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

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 […]