模制玻璃注射瓶检测

GB/T 19381-2015丁基橡胶药用瓶塞物理性能要求与测试

本标准规定了与药瓶配套用的丁基橡胶药用瓶塞受到注射针或输液穿刺器穿刺时的物理性能指标要求和测试方法。本标准适用于丁基橡胶药用瓶塞。

ISO 8362-4-2011注射容器和附件.第4部分:模制玻璃注射瓶

This part of ISO 8362 specifies the shape, dimensions and\ncapacities of glass vials for injectable preparations. It also\nspecifies the material from which such containers are made and the\nperformance requirements for the containers.\nIt applies to colourless or amber glass containers moulded from\nborosilicate or soda-lime-silica glass, with or without an internal\nsurface treatment, and intended to be used in the packaging,\nstorage or transportation of products intended for injection.

EN ISO 8362-1-2009注射容器和附件.第1部分:玻璃管制注射管

This part of ISO 8362 specifies the form, dimensions and capacities of glass vials for injectable preparations. It also specifies the material from which such containers shall be made and the performance requirements of those containers.

NF S93-110-4-2011注射容器和附件.第4部分:模制玻璃注射瓶

La présente partie de l'ISO 8362 spécifie la forme, les dimensions et les capacités des flacons en verre pour préparation injectable. Elle spécifie également le matériau constitutif et les exigences auxquelles ces flacons doivent répondre.Elle s'applique aux flacons en verre blanc ou ambré, moulés en verre borosilicaté ou sodocalcique, avec une surface interne traitée ou non, conçus pour l'emballage, le stockage ou le transport de produits injectables.

DIN EN ISO 7864-2016一次性使用无菌皮下注射器.要求和试验方法(ISO 7864-2016).德文版本EN ISO 7864-2016

The document 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.

DIN EN ISO 8362-4-2011注射容器及附件.第4部分:模压玻璃制成的注射液瓶(ISO 8362-4-2011).德文版 EN ISO 8362-4-2011

This standard specifies the form, dimensions and capacities of glass vials made of moulded glass for injectable preparations. It also specifies the material from which such containers shall be made and the performance requirements of those containers.

DIN EN ISO 8362-5-2016注射容器及附件.第5部分:注射小瓶用冷冻干燥瓶塞(ISO 8362-5-2016).德文版本EN ISO 8362-5-2016

This part of EN ISO 8362 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for injection vials, as described in ISO 8362-1 and ISO 8362-4, which is used in connection with the freeze drying (or lyophilization) of drugs and biological materials.The dimensional requirements are not applicable to barrier-coated closures. Closures specified in this part of ISO 8362 are intended for single use only.

DIN EN ISO 8362-6-2011注射剂用注射容器及附件.第6部分:铝塑组合注射瓶盖(ISO 8362-6-2010).德文版本EN ISO 8362-6-2011

This part of ISO 8362 specifies caps made of aluminium-plastics combinations for injection vilas as specified in ISO 8362-1 and ISO 8362-4.

DIN EN ISO 8362-7-2011注射容器及附件.第7部分:无缘凸铝塑料组合注射瓶盖(ISO 8362-7-2006);德文版本EN ISO 8362-7-2010

The document specifies aluminium-plastics combinations for the injection caps of injection vials as specified in ISO 8362-1 and ISO 8362-4 where the plastics part does not overlap the diameter of the vial body.

DIN EN ISO 8871-5-2017非肠道和制药设备用弹性件.第5部分:功能要求和试验(ISO 8871-5-2016);德文版本EN ISO 8871-5-2016

This part of ISO 8871 specifies requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle.

DIN ISO 4802-1-2017玻璃器皿.玻璃容器内表面耐水解作用.第1部分:滴定法和分类法测定(ISO 4802-1-2016)

This part of ISO 4802 specifies: a) a method for determining the hydrolytic resistance of the interior surfaces of glass containers when subjected to attack by water at 121 °C ± 1 °C for 60 min ± 1 min. The resistance is measured by titration of a known aliquot portion of the extraction solution produced with hydrochloric acid solution, in which case the resistance is inversely proportional to the volume of acid required; b) a classification of glass containers according to the hydrolytic resistance of the interior surfaces determined by the methods specified in this part of ISO 4802.

DIN ISO 4802-2-2017玻璃器皿.玻璃容器内表面耐水解作用.第2部分:利用火焰光谱分析和分类法测定(ISO 4802-2-2016)

This part of ISO 4802 specifies: a) methods for determining the hydrolytic resistance of the interior surfaces of glass containers when subjected to attack by water at (121 ± 1) °C for (60 ± 1) min. The resistance is measured by determining the amount of sodium and other alkali metal or alkaline earth oxides in the extraction solution using flame atomic emission or absorption spectrometry (flame spectrometry); b) a classification of glass containers according to the hydrolytic resistance of the interior surfaces determined by the methods specified in this part of ISO 4802. The test method specified in this part of ISO 4802 might not be applicable to containers whose surfaces have been treated with silicon (e. g. containers that are ready for direct filling).

KS P ISO 8362-4-2014注射容器和附件.第4部分:模制玻璃注射瓶

이 표준은 주사용 유리 바이알의 모양, 치수 및 용량에 대하여 규정한다. 또한, 이 표준은 이런 용기를 만드는 재료와 용기의 성능에 대한 요구사항에 대해서도 규정한다.이 표준은, 내부 표면처리에 관계없이, 주사용 약품의 포장, 보관 및 운반의 목적으로 사용되는 붕규산 또는 소다-석회 유리를 성형한 무색 또는 황갈색 유리 용기에 적용한다.