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GB/T 48028-2026Aerosol bacterial retention test method for air-inlet filter on infusion and transfusion devices (English PDF)

输液、输血器具进气器件气溶胶细菌截留试验方法

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Issued by

State Administration for Market Regulation

Level / Type

National · Recommended

Issue date

July 30, 2026

Implementation date

August 1, 2027

Scope

GB/T 48028-2026 is the English-translated version of 输液、输血器具进气器件气溶胶细菌截留试验方法.

GB/T 48028-2026 is a Chinese national standard on a test method for aerosol bacterial retention by the air-inlet filters of infusion and transfusion devices. It adopts ISO 24072:2023, and its title was changed to align with existing standards.

The standard describes the method for testing the aerosol bacterial retention of separate or integrated air intake devices for infusion and blood transfusion equipment.

Its terms and definitions include aerosol, collecting fluid, liquid impinger and sterilization. Collecting fluid is the liquid held in a liquid impinger, used to collect the challenge bacteria for later counting. Issued on 30 July 2026 and applicable from 1 August 2027.

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Document preview — GB/T 48028-2026

National Standard of the People's Republic of China

ICS: 11.040.20
Classification: C 31

Issued by: State Administration for Market Regulation

Foreword
1 Scope
2 Normative references
3 Terms and Definitions

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1: Structure and Drafting Rules of Standardization Documents".

This document adopts ISO 24072:2023 "Test method for aerosol bacterial retention of infusion apparatus air intake devices".

The following minimal editorial changes have been made to this document.

---To align with existing standards, the standard name has been changed to "Test Method for Aerosol Bacterial Retention of Air Intake Devices for Infusion and Blood Transfusion Equipment".

1 Scope

This document describes a method for aerosol bacterial retention testing of separate or integrated air intake devices for infusion and blood transfusion equipment.

2 Normative references

This document has no normative references.

3 Terms and Definitions

The following terms and definitions apply to this document.

The URLs for the terminology databases maintained by ISO and IEC for standardization are as follows.

3.5 The probability of a single live microorganism remaining on the product after sterilization. [Source: GB/T 19971-2026, 3.307, with modifications]

3.1 Aerosol

Suspension of solid or liquid particles in a gas.

3.3 Collecting fluid

Collecting fluid

The liquid used to collect challenging bacteria and for subsequent counting analysis is contained in a liquid impact sampler.

3.4 Liquid Impinger

Collect challenge bacteria into a designated collection solution in a glass vial connected to an air pump for analysis.

Note 1. The impact sampler inlet extends near the bottom of the glass bottle, drawing air in through a port near the top of the bottle, causing the air to bubble. Microorganisms are collected through a collection solution.

Note 2. Impact samplers are also known as bubblers.

3.6 Sterilization

The process that has been confirmed to eliminate any surviving microorganisms in the product.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 7 pages — is available in the English PDF.

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