GB 28232-2020_English: PDF (GB28232-2020)
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Hygienic requirements for ozone disinfector
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| Standard ID | GB 28232-2020 (GB28232-2020) | | Description (Translated English) | Hygienic requirements for ozone disinfector | | Sector / Industry | National Standard | | Classification of Chinese Standard | C50 | | Classification of International Standard | 11.080 | | Word Count Estimation | 18,143 | | Date of Issue | 2020-04-09 | | Date of Implementation | 2020-11-01 | | Drafting Organization | Shanghai Center for Disease Control and Prevention, China Center for Disease Control and Prevention, Environmental and Health-related Product Safety Institute, Chinese People's Liberation Army Center for Disease Control and Prevention, Jiangsu Provincial Center for Disease Control and Prevention, Shandong Provincial Center for Disease Control and Prevention, Heilongjiang Provincial Center for Disease Control and Prevention, Zhejiang Provincial Center for Disease Control and Prevention | | Administrative Organization | National Health Commission of the People's Republic of China | | Proposing organization | National Health Commission of the People's Republic of China | | Issuing agency(ies) | State Administration for Market Regulation, National Standardization Administration | | Standard ID | GB 28232-2011 (GB28232-2011) | | Description (Translated English) | Safety and sanitation standard for ozone generator | | Sector / Industry | National Standard | | Classification of Chinese Standard | C59 | | Classification of International Standard | 11.080 | | Word Count Estimation | 14,148 | | Date of Issue | 2011-12-30 | | Date of Implementation | 2012-05-01 | | Quoted Standard | GB/T 191; GB/T 1408; GB/T 2829; GB 5749; GB 9706.1; GB/T 14710; GB 18466; disinfection technical specifications Ministry of Health, 2002; disinfection product label instructions management practices Ministry of Health 2005 | | Drafting Organization | Sichuan University School of Public Health | | Administrative Organization | Ministry of Health | | Regulation (derived from) | Announcement of Newly Approved National Standards No. 23 of 2011 | | Proposing organization | People's Republic of China Ministry of Health | | Issuing agency(ies) | Ministry of Health of People's Republic of China; Standardization Administration of China | | Summary | This Chinese standard specifies the used water, air and surface disinfection ozone generator technical requirements, scope of application, use, test methods, marking and packaging, transportation and storage, labeling and use instructions and precautions. This standard applies to physically preparing for the disinfection of ozone and ozone generators. This standard does not apply to chemically preparing ozone ozone generator. |
GB 28232-2020
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.080
C 50
Replacing GB 28232-2011
Hygienic requirements for ozone disinfector
ISSUED ON: APRIL 09, 2020
IMPLEMENTED ON: NOVEMBER 01, 2020
Issued by: State Administration for Market Regulation;
Standardization Administration of PRC.
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 6
4 Raw material requirements ... 7
5 Technical requirements ... 9
6 Application scope ... 14
7 Method of use ... 14
8 Testing method ... 17
9 Transportation and storage ... 20
10 Nameplate and instruction manual ... 20
Appendix A (Normative) Ozone concentration determination method ... 22
Appendix B (Normative) Ozone output determination method ... 25
Appendix C (Normative) Ozone power consumption determination method .. 27
Hygienic requirements for ozone disinfector
1 Scope
This standard specifies the raw material requirements, technical requirements,
application scope, use methods, inspection methods, transportation and
storage, nameplates and instruction manual for use of ozone disinfectors.
This standard applies to ozone disinfectors that generate ozone through
dielectric barrier discharge, ultraviolet radiation, electrolysis.
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 5749 Standards for drinking water quality
GB/T 5750.10 Standard examination methods for drinking Water -
Disinfection by-products parameters
GB/T 15436 Ambient air - Determination of nitrogen oxides - Saltzman
method
GB 17988 Safety and sanitation requirements for disinfecting tableware
cabinet
GB/T 18202 Hygienic standard for ozone in indoor air
GB 18466 Discharge standard of water pollutants for medical organization
GB/T 19258 UV germicidal lamp
GB 28235 Safety and sanitary standard for ultraviolet appliance of air
disinfection
GB 30689 Hygienic requirements for washer-disinfectors employing
chemical disinfection for thermolabile endoscopes
GB/T 38497 Evaluation method of endoscopic disinfection effect
GBZ 2.1 Occupational exposure limits for hazardous agents in the workplace
Part 1: Chemical hazardous agents
at the inlet end of the ozone generator.
4.1.1.3 Cooling system
4.1.1.3.1 When air is used as the cooling method of the ozone generator, the
relative humidity of the cooling air shall be ≤ 85%.
4.1.1.3.2 When water is used as the cooling method of the ozone generator,
the cooling water that directly cools the ozone generator is 6.5 ≤ pH ≤ 8.5,
chloride content ≤ 250 mg/L, total hardness (calculated as CaCO3) ≤ 450 mg/L,
turbidity (scattering turbidity unit) ≤ 1 NTU.
4.1.2 Ultraviolet radiation type
4.1.2.1 The ultraviolet lamp tube shall be made of quartz glass or raw materials
with equivalent ultraviolet transmittance.
4.1.2.2 The initial ozone output rate of the ozone ultraviolet germicidal lamp
shall not be less than 80% of the indicated value, in line with the requirements
of GB/T 19258.
4.1.3 Electrolysis type
4.1.3.1 The material of the electrolytic reaction tank shall be selected from
ozone-resistant polymer or metal materials; the membrane electrode material
shall be selected from proton exchange membranes and precious metals and
their alloys.
4.1.3.2 The gas supply source shall use deionized water with conductivity ≤ 5
µS/cm.
4.2 Ozone disinfector components
The parts contacting ozone shall use ozone-resistant materials, to ensure long-
term stable operation in an ozone environment.
4.3 Ozone-water mixing device
4.3.1 Ozone-water mixing elements with low energy consumption and high
dissolved gas efficiency shall be used; the dissolved gas efficiency shall be ≥
50%.
4.3.2 A ozone-water separation device shall be installed to separate
undissolved gaseous ozone; an ozone tail gas decomposition device shall be
installed to decompose the separated ozone gas.
4.4 Monitoring device
5.1.3 By-products
5.1.3.1 With air as the gas source, the concentration of nitrogen oxides (NOx)
produced by the ozone disinfector shall not be greater than 2.5% of the ozone
concentration.
5.1.3.2 When used for drinking water disinfection, the bromate concentration in
the water shall be ≤ 0.01 mg/L; the formaldehyde concentration shall be ≤ 0.9
mg/L.
5.1.4 Ozone leakage
The ozone disinfector is used under human conditions; it shall be airtight when
using the ozone gas for sterilization. The ozone leakage in the surrounding
environment shall be ≤ 0.1 mg/m3.
5.1.5 Residual ozone
After one working cycle of ozone disinfection under airtight conditions, the
residual amount of ozone gas in the airtight room shall be ≤ 0.16 mg/m3.
5.2 Ultraviolet radiation type ozone disinfector
5.2.1 Basic working conditions
Under the conditions of ambient temperature 5 °C ~ 45 °C, relative humidity ≤
85%, power supply voltage 220 V ± 22 V, power supply frequency 50 Hz ± 1
Hz, the ozone disinfector shall be able to be used continuously.
5.2.2 Performance requirements
5.2.2.1 The ozone gas concentration of the ozone disinfector shall be ≥ 60
mg/m3.
5.2.2.2 After turning on for 5 minutes, the ultraviolet lamp’s radiation illuminance
shall be stable under normal working conditions; the fluctuation range shall not
exceed 5% of the average value.
5.2.2.3 The effective life of the new UV lamp shall be ≥ 1000 h.
5.2.3 Leakage
5.2.3.1 UV leakage
At 30 cm away from the periphery of the disinfector, the UV leakage shall be ≤
5 µW/cm2.
5.2.3.2 Ozone leakage
6 Application scope
It is suitable for disinfection of air, water, tableware, food processing pipelines,
medical equipment, medical supplies and surface of objects.
7 Method of use
7.1 Air disinfection
7.1.1 According to the volume of the space to be disinfected and the applicable
volume requirements in the product’s instruction manual, select the applicable
ozone air disinfector model.
7.1.2 Air disinfection shall be carried out in a closed space and indoors without
people. Generally, the ozone concentration is 5 mg/m3 ~ 30 mg/m3, the relative
humidity is ≥ 70%, the action time is 30 min ~ 120 min.
7.1.3 When performing air disinfection, the doors and windows shall be closed;
the power is turned on; the indicator light is on; the switch or remote control is
pressed; the disinfection time is set; the disinfector starts to work. After a
disinfection cycle according to the set procedure, the disinfection treatment is
completed.
7.2 Water disinfection
7.2.1 It can be used for disinfection of drinking water, water for diagnosis and
treatment in medical institutions (non-injection water), sewage, swimming pool
water, central air conditioning cooling water, condensate water in public places.
7.2.2 According to the type of water to be disinfected, select the corresponding
specifications of ozone water disinfector models according to relevant
standards. Install and operate the ozone water disinfector in accordance with
the requirements of the instruction manual.
7.2.3 When used for disinfection of drinking water, the exposure time of ozone
and water before the water leaves the factory shall be ≥ 12 min; the residual
ozone in the water after disinfection shall be ≤ 0.3 mg/L; the residual ozone in
the water at the end of the pipe network shall be ≥ 0.02 mg/L .
7.2.4 For the disinfection of water for diagnosis and treatment (non-injection
water) in medical institutions, the general ozone input amount is 0.5 mg/L ~ 1.5
mg/L, the remaining ozone concentration in the water is maintained at 0.1 mg/L
~ 0.5 mg/L for 5 min ~ 10 min. For poor water quality or serious pollution, the
ozone input is 3 mg/L ~ 6 mg/L.
7.4.1.3 When using ozone water to sterilize medical equipment and supplies,
install an ozone water disinfector in accordance with the instruction manual.
When disinfecting, put the medical equipment and supplies that need to be
disinfected after washing into the container; turn on the power; soak in ozone
water or continue to rinse and disinfect for a specified time to complete the
disinfection. During disinfection, the ozone concentration in the water shall be
≥ 10 mg/L; the disinfection time shall be ≥ 40 min.
7.4.2 Disinfection of bed unit
7.4.2.1 According to the instruction manual of bed unit and its supplies to be
disinfected, select the applicable ozone bed unit disinfector (machine) model.
7.4.2.2 When using, take out the sterilization sealed bag equipped with the bed
unit disinfector, put the items to be sterilized into the bag; seal the bag opening;
insert the air pipe on the disinfector into the air nozzle of the sealed bag; turn
on the power; turn on the power switch; start the disinfection button, the
disinfector starts to work (the sealed bag needs to be vacuumed before
disinfection) until the disinfection process is all over. During disinfection, the
ozone concentration in the sealed bag is generally ≥ 200 mg/L; the relative
humidity is ≥ 70%; the maintenance time is ≥ 30 min.
7.4.3 Endoscope disinfection
7.4.3.1 According to the instruction manual of the type of endoscope to be
sterilized, select the applicable ozone automatic endoscope disinfector
(machine) model.
7.4.3.2 When disinfecting the endoscope, first clean the used endoscope by
hand; then put it into the machine tank according to the natural bending state
of the endoscope; connect the air and water supply pipes; cover the inner cover
of the decontamination tank; meanwhile close the cover of the basin. Turn on
the power; turn on the power switch; select the disinfection program and time
according to the type of endoscope; start the disinfection button, the disinfector
will start working until the disinfection process is all over and the disinfection
treatment is completed. When disinfecting, it is generally required that the
ozone concentration in the water shall be ≥ 11 mg/L.
7.5 Surface disinfection of object
7.5.1 According to the size of the surface area of the object to be disinfected
and the requirements of the product instruction manual, select the applicable
ozone surface disinfector model.
7.5.2 When using ozone gas to disinfect the surface of an object, it shall close
the doors and windows; turn on the power, the indicator light is on; press the
switch or remote control; set the disinfection time, the disinfector starts to work.
8.2.1 Performance requirements
8.2.1.1 Ozone concentration of ozone disinfector
It is determined according to the method specified in Appendix A.
8.2.1.2 Ultraviolet radiation illuminance and its fluctuation range
8.2.1.2.1 Ultraviolet radiation illuminance
It is determined according to the method specified in GB 28235.
8.2.1.2.2 Illumination fluctuation range of ultraviolet radiation
When starting up for 5 min, 10 min, 15 min, 30 min, 60 min, 120 min, the
irradiance of the ultraviolet germicidal lamp is measured respectively, to
calculate the average value and its fluctuation range.
8.2.1.2.3 Effective life of UV germicidal lamp
It is determined according to the method specified in GB 28235.
8.2.2 Leakage
8.2.2.1 UV leakage
After turning on the ozone disinfector for 5 minutes to stabilize, at a distance of
30 cm from the outer surface of the disinfector, use an ultraviolet radiation
illuminance meter to detect the ultraviolet radiation illuminance.
8.2.2.2 Ozone leakage
It is determined according to the method specified in GB/T 18202.
8.2.3 Residual ozone
It is determined according to the method of 8.1.4.
8.3 Electrolysis type ozone disinfector
8.3.1 Performance requirements
8.3.1.1 Ozone concentration of ozone disinfector
It is determined according to the method specified in Appendix A.
8.3.1.2 Power consumption of ozone disinfector
It is determined according to the method specified in Appendix C.
Appendix A
(Normative)
Ozone concentration determination method
A.1 Iodometry
A.1.1 Purpose
The chemical method is used in the laboratory to accurately determine the
concentration of ozone gas or ozone contained in ozone water produced by the
ozone disinfector.
A.1.2 Test equipment
A.1.2.1 Pipette (1 mL, 5 mL, 10 mL, 25 mL).
A.1.2.2 Burette (2 mL, 5 mL, 10 mL, 25 mL, 50 mL).
A.1.2.3 Iodine measuring flask (100 mL, 250 mL).
A.1.2.4 Volumetric flasks (50 mL, 100 mL, 250 mL, 500 mL, 1000 mL).
A.1.2.5 Conical flask (100 mL, 250 mL, 500 mL).
A.1.2.6 Balance (0.1 mg).
A.1.2.7 Atmospheric sampler.
A.1.2.8 Other equipment.
A.1.3 Reagents
A.1.3.1 Prepare 3 mol/L sulfuric acid, 200 g/L potassium iodide and 5 g/L starch
solutions.
A.1.3.2 Prepare and calibrate 0.05 mol/L sodium thiosulfate titrant.
A.1.4 Test method
A.1.4.1 Sampling: When detecting the concentration of ozone aqueous solution,
precision take a sample of 100.0 mL ~ 300.0 mL (when the concentration is low,
but not less than 10 mg/L, take 400.0 mL). Place it in a 500 mL conical flask
with stopper. Add 20 mL of 200 g/L potassium iodide solution and mix well. Then
add 5 mL of 3 mol/L sulfuric acid. Add the stopper. Let it stand for 5 min.
Note: When sampling involves water flow, the water flow is set in accordance
Where:
I - The light intensity after the beam penetrates the ozone;
Io - Intensity of incident light without ozone;
K - The absorption coefficient of ozone to light wavelength;
L - The length of the optical path of the ozone sample cell;
C - Ozone concentration.
According to this formula, under the condition of known K and L values, the
ozone concentration can be measured by determining the I/I0 value.
A.2.1.2 Determination
According to the application, it is divided into two types: detecting air ozone and
detecting water-soluble ozone. Follow the instruction manual of the instrument.
Before using the instrument, it can be used only after it has been certified by a
national authorized measurement unit.
A.2.2 Electrochemical method
A.2.2.1 Principle
The ozone in water produces electrochemical reduction on the electrochemical
surface: O3 + H2O + 2e- →O2 + 2OH-
The current characteristic curve in the electrochemical circuit is proportional to
the concentration of molecular ozone in the solution.
The electrochemical detector is mainly used for on-line continuous detection
and control of water-soluble ozone concentration.
A.2.2.2 Operation
The widely used "membrane electrode" dissolved ozone detector can be used.
Before using the instrument, it can be used only after it has been certified by a
national authorized measurement unit.
......
GB 28232-2011
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS11.080
C 59
Safety and sanitation standard for ozone generator
ISSUED ON. DECEMBER 30, 2011
IMPLEMENTED ON. MAY 1, 2012
Issued by. Ministry of Health of the People's Republic of China;
Standardization Administration Committee.
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 5
4 Specifications and classifications ... 6
5 Name and model ... 7
6 Technical requirements ... 7
7 Application scope ... 9
8 Application methods ... 9
9 Inspection and methods ... 10
10 Marking and packing ... 13
11 Transportation and storage ... 14
12 Labels and instructions ... 14
13 Precautions ... 15
Appendix A ... 16
Appendix B ... 19
Appendix C ... 21
Foreword
All technical content of this standard is mandatory.
The appendix A, appendix B and appendix C of this standard are normative.
This standard was put forward by and shall be under the jurisdiction of the Ministry of
Health of People's Republic of China.
Drafting organizations of this standard. Huaxi School of public health of Sichuan
University, Chengdu Tian Tian Medical Electrical Technology Co., Ltd.
The main drafters of this standard. Zhang Zhaowu, Jiang Tianhua, Wang Guoqing, Liu
Hengchuan.
Safety and sanitation standard for ozone generator
1 Scope
This standard specifies the technical requirements, application scope, application
methods, inspection methods, marking and packaging, transportation and storage,
labels and instructions, and matters needing attention for ozone generator that is used
for disinfection of water, air and object surfaces.
This standard is applicable to ozone generator that produces ozone by the physical
method and is used for disinfection.
This standard is not applicable to ozone generator that produces by the chemical
method.
2 Normative references
The clauses in the following documents become the provisions of this standard by
reference in this standard. For dated references, subsequent amendments (excluding
corrections) or revisions do not apply to this standard. However, the parties are
encouraged to research and reach an agreement on whether the latest version of these
documents can be used according to this standard. For undated references, the latest
edition applies to this standard.
GB/T 191 Packaging. Pictorial marking for handling of goods
GB/T 1408 Test method for power frequency electrical strength of solid insulating
materials
GB/T 2829 Sampling procedures and tables for periodic inspection by attributes
GB 5749 Standards for drinking water quality
GB 9706.1 Medical electrical equipment - Part 1. General requirements for safety
GB/T 14710 Environmental requirement and test methods for medical electrical
equipment
GB 18466 Discharge standard of water pollutants for medical organization
Disinfection technical specification (2002 Edition), Ministry of Health
After the gas is penetrated, phenomenon of voltage decreases between the poles and
the dark glow around the electrode.
3.9 Epilogue gas
An ozone-containing gas that is produced in an ozone water generator but not
completely dissolved in water.
3.10 Dew point
The temperature at which the gas source starts to become dew; the lower the relative
humidity of the gas, the lower the dew point temperature.
3.11 Specific consumption
The electric energy that is consumed by the ozone generator to produce a unit weight
of ozone.
4 Specifications and classifications
4.1 Specifications
The specifications of the ozone generator are represented by the amount of ozone
produced in a unit time (the basic unit is g/h).
4.2 Classification
4.2.1 Type
4.2.1.1 Work type is divided into ozone generator or ozone-water generator.
4.2.1.2 Placement is divided into table, standing, mobile and separate type.
4.2.2 Model marking
4.2.2.1 The structure of the ozone generation unit is divided into tube type (G) and
plate type (B).
4.2.2.2 The control methods of the ozone generator are divided into common type
(fixed type, P) and adjustable type [manual-adjusted (R), and program-adjusted (C)].
4.2.2.3 The working frequency of the power supply is divided into power frequency,
medium frequency and high frequency.
b) The frequency of the power supply is 50Hz±1Hz, the voltage is 220V±22V, the
atmospheric pressure is 86kPa~106kPa, and the relative humidity is
65%~85%, the temperature is room temperature;
c) The exit gas temperature should be < 27°C;
d) The output ozone concentration of closed type ozone generator should be ≥
12mg/L.
When the above conditions are changed, the corresponding indicator such as
discharge (corona discharge or glow discharge) per unit area of ozone yield,
concentration, output and electricity consumption should be measured according to
the specific conditions.
6.2.2 All kinds of electrical insulation parts of the ozone generator should meet the
requirements of high voltage insulation performance and structure. The insulation parts
in the environment of the glow discharge, ozone oxidation should also meet the
requirements of GB 9706.1.
6.2.3 For those using water as coolant, the consumption of cooling water per kilogram
of ozone should not exceed 1.5×103 kg.
6.2.4 The average life-span should be ≥ 20 000 h；accumulative working time without
fault should be ≥ 8 000 h.
6.3 Conditions for using ozone generator
Under the condition of ambient temperature below 45°C, atmospheric pressure
86kPa~106kPa, relative humidity 65%~85%, and the cooling water temperature lower
than 35°C, the ozone generator should be able to be used continuously.
6.4 Requirements for disinfection
6.4.1 Disinfection of air
6.4.1.1 Air disinfection should be carried out in a closed space with no human inside.
The ozone concentration should be ≥ 20mg/m3, the action time should be ≥ 30min.
6.4.1.2 The effect of disinfection should comply with the related requirements of the
“Disinfection technical specification” (2002 Edition).
6.4.2 Disinfection of water
6.4.2.1 It can be used to disinfect medical institutions’ diagnosis-water (non-injection
water), dirt-water, and the water in public places.
6.4.2.2 When it is used to disinfect the medical institutions’ diagnosis-water (non-
9.4.1 For ozone generation unit’s performance spot inspection, the sampling ratio is
5%. For example, sampling unit is ozone generating unit in a single ozone generator,
and the total number of ozone generation units is < 60, then, the sampling number
should be ≥ 3 ozone generating units. The ozone generating unit’s performance test
conditions should be in accordance with 6.2.1.
9.4.2 If the data measured by performance test is 10%~20% lower than the
performance requirements and the proportion is ≥ 20% of the units checked. Then, re-
test can be carried out after finding the causes. If the performance requirements are
still not met after re-test, then, increase the sampling proportion of the ozone
generating unit to 25%. If there is no failing of the performance requirements, then spot
test can be stopped. After expansion of the sampling proportion, if the proportion of
failing ozone generating units exceeds 5% of the checked-number, then, the causes
should be thoroughly found; and the production can only be resumed after problems
are solved.
9.4.3 For new-type products or formal-products that are being manufacturing, when
there are major changes in structure, material or process, or when continuous
production life of one product exceeds 3 years, then, a number of ozone generation
units should be randomly selected to test its performance parameters and service life.
9.5 Exit-factory inspection
9.5.1 Ozone generation unit should be accurately located in the ozone generator.
Components for fastening, support and connection should be firmly installed.
9.5.2 Appearance inspection of ozone generator
Internal appearance inspection includes. parts of ozone generating unit should be
clean, no oil stains, water stains, dust or other foreign objects; the anti-corrosion
coating inside of the ozone generator should be smooth and clean with no peeling,
chipping or other adverse conditions; The high-voltage power transmission and
distribution system should be tidy and should not cause abnormal transmission and
distribution.
External appearance inspection should include. the external shell surface should be
smooth with no scar, bump, dent, or other defects affecting the appearance;
protections and other adverse conditions (if on-site external decoration will be done
according to the requirements of the buyer, this test can be carried out when
appropriate). All kinds of appurtenances (parts) on the external shell should be installed
at the accurate location, firmly fastened, and quality acceptable. Any part of the shell
shall not obstruct installation, maintenance, cleaning etc. For ozone generators with
high pressure device, the shell should be flame-retardant.
9.5.3 The interface of the ozone generator with each instrument (meter), or with
10.2.2 The package shall be suitable for water/land transportation and meet loading
requirements.
10.2.3 The text and signs outside the package include the following.
a) Company name or trademark, registered address, production address, zip code,
contact number;
b) Product name, model, specification;
c) Product net weight, gross weight, center of gravity, lifting mark;
d) Date of production, exit-factory number;
e) Power connection condition, input power;
f) Storage and transportation marks, such as "fragile items", "Rain fear", "limit of
stacking layer", etc., shall conform to the GB/T 191 regulations.
10.2.4 Accessories, spare parts can be packaged separ...
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