YY/T 0104-2018 English PDFUS$359.00 ยท In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0104-2018: Three-edged needle Status: Valid YY/T 0104: Historical versions
Basic dataStandard 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 contentsPreface 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 0104-2018foreword4:1 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 needle1 ScopeThis 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 referencesThe 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 ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0104-2018_English be delivered?Answer: Upon your order, we will start to translate YY/T 0104-2018_English as soon as possible, and keep you informed of the progress. 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Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.Question 5: Should I purchase the latest version YY/T 0104-2018?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 0104-2018 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically. |
