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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.

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Document preview — YY/T 0923-2024

National Standard of the People's Republic of China

Issued by: National Medical Products Administration

Foreword
1 Scope
2 Normative references
3 Terms and definitions

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

......
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

Cited by

GB/T 19335-2022Blood flow products for single use — General specification

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