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YY/T 1148-2024 English PDF

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YY/T 1148-2024: Spinal needle
Status: Valid

YY/T 1148: Historical versions

Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
YY/T 1148-2024289 Add to Cart 3 days Spinal needle Valid
YY/T 1148-2009209 Add to Cart 3 days Spinal needle Valid

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Basic data

Standard ID: YY/T 1148-2024 (YY/T1148-2024)
Description (Translated English): Spinal needle
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C31
Classification of International Standard: 11.040.20
Word Count Estimation: 14,121
Date of Issue: 2024-07-08
Date of Implementation: 2025-07-20
Older Standard (superseded by this standard): YY/T 1148-2009
Issuing agency(ies): State Drug Administration

YY/T 1148-2024: Spinal 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 1148-2009 Lumbar puncture 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 2 4.3 Mark 3 5 Materials 3 6 Requirements and test methods 3 6.1 Appearance 3 6.2 Size 3 6.3 Needle seat, bushing seat 3 6.4 Needle 3 6.5 Needle tip 4 6.6 Coordination 4 6.7 Connection firmness 4 6.8 scale line 4 7 Sterilization 5 8 Logo 5 8.1 Primary packaging 5 8.2 Rack or multi-unit packaging 5 9 Packaging 5 10 Transportation and storage 5 References 6

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 1148-2009 "Lumbar Puncture Needle". Compared with YY/T 1148-2009, except for structural adjustments and editorial changes, In addition to the above, the main technical changes are as follows. a) The scope has been changed (see Chapter 1, Chapter 1 of the.2009 edition); b) Added material requirements (see Chapter 4); c) Added appearance requirements (see 5.1); d) Added integrity requirements (see 5.3); e) Added scale line requirements (see 5.7); f) Sterilization requirements have been added (see Chapter 6). 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 Institute of Medical Device Inspection, Shanghai Ess Medical Technology Co., Ltd., 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 Rui, Hua Songhe, Wang Dan, Sun Hongrong, Liu Mian, Zhang Qian, Su Weidong, Zhu Yizhong and Zhang Shuwen. The previous versions of this document and the documents it replaces are as follows. ---First published in 1977 as YY/T 1148-1977, first revised in.2009; ---This is the second revision. Lumbar puncture needle

1 Scope

This document specifies the nominal outer diameter of 0.40mm~1.60mm for use in human subarachnoid block (abbreviated as lumbar anesthesia). Requirements for lumbar puncture needles (abbreviated as lumbar puncture needles) used for puncture and injection of medicinal solutions. This document applies to reusable lumbar puncture needles. This document does not apply to single-use lumbar puncture needles for anesthesia.

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 18457 Stainless steel needle tubes for medical device manufacturing YS/T 76 Lead Brass Drawing Rod YY/T 0916.6 Small-bore connectors for medical liquids and gases Part 6.Connectors for axial applications

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 structure and component names of the lumbar puncture needle are shown in Figure 1.
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