YY/T 0923-2024Test method for microbial ingress on infusion access adapters for fluid and blood lines (English PDF)
液路、血路用连接件微生物侵入试验方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
July 8, 2024
Implementation date
July 20, 2025
Scope
YY/T 0923-2024 is the English-translated version of 液路、血路用连接件微生物侵入试验方法.
YY/T 0923 is the test method for microbial ingress through the connectors used on fluid and blood lines. It answers the question that decides whether a needleless connector or an access adapter is safe in practice: not whether it is sterile when it leaves the factory, but whether organisms can travel through it into the line during days of repeated access in a ward. The method challenges the connector under conditions meant to represent use and looks for what gets through. It is the safety counterpart to the product standard YY/T 0581.2 on needleless access adapters. For a manufacturer or an importer of connectors, access adapters and closed systems for the Chinese market, this is the method behind a microbial ingress claim.
Document preview — YY/T 0923-2024
National Standard of the People's Republic of China
Issued by: National Medical Products Administration
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- About this edition
- Classification and status
- How a Chinese national standard is set out
- About this English translation
Foreword
This document was issued on 8 July 2024 by the National Medical Products Administration and takes effect on 20 July 2025.
It is a YY/T standard: it is recommended rather than compulsory, but it is the method a Chinese reviewer applies when assessing a registration submission.
1 Scope
YY/T 0923 is the test method for microbial ingress through the connectors used on fluid and blood lines. It answers the question that decides whether a needleless connector or an access adapter is safe in practice: not whether it is sterile when it leaves the factory, but whether organisms can travel through it into the line during days of repeated access in a ward. The method challenges the connector under conditions meant to represent use and looks for what gets through. It is the safety counterpart to the product standard YY/T 0581.2 on needleless access adapters. For a manufacturer or an importer of connectors, access adapters and closed systems for the Chinese market, this is the method behind a microbial ingress claim.
Remaining clauses in the full document
- 2 Normative references
- 3 Terms and definitions
- About this edition
- Classification and status
- How a Chinese national standard is set out
- About this English translation
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
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YY/T 0923-2024
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