CurrentMandatory

GB28235-2020

Hygienic requirements for ultraviolet appliance of disinfection

紫外线消毒器卫生要求

GB 28235-2020 is a current mandatory Chinese national standard for Hygienic requirements for ultraviolet appliance of disinfection. It appears in the Food compliance cluster with a product safety focus and has an implementation date of Nov 1, 2020.

Applicability depends on product scope, certification route, competent authority notices and transition rules. Requst for the translation or verify source before using this record in a compliance decision.

Compliance overview

Scope and applicability

This standard applies to ultraviolet appliances of disinfection that utilize C-band ultraviolet rays (wavelength range of 200nm~280nm) as the germicidal factor. It covers three main product categories: UV air disinfectors, UV water disinfectors, and UV surface disinfectors. It is mandatory for all manufacturers of these UV sterilization devices entering the Chinese market. The standard replaces the previous GB 28235-2011 and introduces specific requirements for water and surface disinfection applications.

Technical requirements

The standard specifies comprehensive raw material requirements for UV lamps and other components, mandating that lamp materials must use quartz glass or materials with a UV transmittance not lower than quartz. It sets strict initial UV intensity thresholds for double-ended and single-ended lamps based on their nominal power. Manufacturers must ensure that the effective lifetime of UV lamps is no less than 1,000 hours. For technical performance, the standard defines operating conditions, including voltage, temperature, and humidity limits. It regulates the fluctuation range of UV intensity (must not exceed 5% of the mean after stabilization) and sets noise limits for the equipment (≤55 dB(A)). For air disinfectors, the initial cyclic wind volume must be no less than 8 times the applicable volume. The standard outlines specific disinfection efficacy requirements for different applications. For air disinfection, it requires a kill rate of ≥99.9% for target bacteria in simulated field tests and a mortality rate of ≥90.0% for natural bacteria in field tests. For water and surface disinfection, it mandates specific log reductions for indicator microorganisms like Escherichia coli and Staphylococcus aureus. Compliance with these efficacy limits is critical for market approval. Safety requirements include strict limits on UV leakage (≤5 μW/cm² at 30cm from the device or in the safety zone of upper-room units) and ozone leakage (1-hour average permissible concentration of 0.1 mg/m³ in occupied indoor air). Upper-room UV air disinfectors must be equipped with human body induction protection devices.

Testing methods

The standard details several testing methodologies to verify compliance. UV intensity measurement is conducted using a UV intensity meter or an online measurement system, as specified in Annex A. The lifetime test (Annex B) measures the effective usage time until the UV intensity drops to 70% of its initial value. Disinfection efficacy is evaluated through laboratory microbial kill tests, simulated field tests, and field tests for air (Annexes C & D), water (Annexes E & F), and object surfaces (Annexes G & H), utilizing specific indicator microorganisms and standardized sampling methods.

FAQs

What products are regulated under GB 28235-2020?

GB 28235-2020 regulates ultraviolet appliances of disinfection that use C-band UV (200nm-280nm). This includes UV air disinfectors, UV water disinfectors, and UV surface disinfectors used in medical institutions, laboratories, public places, and for drinking water or medical instrument sterilization.

Are there any updates from the previous version of GB 28235-2020?

Yes, compared to GB 28235-2011, the 2020 version expands the scope to include UV water and surface disinfectors. It modifies raw material requirements to be mandatory, removes electrical safety technical requirements, and adds multiple normative annexes detailing testing methods for UV intensity, lifetime, and disinfection efficacy across different applications.

What are the key safety limits for UV leakage under this standard?

The standard sets strict UV leakage limits to protect users. For upper-room UV air disinfectors, leakage must be ≤5 μW/cm² in the safety area below 2.1m. For other UV air and surface disinfectors, leakage at 30cm from the device must be ≤5 μW/cm². Additionally, ozone leakage must not exceed a 1-hour average of 0.1 mg/m³ in occupied spaces.

The summary above provides a high-level overview of GB 28235-2020. To ensure complete compliance for your UV disinfection products entering the Chinese market, a precise and professional translation of the full technical specifications is essential. Purchase our high-quality English translation of GB 28235-2020 today to access all detailed parameters, tables, and testing procedures.

Applicability hints

Type
Product
CCS
C50
ICS
11.080
Competent department
National Disease Control and Prevention Administration
Technical committee
National Disease Control and Prevention Administration

Relationships

Replaces:GB 28235-2011