YY/T 0581.2-2011Infusion access adapters - Part 2: Needleless access adapters (English PDF)
输液连接件 第2部分：无针连接件
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 31, 2011
Implementation date
June 1, 2013
Scope
YY/T 0581.2-2011 is the English-translated version of 输液连接件 第2部分：无针连接件.
YY/T 0581.2 covers needleless connectors, the valved access ports that let a syringe or line be attached to a catheter without a needle. They exist to eliminate needlestick injury, and they introduced a problem of their own: an internal geometry that is hard to disinfect and hard to flush becomes a reservoir for the organisms that cause catheter-related bloodstream infection. This part sets the requirements such connectors have to meet and the test methods that verify them, covering the seal and its integrity under repeated access, flow, the priming volume and dead space, resistance to microbial ingress, and compatibility with the luer fittings they mate with. Needleless connectors are used on virtually every intravenous line in Chinese hospitals. It carries Amendment 1 of 2018.
Document preview — YY/T 0581.2-2011
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 11 April 2018 by the National Medical Products Administration and takes effect on 1 June 2013.
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 0581.2 covers needleless connectors, the valved access ports that let a syringe or line be attached to a catheter without a needle. They exist to eliminate needlestick injury, and they introduced a problem of their own: an internal geometry that is hard to disinfect and hard to flush becomes a reservoir for the organisms that cause catheter-related bloodstream infection. This part sets the requirements such connectors have to meet and the test methods that verify them, covering the seal and its integrity under repeated access, flow, the priming volume and dead space, resistance to microbial ingress, and compatibility with the luer fittings they mate with. Needleless connectors are used on virtually every intravenous line in Chinese hospitals. It carries Amendment 1 of 2018.
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.
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