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YY/T 0104-2018 English PDF

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YY/T 0104-2018: Three-edged needle
Status: Valid

YY/T 0104: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 0104-2018English359 Add to Cart 4 days [Need to translate] Three-edged needle Valid YY/T 0104-2018
YY/T 0104-2018English359 Add to Cart 4 days [Need to translate] Three-edged needle Valid YY/T 0104-2018
YY 0104-1993English279 Add to Cart 3 days [Need to translate] three edged needle Obsolete YY 0104-1993

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Basic data

Standard ID YY/T 0104-2018 (YY/T0104-2018)
Description (Translated English) Three-edged needle
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C42
Classification of International Standard 11.040.60
Word Count Estimation 16,129
Date of Issue 2018-06-26
Date of Implementation 2019-07-01
Issuing agency(ies) State Drug Administration
Summary This standard specifies the structure, classification and specifications, requirements, test methods, packaging, marking, instruction manual, transportation and storage of triangular needles. This standard applies to the three-edged needles used in three-edged acupuncture therapy.

YY/T 0104-2018: Three-edged 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 11:040:60 C42 Pharmaceutical Industry Standard of the People's Republic of China YY 0104-2018 Replace YY 0104-1993 Three-edged needle According to the State Drug Administration medical device industry Standard Announcement (No: 76 of 2022), this standard is from From September 7, 2022, it will be converted into a recommended standard, no Enforce it again: Released on:2018-06-26 2019-07-01 Implementation Released by the State Drug Administration

table of contents

Preface III 1 Scope 1 2 Normative references 1 3 Structure, Classification and Specification 1 4 Requirements 2 5 Test method 3 6 packs of 4 7 Logo, instruction manual 5 8 Transport and storage6 Appendix A (informative appendix) Guidelines for materials 7 Appendix B (Normative Appendix) Puncture force test method 8 Appendix C (Informative Appendix) Inspection Rules 10 Reference 12 YY 0104-2018

foreword

4:1 of this standard is a recommended clause, and the rest are mandatory clauses: This standard is drafted in accordance with the rules given in GB/T 1:1-2009: This standard replaces YY 0104-1993 "Three-edged Needle": Compared with YY 0104-1993, there are major technical changes except editorial revisions as follows: --- Modified the requirements for the specifications and dimensions of the three-edged needle (see 3:3, 4:1, 3:2, 3:3, 4:2 of the:1993 edition); --- Modified the requirements and test methods for surface roughness (see 4:3, 5:3, 4:10, 5:2 of the:1993 edition); --- Added the requirements and test methods for needle tip penetration force (see 4:4, Appendix B); --- Increased the requirements for the connection firmness of the non-integrated triangular rib (see 4:5); --- Increased the sterility requirements for single-use sterile triangular needles (see 4:7); --- Added the requirement for ethylene oxide residue for single-use sterile triangular needles (see 4:8); --- Added requirements for biocompatibility (see 4:9); --- Modified the packaging, signs, instructions for use and storage requirements (see Chapter 6, Chapter 7, Chapter 8, Chapter 7 of the:1993 edition); --- Added Appendix A; --- Modified the content of the inspection rules (see Appendix C, Chapter 6 of the:1993 edition); --- Deleted the requirements for the manufacturing materials of the three-edged needle (4:3 of the:1993 edition): Please note that some contents of this document may refer to patents: The issuing agency of this document assumes no responsibility for identifying these patents: This standard was proposed by the State Drug Administration: This standard is under the jurisdiction of the Physical Therapy Equipment Sub-Technical Committee (SAC/TC10/SC4) of the National Medical Electrical Appliances Standardization Technical Committee: This standard was drafted: Tianjin Medical Device Quality Supervision and Inspection Center, Suzhou Medical Supplies Factory Co:, Ltd: The main drafters of this standard: Zhang Haiming, Qi Lijing, Zhang Yun, Qian Xuebo, Xu Aimin: The previous releases of the standards replaced by this standard are as follows: ---YY 0104-1993: YY 0104-2018 Three-edged needle

1 Scope

This standard specifies the structure, classification and specifications, requirements, test methods, packaging, marking, instruction manual, transportation and storage of triangular needles: This standard is applicable to the three-edged needle used for three-edged acupuncture therapy:

2 Normative references

The following documents are indispensable for the application of this document: For dated references, only the dated version applies to this document pieces: For undated references, the latest version (including all amendments) applies to this document: GB/T 191-2008 Packaging, storage and transportation icon marks GB/T 4340:1-2009 Vickers hardness test for metallic materials - Part 1: Test method GB/T 9969 General Rules for Instructions for Use of Industrial Products GB/T 10610-2009 Product Geometric Specifications (GPS) Surface Structure Profile Method Evaluation of Surface Structure Rules and method GB/T 14233:1-2008 Test methods for medical infusion, blood transfusion and injection equipment Part 1: Chemical analysis methods GB/T 14233:2-2005 Test methods for medical infusion, blood transfusion and injection equipment Part 2: Biological test methods GB/T 16886:1-2011 Biological evaluation of medical devices Part 1: Evaluation and testing in the risk management process YY/T 0149-2006 Test method for corrosion resistance of stainless steel medical devices YY/T 0466:1 Symbols for Medical Device Labeling, Marking and Information Provision for Medical Devices Part 1: General Requirements 3 Structure, classification and specification 3:1 Structure The typical structure of the three-edged needle and the names of its components are shown in Figure 1: illustrate: L1---full length; L2---needle tip length; D --- needle outer diameter; d --- Outer diameter at the widest point of the needle tip: Fig:1 Typical structure diagram of triangular needle 3:2 Classification According to whether it is sterile or not, three-edged needles can be divided into two types: sterile and non-sterile: According to the combination of the needle point and the needle handle, the three-edged needle can be YY 0104-2018

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