GB/T 38502-2020 in English

VALID

Test method for bactericidal effect of disinfectant in laboratory

Issued on:2020-03-06
Implemented on:2020-10-01
File Format:PDF
Delivery:Via email within 5 business days

Price(USD)： $370.00
$359.00

Standard No:	GB/T 38502-2020
Document status:	VALID
Title in English:	Test method for bactericidal effect of disinfectant in laboratory
Title in Chinese:	消毒剂实验室杀菌效果检验方法
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 5 business days
Issued on:	2020-03-06
Implemented on:	2020-10-01
ICS Classification:	11.080-Sterilization and disinfection
Chinese Classification:	C50-Sanitation in general
Professional Classification:	GB-National Standard
Related Keywords:	quantitative test viscous/solution disinfectant kill test method carrier test quantitative test conventional unified disinfectant laboratory evaluation system
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《GB/T 38502-2020消毒剂实验室杀菌效果检验方法》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

Analysis of the core content of the standard

This standard specifies the complete technical system for laboratory testing of the bactericidal effect of disinfectants, covering key links such as bacterial suspension preparation, neutralizer identification, and quantitative/qualitative killing tests.

Test type	Applicable scenarios	Qualification standard
Suspension quantitative test	Conventional disinfectant evaluation	Kill log value ≥5.00
Carrier quantitative test	Viscous/solution disinfectant	Kill log value ≥3.00
Qualitative sterilization test	Medical device sterilization	All 30 samples showed sterile growth

Key operating points

1. Specifications for preparation of bacterial suspensions

The standard requires that the concentration of the vegetative suspension be controlled at 1×10⁸-5×10⁸ CFU/mL, and the spore suspension must be heat-treated at 80℃ 10min to remove the vegetative bodies. The preparation of bacterial slices requires defatting pretreatment, and the amount of bacteria recovered from the carrier should reach 1×10⁶-5×10⁶ CFU/slice.

2. Neutralizer identification test

Four groups of controls must be verified: neutralization product group, neutralizer group, positive control group, and negative control group. The qualified standard requires that the colony count error rate of the first three groups is ≤15%, and there is no sterile growth in the negative control group.

3. Quantitative killing test design

Three action time gradients need to be set (0.5 times, 1 times, and 1.5 times the shortest time in the instructions), and the concentration of organic interferences should be selected according to the usage scenario: 0.3% or 3.0% bovine serum albumin.

Example of calculation of logarithmic killing value

When the average colony count of the positive control group is 5.0×10⁷ CFU/mL (logarithm 7.70) and no colonies are detected in the experimental group:
Logarithmic killing value = 7.70-0 = ≥7.70

Requirements for special microbiological inspection

Microbial type	Representative strain	Culture conditions	Qualified standard
Mycobacterium	Mycobacterium chelonae subspecies	36℃±1℃ 7 days	Kill log value ≥ 4.00
Fungus	Candida albicans/Aspergillus niger	30-36℃ 72 hours	Kill log value ≥ 4.00

Implementation suggestions

The laboratory must meet the biosafety level II standard, and the strain should be subcultured no more than the 8th generation
A positive control and a negative control must be set up for each test
The influencing factor test should test the effects of organic matter, temperature, and pH
The carrier test is recommended to use Cloth piece (40 woven yarn white cotton cloth) is used as the standard carrier

Note: This standard was first published in 2020, replacing the original scattered test methods and establishing a unified disinfectant laboratory evaluation system.

More samples: JC/T 2453-2018 DL/T 5154-2012 NB/T 47013.2-2015

Sample only — not a preview of GB/T 38502-2020

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