2    规范性引用文件

2    Normative Reference

      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（包括所有的修改单）适用于本文件。

The following referenced documents are indispensable for the application of this document. For dated references, only the dated edition is applicable to this document. For undated references, the latest edition (including all the revisions) is applicable to this document.

GB/T1962.1      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

GB/T 1962.1   Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirement

GB/T1962.2      注射器、注射针及其他医疗器械6%(鲁尔)圆锥接头   第2部分:锁定接头

GB/T 1962.2   Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings

GB/T6682         分析实验室用水规格和试验方法

GB/T 6682   Water for analytical laboratory use - Specification and test methods

GB8368            一次性使用输液器    重力输液式

GB 8368   Infusion sets for single use, gravity feed

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

GB/T 14233.1   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/T 14233.2   Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods

GB15810          一次性使用无菌注射器

GB 15810   Sterile hypodermic syringes for single use

GB15811           一次性使用无菌注射针

GB 15811   Sterile hypodermic needles for single use

GB/T16886.1     医疗器械生物学评价 第1部分:评价与试验

GB/T 16886.1   Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

GB18278          医疗保健产品灭菌    确认和常规控制要求    工业湿热灭菌

GB 18278   Sterilization of health care products - Requirements for validation and routine control - Industrial moist heat sterilization

GB18279          医疗器械    环氧乙烷灭菌       确认和常规控制

GB 18279   Medical devices - Validation and routine control of ethylene oxide sterilization

GB18280          医疗保健产品的灭菌 确认和常规控制要求    辐射灭菌

GB 18280   Sterilization of health care products - Requirement for validation and routine control - Radiation sterilization

GB18457          制造医疗器械用不锈钢针管

GB 18457   Stainless steel needle tubing for the manufacture of medical devices

GB18671          一次性使用静脉输液针

GB 18671   Disposable intravenous needles

YY/T0243         一次性使用无菌注射器用活塞

YY/T 0243   Plunger seal of syringes for single use

YY/T0296         一次性使用注射针    识别色标

YY/T 0296   Hypodermic needles for single use - Color coding for identification

YY/T0466.1      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   Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 1: General requirements

ISO7864:1993   一次性使用无菌皮下注射针(Sterile hypodermic needles for single use)

ISO 7864:1993   Sterile hypodermic needles for single use

ISO8536-2        医用输液器具    第2 部分:输液瓶塞(Infusion equipment for medical use—Part2:

Closures for infusion bottles)