一次性使用无菌皮下注射器检测

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

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（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）。

JJG 18-2008医用注射器检定规程

本规程适用于医用注射器的首次检定、后续检定和使用中检验。

YBB 0008-2004预灌封注射器用溴化丁基橡胶活塞

本标准适用于预灌封注射器用溴化丁基橡胶活塞。活塞类型为扣合式(PSL)或螺纹式(PT)。

YBB 0009-2004预灌封注射器用不锈钢注射针

本标准适用于组合在预灌封注射器玻璃针管上，用于人体皮内、皮下、肌肉、静脉等注射用的不锈钢注射针。

YBB 0011-2004预灌封注射器组合件(带注射针)

本标准适用于预灌封注射器组合件。组合件由玻璃针管、橡胶活塞、不锈钢注射针、针头护帽和推杆组成。

ISO 7864-2016一次性使用无菌皮下注射器.要求和试验方法

This International Standard specifies requirements for sterile hypodermic needles for single use of designated metric sizes 0,18 mm to 1,2 mm. It does not apply to those devices that are covered by their own standard such as dental needles and pen needles.

ISO 7886-3-2020一次性使用无菌皮下注射器. 第3部分: 固定剂量免疫接种用自动报废注射器

This document specifies the properties and performance of sterile single-use hypodermic syringes with an auto-disable syringe feature intended to deliver a fixed dose of vaccine immediately after filling. The syringes can be made of plastic, rubber or other materials and can be with or without needle and needle protection feature. This document does not specify the design of the auto-disable syringe feature. This document is not applicable to syringes for use with insulin (covered by ISO 8537), syringes for use with power-driven syringe pumps (covered by ISO 7886-2), reuse prevention syringes (covered by ISO 7886-4) or syringes designed to be prefilled (covered by the ISO 11040 series). It does not address compatibility with injection fluids/vaccines.    

US ISO 7886-1-2017一次性使用无菌皮下注射器.第1部分：手动注射器（第2版）

This Uganda Standard specifies requirements and test methods for verifying the design of empty sterile singleuse hypodermic syringes, with or without needle, made of plastic or other materials and intended for the aspiration and injection of fluids after filling by the end-users. This standard does not provide requirements for lot release. The syringes are primarily for use in humans. (This Uganda standard cancels and replaces US ISO 78861:1993, Sterile hypodermic syringes for single use - Part 1:Syringes for manual use, which has been technically revised).

US ISO 7886-2-1996一次性使用无菌皮下注射器第2部分：电动注射泵用注射器

This part of ISO 7886 specifies requirements for sterile Single-use hypodermic syringes of nominal capacity 5 ml and above, made of plastics materials and intended for use with power-driven Syringe Pumps. This part of ISO 7886 does not apply to syringes for use with insulin (specified in ISO 8537), Single-use syringes made of glass (specified in ISO 595), syringes prefilled with the injection by the manufacturer and syringes supplied with the injection as a kit for filling by a pharmaeist. lt does not address compatibility with injection fluids.

US ISO 7886-3-2005一次性使用无菌皮下注射器.第3部分：固定剂量免疫用自动禁用注射器

This part of ISO 7886 specifies the properties and performance of sterile single-use hypodermic syringes with or without needle, made of plastic materials and stainless steel and intended for the aspiration of vaccines or for the injection of vaccines immediately after filling. Upon delivering a fixed dose of vaccine, the syringe is automatically rendered unusable. This part of ISO 7886 does not specify the design of the auto-disable feature, which is left to the discretion of the manufacturer. This part of ISO 7886 is not applicable to syringes for use with insulin (specified in ISO 8537), syringes made of glass (specified in ISO 595), syringes for use with powerdriven syringe pumps (specified in ISO 7886-2), autodisable syringes for variable dose delivery and syringes designed to be prefilled. It does not address compatibility with injection fluids/vaccines.

US ISO 7886-4-2006一次性使用无菌皮下注射器第4部分：防止重复使用的注射器

This part of ISO 7886 specifies requirements for sterile single-use hypodermic syringes made of plastics materials with or without needle, and intended for the aspiration of fluids or for the injection of fluids immediately after filling and of design such that the syringe can be rendered unusable after use. This part of ISO 7886 is not applicable to syringes made of glass (specified in ISO 595), auto-disable syringes for fixed dose immunization (ISO 7886-3) and syringes designed to be pre-filled. It does not address compatibility with injection fluids. Other standards can be applicable when syringes are used for any other intended purpose than those specified in this part of ISO 7886.

EN ISO 7886-2-1997一次性使用无菌皮下注射器.第2部分:带动力驱动注射泵的注射器

This part of ISO 7886 specifies requirements for sterile single-use hypodermic syringes of nominal capacity 5 ml and above, made of plastics materials and intended for use with power-driven syringepumps.This part of ISO 7886 does not apply to syringes for use with insulin (specified in ISO 85371, single-use syringes made of glass (specified in ISO 595), syr-inges prefilled withThe injection byThe manufacturer and syringes supplied withThe injection as a kit forfilling by a pharmacist. It does not address compati-biiity with injection fluids.