一次性使用無菌皮下注射器檢測

一次性使用無菌皮下注射器檢測項目報價？??解決方案？??檢測周期？??樣品要求？

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GB/T 1962.1-2015注射器、注射針及其他醫療器械6%(魯爾)圓錐接頭 第1部分:通用要求

GB/T 1962的本部分規定了注射器、注射針及其他醫療器械6%（魯爾）圓錐接頭通用要求的尺寸、要求、試驗方法。本部分適用于剛性和半剛性的注射器、注射針及其他醫療器械（魯爾）圓錐接頭通用要求（以下簡稱圓錐接頭）。不適用于較柔軟的或彈性體材料制成的6%（魯爾）圓錐接頭。圖1所示的是典型的6%（魯爾）外圓錐接頭（外接頭）和6%（魯爾）內圓錐接頭（內接頭）。

JJG 18-2008醫用注射器檢定規程

本規程適用于醫用注射器的首次檢定、后續檢定和使用中檢驗。

YBB 0008-2004預灌封注射器用溴化丁基橡膠活塞

本標準適用于預灌封注射器用溴化丁基橡膠活塞。活塞類型為扣合式(PSL)或螺紋式(PT)。

YBB 0009-2004預灌封注射器用不銹鋼注射針

本標準適用于組合在預灌封注射器玻璃針管上，用于人體皮內、皮下、肌肉、靜脈等注射用的不銹鋼注射針。

YBB 0011-2004預灌封注射器組合件(帶注射針)

本標準適用于預灌封注射器組合件。組合件由玻璃針管、橡膠活塞、不銹鋼注射針、針頭護帽和推桿組成。

ISO 7864-2016一次性使用無菌皮下注射器.要求和試驗方法

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 7886-3-2020一次性使用無菌皮下注射器. 第3部分: 固定劑量免疫接種用自動報廢注射器

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 7886-1-2017一次性使用無菌皮下注射器.第1部分：手動注射器（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 7886-2-1996一次性使用無菌皮下注射器第2部分：電動注射泵用注射器

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 7886-3-2005一次性使用無菌皮下注射器.第3部分：固定劑量免疫用自動禁用注射器

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 7886-4-2006一次性使用無菌皮下注射器第4部分：防止重復使用的注射器

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 7886-2-1997一次性使用無菌皮下注射器.第2部分:帶動力驅動注射泵的注射器

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.