针灸针电子书

Preface

Introduction

1 Scope

2 Normative References

3 Term s and Definitions

3.1 Body of the Needle

3.2 Hand le of the Need le

3.3 Tip of the Need le

3.4 Root of the Needle

3.5 Tail of the Needle

3.6 Sterile Acupuncture Need les

3.7 Un-sterilized Acupuncture Need les

3.8 Guide Tube

3.9 Hardness of Need le Body

3.10 Primary Package

3.11 Secondary Package

4 Classification

5 Requirements

6 Test Methods

6.1 Appearance

6.2 Surface Coarseness

6.3 Measurement

6.4 Function

6.4.1 Hardness Test

6.4.2 Test for Needle Tip Strength,Sharpness and Puncture Performance

6.4.3 Test for Resilience of the Need le Body.

6.4.4 Test for the Firmness of the Connecting between the Needle Body and the Hand le

6.4.5 Test for Protuberances on the Needle Handle

6.4.6 Test for the Corrosive Nature of the Needle Body

6.4.7 Test of Sterility

7 Packaging

8 Labelling

8.1 Primary Package

8.2 Secondary Package

9 Storage and Transport

Annex A (Normative) Test M ethods for the Strength and Sharpness of the Acupuncture Need le Tip

A.1 Definitions

A.2 Apparatus for Measuring the Strength and Sharpness of the Acupuncture Needle Tip

A.3 The Steel Block of the Strength of the Sam ple Acupuncture Needle Tip

A.4 The Alum inum Foil of the Measuring Apparatus Used to Test the Sharpness of the Acupuncture Needle Tip

A.5 Test Methods

Annex B (Normative) Test M ethods for the Puncture Performance of the Acupuncture Need le Tip

B.1 Method 1:Test Method of the Qualitative

B.2 Method 2:Test Method of the Quantitative

B.2.1 The Testing Apparatus for Evaluating Puncture Force

B.2.2 The Polymerized Film Materials

B.2.3 The Steps for Evaluating Puncture Force

B.2.4 Recording the Peak Values of the Coordinate Figures

B.3 The Results Indicate

B.4 Diagram of the Typical Features of the Need le Piercing Through the Film

B.5 Diagram of the Need le's Typical Puncture Force(F0、F1、F2)

Annex C (Normative) Test M ethod for Corrosion Resistance——Testing w ith Citric Acid Solution

C.1 Test Instruments

C.2 Reagent

C.3 Preparation

C.3.1 TestWater

C.3.2 Citric Acid Solution Com pound

C.3.3 Preparation

C.4 Test Procedure

C.5 Test Evaluation

Annex D (Informative) References

前 言

引 言

1 范围

2 规范性引用文件

3 术语与定义

3.1 针体

3.2 针柄

3.3 针尖

3.4 针根

3.5 针尾

3.6 无菌针灸针

3.7 未灭菌针灸针

3.8 导管

3.9 针体硬度

3.10 初包装

3.11 中包装

4 分类

5 要求

6 试验方法

6.1 外观

6.2 表面粗糙度

6.3 尺寸

6.4 性能

6.4.1 硬度试验

6.4.2 针尖强度和锋利度、穿刺性能试验

6.4.3 针体韧性试验

6.4.4 针体与针柄连接牢固度试验

6.4.5 针柄毛刺试验

6.4.6 针体耐腐蚀性能试验

6.4.7 无菌试验

7 包装

8 标志、使用说明书

8.1 单支包装或单元包装的初包装

8.2 中包装

9 运输、贮存

附 录 A(规范性附录)针灸针针尖强度和锋利度测试

A.1 定义

A.2 针灸针针尖强度和锋利度测定仪

A.3 试验针灸针针尖强度的钢块

A.4 检验针灸针针尖锋利度测定仪用的铝箔

A.5 试验方法

附 录 B(规范性附录)针灸针针尖穿刺性能试验方法

B.1 方法一：定性试验方法

B.2 方法二：定量试验方法

B.2.1 穿刺力评价用试验仪器

B.2.2 聚合膜材料

B.2.3 穿刺力评价试验步骤

B.2.4 记录坐标图中的峰值力

B.3 结果表示

B.4 针穿刺膜材典型特征坐标图

B.5 典型的针穿刺力F0、F1、F2坐标图

附 录 C(规范性附录)耐腐蚀性能试验方法——柠檬酸溶液试验法

C.1 试验器具

C.2 试剂

C.3 准备

C.3.1 试验用水

C.3.2 柠檬酸溶液配制

C.3.3 准备

C.4 试验步骤

C.5 试验评价

附 录 D(资料性附录)文献目录