GB/T 1962.1-2015 in English

《GB/T 1962.1-2015注射器、注射针及其他医疗器械6%（鲁尔）圆锥接头 第1部分：通用要求》由TC95（全国医用注射器（针）标准化技术委员会）归口，主管部门为国家药品监督管理局。
GB/T 1962的本部分规定了注射器、注射针及其他医疗器械6%（鲁尔）圆锥接头通用要求的尺寸、要求、试验方法。?本部分适用于刚性和半刚性的注射器、注射针及其他医疗器械6%（鲁尔）圆锥接头通用要求（以下简称圆锥接头）。不适用于较柔软的或弹性体材料制成的6%（鲁尔）圆锥接头。?图1所示的是典型的6%（鲁尔）外圆锥接头（外接头）和6%（鲁尔）内圆锥接头（内接头）。?注： 虽然要精确的定义刚性或半刚性材料的特性有一定难度，但通常将玻璃和金属当作典型的刚性材料。与之相对照，虽然壁厚是影响部件刚性的重要因素，但许多塑料被当作是半刚性材料。

Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment — Part 1: General Requirement

1 Scope

This part of GB/T 1962 specifies dimensions, requirements and test methods for conical fittings with a 6% (Luer) taper for use with hypodermic syringes and needles and with certain other apparatus for medical use.

This part is applicable to conical fittings made of rigid and of semi-rigid materials and with a 6% (Luer) taper for use with hypodermic syringes and needles and with certain other apparatus for medical use (hereinafter referred to as conical fittings). It is not applicable to conical fittings with a 6% (Luer) taper and made of more flexible or elastomeric materials.

Figure 1 illustrates typical male 6% (Luer) conical fitting (“male fitting”) and female 6% (Luer) conical fitting (“female fitting”).

Note: It is not practicable to define the characteristics of rigid or semi-rigid materials with precision, but glass and metal may be considered as typical rigid materials. By contrast, many plastic materials may be regarded as semi-rigid although the wall thickness is an important factor influencing the rigidity of a component.

2 Normative References

The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 7886 Sterile Hypodermic Syringes for Single Use

Foreword II
1 Scope
2 Normative References
3 Dimensions
4 Requirements
5 Test Methods
Annex A (Informative) Liquid Leakage