YY/T 0923-2024 Test method for microbial ingress on infusion access adapters for fluid lines and blood lines
1 Scope
This document specifies the test method for microbial ingress on infusion access adapters for fluid lines and blood lines.
It is applicable to needleless access adapters for infusion and transfusion and needle access adapters (heparin plugs).
2 Normative references
The following documents contain provisions 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.
YY/T 0581.1 Infusion access adapters - Part 1: Needle access adapters (heparin plugs)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
microbial ingress
process in which microorganisms enter sterile infusion and transfusion lines through access adapters during clinical use
4 Apparatus and reagents
4.1 Filter device, matched with sterile filter cup.
4.2 Thermostatic incubator.
4.3 Biological safety cabinet.
4.4 Pipettor.
4.5 Sterile hypodermic syringe, 10mL.
4.6 Sterile hypodermic needle, which shall meet the requirements of YY/T 0581.1.
4.7 Sterile microporous membrane, with the nominal pore size of 0.45μm.
4.8 Disinfectant, as specified by the manufacturer.
4.9 Sterile sodium chloride injection.
4.10 Soybean-casein digest agar medium (TSA).
5 Test strains
The test should be carried out using two kinds of gram-negative bacteria and two kinds of gram-positive bacteria respectively. The recommended test strains are shown in Table 1.
Table 1 Recommended test strains
Strain classification Name of strain
Gram-positive bacteria Staphylococcus epidermidis
Staphylococcus aureus
Gram-negative bacteria Pseudomonas aeruginosa
Klebsiella pneumoniae
Other common microorganisms causing clinical infusion and transfusion infection may also be used.
6 Sampling
The test samples shall be randomly taken from the sterilized finished products.
7 Test method
7.1 Single test
7.1.1 Inoculation
Foreword i
Introduction iii
1 Scope
2 Normative references
3 Terms and definitions
4 Apparatus and reagents
5 Test strains
6 Sampling
7 Test method
8 Quality control
9 Test report
