GB 28235-2020Hygienic requirements for ultraviolet appliance of disinfection (English PDF)
紫外线消毒器卫生要求
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Issued by
State Administration for Market Regulation; Standardization Administration of China
Level / Type
National · Mandatory
Issue date
April 9, 2020
Implementation date
November 1, 2020
Scope
GB 28235-2020 is the English-translated version of 紫外线消毒器卫生要求.
GB 28235-2020 is the Chinese national standard on hygienic requirements for ultraviolet appliance of disinfection, in the field of health care technology. It carries no /T suffix, which in the Chinese system means compliance is mandatory: a product or a practice within its scope has to meet it to be lawfully made, sold or carried out in China. It was issued on 9 April 2020 by the State Administration for Market Regulation; Standardization Administration of China, and has been in force since 1 November 2020. Classification: ICS 11.080, CCS C50. This page is published from the official record of the standard held by the Chinese standards administration: the identification, the dates, the classification and the issuing body are taken from there. The clause text, the tables and the numeric limits are in the document itself, which is delivered complete in English translation.
Document preview — GB 28235-2020
National Standard of the People's Republic of China
- ICS
- 11.080
- Classification
- C50
Issued by: State Administration for Market Regulation; Standardization Administration of China
Contents
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Raw material requirements
- 4.1 Ultraviolet air sterilizer
- 4.1.1 UV lamp
- 4.1.2 Requirements for other raw materials
- 4.2 UV water sterilizer
- 4.2.1 UV lamp
- 4.2.2 Other raw material requirements
- 4.3 Ultraviolet sterilizer
- 4.3.1 UV lamp
- 4.3.2 Requirements for other raw materials
- 5 Technical requirements
- 5.1 Ultraviolet air sterilizer
- 5.1.2 Main components UV lamp
- 5.1.5 Disinfection effect
- 5.1.6 Leakage
- 5.2 UV water sterilizer
- 5.2.2 Main components UV lamp
- 5.2.4 Disinfection effect
- 5.3 Ultraviolet sterilizer
- 5.3.2 Main components UV lamp
- 5.3.4 Disinfection effect
- 5.3.5 Leakage
- 6 Scope of application
- 7 How to use
- 7.1 UV air sterilizer
- 7.2 UV water sterilizer
- 7.3 Ultraviolet sterilizer
- 8 Inspection methods
- 8.1 Ultraviolet air sterilizer
- 8.1.1 Main components
- 8.1.4 Disinfection effect
- 8.1.5 Leakage
- 8.2 UV water sterilizer
- 8.2.1 Main components
- 8.2.3 Disinfection effect
- 8.2.4 Leakage
- 8.3 Ultraviolet sterilizer
- 8.3.1 Main components
- 8.3.3 Disinfection effect
- 8.3.4 Leakage
- 9 Logos and packaging
- 10 Transportation and Storage
Foreword
All technical contents of this standard are mandatory. This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces GB 28235-2011 "Safety and Hygiene Standards for Ultraviolet Air Disinfectors". Compared with GB 28235-2011, the main The technical changes are as follows:
--- Modified the scope;
--- Modified the definition and name of "ultraviolet sterilization lamp" and added "ultraviolet disinfection", "ultraviolet disinfection device" and "upper level ultraviolet radiation" Definitions of "line air sterilizer", "ultraviolet effective dose", "ultraviolet water sterilizer", "ultraviolet surface sterilizer";
--- Deleted the contents of "specifications and classifications" and "names and models" that do not belong to product safety and hygiene requirements;
--- Modified the requirements for raw materials, made it into a separate chapter, and changed the requirements for raw materials closely related to product effectiveness and safety indicators to strong Mandatory clause;
--- Modified the technical requirements and deleted the technical requirements for electrical safety;
--- Modified the content of the application scope;
--- Modified the content of "Precautions" and merged it with "Label and User Manual" into the chapter of "Nameplate and User Manual";
--- Added the relevant requirements of ultraviolet water disinfector and ultraviolet surface disinfector;
--- Added Appendix A "Measurement Method of Ultraviolet Intensity", Appendix B "Life Test Method", Appendix C "Air Disinfection Simulation Site" Test ", Appendix D" Air Disinfection Field Test ", Appendix E" Water Disinfection Laboratory Microbial Kill Test ", Appendix F" Water Disinfection Simulated field test and field test ", Appendix G" Object surface disinfection laboratory microorganism killing test "and Appendix H" Object table "Surface disinfection simulation field test and field test". This standard is proposed and managed by the National Health Commission of the People's Republic of China. This standard was drafted by: Jiangsu Provincial Health Supervision Office, Wuhan Center for Disease Control and Prevention, Shandong Provincial Health and Health Commission Law Enforcement Supervision Bureau, China Center for Disease Control and Prevention, Environmental and Health Related Product Safety Institute. The main drafters of this standard. Gu Jian, Liang Jiansheng, Cheng Yeqi, Yuan Qingchun, Shi Yuchang, Qiu Xingfen, Li Yan, Wang Jian, Zhou Yaoqing, He Zhiming, Qiao Weihan, Song Hengzhi, Huang Yehui. The previous versions of the standard replaced by this standard are as follows:
--- GB 28235-2011. Hygienic requirements for ultraviolet sterilizers
1 Scope
GB 28235-2020 is the Chinese national standard on hygienic requirements for ultraviolet appliance of disinfection, in the field of health care technology. It carries no /T suffix, which in the Chinese system means compliance is mandatory: a product or a practice within its scope has to meet it to be lawfully made, sold or carried out in China. It was issued on 9 April 2020 by the State Administration for Market Regulation; Standardization Administration of China, and has been in force since 1 November 2020. Classification: ICS 11.080, CCS C50. This page is published from the official record of the standard held by the Chinese standards administration: the identification, the dates, the classification and the issuing body are taken from there. The clause text, the tables and the numeric limits are in the document itself, which is delivered complete in English translation.
This standard specifies the raw material requirements, technical requirements, application scope, use methods, inspection methods, signs and packaging of ultraviolet sterilizers, Transportation and storage, nameplate and instruction manual. This standard applies to ultraviolet sterilizers with C-band ultraviolet (wavelength range of.200nm ~ 280nm) as the sterilization factor.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article Pieces. For the cited documents without date, the latest version (including all amendments) applies to this document.
GB/T 191 Graphic mark for packaging, storage and transportation
GB 5749 Sanitary Standards for Drinking Water
GB/T 5750.2 Standard Test Method for Drinking Water Collection and Storage of Water Samples
GB/T 5750.12 Standard test method for drinking water Microbiological indicators
GB/T 10682 Double-end fluorescent lamp performance requirements
GB/T 14294-2008 Combined air conditioning unit
GB/T 15144 Performance requirements for AC electronic ballasts for tubular fluorescent lamps
GB 15982 Hygienic standard for hospital disinfection
GB/T 17219 Safety evaluation standard for drinking water transmission and distribution equipment and protective materials
GB/T 17262 Single-end fluorescent lamp performance requirements
GB 17625.1 electromagnetic compatibility limit harmonic current emission limit (equipment input current <=16A per phase)
GB/T 17743 Limits and measurement methods for radio disturbance characteristics of electrical lighting and similar equipment
GB 17988 Safety and hygiene requirements for tableware disinfection cabinets
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 Ultraviolet lamp A special electric light source that uses ultraviolet light directly for disinfection purposes.
3.2 Ultraviolet disinfection After pathogenic microorganisms absorb ultraviolet energy with a wavelength between.200nm and 280nm, their genetic The cells no longer divide and multiply, and achieve the purpose of disinfection to kill pathogenic microorganisms.
3.3 Ultraviolet disinfection ultraviolet disinfectionofdisinfection Using ultraviolet lamps as the light source and using the ultraviolet radiation radiated by the lamp as the sterilization factor to disinfect the pathogenic microorganisms on the transmission medium instrument.
3.4 Ultraviolet air disinfector ultravioletapplianceforairdisinfection An ultraviolet sterilizer that uses ultraviolet lamps, filters, fans and ballasts to achieve the purpose of air disinfection.
Note. The filter and fan do not have the role of sterilization factor.
3.5 Upper flat shot ultraviolet air sterilizer upperflatshotultravioletapplianceforairdisinfection Installed on the top or top of the indoor wall, >=2.1m above the ground, ultraviolet rays are emitted parallel to the ground, ultraviolet rays for the purpose of air disinfection Gas sterilizer.
3.6 Ultraviolet water disinfection ultravioletapplianceforwaterdisinfection It is composed of ultraviolet light, quartz tube, ballast and other components sealed in the container to achieve the purpose of water disinfection. Poison.
3.7 Ultraviolet surface disinfection ultravioletapplianceforsurfacedisinfection A disinfection instrument that uses ultraviolet light, power adapter and other components to achieve the purpose of disinfecting the surface of objects.
3.8 Ultraviolet intensity Ultraviolet energy received per unit area per unit time perpendicular to the direction of UV propagation.
Note. Common units are microwatts per square centimeter (µW/cm2) or watts per square meter (W/m2).
3.9 Ultraviolet effective dose Within a certain operating time, the ultraviolet disinfectant can achieve the dose of microorganism killing ultraviolet.
Note. Also known as the biological verification dose of ultraviolet sterilizer.
3.10 Disinfection cycle The ultraviolet sterilizer implements a sterilization operation process to meet the whole process of sterilization requirements.
4.1.1 UV lamp
4.1.1.1 Raw materials The ultraviolet lamp should use quartz glass or raw materials with ultraviolet transmittance not lower than quartz glass.
4.1.1.2 UV intensity The initial UV intensity of double-ended and single-ended UV lamps should be no less than 93% of the values specified in Table 1 and Table 2, respectively, and the intensity of other UV lamps Degree should meet the requirements of relevant standards. Table
1 Initial UV intensity specifications for double-ended UV lamps Nominal power/W 4 6 8 13 15 18 30 36 60 75 100 150 250 320 400 550 750 1000 UV intensity/(µW/cm2) 9 15 22 35 50 62 100 135 190 250 305 400 650 720 9001 15013001730 Table
2 The specified value of initial UV intensity of single-ended UV lamp Nominal power/W 5 7 9 11 18 24 36 55 75 95 150 UV intensity/(µW/cm2) 9 16 22 33 51 65 110 150 170 304 400
4.1.1.3 Starting performance 4.1.1.3.1 should have good starting performance. 4.1.1.3.2 Electronic ballasts should be used, and should comply with relevant standards such as GB/T 15144 or GB 19510.1.
4.1.1.4 Other technical performance Should meet the requirements of GB/T 19258 and other relevant standards.
4.1.2 Requirements for other raw materials
4.1.2.1 The filter media should have the function of blocking ultraviolet leakage. The filter net using fiber filter material should not have dust falling off.
4.1.2.2 The parts and casing of the ultraviolet air sterilizer should be made of flame retardant, ultraviolet radiation resistant and corrosion resistant materials Except for sheet metal parts), the wind speed regulator should not be used.
4.1.2.3 The universal wheel of the mobile ultraviolet air sterilizer should adopt a silent universal wheel.
4.1.2.4 The upper level ultraviolet radiation air sterilizer should be equipped with human body induction protection device.
4.2.1 UV lamp
4.2.1.1 Raw materials Should meet the requirements of 4.1.1.1.
4.2.1.2 UV intensity Should meet the requirements of 4.1.1.2.
4.2.1.3 Starting performance Should meet the requirements of 4.1.1.3.
4.2.1.4 Other technical performance Should meet the requirements of GB/T 19258 and other relevant standards.
4.2.2 Other raw material requirements
4.2.2.1 Other materials in contact with water of the ultraviolet water sterilizer should meet the requirements of GB/T 17219, in which the quartz tube per mm of quartz The thickness of ultraviolet transmittance should not be less than 90%.
4.2.2.2 The ultraviolet intensity meter (if any) shall have a certificate of conformity for verification.
4.3.1 UV lamp
4.3.1.1 Raw materials Should meet the requirements of 4.1.1.1.
4.3.1.2 UV intensity Should meet the requirements of 4.1.1.2.
4.3.1.3 Starting performance Should meet the requirements of 4.1.1.3.
4.3.1.4 Other technical performance Should meet the requirements of GB/T 19258 and other relevant standards.
4.3.2 Requirements for other raw materials
4.3.2.1 The ultraviolet surface disinfector should be in good sealing performance, and the door with brake lock switch should be installed.
4.3.2.2 The body of the ultraviolet sterilizer should be heat-resistant, smooth and smooth.
4.3.2.3 The four corners of the body of the ultraviolet sterilizer should be arc-shaped, and materials with better reflective properties should be used if possible.
5.1 Ultraviolet air sterilizer
5.1.1 Basic working conditions The UV air sterilizer works normally in the following environments.
a) Use power supply voltage. 220V ± 22V, power supply frequency. 50Hz ± 1Hz;
b) Ambient temperature. 5 °C ~ 40 °C;
c) Relative humidity. <=80%.
5.1.2 Main components UV lamp
5.1.2.1 UV intensity Should meet the requirements of 4.1.1.2.
5.1.2.2 Fluctuation range of UV intensity After starting for 5 minutes, the change of UV intensity should reach a stable level under normal working conditions, and the fluctuation range should not exceed 5% of the average.
5.1.2.3 Effective life The effective life of the main components UV lamp should be >=1000h.
5.1.3 Working noise The whole machine should be stable and reliable, without vibration, and the noise limit should be <=55dB (A weighting).
5.1.4 Circulation air volume The initial circulating air volume of the whole machine should not be less than 8 times the applicable volume.
5.1.5 Disinfection effect
5.1.5.1 Simulated field test Under the condition that the laboratory temperature is 20 °C ~ 25 °C, the relative humidity is 50% ~ 70%, the start-up function is up to the product instruction manual The time (the maximum disinfection time should not exceed 2h), the killing rate of air-contaminated Staphylococcus albicans (8032) should be >=99.9%.
5.1.5.2 Field test Under the natural conditions on site, in accordance with the conditions stipulated in the product instruction manual, the power-on effect will last for the time specified in the product instruction manual (the longest Disinfection time should not exceed 2h), the rate of natural bacteria in the air should be >=90.0%. For disinfection of ambient air in medical institutions, after disinfection The total number of colonies in the air should also meet the hygienic standard value of GB 15982; for disinfection in other places, the total number of colonies in the air after disinfection should also be Meet the requirements of relevant standards.
5.1.6 Leakage
5.1.6.1 UV leakage The ultraviolet radiation leakage of the upper level flat-air ultraviolet air sterilizer should be <=5µW/cm2 in the safe area below 2.1m. Other ultraviolet rays The air sterilizer is 30cm away from the periphery of the sterilizer, and the ultraviolet leakage should be <=5µW/cm2.
5.1.6.2 Ozone leakage When the ultraviolet air sterilizer is working, the average allowable ozone concentration in indoor air environment is 0.1mg/m3 in 1h under the condition of people.
5.2 UV water sterilizer
5.2.1 Basic working conditions The UV water sterilizer works normally in the following environment. Use power supply voltage. 220V ± 22V, power supply frequency. 50Hz ± 1Hz; ambient temperature. 5 °C ~ 40 °C.
5.2.2 Main components UV lamp
5.2.2.1 UV intensity Should meet the requirements of 4.1.1.2.
5.2.2.2 Ultraviolet intensity fluctuation range Should meet the requirements of 5.1.2.2.
5.2.2.3 Effective life Should meet the requirements of 5.1.2.3.
5.2.3 Effective UV dose Should comply with the provisions of GB/T 19837.
5.2.4 Disinfection effect
5.2.4.1 Laboratory microorganism killing test Under the condition of laboratory temperature of 20 °C ~ 25 °C, the minimum effective dose of disinfection and other parameters and procedures according to the product instruction manual The disinfection process should be carried out in order to reduce E. coli (8099) to 0CFU/100mL.
5.2.4.2 Simulated field test Under the natural conditions of the test site, the disinfection treatment is carried out according to the parameters and procedures such as the minimum effective dose of disinfection specified in the product instruction manual. E. coli (8099) should be reduced to 0CFU/100mL.
5.2.4.3 Field test Under the natural conditions on site, the disinfection treatment shall be carried out according to the parameters and procedures such as the minimum effective dose of disinfection specified in the product instruction manual. For disinfection of sewage in medical institutions, the number of fecal coliforms in the water after disinfection should meet the standard value of GB 18466; used for disinfection of domestic drinking water The microbial indicators in the water after disinfection should meet the standard value of GB 5749; for disinfection of swimming pool water, the microbial indicators in the water after disinfection should be Comply with the standard value of GB 37488; for disinfection of reclaimed water, the microbial indicators in the water after disinfection should comply with the relevant standards of urban wastewater recycling Quasi-standard value; for other water quality disinfection, the microbial index after disinfection should comply with the relevant standards.
5.3 Ultraviolet sterilizer
5.3.1 Basic working conditions Should meet the requirements of 5.1.1.
5.3.2 Main components UV lamp
5.3.2.1 UV intensity It shall meet the requirements of 4.3.1.2.
5.3.2.2 Ultraviolet intensity fluctuation range Should meet the requirements of 5.1.2.2.
5.3.2.3 Effective life Should meet the requirements of 5.1.2.3.
5.3.3 Working noise Should meet the requirements of 5.1.3.
5.3.4 Disinfection effect
5.3.4.1 Laboratory microorganism killing test In the laboratory temperature is 20 °C ~ 25 °C, the power is turned on until the time specified in the product manual, and the logarithm of the index microorganisms is killed The value should meet the requirements of Table 3. Table
5.3.5 Leakage
5.3.5.1 UV leakage At a distance of 30cm from the periphery of the sterilizer, the ultraviolet leakage should be <=5µW/cm2.
5.3.5.2 Ozone leakage Should meet the requirements of 5.1.6.2.
6 Scope of application
6.1 UV air sterilizer Suitable for medical and health institutions, pathogenic microbiology laboratories, production workshops with hygienic requirements, public places, schools, nursery institutions and other fields Therefore, indoor dynamic air disinfection under manned conditions can also be used under unmanned conditions.
6.2 UV water sterilizer Suitable for disinfection of various water bodies.
6.3 Ultraviolet sterilizer It is suitable for disinfecting the surface of medical equipment and supplies, tableware (drinking utensils) and other objects.
7.1 UV air sterilizer
7.1.1 According to the volume of the space to be disinfected and the applicable volume requirements in the product instruction manual, select the applicable ultraviolet air disinfection Poison device model.
7.1.2 Install ultraviolet air sterilizer according to the requirements of the instruction manual.
7.1.3 When performing air disinfection, the doors and windows should be closed, the power supply should be turned on, the indicator light is on, and the switch or remote control should be pressed to set the disinfection time. start working. After a sterilization cycle according to the set procedure, the sterilization process is completed. The operation mode of dynamic air sterilizer adopts automatic interruption run.
7.2 UV water sterilizer
7.2.1 According to the water quality, quantity and temperature of the water to be disinfected, choose the UV water sterilizer model of corresponding specifications.
7.2.2 Install the ultraviolet water sterilizer according to the requirements of the instruction manual.
7.2.3 When performing water disinfection, the power should be turned on, the indicator light is on, press the switch or the remote control, the sterilizer starts to work, and the disinfection process is completed.
7.3 Ultraviolet sterilizer
7.3.1 According to the surface area of the object to be sterilized and the requirements of the product instruction manual, select the applicable ultraviolet object surface sterilizer model.
7.3.2 When performing disinfection, the power should be turned on, the indicator light is on, press the switch or the remote control, set the disinfection time, according to the product manual Make sure that the surface of the sterilized items are exposed to ultraviolet radiation. When using the ultraviolet disinfection box, the items to be disinfected should be placed in an appropriate amount. Should be placed too full, over crowded, and close the door with a brake lock switch, the sterilizer begins to work. After a sterilization cycle according to the set procedure, complete Into disinfection.
8.1.1 Main components
8.1.1.1 UV intensity Determine according to the method of Appendix A.
8.1.1.2 UV intensity fluctuation range Set 5 time detection points, which should include 5 minutes of lighting and effective disinfection time. range.
8.1.1.3 Effective life Determine according to the method specified in Appendix B.
8.1.2 Working noise According to the method specified in GBZ /T 189.8.
8.1.3 Circulation air volume According to the method specified in B.2.1 of GB/T 14294-2008.
8.1.4 Disinfection effect
8.1.4.1 Simulated field test Determine according to the method specified in Appendix C.
8.1.4.2 Field test Determine according to the method specified in Appendix D.
8.1.5 Leakage
8.1.5.1 UV leakage Turn on the ultraviolet sterilizer for 5 minutes. After stabilization, check the ultraviolet intensity with an ultraviolet intensity meter according to the distance specified in 5.1.6.1.
8.1.5.2 Ozone leakage According to the method specified in GB/T 18202.
8.2.1 Main components
8.2.1.1 UV intensity Determine according to the method of Appendix A.
8.2.1.2 Ultraviolet intensity fluctuation range Determine according to the method of 8.1.1.2.
8.2.1.3 Effective life Determine according to the method specified in Appendix B.
8.2.2 Effective UV dose According to the method specified in GB/T 19837.
8.2.3 Disinfection effect
8.2.3.1 Laboratory microorganism killing test Determine according to the method specified in Appendix E.
8.2.3.2 Simulated field test or field test Determine according to the method specified in Appendix F.
8.2.4 Leakage
8.2.4.1 UV leakage Determine according to the method of 8.1.5.1.
8.2.4.2 Ozone leakage According to the method specified in GB/T 18202.
8.3.1 Main components
8.3.1.1 UV intensity Determine according to the method of Appendix A.
8.3.1.2 UV intensity fluctuation range Determine according to the method of 8.1.1.2.
8.3.1.3 Effective life Determine according to the method specified in Appendix B.
8.3.2 Working noise According to the method specified in GBZ /T 189.8.
8.3.3 Disinfection effect
8.3.3.1 Laboratory microorganism killing test Determine according to the method specified in Appendix G.
8.3.3.2 Simulated field test or field test Determine according to the method specified in Appendix H.
8.3.4 Leakage
8.3.4.1 UV leakage Determine according to the method of 8.1.5.1.
8.3.4.2 Ozone leakage According to the method specified in GB/T 18202.
9 Logos and packaging
9.1 The packaging label shall meet the requirements of the rel...
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 32 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 191Graphical symbols marking for handling and storage of packages
- GB 5749Standards for drinking water quality
- GB/T 5750.2Standard examination methods for drinking water—Part 2: Collection and preservation of water samples
- GB/T 5750.12Standard examination methods for drinking water—Part 12: Microbiological indices
- GB/T 14294-2008Central station air handling units
- GB 15982Hygienic standard for disinfection in hospitals
GB/T 10682 · GB/T 15144 · GB/T 17262 · GB 17625.1 · GB/T 17743 · GB 17988 · GB/T 18202 · GB/T 18204.9 · GB/T 18204.10 · GB 18466 · GB/T 19258 · GB 19510.1
Similar standards
Editions of GB 28235
| Edition | Title | Revision | Status |
|---|---|---|---|
| GB 28235-2020 | Hygienic requirements for ultraviolet appliance of disinfection | current edition | Current |
| GB 28235-2011 | Safety and sanitary standard for ultraviolet appliance of air disinfection | previous edition | Superseded |
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Related Standards
GB 15982-2012 — Hygienic standard for disinfection in hospitals
GB 37488-2019 — Hygienic indicators and limits for public places
GB 5749-2022 — Standards for drinking water quality
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