Contents 1 Pinyin 2 English Reference 3 Preface 4 1. Scope 5 2. Normative reference documents 6 3. Basic terms of disinfection 7 4. Disinfection application terms 8 5. Industrial sterilization terms 9 References 1 Pinyin
WS/T 4662014 xiāo dú zhuān yè míng cí shù yǔ 2 English reference
Disinfection professional terms
ICS 11.080
C 59
The Health Industry Standard of the People's Republic of China WS/T 4662014 "Disinfection professional terms" was issued by the National Health and Family Planning Commission of the People's Republic of China in August 2014. Released on February 25th and implemented on February 1st, 2015.
3 Foreword
This standard is drafted in accordance with the rules given in GB/T 1.12009.
This standard is drafted by the Shanghai Disinfectant Association, the Institute of Environmental and Health-related Product Safety of the Chinese Center for Disease Control and Prevention, the Zhejiang Provincial Center for Disease Control and Prevention, the People's Republic of China and the Guangzhou Entry-Exit Inspection and Quarantine Bureau participated in the drafting.
The main drafters of this standard: Xue Guangbo, Zhang Liubo, Li Hua, Hu Guoqing, Bian Xuelian, Wu Gang, Zhu Xiaoming, Liao Ruyan, Shen Jin, Sun Wensheng, Guo Xiuling, Wang Hongmin, Li Yan, Li Tao, Zhang Jian.
Terminology for disinfection 4 1. Scope
This standard defines the terms commonly used in disinfection in my country, and provides definitions and explanations. This standard applies to the use of terminology in the professional field of disinfection. 5 2? Normative reference documents
The following documents are essential for the application of this document. For dated references, only the dated version applies to this document. For undated referenced documents, the latest version (including all amendments) applies to this document.
Chinese Pharmacopoeia (2010 Edition) 6 3. Basic Disinfection Terminology
3.1
Save?preservation
Preservation
Preventing biological spoilage of a substance by physical, chemical, or biological means.
3.2
Pasteurization
A method of sterilizing by intermittent heating at a lower temperature. This sterilization method was first established by Louis Pasteur. Got its name.
3.3
Survlvor curve? Survlvor curve
Graphically represented, when sterilized under specified conditions, the number of microorganisms increases with exposure to the dose of sterilizing factor The situation changes due to the increase or the extension of time.
3.4
Survival time? ST
When exposed to bactericidal factors under specified conditions, the longest survival time of microorganisms among the biological indicators tested time.
3.5
Reference microorganism ***
A strain obtained from a recognized bacterial culture bank.
3.6
CT value?concentrationtime?value; CT
The product of the concentration of the disinfectant and the action time, used to compare the bactericidal effect of the disinfectant.
3.7
D value? D value
The time required to kill 90% of the total number of specific test microorganisms under set exposure conditions.
3.8
Antisepsis
Kill or inhibit the growth and reproduction of microorganisms on living tissues to prevent infection.
3.9
Antiseptic? Antiseptic preparations used for antisepsis.
3.10
Phenol coefficient?phenol coefficient
The bactericidal effect of a disinfectant is a multiple of the bactericidal effect of phenol, and is an indicator used to compare the bactericidal effect of disinfectants.
3.11
Recognized culture collection?
Established in accordance with the Budapest Convention on "Internationally Recognized Patents and Regulations for the Preservation of Microbial Cultures" International culture preservation institution.
3.12
Chemical germicide? Chemical germicide
A chemical or chemical mixture used to kill microorganisms.
3.13
K value?K value
Disinfection rate constant. The larger the K value, the faster the disinfection speed.
3.14
Antibacterial? Antibacterial
The process of using chemical or physical methods to kill bacteria or hinder the growth, reproduction and activity of bacteria.
3.15
Antibacterial agent
A preparation that can kill microorganisms or inhibit their growth and reproduction.
3.16
N value?N value
The dilution coefficient or concentration index of the disinfectant is used to indicate the degree of influence of the concentration of the disinfectant on the disinfection effect. The larger the N value is, the greater the impact of concentration changes on the disinfection effect.
3.17
Inactivation
An operation that causes microorganisms to lose their ability to grow and reproduce.
3.18
Sterilization
The process of killing or removing all microorganisms on the transmission medium.
3.19
Sterilizer?sterile agent
A preparation that can kill all microorganisms and meet sterilization requirements.
3.20
Sterilizer?sterilizer
An instrument that can kill all microorganisms and meet sterilization requirements.
3.21
Sterilizing factor? sterilizing factor
Physical, chemical or biological sterilizing factor, or a combination of factors. They can exert a sterilizing effect under specified conditions and make the items being processed sterile.
3.22
Mean single survivor time; MSST
Within a certain range, there is a relationship between the disinfection time and the number of surviving bacteria. Logarithmic functional relationship: As the action time increases, the number of surviving bacteria decreases logarithmically, and the theoretical time for the number of test bacteria to reduce to 1 bacteria is the MSST. It is an indicator for measuring the killing effect of disinfectants on microorganisms.
3.23
Q value Q value
Temperature coefficient, indicating the multiple that the disinfection speed increases for every 1℃ increase in temperature.
3.24
Decontamination
The process of removing and/or killing microorganisms in the environment or items. Also used to remove or neutralize hazardous chemicals and radioactive materials.
3.25
Cleaning? Cleaning
Removing contamination from items to the extent required for their intended use or further processing.
3.26
Virucide
A chemical or biological agent used to kill viruses.
3.27
Bactericide?bactericide
A chemical or biological agent used to kill bacteria.
3.28
Mycobacterium tuberculosis agent? tuberculocide
A chemical or biological agent used to kill Mycobacterium tuberculosis.
3.29
Germicide
A chemical or biological agent that can kill microorganisms, especially pathogenic microorganisms.
3.30
Fungicide?fungicide
A chemical or biological agent used to kill fungi.
3.31
Sporicide?sporicide
A preparation used to kill microbial spores.
3.32
Tenminute critical concentration to kill bacteria
The maximum critical dilution for killing test bacteria when the disinfectant acts for 10 minutes Concentration is an indicator for evaluating the bactericidal effect of disinfectants.
3.33
Biocide
A general term for all preparations that can kill living organisms.
3.34
Biological disinfection
A method of disinfection using plant extracts, microbial peptides, biological enzymes, etc.
3.35
Biological disinfectant? Biological disinfectant
Disinfectants prepared from plant extracts, microbial peptides, biological enzymes, etc.
3.36
Microorganisms? microani ***
Tiny entities that can only be seen under a microscope, including bacteria, fungi, viruses, certain protozoa and Algae.
3.37
Microbial classification? microbial characterization
A general method of classifying microorganisms into their types.
Note: For example, various types can be combined according to the selective culture medium used, colony or cell structure morphology, staining characteristics or other characteristics.
3.38
Disinfection
Kill or remove pathogenic microorganisms on the transmission medium to make them harmless.
3.39
Disinfection kiics
A quantitative theoretical study of the death patterns of microorganisms during the disinfection process.
3.40
Disinfectant
A preparation for disinfection made from one or more chemical or biological microbicidal factors.
3.41
Disinfector
A sterilizing device made of one or more physical or chemical microbicidal factors.
3.42
Disinfectionology
The science that studies the theories, techniques and methods of killing, removing and inhibiting pathogenic microorganisms and other harmful microorganisms in the external environment .
3.43
Bacteriostasis
The process of using chemical or physical methods to inhibit or hinder the growth, reproduction and activity of bacteria.
3.44
Bacteriostat?bacteriostat
A preparation that inhibits the growth and reproduction of bacteria but cannot kill them. 7 4. Disinfection application terms
4.1
Semicritical medical equipment? semicritical items
Moderately hazardous equipment
Only and Medical equipment that comes into contact with damaged skin and mucous membranes without entering sterile tissue.
4.2
Plasma?pla *** a
It is a highly ionized gas cloud. In a specific electric field, gas molecules are ionized, partially or All are ionized into charged particles (electrons, ions) and uncharged particles (molecules, excited atoms, etc.), and at the same time ultraviolet rays, gamma rays, beta particles, etc. are produced. These components together constitute plasma.
4.3
Low level disinfection? low level disinfection
Disinfection treatment that only requires the killing of general bacterial propagules and lipophilic viruses.
4.4
Low level disinfectant? low level disinfectant
A disinfectant that can only kill general bacterial propagules and lipophilic viruses and meet low-level disinfection requirements .
4.5
Multidrugresistant bacteria? multidrugresistant?ani *** ; MDRO
Treat three or more antibacterial drugs (or disinfectants) at the same time Resistant bacteria appear.
4.6
Non-critical medical devices? noncritical items
Low-risk equipment
Directly or indirectly, without harming health Medical devices that come into contact with skin.
4.7
High level disinfection? High level disinfection
Requires the killing of all bacterial propagules, mycobacteria, viruses, fungi and pathogenic bacterial spores disinfection treatment.
4.8
High level disinfectant? high level disinfectant
It can kill all bacterial propagules, mycobacteria, viruses, fungi and their spores, etc. It is also a disinfectant that has a certain killing effect on pathogenic bacterial spores and meets high-level disinfection requirements.
4.9
Critical medical equipment? critical items
Highly hazardous equipment
Pass through the skin or mucous membrane and enter the sterile Equipment inside tissues or organs, or medical equipment in close contact with damaged tissue, skin, or mucous membranes.
4.10
Colony forming unit; CFU
A visible colony formed by the growth and reproduction of microorganisms on a solid medium.
4.11
Air disinfection
Use disinfectants to kill pathogenic microorganisms suspended in the air in a closed room to achieve harmless treatment .
4.12
Air disinfectant? air disinfectant
A preparation used to kill pathogenic microorganisms in the air to achieve disinfection requirements.
4.13
Sterilization process challenge device?process challenge device
A specially designed simulated object to be sterilized, with specific resistance to the sterilization process. Used A device used to evaluate the effectiveness of the sterilization process.
4.14
Sterilization load? sterilization load
Place it in the sterilizer. Items intended to be processed or sterilized using specific sterilization procedures.
4.15
Disinfection of mucous membrane
Kill or remove microorganisms contaminating mucous membranes such as the oral cavity, nasal cavity, vagina and external genitalia, and The process of meeting disinfection requirements.
4.16
Disinfectant for mucosal membrane
A preparation used for mucosal disinfection.
4.17
Culture conditions? Culture conditions
A combination of growth media and culture methods used to promote the germination, growth and reproduction of microorganisms. NOTE: Incubation methods may include temperature, time, and other conditions specified for incubation.
4.18
Skin disinfection?skin disinfection
Kill or remove pathogenic microorganisms on human skin and meet disinfection requirements.
4.19
Skin disinfectant?skin disinfectant
Preparations used for disinfection on human skin.
4.20
Damaged skin? Damaged skin
Skin with damage on the surface of the human body.
4.21
General subject surface
General subject surface
Various places, such as schools, daycare institutions, Surfaces of utensils, instruments, articles and facilities in medical and health institutions, public places, homes, etc.
4.22
General subject surface disinfectant? General subject surface disinfectant
A preparation used to kill microorganisms contaminated on the surface of ordinary objects and achieve disinfection effects.
4.23
Aerosol sprayer? aerosol sprayer
The range of possible mist particle diameters is below 50 μm, of which more than 90% are particles with a diameter less than 20 μm. , a sprayer with a spray flow rate of 100 mL/min or more.
4.24
Cleaning method?clean
A process that reduces the number of contaminated microorganisms on an object below the safe level required by public health regulations.
4.25
Inoculated carrier
Support material that has been infected with a specified number of test microorganisms.
4.26
Killing log value?
When the number of microorganisms is expressed as a logarithm, the value of the reduction of microorganisms before and after disinfection.
4.27
Killing rate; KR
In the microbial killing test, the value expressed as a percentage reduction in the number of microorganisms.
4.28
Killing index; KI
The degree of reduction of microorganisms after disinfection. KI can be calculated by formula (1):
………(1)
In the formula:
Nc——the number of bacteria before disinfection;
Nd——Number of bacteria remaining after disinfection.
4.29
Hand disinfection (antisepsis)?hand antisepsis
The process of killing or removing pathogenic microorganisms on hands and meeting disinfection requirements. It can be divided into hygienic hand disinfection and surgical hand disinfection.
4.30
Hand antiseptic agent?hand antiseptic agent
Chemical agent used for hand disinfection.
4.31
Disinfection at any time? concurrent disinfection
When there is a source of infection, the environment and items that may be contaminated by the pathogens discharged from it are disinfected in a timely manner.
4.32
Surgical hand antisepsis (antisepsis)? Surgical hand antisepsis
The process of disinfecting the hands and forearms of medical personnel before surgery.
4.33
Intact skin?intact skin
Normal, undamaged skin on the surface of the human body.
4.34
Hygienic hand disinfection (antisepsis)? hygienic hand antisepsis
The process of preventive disinfection of hands.
4.35
sterile
No viable microorganisms.
4.36
Sterility assurance level; SAL
The probability of a single viable microorganism present on the product after sterilization. Usually expressed as 10n.
4.37
Test of sterility
A test conducted to determine whether there are viable microorganisms on a unit product or part thereof, is a set, part of a validation or requalification.
4.38
Sterility? sterility
A state without viable microorganisms. However, this absolute statement that there are no viable microorganisms cannot be proven in practice.
4.39
Test for sterility? test for sterility
In accordance with the test methods stipulated in the "People's Republic of China and the Pharmacopoeia", the sterilized The processed products are inspected as a basis for release.
4.40
Material safety data sheet
Detailed description of material characteristics, potential hazards to people and the environment, and safe operation and handling of materials Documentation of preventive measures.
4.41
Disinfection cycle? Disinfection cycle
The whole process of a disinfection operation to meet the disinfection requirements.
4.42
Fumigation disinfection
A method of using disinfectant gas to kill pathogenic microorganisms in a confined space to achieve harmless treatment.
4.43
Cyclic wind volume
The air volume flow rate that circulates through the air sterilizer every hour, in m3/h.
4.44
Disposable hygienic article
Disposable hygienic article
Disposable hygienic article
Disposable hygienic article
Disposable hygienic article
Disposable hygienic article Various daily necessities that are in direct or indirect contact and used for the purpose of human physiological hygiene or health care (antibacterial or bacteriostatic). Products can be solid or liquid.
4.45
Health care product?health care product
Medical devices, pharmaceutical products (drugs and biological products) and in vitro diagnostic medical devices.
4.46
Medical items
Instruments, equipment, utensils, materials or other items used alone or in combination with the human body.
4.47
Disinfectant for medical items
A preparation used to treat medical devices to achieve disinfection or sterilization effects.
4.48
Disinfection of epidemic focus
Disinfection of contaminated environment and items in the epidemic focus. The foci is the area within which pathogenic microorganisms excluded from the source of infection can reach.
4.49
Preventive disinfection
Disinfection of places and items that may be contaminated by pathogenic microorganisms when no clear source of infection exists .
4.50
Product of neutralization
The product after the action of neutralizer and disinfectant.
4.51
Neutralizer
In microbial killing tests, used to eliminate test microorganisms and disinfectant suspensions, as well as microorganisms The residual disinfectant on the surface makes it lose its inhibitory and killing effect on microorganisms.
4.52
Intermediate level disinfection? Intermediate level disinfection
Disinfection treatment that requires the killing of bacterial propagules, mycobacteria, fungi and viruses.
4.53
Intermediate level disinfectant? Intermediate level disinfectant
Can kill bacterial propagules, mycobacteria, fungi and viruses to achieve intermediate level disinfection preparation.
4.54
Terminal sterilization
The sterilization process performed after the product is loaded into the inner packaging.
4.55
Terminal disinfection
Thorough disinfection after the source of infection leaves the foci.
4.56
Ultraviolet radiation luminance? ultraviolet radiation luminance
The ultraviolet radiation per unit area measured at a specific distance from the midline of the surface of the ultraviolet germicidal lamp tube Radiation intensity, unit is μW/cm2.
4.57
Ultraviolet appliance for air disinfection
A disinfection appliance that uses a combination of ultraviolet germicidal lamps, filters and fans to achieve disinfection purpose equipment. Its filters and fans do not have the function of bactericidal factors.
4.58
Ultraviolet germicidal larmp?ultraviolet germicidal larmp
A special electric light source that directly uses ultraviolet rays (center wavelength is 253.7 nm) for disinfection purposes.
4.59
Natural bacteria
Bacteria that naturally exist on the disinfection object and are not artificially contaminated.
4.60
Minimum bactericide concentration? MBC
The lowest concentration of chemical or biological agents to kill bacteria.
4.61
Minimum inhibitory concentration; MIC
The lowest concentration of chemical or biological agents that inhibit bacterial growth.
4.62
Z value?Z value
During heat sterilization, reduce the action time by 90%, or reduce the D value by a logarithmic value, which is required Increase the temperature by degrees (°C) accordingly.
The Z value is an indicator of the sensitivity of microorganisms to heat.
8 5? Industrial sterilization terminology
5.1
Installation qualification; IQ
After the provided equipment is installed according to the technical requirements, it is tested and The process of writing.
5.2
Exposure time? exposure time
Disinfection time
Action time
At the specified dose and Under the conditions, the effective contact time between the disinfection factor and the items being disinfected.
5.3
Change control? Change control
The formal evaluation and determination of proposed modifications to a product or program as appropriate.
5.4
Parametric release?
Processing is performed according to the specified program parameters, and the records generated are within the range specified by the processing program, indicating a certain product Has been sterilized.
5.5
Product?product
Healthcare products including raw materials, semi-finished products, and assembled components.
5.6
Product unit
A collection of products or components in an inner packaging.
5.7
Process variable?process variable
Conditions within the scope of the sterilization program, changes in which can affect the effect of killing microorganisms. For example: time, temperature, pressure, concentration, humidity, wavelength, etc.
5.8
Process parameter? Process parameter
The value specified by the sterilization program.
Note: The technical specifications of the sterilization process include the process parameters and their allowable variation range.
5.9
Requalification
A partial confirmation activity that is re-conducted to confirm that a certain sterilization or disinfection procedure continues to be qualified.
5.10
Supply services servlces
Various external sources necessary to adjust the performance of sterilization equipment. Such as electricity, water, compressed air, drainage pipes.
5.11
fault
One or more program parameters exceed specified tolerances.
5.12
Specify?specify
Contents specified in detail within the scope of the approval document.
5.13
Chemical indicator?chemical indicator
Based on chemical or physical changes produced by exposure to a certain sterilization (disinfection) process, in a or An indicating device that displays changes in multiple predetermined program parameters.
5.14
Environmental control?envlronmental control
An engineering or program system established within the production area to control environmental pollution within the specified scope. Note: This can include air filters, liquid filters, surface disinfection, personnel clothing and various administrative measures.
5.15
Calibration
Under specified conditions, use specified instruments and equipment to perform standard operations to determine a certain meter or measurement system The relationship between an indicated value or measured quantity of a material and the associated value of the same quantity measured under standard conditions.
5.16
Sterilization process? sterilization process
A series of operations required to achieve sterility regulations. Includes product pre-treatment (if required), exposure to appropriate sterilization factors under specified conditions and post-treatment as required. Sterilization procedures do not include cleaning, disinfection or packaging processes before sterilization.
5.17
Presterilization count
The number of viable microorganisms on each product before sterilization.
5.18
Inner packaging? primary package
The inner part of the product packaging system is used to maintain the sterility of the product.
5.19
Batch
A certain amount of materials, semi-finished products or finished products (disinfection products or sanitary products) produced in a certain production cycle, In theory they have the same characteristics and qualities.
5.20
Validation
Obtaining data, recording and organizing results in order to set a procedure for sustainably producing products that meet predetermined technical specifications documentation process.
5.21
Killing time?KT
When exposed to bactericidal factors under specific conditions, all microorganisms in the tested biological indicators are inactivated time.
5.22
Set?establish
Parameters used for sterilization (disinfection) procedures determined through theoretical evaluation and confirmed by experiments.
5.23
Bioburden? bioburden
The total number of viable microorganisms present on a product or piece of packaging.
5.24
Biological indicator? Biological indicator
Microorganisms that have a certain resistance to specific sterilization or disinfection procedures and can be used to monitor the effectiveness of disinfection and sterilization Inspection equipment.
5.25
Performance qualification; PQ
Proves that the equipment has been installed and operated according to the operating procedures, and can produce products that meet the technical requirements from beginning to end according to predetermined specifications. Specifications of products and the process of documenting them.
5.26
Operational qualification; OQ
Prove that the installed equipment operates within the predetermined range when used according to the operating procedures, and record it in writing process. 9 References
[1] ISO/TS 11139 Sterilization of health care products Vocabulary
[2] Ministry of Health of the People’s Republic of China and the People’s Republic of China. Disinfection Technical Specifications, 2002.
[3] Shanghai Disinfection Products Association. Technical Specifications for Disinfection of Public Places [M]. Beijing: China Standards Publishing House, 2010.
[4] Shanghai Disinfection Products Association, Technical Specifications for Hospital Disinfection [M]. Beijing: China Standards Publishing House Society, 2008.
[5]?Block S S. Disinfection, sterilization and preservation[M]. Philadelphia: Lippincott Williams & Wilkins, 2001.
[6]?Russell D .Principles and practice of disinfection, preservation and sterilization[M]. 3rd ed. WileyBackwell, 1999.
[7]?Xue Guangbo. Sterilization·Disinfection·Preservation·Preservation [M]. Beijing: People's Health Publishing House, 2008.
[8] Xue Guangbo, Progress in Modern Disinfection: Volume 1 [M]. Beijing: People's Health Publishing House Society, 2012.