GB/T 26371-2020 in English
VALIDHygienic requirements for peroxide disinfectants
- Issued on:2020-06-02
- Implemented on:2020-12-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
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《GB/T 26371-2020过氧化物类消毒液卫生要求》由628（国家疾病预防控制局）归口，主管部门为国家疾病预防控制局。
Introduction
Core changes in the standard revision
| Dimensions | 2010 version | 2020 version | Technical significance |
|---|---|---|---|
| Physical and chemical indicators | Only the content of basic ingredients is specified | Seven new indicators such as pH value and heavy metals are added | The safety of mucosal disinfection is improved |
| Scope of application | Four types of scenarios | Expanded to seven major application areas | Covering new needs such as endoscope sterilization |
| Test method | Mainly based on suspension test | Add requirements for carrier test method | Close to actual use scenarios |
Technical analysis of key indicators
The content of active ingredients in peracetic acid disinfectant is required to be 85%-115% of the labeled value, and the decline rate of active ingredients in the stability test is ≤15%. When used for mucous membrane disinfection, heavy metal indicators such as lead (≤5mg/kg) and arsenic (≤3mg/kg) need to be specially tested.
Hospital dialysis machine disinfection case
According to clause 7.6 of the standard, the cleaning and disinfection of dialysis machine pipelines should use peracetic acid compound disinfectant, and sterilization verification should be carried out according to the requirements of GB/T27949, which must meet the simulated on-site sterilization requirements for Bacillus subtilis var. niger spores.
Implementation recommendations
- Medical institutions: Update the procurement standards for disinfectants, and focus on checking the pH value (labeled value ± 1.0) and heavy metal test reports
- Manufacturers: Improve the packaging design according to GB19105, and increase light protection and exhaust holes
- Disease control departments: When conducting field tests for air disinfection, refer to the requirements of WS/T368 for a natural bacteria kill rate of ≥ 1.00
Technology evolution analysis
This standard includes endoscopic disinfection and sterilization in its scope of application for the first time, reflecting the technological breakthrough of peroxide disinfectants in the treatment of precision instruments. By limiting the content of impurities such as sulfate (tested according to GB/T9728), the problem of the corrosiveness of traditional disinfectants to medical devices has been solved.
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