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YY/T 0923-2024: Test method for microbial ingress on infusion access adapters for fluid lines and blood lines
Status: Valid YY/T 0923: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0923-2024 | English | 209 |
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Test method for microbial ingress on infusion access adapters for fluid lines and blood lines
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YY/T 0923-2024
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| YY/T 0923-2014 | English | 155 |
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Needleless accedd ports for fluid lines and blood lines. Test method for microbial ingress
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YY/T 0923-2014
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Basic data | Standard ID | YY/T 0923-2024 (YY/T0923-2024) | | Description (Translated English) | Test method for microbial ingress on infusion access adapters for fluid lines and blood lines | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.080.01 | | Word Count Estimation | 10,149 | | Date of Issue | 2024-07-08 | | Date of Implementation | 2025-07-20 | | Older Standard (superseded by this standard) | YY/T 0923-2014 | | Issuing agency(ies) | State Drug Administration | YY/T 0923-2024: Test method for microbial ingress on infusion access adapters for fluid lines and blood lines
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.080.01
CCSC31
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY/T 0923-2014
Microbial intrusion test method for connectors for liquid and blood circuits
bloodlines
Released on 2024-07-08
2025-07-20 Implementation
The State Drug Administration issued
Table of Contents
Preface III
Introduction IV
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Instruments and Reagents 1
5 Test strains 1
6 Sampling 2
7 Test method 2
8 Quality Control 3
9 Test Report 3
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting.
This document replaces YY/T 0923-2014 "Test Method for Microbial Invasion of Needleless Interfaces for Liquid and Blood Paths" and is compatible with YY/T 0923-2014
Compared with the previous version, in addition to structural adjustments and editorial changes, the main technical changes are as follows.
a) Added "Piercing connector (heparin cap)" in "Scope" (see Chapter 1);
b) "Test Principles" was deleted (see Chapter 4 of the.2014 edition);
c) The requirements for “test strains” have been changed (see Chapter 5, Chapter 6 of the.2014 edition);
d) Deleted the general provisions in “Test methods” (see 8.1 of the.2014 edition);
e) Added the methods of “piercing connector (heparin cap)” and “sterilization cap” in “single test” (see 7.1);
f) Changed the requirements for repeated tests in "Test methods" (see 7.2, 8.2.5 of the.2014 edition);
g) Added general requirements for “quality control” (see 8.1);
h) The test method and requirements for “positive control” have been changed (see 8.2, 8.3 of the.2014 edition);
i) The test method and requirements for “negative control” have been changed (see 8.3, 8.4 of the.2014 edition).
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document is under the jurisdiction of the National Technical Committee for Standardization of Medical Infusion Equipment (SAC/TC106).
This document was drafted by. Shandong Medical Device and Drug Packaging Inspection Institute, Henan Tuoren Medical Device Group Co., Ltd., Shandong
Ande Medical Supplies Co., Ltd., Lepu (Beijing) Medical Devices Co., Ltd., B. Braun Medical (Shanghai) International Trading Co., Ltd.,
Wuhan Zhixun Chuangyuan Technology Development Co., Ltd. and Jiangxi Sanxin Medical Technology Co., Ltd.
The main drafters of this document are. Fang Liangyan, Wang Wenqing, Zhang Jing, Yu Haiyan, Yang Tingru, Sun Yun, Wu Qiyu, Wang Yi, Luan Tongqing, and Li Chunqiao.
The previous versions of this document and the documents it replaces are as follows.
---First published in.2014 as YY/T 0923-2014;
---This is the first revision.
Introduction
Connectors for infusion and blood transfusion are usually divided into puncture connectors and needleless connectors, which are mainly used for the connection and sealing of infusion and blood transfusion lines.
Seal, used with indwelling needles, central venous catheters and other instruments. In clinical practice, the connectors need to be disinfected according to the manufacturer's regulations before each use.
If the connector has design defects that are not conducive to disinfection, the disinfection procedure is unreasonable, etc., the microorganisms at the connection may
It may enter the infusion and blood transfusion lines, causing catheter-related bloodstream infection.
The microbial invasion test uses artificial contamination to replace natural contamination microorganisms, and inoculates the connector with common clinical blood-borne infection microorganisms.
The microorganisms were disinfected according to the disinfection procedures specified by the manufacturer, and microorganisms were collected by simulating clinical infusion, blood transfusion, tube flushing, tube sealing, etc.
Biological tests are carried out to evaluate the design of the connector and the disinfection procedures specified by the manufacturer.
Microbial intrusion test method for connectors for liquid and blood circuits
1 Scope
This document describes the test method for microbial intrusion into connectors used in fluid and blood circuits.
This document applies to needle-free connectors and puncture connectors (heparin caps) for infusion and blood transfusion.
2 Normative references
The contents of the following documents constitute essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
YY/T 0581.1 Infusion connectors Part 1.Piercing connectors (heparin caps)
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Microbial invasion
During clinical use, microorganisms enter the sterile infusion and blood transfusion circuits through connectors.
4.Instruments and reagents
4.1 Filter device, equipped with sterile filter cup.
4.2 Constant temperature incubator.
4.3 Biological safety cabinet.
4.4 Pipette.
4.5 Sterile syringe, 10mL.
4.6 Sterile injection needles shall comply with the requirements for injection needles in YY/T 0581.1.
4.7 Sterile microporous filter membrane, nominal pore size 0.45 μm.
4.8 Disinfectant, to be specified by the manufacturer.
4.9 Sterile sodium chloride injection.
4.10 Tryptic Soy Agar (TSA).
5 Experimental strains
It is advisable to use two Gram-negative bacteria and two Gram-positive bacteria for the test. The recommended test strains are shown in Table 1.
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