GB/T 14233.3-2024 Test methods for infusion, transfusion, injection equipments for medical use - Part 3: Microbiological test methods
1 Scope
This document describes the methods for test for sterility, bacterial endotoxin test, test of bioburden, and test of sterility for infusion, transfusion, injection equipment for medical use.
This document is applicable to infusion, transfusion, injection equipment for medical use.
2 Normative references
The following documents contain requirements which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 19973.1 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
test for sterility
technical operation performed on products that have been subjected to aseptic processing or sterilization processes to examine whether they are sterile
3.2
direct inoculation method
test method for/of sterility in which the product is directly immersed in liquid medium for incubation
3.3
membrane filtration method
test method for/of sterility in which the eluate obtained after eluting liquid products or non-liquid products with a rinsing fluid is subjected to membrane filtration, and the filter membrane is then cultured
3.4
medium filling method
test method for/of sterility in which liquid medium is filled into the internal cavity or passage of the product for incubation
3.5
medium elution method
test method for/of sterility in which microorganisms that may be present on the product are eluted using liquid medium, and the elution medium is collected and incubated
3.6
bacterial endotoxin test
method that utilizes the Tachypleus Amebocyte Lysate (TAL) to detect or quantify bacterial endotoxins produced by Gram-negative bacteria, in order to determine whether the product meets the specified limits for bacterial endotoxins
3.7
endotoxin limit
maximum acceptable amount of endotoxin in the product or in a test solution prepared from the product
3.8
test of bioburden
test method used to determine the total number of viable microorganisms on a product
3.9
sample item portion; SIP
specified part of a health care product that is tested
[Source: ISO 11139:2018, 3.244]
3.10
recovery efficiency
measure of the ability of a specified technique to remove, collect and/or culture microorganisms from a product
[Source: ISO 11139:2018, 3.228]
3.11
bioburden correction factor
numerical value applied to a viable count to compensate for incomplete removal of microorganisms from a product and/or failure to culture microorganisms
[Source: ISO 11139:2018, 3.24]
3.12
bioburden estimate
value established by applying a bioburden correction factor to a bioburden count
[Source: ISO 11139:2018, 3.25]
Foreword III
Introduction IV
1 Scope
2 Normative references
3 Terms and definitions
4 Test for sterility
4.1 Materials and instruments
4.2 Test environment
4.3 Method development and validation
4.4 Test specimen testing
5 Bacterial endotoxin test
5.1 Materials and instruments
5.2 Test environment
5.3 Method development and validation
5.4 Test specimen testing
5.5 Test report
6 Test of bioburden
6.1 Materials and instruments
6.2 Test environment
6.3 Method development and validation
6.4 Product testing
7 Test of sterility
7.1 Materials and instruments
7.2 Test environment
7.3 Method development and validation
7.4 Product testing
Bibliography
Standard
GB/T 14233.3-2024 Test methods for infusion, transfusion, injection equipments for medical use—Part 3: Microbiological test methods (English Version)
Standard No.
GB/T 14233.3-2024
Status
valid
Language
English
File Format
PDF
Word Count
10500 words
Price(USD)
315.0
Implemented on
2026-11-1
Delivery
via email in 1 business day
Detail of GB/T 14233.3-2024
Standard No.
GB/T 14233.3-2024
English Name
Test methods for infusion, transfusion, injection equipments for medical use—Part 3: Microbiological test methods
GB/T 14233.3-2024 Test methods for infusion, transfusion, injection equipments for medical use - Part 3: Microbiological test methods
1 Scope
This document describes the methods for test for sterility, bacterial endotoxin test, test of bioburden, and test of sterility for infusion, transfusion, injection equipment for medical use.
This document is applicable to infusion, transfusion, injection equipment for medical use.
2 Normative references
The following documents contain requirements which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 19973.1 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
test for sterility
technical operation performed on products that have been subjected to aseptic processing or sterilization processes to examine whether they are sterile
3.2
direct inoculation method
test method for/of sterility in which the product is directly immersed in liquid medium for incubation
3.3
membrane filtration method
test method for/of sterility in which the eluate obtained after eluting liquid products or non-liquid products with a rinsing fluid is subjected to membrane filtration, and the filter membrane is then cultured
3.4
medium filling method
test method for/of sterility in which liquid medium is filled into the internal cavity or passage of the product for incubation
3.5
medium elution method
test method for/of sterility in which microorganisms that may be present on the product are eluted using liquid medium, and the elution medium is collected and incubated
3.6
bacterial endotoxin test
method that utilizes the Tachypleus Amebocyte Lysate (TAL) to detect or quantify bacterial endotoxins produced by Gram-negative bacteria, in order to determine whether the product meets the specified limits for bacterial endotoxins
3.7
endotoxin limit
maximum acceptable amount of endotoxin in the product or in a test solution prepared from the product
3.8
test of bioburden
test method used to determine the total number of viable microorganisms on a product
3.9
sample item portion; SIP
specified part of a health care product that is tested
[Source: ISO 11139:2018, 3.244]
3.10
recovery efficiency
measure of the ability of a specified technique to remove, collect and/or culture microorganisms from a product
[Source: ISO 11139:2018, 3.228]
3.11
bioburden correction factor
numerical value applied to a viable count to compensate for incomplete removal of microorganisms from a product and/or failure to culture microorganisms
[Source: ISO 11139:2018, 3.24]
3.12
bioburden estimate
value established by applying a bioburden correction factor to a bioburden count
[Source: ISO 11139:2018, 3.25]
Contents of GB/T 14233.3-2024
Foreword III
Introduction IV
1 Scope
2 Normative references
3 Terms and definitions
4 Test for sterility
4.1 Materials and instruments
4.2 Test environment
4.3 Method development and validation
4.4 Test specimen testing
5 Bacterial endotoxin test
5.1 Materials and instruments
5.2 Test environment
5.3 Method development and validation
5.4 Test specimen testing
5.5 Test report
6 Test of bioburden
6.1 Materials and instruments
6.2 Test environment
6.3 Method development and validation
6.4 Product testing
7 Test of sterility
7.1 Materials and instruments
7.2 Test environment
7.3 Method development and validation
7.4 Product testing
Bibliography
