YY/T 0282-2024Syringe needles (English PDF)

注射针

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

July 8, 2024

Implementation date

July 20, 2025

Scope

YY/T 0282-2024 is the English-translated version of 注射针.

YY/T 0282 is the product standard for the hypodermic syringe needle, one of the highest-volume medical devices in existence and one where the requirements are almost entirely dimensional and mechanical. What matters is the bore and its consistency, the sharpness and geometry of the bevel that decide the force of penetration and the pain that follows, the strength of the bond between cannula and hub, and the resistance of the cannula to bending and breaking. Sterility, particulate cleanliness and the lubricant on the surface complete the picture. The 2024 edition takes effect on 20 July 2025. For a manufacturer or an importer of needles for the Chinese market, this is the standard the product specification and the registration test report follow.

Document preview — YY/T 0282-2024

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
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

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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