YY/T 0282-2024 English PDF

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YY/T 0282-2024: Syringe needle
Status: Valid

YY/T 0282: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0282-2024	369	Add to Cart	4 days	Syringe needle	Valid
YY/T 0282-2009	150	Add to Cart	Auto, < 3 mins	Syringe needle	Valid
YY/T 0282-1995	359	Add to Cart	3 days	Injection needles	Obsolete

Similar standards

YY 0285.1   YY 0285.3   YY 0285.4   YY/T 0286.5   YY/T 0285.6   

Basic data

Standard ID: YY/T 0282-2024 (YY/T0282-2024)
Description (Translated English): Syringe needle
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C31
Classification of International Standard: 11.040.20
Word Count Estimation: 18,152
Date of Issue: 2024-07-08
Date of Implementation: 2025-07-20
Older Standard (superseded by this standard): YY/T 0282-2009
Issuing agency(ies): State Drug Administration

YY/T 0282-2024: Syringe needle

---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 11.040.20 CCSC31 Pharmaceutical Industry Standards of the People's Republic of China Replaces YY/T 0282-2009 Injection needle Released on 2024-07-08 2025-07-20 Implementation The State Drug Administration issued

Table of Contents

Preface III 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Structure and classification 1 4.1 Structural type 1 4.2 Basic dimensions of injection needles 2 4.3 Mark 2 5 Materials 3 6 Requirements and test methods 3 6.1 Appearance 3 6.2 Size 3 6.3 Cleaning 3 6.4 Integrity 3 6.5 Needle tip 3 6.6 Needle Seat 3 6.7 Leakage 3 6.8 Needle tube rigidity 3 6.9 Needle tube toughness 3 6.10 Needle tube corrosion resistance 4 6.11 Connection firmness 4 6.12 Patency 4 7 Sterilization 4 8 Logo 5 9.1 Primary packaging 5 9.2 Rack or multi-unit packaging 5 9 Packaging 5 10 Transportation and storage 5 Appendix A (Informative) Guidelines for the Use of Injection Needles 6 Appendix B (Informative) Needle tip geometry and designations for injection needles 7 Appendix C (Informative) Injection needle penetration force test and evaluation method 8 Reference 10

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 0282-2009 "Injection Needles". Compared with YY/T 0282-2009, except for structural adjustments and editorial changes, In addition, the main technical changes are as follows. a) The scope has been changed (see Chapter 1, Chapter 1 of the.2009 edition); b) Added basic size specifications of injection needles (see Table 1); c) Added material requirements (see Chapter 5); d) Added appearance requirements (see 6.1); e) Added integrity requirements (see 6.3); f) Added leakage requirements (see 6.6); g) Sterilization requirements have been added (see Chapter 7). 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 Syringes (Needles) (SAC/TC95). This document was drafted by. Shanghai Ess Medical Technology Co., Ltd., Shanghai Medical Device Inspection Institute, Zhejiang Kangdelai Medical Devices Medical Devices Co., Ltd., Zhejiang Fulte Medical Devices Co., Ltd., and Xinjiang Uygur Autonomous Region Drug Inspection Institute. The main drafters of this document are. Sun Hongrong, Li Ruirui, Hua Songhe, Sun Rui, Wang Dan, Zhang Qian, Su Weidong, Zhang Shuwen and Zhu Yizhong. The previous versions of this document and the documents it replaces are as follows. ---First published in 1965 as YY/T 0282-1965, first revised in 1980, second revised in 1988, third revised in.1995 The fourth revision was in.2009; ---This is the fifth revision. Injection needle

1 Scope

This document specifies the nominal outer diameter of 0.40mm~1.60mm, which is used for injection of drugs in human body subcutaneously, intradermally, intramuscularly, intravenously, orally, etc. Requirements for needles for injections, vaccines, anesthetics, or intravenous infusions and blood transfusions. This document applies to reusable needles. This document does not apply to sterile injection needles for single use.

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. GB/T 191 Pictorial markings for packaging, storage and transportation GB/T 1962.1 6% (Luer) cone connectors for syringes, needles and other medical devices Part 1.General requirements GB/T 1962.2 6% (Luer) cone connectors for syringes, needles and other medical devices Part 2.Locking connectors GB/T 18457 Stainless steel needle tubes for medical device manufacturing YS/T 76 Lead Brass Drawing Rod

3 Terms and definitions

There are no terms or definitions that require definition in this document.

4 Structure and classification

4.1 Structural type The injection needle structure and component names are shown in Figure 1. ......

Image     

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