标准摘要
[中文适用范围]: ISO 9187 的这一部分规定了用于注射药品的三种形式的玻璃安瓿(B、C 和 D 型)的材料、尺寸、容量、性能和包装要求。 适用于带色环和不带色环的安瓿瓶;带有颜色断裂环的安瓿的提供以及断裂环颜色的选择须经制造商和用户之间的协议。 符合 ISO 9187 这一部分的安瓿仅供一次性使用。 [外文原描述]: ISO 9187-1:2010 specifies materials, dimensions, capacities, performance and packaging requirements for three forms of glass ampoule (forms B, C and D) for injectable pharmaceutical products. ISO 9187-1:2010 is applicable to ampoules with and without a colour break-ring; the provision of ampoules with a colour break-ring, and the choice of colour of the break-ring, is subject to agreement between the manufacturer and user. Ampoules complying with ISO 9187-1:2010 are intended for single use only.
英文名称Injection equipment for medical use — Part 1: Ampoules for injectables