1   范围

1   Scope

YY/T 0573的本部分规定了在输送至预设的疫苗剂量时，会自动失效的一次性使用无菌注射器 (以下简称注射器）的术语和定义、命名、物理要求、化学要求、生物要求、包装和标志等。

This part of YY/T 0573 specifies the terms and definitions, nomenclature, physical, chemical, biological requirements, packing and labeling of sterile single-use hypodermic syringes (hereinafter referred to as the syringe) that will be passively and automatically rendered after delivery of a nominal fixed dose of vaccine.

本部分适用于由塑料材料和不锈钢材料制成的供抽吸疫苗或注人疫苗后立即注射用的带针或不带针的一次性使用无菌注射器。

This part is applicable to the sterile single-use hypodermic syringes intended to aspirate or inject a fixed dose of vaccine immediately after filling. The syringes can be made of plastic and stainless steel and can be with or without needle.

本部分不适用于胰岛素注射器、玻璃注射器、带动力驱动注射栗的注射器、不固定剂量的自毁型注射器以及预装药液的注射器。

This part is not applicable to syringes for use with insulin, syringes made of glass, syringes for use with power-driven syringe pumps, auto-disable syringes for not fixed dose or syringes designed to be prefilled.

2   规范性引用文件

2   Normative References

下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件，仅注日期的版本适用于本文件。凡是不注日期的引用文件，其最新版本（包括所有的修改単)适用于本文件。

The following documents are indispensable for the application of this document. For all dated references, only the dated editions are applicable to this document. For undated references, the latest edition (all revision lists included) is applicable to this document.

GB/T 191—2008 包装储运图示标志（ISO 780:1997，MOD）

GB/T 191-2008      Packaging - Pictorial marking for handling of goods (ISO 780:1997, MOD)

GB/T 6682—2008 分析实验室用水规格和试验方法（ISO 3696:1987,MOD）

GB/T 6682-2008    Water for analytical laboratory use - Specification and test methods (ISO 3696:1987, MOD)

GB/T14233.1—2008 医用输液、输血、注射器具检验方法 第一部分：化学分析方法

GB/T 14233.1-2008       Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods

GB/T14233.2 医用输液、输血、注射器具检验方法 第2部分：生物学试验方法

GB/T14233.2  Test methods for infusion, transfusion and injection equipment for medical use - Part 2: Biological test methods

GB15810 —次性使用无菌注射器

GB 15810       Sterile hypodermic syringes for single use

GB15811—2016 一次性使用无菌注射针（ISO 7864：1993，NHQ）

GB 15811-2016     Sterile hypodermic needles for single use (ISO 7864:1993, NEQ)

GB/T 18457—2015 制造医疗器械用不锈钢针管(ISO 9626:1991/Amd.1:2001,MOD)

GB/T 18457-2015  Stainless steel needle tubing for the manufacture of medical devices (ISO 9626:1991/Amd.1:2001, MOD)

YY/T 0466.1 医疗器械 用于医疗器械标签、标记和提供信息的符号 第1部分：通用要求 (YY/T 0466.1—201 6,ISO 15223-1：2012,IDT)

YY/T 0466.1  Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 1: General requirements (YY/T 0466.1-2016, ISO 15223-1:2012, IDT)

3   术语和定义

3     Terms and definitions

GB15810界定的以及下列术语和定义适用于本文件。

For the purposes of this document, the terms and definitions given in GB15810 and the following apply.

预设的固定剂量注射完毕时，自毁性能自动起作用，以防止注射器和针的再次使用的特性。

feature that passively activates upon delivering injection of the nominal fixed dose to prevent subsequent reuse of the syringe and the needle.