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GB 28232-2020Hygienic requirements for ozone disinfector (English PDF)

臭氧消毒器卫生要求

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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 28232-2020 is the English-translated version of 臭氧消毒器卫生要求.

GB 28232-2020 is the Chinese national standard on hygienic requirements for ozone disinfector, 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 28232-2020

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 Ozone generator
  • 4.1.1 Dielectric barrier discharge type
  • 4.1.1.2 Air supply source
  • 4.1.1.3 Cooling system
  • 4.1.2 Ultraviolet radiation type
  • 4.1.3 Electrolysis type
  • 4.3 Ozone-water mixing device
  • 4.4 Monitoring device
  • 5 Technical requirements
  • 5.1 Dielectric barrier discharge type ozone disinfector
  • 5.1.2 Performance requirements
  • 5.1.3 By-products
  • 5.2 Ultraviolet radiation type ozone disinfector
  • 5.2.2 Performance requirements
  • 5.2.3 Leakage
  • 5.3 Electrolysis type ozone disinfector
  • 5.3.2 Performance requirements
  • 5.4 Disinfection effect
  • 5.4.3 Disinfection of tableware and food processing pipelines
  • 5.4.4 Disinfection of medical equipment and supplies
  • 6 Application scope
  • 7 Method of use
  • 7.1 Air disinfection
  • 7.2 Water disinfection
  • 7.3 Disinfection of tableware and food processing pipelines
  • 7.4 Disinfection of medical equipment and supplies
  • 7.4.1 Disinfection of general medical equipment and supplies
  • 7.4.2 Disinfection of bed unit
  • 7.4.3 Endoscope disinfection
  • 7.5 Surface disinfection of object
  • 8 Testing method
  • 8.1 Dielectric barrier discharge type ozone disinfector
  • 8.1.1 Performance requirements
  • 8.1.1.6 Life
  • 8.1.2 By-products
  • 8.2 Ultraviolet radiation type ozone disinfector
  • 8.2.1 Performance requirements
  • 8.2.2 Leakage
  • 8.3 Electrolysis type ozone disinfector
  • 8.3.1 Performance requirements
  • 9 Transportation and storage

1 Scope

GB 28232-2020 is the Chinese national standard on hygienic requirements for ozone disinfector, 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, 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

3 Terms and definitions

The following terms and definitions apply to this document.

3.1 Ozone generation unit It is the most basic component that produces ozone.

3.2 Ozone generator A device necessary to generate ozone through dielectric barrier discharge, ultraviolet radiation or electrolysis.

3.3 Ozone disinfector The whole devices necessary to use the ozone generated by the ozone generator with gas or water as a carrier for disinfection.

3.4 Ozone-water mixing equipment A device that mixes ozone gas and water to dissolve ozone in water.

3.5 Monitoring device A device for monitoring the concentration of ozone in water/air and manually or automatically regulating the concentration of ozone, including on-site monitoring and control equipment, on-site data collectors and data processing centers.

4.1.1 Dielectric barrier discharge type

4.1.1.1 Medium and materials The medium and electrode materials of the ozone generating unit shall use ozone-resistant materials, to ensure long-term stable operation under discharge conditions and in an ozone environment.

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

4.2 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.

5.1 Dielectric barrier discharge type ozone disinfector

5.1.1 Basic working conditions The ozone disinfector shall be able to be used continuously under the conditions of ambient temperature 5 °C ~ 45 °C, relative humidity <= 85%, cooling water inlet temperature <= 35°C.

5.1.3 By-products

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

1 Hz, the ozone disinfector shall be able to be used continuously.

5.3 Electrolysis type ozone disinfector

5.3.1 Basic working conditions Same as 5.2.1.

5.4 Disinfection effect

5.4.1 Air disinfection When the ozone disinfector is used for air disinfection, in accordance with the method of use specified in the product instruction manual, it is turned on until the time specified in the product instruction manual, then the microbial killing indicators shall meet the requirements of Table 3.

5.4.2 Water disinfection When the ozone disinfector is used for water disinfection, in accordance with the method of use specified in the product instruction manual, it is turned on to the time specified in the product instruction manual, then the microbial killing indicators shall meet the requirements of Table 4.

5.4.3 Disinfection of tableware and food processing pipelines

5.4.3.1 Disinfection of tableware with ozone tableware disinfection cabinet shall meet the requirements of GB 17988.

5.4.3.2 The disinfection of tableware and food processing pipelines with ozone water shall meet the requirements of Table 5.

5.4.4 Disinfection of medical equipment and supplies

5.4.5 Surface disinfection of object When the ozone disinfector is used for object disinfection, follow the method of use specified in the product instruction manual, to start the disinfector to the time specified in the product instruction manual; the microbial killing indicators shall meet the requirements of Table 7.

6 Application scope

It is suitable for disinfection of air, water, tableware, food processing pipelines, medical equipment, medical supplies and surface of objects.

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.

7.2 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.

7.2.5 When used in hospital sewage treatment, the general ozone input amount is 10 mg/L ~ 15 mg/L; the sewage is fully exposed to ozone for 12 min ~ 15 min before being discharged.

7.3 Disinfection of tableware and food processing pipelines

7.3.1 According to the instruction manuals of the tableware and food processing pipelines to be sterilized, select the applicable ozone disinfector (machine) model.

7.3.2 When using an ozone disinfection cabinet to disinfect tableware, put the tableware that needs to be disinfected after washing and drying into the cabinet; close the cabinet door; turn on the power; start the disinfection button, the disinfector starts to work until this disinfection process is completed, which is the end of disinfection treatment. During disinfection, the ozone concentration in the disinfection cabinet shall generally be >= 20 mg/L, the relative humidity >= 70%, the disinfection time shall be >= 30 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.

7.5 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;

8.1.1 Performance requirements

8.1.1.1 Ozone concentration of ozone disinfector It is determined according to the method specified in Appendix A.

8.1.1.4 Tuning performance Change the intake air flow and power of the ozone disinfector, to determine the ozone output according to the method in 8.1.1.2; test the tuning range of the ozone output.

8.1.1.5 Variation After the ozone disinfector runs for 4 hours, under the designed rated power and intake air flow conditions, at least 5 determinations (time average distribution) of ozone concentration and power consumption are made within 2 hours; the difference between the maximum value and the minimum value in the measured value is divided by average value; the result obtained is the variable value.

8.1.2 By-products

8.1.2.1 Nitrogen oxides It is determined according to the method specified in GB/T 15436.

8.1.2.2 Bromate It is determined according to the method specified in GB/T 5750.10.

8.1.2.3 Formaldehyde It is determined according to the method specified in GB/T5750.10.

8.1.3 Ozone leakage It is determined according to the method specified in GB/T18202.

8.1.4 Residual ozone After the ozone disinfector has finished a working cycle, open the door of the disinfector according to the instruction manual; use an ozone concentration meter to measure the ozone concentration in the cavity of the disinfector and the surrounding environment. Before the test, it shall determine the original ozone concentration in the air;

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.

8.3.1 Performance requirements

8.4 Disinfection effect The endoscope is determined according to the method specified in GB/T 38497; the tableware disinfection cabinet is determined according to the method specified in GB 17988.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 31 pages — is available in the English PDF.

Referenced standards

Similar standards

Editions of GB 28232

EditionTitleRevisionStatus
GB 28232-2020Hygienic requirements for ozone disinfectorcurrent editionCurrent
GB 28232-2011Safety and sanitation standard for ozone generatorprevious editionSuperseded

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