatic tools and electric tools,
which are generally composed of drill, saw blade, host machine, gas
connection line, battery and other components. AND it shall follow the
requirements of the user instructions to clean, pack and sterilize each part.
8.2 Sterilization of surgical dressings
8.2.1 Preparation before sterilization
8.2.1.1 The surgical dressings shall be stored in an environment of the
temperature of 18 °C ~ 22 °C AND relative humidity of 35% ~ 70% before
sterilization.
8.2.2 Sterilization method
8.2.2.1 As for the cotton cloth dressings and cotton yarn dressings, it is
preferable to select the pressure steam sterilization.
8.2.2.2 The surgical dressings complying with the requirements of YY/T 0506.1
shall be subjected to corresponding sterilization methods based on different
materials.
8.3 Sterilization of surgical sutures
8.3.1 Surgical suture classification. It is divided into absorbable suture and
non-absorbable suture. Absorbable sutures include ordinary gut, chrome gut,
and synthetic absorbable suture and so on. Non-absorbable sutures include
medical thread, polypropylene suture, polyester suture, nylon thread, metal
wire and so on.
9 Disinfection of semi-critical items
9.1 Disinfection methods
9.1.1 As for the semi-critical items such as the heat resistant and moisture
resistant items (e.g. oral care appliances), it is preferable to select the pressure
steam sterilization method; as for the non-heat resistant items such as
thermometer (anal thermometer or mouth thermometer), oxygen mask, and
anesthesia mask, it shall use high level disinfection or middle level disinfection.
9.2 Precautions
9.2.1 The items to be disinfected shall be thoroughly washed before
disinfection and sterilization.
9.2.2 When there is blood or other organic contaminants in the piping, it shall
use ultrasonic and medical detergent for soaking and washing. AND the items
after being washed shall be disinfected promptly.
9.2.3 The disinfectants in use shall be monitored for their concentration AND
be used within the validity period.
WS/T 367-2012
WS
HEALTHCARE INDUSTRY STANDARD
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
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
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
It refers to the reagent used in the washing process to remove the organic
matter, inorganic matter and microorganisms from the items under
treatment.
3.4
Disinfection
It refers to the treatment of removing or killing pathogenic microorganisms
on the media in order to achieve harmlessness.
3.5
Disinfectant
It refers to the reagent which can kill the microbes on the media AND reach
to the requirements of disinfection.
3.6
High-efficacy disinfectant
It refers to the disinfection reagent which can kill all bacterial propagules
(including mycobacteria), viruses, fungi and spores, etc., AND have a
certain killing effect against the bacterial spores.
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.
4.4 The disinfected products used by the medical institutions shall comply with
the relevant national provisions, AND the relevant certificates of the disinfected
products shall be reviewed and archived for reference.
4.5 The medical institutions shall maintain the clean and dry surface of the
diagnosis and treatment environment, conduct timely and effective disinfection
in the case of pollution; AND conduct regular disinfection against the
departments of high infection risk.
4.6 The medical institutions shall, combining with the actual disinfection and
sterilization work of the unit, provide the corresponding protective equipment
for the workers engaging in the cleaning, disinfection and sterilization of the
treatment instrument, appliance, and item, in order to protect the occupational
safety of medical staff.
4.7 The medical institutions shall regularly check and monitor the disinfection
work, conduct timely analysis and feedback, AND make corrections in time if
finding problems.
4.8 Medical staff shall master the basic knowledge of disinfection and
sterilization and occupational protection skills.
5 Basic principles of disinfection and sterilization
5.1 Basic requirements
5.1.1 The reusable treatment instrument, appliance and items shall, after use,
be firstly cleaned and then disinfected or sterilized.
5.1.5 Disinfection products used in the disinfection of medical institutions shall
be approved by the health administrative department OR comply with the
relevant standard technical specifications, AND shall follow the approved
scope, methods and precautions.
5.2 Selection principles of disinfection and sterilization method
5.2.1 The corresponding disinfection and sterilization method is selected
based on the risk of infection after the item is contaminated.
5.3 Occupational protection
5.3.1 It shall take appropriate occupational protection measures in accordance
with different disinfection and sterilization methods.
5.3.2 Occupational exposure to medical personnel shall be prevented during
the recovery and cleaning of contaminated treatment instruments, appliances,
and items.
5.3.3 Handling sharp instruments and appliances shall take effective protective
measures to avoid or reduce the occurrence of weapon injuries.
6 Washing and cleaning
6.1 Scope of application
Washing is applicable to all the moisture-resistant treatment instruments,
appliances and items; AND cleaning is applicable to all kinds of item surfaces.
6.2 Washing and cleaning methods
6.3 Precautions
6.3.1 The items with chamber or with uneven surface shall, after being soaked
in detergent, be carefully brushed manually or cleaned ultrasonically. The
complex items which can be disassembled shall be cleaned after disassembly.
6.3.2 Cleaning water and detergent shall comply with the provisions of WS
310.1.
6.3.3 The manual cleaning tools such as brushes shall, after daily use, be
cleaned and disinfected.
6.3.4 The cleaning of endoscopic and oral equipment shall follow the relevant
national provisions.
6.3.5 As for the splash containing a small amount of blood or body fluids and
other substances, it may be firstly cleaned and then disinfected; as for the
splash of a large amount, it shall firstly use the moisture-absorbing material to
remove visible contaminants AND then clean and disinfect it.
7 Common disinfection and sterilization methods
Common disinfection and sterilization methods shall be in accordance with the
provisions of Appendix C; AND as for the products used, it shall check the
relevant certificates.
8 Sterilization of critical items
8.1 Sterilization of surgical instruments, appliances and items
8.1.1 Preparation before sterilization
Cleaning, packaging, and loading shall follow the requirements of WS 310.2.
8.1.2 Sterilization method
8.1.2.7 Power tools. They are divided in pneumatic tools and electric tools,
which are generally composed of drill, saw blade, host machine, gas
connection line, battery and other components. AND it shall follow the
requirements of the user instructions to clean, pack and sterilize each part.
8.2 Sterilization of surgical dressings
8.2.1 Preparation before sterilization
8.2.1.1 The surgical dressings shall be stored in an environment of the
temperature of 18 °C ~ 22 °C AND relative humidity of 35% ~ 70% before
sterilization.
8.2.2 Sterilization method
8.2.2.1 As for the cotton cloth dressings and cotton yarn dressings, it is
preferable to select the pressure steam sterilization.
8.2.2.2 The surgical dressings complying with the requirements of YY/T 0506.1
shall be subjected to corresponding sterilization methods based on different
materials.
8.3 Sterilization of surgical sutures
8.3.1 Surgical suture classification. It is divided into absorbable suture and
non-absorbable suture. Absorbable sutures include ordinary gut, chrome gut,
and synthetic absorbable suture and so on. Non-absorbable sutures include
medical thread, polypropylene suture, polyester suture, nylon thread, metal
wire and so on.
9 Disinfection of semi-critical items
9.1 Disinfection methods
9.1.1 As for the semi-critical items such as the heat resistant and moisture
resistant items (e.g. oral care appliances), it is preferable to select the pressure
steam sterilization method; as for the non-heat resistant items such as
thermometer (anal thermometer or mouth thermometer), oxygen mask, and
anesthesia mask, it shall use high level disinfection or middle level disinfection.
9.2 Precautions
9.2.1 The items to be disinfected shall be thoroughly washed before
disinfection and sterilization.
9.2.2 When there is blood or other organic contaminants in the piping, it shall
use ultrasonic and medical detergent for soaking and washing. AND the items
after being washed shall be disinfected promptly.
9.2.3 The disinfectants in use shall be monitored for their concentration AND
be used within the validity period.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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