YY 0104-2018 English PDF

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YY 0104-2018: Three-edged needle
Status: Obsolete

YY 0104: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY 0104-2018	599	Add to Cart	3 days	Three-edged needle	Obsolete
YY/T 0104-2018	359	Add to Cart	4 days	Three-edged needle	Valid
YY 0104-1993	279	Add to Cart	3 days	three edged needle	Obsolete

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Basic data

Standard ID: YY 0104-2018 (YY0104-2018)
Description (Translated English): Three-edged needle
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: C42
Classification of International Standard: 11.040.60
Word Count Estimation: 15,143
Date of Issue: 2018-06-26
Date of Implementation: 2019-07-01
Older Standard (superseded by this standard): YY 0104-1993
Regulation (derived from): State Drug Administration Announcement No. 40 of 2018
Issuing agency(ies): State Drug Administration

YY 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.
Three-edged needle ICS 11.040.60 C42 People's Republic of China Pharmaceutical Industry Standard Replacing YY 0104-1993 Triangular needle Published on.2018-06-26 2019-07-01 implementation State Drug Administration issued

Content

Foreword III 1 Scope 1 2 Normative references 1 3 Structure, classification and specifications 1 4 Requirements 2 5 Test method 3 6 Packing 4 7 logo, instruction manual 5 8 Transportation and storage 6 Appendix A (informative) Materials Guide 7 Appendix B (normative appendix) Puncture force test method 8 Appendix C (informative) Inspection rules 10 Reference 12

Foreword

4.1 of this standard is a recommended clause, and the rest are mandatory. This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY 0104-1993 "Triangular Needle", compared with YY 0104-1993, except for editorial changes, major technical changes as follows. --- Revised the requirements for the size and size of the triangular needle (see 3.3, 4.3,.1993, 3.2, 3.3, 4.2); --- Revised the surface roughness requirements and test methods (see 4.3, 5.3,.1993 edition of 4.10, 5.2); --- Increased the requirements and test methods for needle tip penetration force (see 4.4, Appendix B); --- Added the requirement for non-integrally formed triangular edges for their connection fastness (see 4.5); --- Increased sterility requirements for disposable sterile triangular needles (see 4.7); --- Increased ethylene oxide residue requirements for single-use sterile triangular needles (see 4.8); --- Increased requirements for biocompatibility (see 4.9); ---Modified packaging, marking, 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); --- Removed the requirements for manufacturing materials for triangular needles (4.3 of.1993 edition). Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the National Medical Electrical Equipment Standardization Technical Committee Physical Therapy Equipment Subcommittee (SAC/TC10/SC4). This standard was drafted. Tianjin Medical Device Quality Supervision and Inspection Center, Suzhou Medical Products Factory Co., Ltd. The main drafters of this standard. Zhang Haiming, Qi Lijing, Zhang Wei, Qian Xuebo, Xu Aimin. The previous versions of the standards replaced by this standard are. ---YY 0104-1993. Triangular needle

1 Scope

This standard specifies the structure, classification and specifications, requirements, test methods, packaging, marking, instructions for use, transportation and storage of triangular needles. This standard applies to triangular needles for use in triangular needle therapy.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article. Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB/T 191-2008 packaging storage and transportation icon GB/T 4340.1-2009 Steel materials - Vickers hardness test - Part 1. Test methods GB/T 9969 General guidelines for the use of industrial products GB/T 10610-2009 Product Geometrical Specification (GPS) Surface structure profile method for assessing surface structure rules and method GB/T 14233.1-2008 Medical infusions, blood transfusions, injecting machines - Test methods - Part 1 GB/T 14233.2-2005 Medical infusions, blood transfusions, injecting machines - Test methods - Part 2 GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management YY/T 0149-2006 Test method for corrosion resistance of stainless steel medical instruments YY/T 0466.1 Medical devices for use in medical devices - Labels, markings and information provided - Part 1 . General requirements 3 Structure, classification and specifications 3.1 Structure The typical structure of the triangular needle and the name of each component are shown in Figure 1. Description. L1---all lengths; L2---tip length; D --- needle body outer diameter; d --- The outer diameter of the needle tip is the widest. Figure 1 Typical structure of a triangular needle 3.2 Classification According to whether it is aseptic, the triangular needle can be divided into sterile and non-sterile. According to the combination of the needle tip and the needle handle, the triangular needle can be ......

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