YY 0104-2018Three-edged needle (English PDF)

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).

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 document. 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