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YY 0104-2018: Three-edged needle
Status: Obsolete YY 0104: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY 0104-2018 | English | 599 |
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Three-edged needle
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YY 0104-2018
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| YY/T 0104-2018 | English | 359 |
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Three-edged needle
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YY/T 0104-2018
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| YY 0104-1993 | English | 279 |
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three edged needle
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YY 0104-1993
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PDF similar to YY 0104-2018
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Count Estimation | 15,143 | | Date of Issue | 2018-06-26 | | Date of Implementation | 2019-07-01 | | Older Standard (superseded by this standard) | YY 0104-1993 | | Regulation (derived from) | State Drug Administration Announcement No. 40 of 2018 | | Issuing agency(ies) | State Drug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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