Prefilled syringes — Part 1: Glass cylinders for dental local anaesthetic cartridges
预填充注射器 - 第1部分:牙科局部麻醉药筒用玻璃瓶
发布日期:
2015-11-19
ISO 11040-1:2015规定了一次性使用的1.7 ml、1.8 ml和2.2 ml牙科局部麻醉药筒用玻璃瓶的设计、尺寸、材料、性能和试验方法。
注1:ISO 11499中描述了1.0毫升大小的药筒。
它适用于与药物直接接触的初级包装。
注2:药物在生产和储存期间的效力、纯度、稳定性和安全性可能会受到原包装的性质和性能的强烈影响。
ISO 11040-1:2015 specifies the design, dimensions, materials, performance and test methods for glass cylinders for dental local anaesthetic cartridges with a volume of 1,7 ml, 1,8 ml and 2,2 ml intended for single use only.
NOTE 1 Cartridges of 1,0 ml size are described in ISO 11499.
It applies to primary packs used in direct contact with a drug.
NOTE 2 The potency, purity, stability and safety of a drug during its manufacture and storage can be strongly affected by the nature and performance of the primary pack.