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(Evaluation criteria for on-site disinfection during the new crown pneumonia epidemic)
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Basic data
| Standard ID | WS/T 774-2021 (WS/T774-2021) |
| Description (Translated English) | (Evaluation criteria for on-site disinfection during the new crown pneumonia epidemic) |
| Sector / Industry | Health Industry Standard (Recommended) |
| Classification of Chinese Standard | C50 |
| Word Count Estimation | 13,190 |
| Issuing agency(ies) | National Health Commission |
WS/T 774-2021: (Evaluation criteria for on-site disinfection during the new crown pneumonia epidemic)
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Standard of field disinfection evaluation during COVID-19 epidemic
People's Republic of China Health Industry Standards
2021-02 -20 released
2021-02 -20 implementation
Issued by the National Health Commission of the People's Republic of China
1 Scope...1
2 Normative references...1
3 Terms and definitions...1
4 Evaluation principles...2
5 Evaluation of the disinfection process...3
6 Evaluation of disinfection effect...3
7 Precautions...5
Appendix A (informative) Disinfection process record sheet...6
Appendix B (Normative) On-site disinfection effect evaluation method...9
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2020.
Drafting organizations of this standard. China Center for Disease Control and Prevention, Environmental and Health Related Product Safety Institute, PLA Center for Disease Control and Prevention,
Beijing Municipal Center for Disease Control and Prevention, Jiangsu Provincial Center for Disease Control and Prevention, Shanghai Municipal Center for Disease Control and Prevention, Hubei Provincial Center for Disease Control and Prevention
Center, Shandong Provincial Center for Disease Control and Prevention, Guangdong Provincial Center for Disease Control and Prevention, Wuhan Municipal Center for Disease Control and Prevention, Heilongjiang Province Disease Control Center
Prevention and Control Center
The main drafters of this standard. Shen Jin, Duan Hongyang, Wang Lin, Wei Qiuhua, Tong Ying, Zhang Liubo, Zhang Baoying, Xu Yan, Zhu Renyi, Pan Kai,
Cui Shuyu, Jiang Yongzhong, Zhong Yuwen, Liang Jiansheng, Lin Ling.
Evaluation criteria for on-site disinfection during the new crown pneumonia epidemic
1 Scope
This document stipulates the principles of on-site disinfection evaluation, disinfection process evaluation, disinfection effect evaluation and precautions during the new crown pneumonia epidemic.
This document is suitable for on-site disinfection evaluation related to the new crown pneumonia epidemic.
2 Normative references
The contents of the following documents constitute the indispensable clauses of this document through normative references in the text. Among them, dated reference documents,
Only the version corresponding to that date is applicable to this document; for undated references, the latest version (including all amendments) is applicable to this document
file.
GB/T 38502 Test Method for Laboratory Sterilization Effect of Disinfectants
WS/T 683 Microbiological requirements for disinfection test
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Preventive disinfection
Disinfection of places and objects that may be contaminated by pathogenic microorganisms when there is no clear source of infection.
3.2
Disinfection of epidemic focus
Disinfection of the contaminated environment and articles in the foci. The foci is the range that the pathogenic microorganisms discharged from the source of infection can spread.
3.3
Terminal disinfection
Thorough disinfection after the source of infection leaves the foci.
3.4
Concurrent disinfection
When there is a source of infection, timely disinfection of the environment and articles that may be contaminated by the pathogens discharged from it.
3.5
Process evaluation
According to the evaluation of each link of on-site disinfection, through the verification of key factors such as the disinfection work plan, disinfection products, and disinfection operations, the evaluation
Whether the on-site disinfection work is qualified.
3.6
Disinfection effect evaluation
For the evaluation of on-site disinfection effect, by testing the reduction of microorganisms before and after disinfection, evaluate whether the quality of on-site disinfection work is appropriate
grid.
3.7
Cryogenic disinfection
Disinfection of the environment or articles whose temperature is below 0℃. Low-temperature disinfection requires the use of disinfection factors that have been proven effective at this temperature.
3.8
Responsible entity
During on-site disinfection, the unit or institution that is responsible for the on-site disinfection work carried out.
3.9
Implementing entity
The responsible unit or the unit or institution entrusted by the responsible unit to be responsible for the specific implementation of disinfection operations.
3.10
Evaluation entity
Entrusted by the unit responsible for disinfection, the unit or institution responsible for carrying out on-site disinfection process evaluation and disinfection effect evaluation.
4 Evaluation principles
4.1 The responsible unit for on-site disinfection shall be responsible for determining the implementation unit and the evaluation unit and supervise the implementation of the on-site disinfection and evaluation work. The implementation unit shall
Responsible for the implementation of on-site disinfection work, the evaluation unit should have the corresponding capabilities for process evaluation and disinfection effect evaluation.
4.2 On-site disinfection evaluation includes process evaluation and disinfection effect evaluation.
4.3 All on-site disinfection should be subject to process evaluation, and records should be made and kept as required.
4.4 The disinfection effect should be evaluated in one of the following six situations.
a) Preventive disinfection with a wide range of disinfection and a long duration;
b) End-of-life disinfection of foci of major social impact;
c) The disinfection implementing unit carried out on-site disinfection for the first time;
d) Perform on-site low-temperature disinfection for the first time with low-temperature disinfection technology;
e) Disinfectants and disinfection instruments produced with new materials, new technology and new sterilization principles will be disinfected on site for the first time;
f) There is demand on site.
5 Evaluation of the disinfection process
5.1 Evaluation content
The evaluation of the disinfection process mainly includes the links of disinfection products, disinfection operations, and disinfection work plans.
5.1.1 Disinfecting products
The disinfection products used should meet the relevant national health standards and regulatory requirements, and the health and safety evaluation should be qualified. Disinfectant evaluation information includes disinfection
The name of the agent, the main active ingredients and their content, expiry date, preparation method, scope of use, method of use, etc. Sterilization equipment evaluation information includes
The name of the device, the main sterilization factor and its strength, the scope of use, the method of use, etc.
5.1.2 Disinfection operation
Evaluate whether the entire disinfection operation is carried out in accordance with the disinfection work plan, including but not limited to the scope of disinfection, disinfection procedures, and disinfectant preparation.
Preparation, use of disinfection equipment, personal protection, etc. At the same time, check whether the disinfection records are standardized, including disinfection date, disinfection location, disinfection object,
For the concentration and dosage of disinfectant, action time, disinfection method, etc., please refer to Appendix A for the record sheet.
5.2 Evaluation method
The evaluators participate in the on-site disinfection process throughout the entire process, and check on-site disinfection operations and related disinfection records.
5.3 Judgment of results
The evaluation content of the disinfection process meets the requirements of relevant laws, standards, guidelines or programs before the disinfection process can be judged as qualified.
6 Evaluation of disinfection effect
6.1 Evaluation object
The disinfection effect evaluation objects include the surface of the object and the air. When disinfecting the environment or/and objects, the surface disinfection effect of objects should be evaluated;
When disinfecting air, the effect of air disinfection should be evaluated.
6.2 Evaluation Index
6.2.1 The on-site disinfection effect on the surface of the object is evaluated by natural bacteria or indicator microorganism killing rate, and the on-site air disinfection effect is by natural bacteria.
The extinction rate is evaluated.
6.2.2 The resistance of the indicator microorganisms should be equal to or higher than that of the new coronavirus, easy to cultivate, and comply with laboratory biosafety and WS/T 683
Requirements. Select indicator microorganisms based on the resistance of the new coronavirus to disinfection factors. For chemical disinfection, Staphylococcus aureus can be selected
(ATCC 6538) and Escherichia coli (8099); if there are special requirements, poliovirus type I (poliovirus-I, PV-
Ⅰ) Vaccine strains are used as indicator microorganisms. During physical disinfection, an indicator microorganism that meets the above requirements should be selected according to the characteristics of the disinfection factor.
6.2.3 For on-site disinfection at room temperature, natural bacteria should be selected for preventive disinfection effect evaluation; natural bacteria should be selected for air disinfection effect evaluation of the foci.
The indicator microorganisms are selected for the evaluation of the disinfection effect on the surface of the source object. During low-temperature field disinfection, indicator microorganisms are selected for the evaluation of the disinfection effect of the surface of the object.
See Table 1 for details.
6.3 Evaluation method
6.3.1 Object surface
Take the floor, wall, desktop, bedside table, toilet, doorknob, button, etc. as the key sampling objects. In places where the disinfection factor is difficult to reach
Squares such as drawers, carpets, wall corners, etc. can add sampling points or indicating microbial carriers, and each type of sampling object shall not be less than 2 samples. Natural bacteria
During evaluation, the sampling points before and after disinfection should be set in pairs on the surface of the same object or on the surface of the same type of object, and should not be collected twice in the same area.
The total number of test samples shall not be less than 30.
For on-site disinfection at room temperature, the sampling and culture methods shall be implemented in accordance with Appendix B. During low-temperature field disinfection, put the indicator microorganisms into the corresponding
The low temperature environment is at least 30 minutes, and the disinfection operation can be carried out only after the indicator microorganisms reach the same low temperature. The sampling and culture methods are in accordance with Appendix B
carried out.
6.3.2 Air
The air disinfection effect was evaluated by the flat exposure method. Indoor area ≤30 m2, with 3 points on the inner, middle and outer diagonals, inner and outer points
It should be 1 m away from the wall; if the indoor area is > 30 m2, there are 4 corners and a total of 5 points in the center, and the 4 corners should be 1 m away from the wall. More
In large spaces (indoor area > 60 m2), sampling points can be added according to actual needs. The number of points can be calculated according to formula (1), and the maximum number is 30.
Points. Sampling and culture methods are implemented in accordance with Appendix B.
6.4 Judgment of results
The average killing rate of natural bacteria on the surface of the object is ≥90%, and the number of samples with a killing rate of ≥90% accounts for more than 90%, and it is judged as qualified for disinfection;
The average killing rate of indicating microorganisms is ≥99.9%, and the number of samples with a killing rate of ≥99.9% accounts for more than 90%, and it is judged as qualified for disinfection.
The average killing rate of natural bacteria in the air is ≥90%, and it is judged as qualified for disinfection; the average number of colonies of natural bacteria in the air before disinfection is ≤10 CFU/(dish·15min)
When the sterilization rate is not calculated, the average number of colonies of natural bacteria in the air after disinfection is less than or equal to 4 CFU/(dish·15min), and it is judged as qualified for disinfection.
7 matters needing attention
7.1 When evaluating the on-site disinfection effect, personal protection should be done, and legal and effective personal protection should be selected according to the on-site situation and the requirements of relevant standards.
Protection equipment.
7.2 It is difficult to isolate and cultivate the novel coronavirus, and it is generally not necessary to evaluate the disinfection effect. If live virus is isolated after disinfection, it will be judged
Disqualified for disinfection.
7.3 The nucleic acid of the new coronavirus cannot indicate whether it is alive or not, and the nucleic acid test results cannot be used to evaluate the disinfection effect.
7.4 When evaluating the disinfection effect of the foci, place a layer of sterile cloth/paper on the bottom of the test tube rack, alcohol lamp and other field experiment equipment, and the sampling is completed
After that, all equipment can be brought back to the laboratory after disinfection.
7.5 The test operation should be carried out in a biological safety cabinet to avoid environmental pollution and personal health damage.
Appendix A
(Informative)
...
